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CALDERWOOD & HARKNESS LLP Attorneys at Law

1401 K Street NW, Suite 900 Washington, D.C. 20005

Telephone: (202) 555-7100 Facsimile: (202) 555-7199 www.calderwoodharkness.com

Document Reference: 1037-00002

April 30, 2026

[Date to be confirmed upon final submission]

Food and Drug Administration Center for Devices and Radiological Health (CDRH) Document Mail Center — WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Re: 510(k) Premarket Notification — Solstice Lumina™ CGM System (Lumina C14 Implantable Sensor and Lumina R7 Wearable Reader/Transmitter)

Submission Type: Traditional 510(k)

Dear Sir or Madam:

On behalf of Solstice Biomedical Inc., we respectfully submit the enclosed Traditional 510(k) Premarket Notification for the Solstice Lumina™ Continuous Glucose Monitoring (CGM) System, consisting of the Lumina C14 Implantable Sensor and the Lumina R7 Wearable Reader/Transmitter, seeking clearance to market the device in the United States. The following cover letter provides a summary of the key information contained in this submission and is organized in accordance with FDA guidance on the content and format of 510(k) submissions.

1. Identification of Applicant

The applicant and intended 510(k) holder for this submission is:

Solstice Biomedical Inc. A Delaware corporation (File No. 7834291) 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States of America

Solstice Biomedical Inc. is the wholly owned U.S. subsidiary of Solstice Biomedical Devices Ltd., a private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), with its principal offices located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. Solstice Biomedical Inc. serves as the U.S. agent for the device and, upon clearance, will be the entity of record as the 510(k) holder and the entity responsible for marketing, distribution, and post-market activities related to the Solstice Lumina™ CGM System in the United States.

Contact Person for FDA Correspondence (Primary):

Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: [To be inserted]

Email: [To be inserted]

Regulatory Affairs Contact:

Dr. Niamh Tierney Vice President of Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72, Ireland Telephone: [To be inserted]

Email: [To be inserted]

Authorized Representative and Legal Counsel:

Miriam Calloway, Partner Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: [To be inserted]

Email: [To be inserted]

Ms. Calloway is authorized to act on behalf of Solstice Biomedical Inc. in all matters pertaining to this 510(k) submission, including receipt and response to communications from the Center for Devices and Radiological Health.

2. Device Identification

Trade/Proprietary Name: Solstice Lumina™ CGM System

Common/Usual Name: Continuous Glucose Monitoring System

The Solstice Lumina™ CGM System is a two-component continuous glucose monitoring system designed to provide real-time, continuous measurement of interstitial glucose concentrations. Both device variants described below are submitted under a single 510(k) premarket notification as an integrated system. The system is intended for use only when the two components are used together as described in the proposed labeling.

Device Variants Covered by This Submission:

a. Lumina C14 — Implantable Continuous Glucose Monitoring Sensor

The Lumina C14 is a subcutaneously implantable continuous glucose monitoring sensor designed for a maximum wear duration of fourteen (14) days (336 hours). The sensor employs a fourth-generation enzymatic electrochemical biosensor architecture incorporating Solstice Biomedical's proprietary platinum-iridium electrode coating, designated as PtIr-4G technology. The PtIr-4G electrode coating is engineered to enhance signal stability and reduce electrode fouling over the extended fourteen-day wear period. The C14 sensor is inserted into the subcutaneous tissue of the posterior upper arm via a single-use, spring-loaded applicator device (included in the sensor kit). Once inserted, the sensor continuously measures glucose concentrations in the interstitial fluid and transmits measurement data wirelessly to the Lumina R7 reader/transmitter via Bluetooth Low Energy (BLE) 5.2 protocol. The sensor is factory calibrated and does not require fingerstick blood glucose calibration by the user during normal operation.

b. Lumina R7 — Wearable Reader/Transmitter

The Lumina R7 is a compact, wearable reader/transmitter device designed to be worn on the upper arm in close proximity to the implanted C14 sensor. The R7 receives real-time glucose data from the C14 sensor via BLE 5.2 wireless communication. The device features an integrated display screen capable of presenting real-time glucose values, directional trend arrows indicating the rate and direction of glucose change, and eight (8)-hour trend graphs. The R7 is equipped with configurable audible and vibratory alerts for hypoglycemia and hyperglycemia threshold excursions, as well as rapid rate-of-change alerts. In addition to its standalone display functionality, the R7 communicates glucose data to the Solstice Lumina™ mobile application, which is compatible with both iOS (version 15.0 and later) and Android (version 12.0 and later) operating systems. The mobile application provides extended data visualization, glucose history, reporting features, and optional data sharing with healthcare providers.

Key System Specifications:

Both the Lumina C14 Implantable Sensor and the Lumina R7 Wearable Reader/Transmitter are submitted together as a single integrated CGM system under this Traditional 510(k) submission. The system is not intended for use with any third-party sensor or reader components.

3. Device Classification

The Solstice Lumina™ CGM System is classified as follows:

The applicant notes that the applicable classification for subcutaneous continuous glucose monitoring electrodes (Product Code QKQ) was established pursuant to a reclassification order issued by FDA, the final rule for which became effective in March 2024. This reclassification confirmed the classification of integrated continuous glucose monitoring systems as Class II devices subject to Special Controls, enabling review under the Traditional 510(k) pathway. The special controls applicable to devices classified under Product Code QKQ include, among other things, clinical performance testing demonstrating analytical and clinical accuracy, biocompatibility evaluation, software verification and validation, wireless technology performance testing, electromagnetic compatibility testing, and appropriate labeling. The applicant has addressed each of the applicable special controls in the body of this submission, as summarized in Section 7 below and detailed in the enclosed submission volumes.

4. Predicate Devices

4.1 Primary Predicate Device

The primary predicate device for purposes of this 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System, identified as follows:

Device Name: NovaSense GlucoTrack NX-500 CGM System 510(k) Number: K211034 Date of Clearance: June 18, 2022 Manufacturer: NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 Product Code: QKQ Device Class: Class II

The NovaSense GlucoTrack NX-500 is a continuous glucose monitoring system consisting of a subcutaneous enzymatic electrochemical sensor with a ten (10)-day wear duration and a handheld receiver that communicates with the sensor via Bluetooth Low Energy wireless transmission. The NX-500 was cleared for use by adults (age 18 and older) with Type 1 or Type 2 diabetes mellitus for diabetes treatment decisions, including insulin dosing, without the need for confirmatory fingerstick blood glucose testing. The NX-500 shares the same product code (QKQ), regulatory classification (21 C.F.R. § 862.1355), and intended use as the subject Solstice Lumina™ CGM System. The applicant has identified the NX-500 as the primary predicate because it most closely represents the same type of device with the same intended use, employing a substantially equivalent technological architecture (enzymatic electrochemical glucose sensing with BLE wireless data transmission to an external reader device).

4.2 Secondary Predicate (Reference Device)

The applicant identifies the following device as a secondary predicate (reference device) for purposes of supporting the substantial equivalence comparison, particularly with respect to the extended fourteen (14)-day sensor wear duration and enhanced wireless communication features:

Device Name: NovaSense GlucoTrack NX-700 CGM System 510(k) Number: K230489 Date of Clearance: March 7, 2024 Manufacturer: NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 Product Code: QKQ Device Class: Class II

The NovaSense GlucoTrack NX-700 is the successor model to the NX-500, cleared for the same intended use population and indications. The NX-700 features an extended fourteen (14)-day sensor wear duration (compared to the NX-500's ten-day wear duration), enhanced BLE 5.0 wireless transmission, and an updated glucose estimation algorithm. The applicant references the NX-700 to demonstrate that the fourteen-day wear duration and enhanced BLE communication featured in the Solstice Lumina™ CGM System are consistent with characteristics already reviewed and cleared by FDA in a device sharing the same product code and intended use.

4.3 Additional Reference (Corporate Pedigree)

Device Name: Solstice GlucoStrip RX-200 Test Strip Reader 510(k) Number: K192847 Date of Clearance: November 14, 2019 Manufacturer: Solstice Biomedical Inc., Cambridge, MA Product Code: NBW Device Class: Class II

The Solstice GlucoStrip RX-200 is referenced herein solely for purposes of establishing Solstice Biomedical Inc.'s prior history of successful FDA regulatory interaction and the company's corporate regulatory pedigree in the glucose monitoring device space. The RX-200 is not cited as a predicate device for purposes of the substantial equivalence determination for the Solstice Lumina™ CGM System, as it is a point-of-care blood glucose test strip reader (Product Code NBW) and does not share the same technological characteristics or product code as the subject device.

5. Intended Use / Indications for Use

The intended use and indications for use of the Solstice Lumina™ CGM System are as follows:

The Solstice Lumina™ CGM System is a prescription-use (Rx only) continuous glucose monitoring system intended for the continuous monitoring of glucose levels in the interstitial fluid of persons aged eighteen (18) years and older with Type 1 or Type 2 diabetes mellitus. The system is intended to replace fingerstick blood glucose testing for diabetes treatment decisions, including but not limited to insulin dosing decisions. The system measures glucose concentrations over a measurement range of 40 to 400 mg/dL.

The Lumina C14 sensor is designed for a maximum wear duration of fourteen (14) days (336 hours) per sensor. After the fourteen-day wear period, the sensor must be removed and replaced with a new sensor.

The Solstice Lumina™ CGM System is intended for use by patients as an aid in the management of diabetes. The system is not intended for use in critically ill patients, during surgical procedures, or as a substitute for laboratory glucose testing for the diagnosis of diabetes. The system is not intended for use in pediatric patients (under 18 years of age).

A completed FDA Form 3881 (Indications for Use Statement) is enclosed with this submission as part of the submission package. The indications for use set forth on Form 3881 are consistent with the indications described in this cover letter and the enclosed proposed labeling.

6. Summary of Substantial Equivalence Argument

The applicant submits that the Solstice Lumina™ CGM System is substantially equivalent to the primary predicate device, the NovaSense GlucoTrack NX-500 CGM System (510(k) No. K211034), and the secondary predicate device, the NovaSense GlucoTrack NX-700 CGM System (510(k) No. K230489). The subject device and the predicate devices share the same intended use, the same patient population, the same general technological characteristics (enzymatic electrochemical subcutaneous glucose sensing with wireless data transmission to an external reader device), and the same product code and regulatory classification.

The applicant has identified the following five (5) key technological differences between the Solstice Lumina™ CGM System and the primary predicate device (K211034):

1. Sensor Wear Duration. The Lumina C14 sensor supports a fourteen (14)-day wear duration, compared to the ten (10)-day wear duration of the primary predicate (NovaSense NX-500). The applicant notes that the secondary predicate device (NovaSense NX-700, K230489) has been cleared with an equivalent fourteen-day wear duration, confirming that this extended duration has been reviewed and found acceptable by FDA for devices of the same type and intended use.

2. Electrode Material. The Lumina C14 sensor employs a proprietary platinum-iridium (PtIr-4G) electrode coating, whereas the primary predicate utilizes a platinum electrode. The platinum-iridium alloy provides enhanced signal stability and extended electrode longevity without altering the fundamental electrochemical sensing mechanism. Biocompatibility testing of the PtIr-4G electrode material has been conducted in accordance with the ISO 10993 series, and results are enclosed in this submission.

3. Bluetooth Low Energy (BLE) Version. The Lumina System utilizes BLE 5.2 for wireless communication between the C14 sensor and the R7 reader, whereas the primary predicate utilizes BLE 5.0. BLE 5.2 is a backwards-compatible evolution of the BLE standard offering improved power efficiency and connection stability. The upgrade in BLE version does not alter the fundamental method of wireless data transmission or raise new safety or effectiveness concerns. Wireless performance testing data, including electromagnetic compatibility (EMC) testing, is enclosed.

4. Reader Form Factor. The Lumina R7 reader/transmitter is designed as an arm-worn wearable device, whereas the primary predicate employs a handheld receiver. Both devices perform the same function of receiving, processing, and displaying glucose data transmitted from the implanted sensor. The change in form factor does not alter the technological characteristics related to glucose measurement or data display and does not raise new questions of safety or effectiveness.

5. Proprietary Glucose Estimation Algorithm. The Lumina System uses Solstice Biomedical's proprietary LuminaPredict algorithm (version 2.1) for glucose estimation and trend prediction, whereas the primary predicate uses NovaSense's proprietary algorithm. Both algorithms perform the same function of converting raw electrochemical sensor signals into glucose concentration values. Software verification, validation, and lifecycle documentation for the LuminaPredict algorithm are enclosed, prepared in accordance with IEC 62304 and applicable FDA guidance.

The applicant submits that none of the above-identified technological differences raise new questions of safety or effectiveness that cannot be resolved through the data and information provided in this submission. The enclosed performance data demonstrates that the Solstice Lumina™ CGM System meets or exceeds the analytical and clinical accuracy performance of the predicate devices. Specifically, the clinical study data demonstrate a Mean Absolute Relative Difference (MARD) of ≤ 9.0% across the measurement range (40–400 mg/dL), and ≥ 99% of paired data points fall within Zones A and B of the Clarke Error Grid Analysis. These results confirm that the Solstice Lumina™ CGM System provides glucose measurement accuracy that is at least as good as that demonstrated by the predicate devices.

A detailed Substantial Equivalence Comparison Table, providing a feature-by-feature comparison of the subject device against both the primary and secondary predicate devices, is enclosed in the submission package.

7. Summary of Submission Contents

The following documents and materials are enclosed as part of this 510(k) submission:

1. CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)

2. Indications for Use Statement (FDA Form 3881)

3. 510(k) Summary prepared in accordance with 21 C.F.R. § 807.92

4. Truthful and Accurate Statement in accordance with 21 C.F.R. § 807.87(j)

5. Class III Summary and Certification — Not Applicable. The Solstice Lumina™ CGM System is a Class II device (Product Code QKQ). This section is included in the submission index for completeness and is marked as not applicable.

6. Financial Certification / Disclosure Statement prepared in accordance with 21 C.F.R. Part 54, including financial disclosure information for all clinical investigators participating in Protocol SBD-LUM-CL-001 ("LUMINA-US")

7. Declarations of Conformity and Summary Reports for applicable recognized consensus standards, including but not limited to ISO 10993, IEC 62304, IEC 60601-1, IEC 62133, and ISO 14971

8. Executive Summary providing an overview of the device, its intended use, the substantial equivalence rationale, and a summary of testing and clinical data

9. Device Description including detailed technical specifications, drawings, photographs, principles of operation, system architecture diagrams, and descriptions of the Lumina C14 sensor, Lumina R7 reader, sensor applicator, and Lumina mobile application

10. Substantial Equivalence Comparison including detailed feature-by-feature comparison tables mapping the subject device against the primary predicate (K211034) and secondary predicate (K230489), with analysis of similarities and differences

11. Proposed Labeling including Instructions for Use (IFU), package labeling, physician labeling (prescribing information), Quick Start Guide, and screenshots of the Lumina mobile application user interface

12. Sterilization and Shelf Life documentation, including sterilization validation reports for the Lumina C14 sensor (ethylene oxide sterilization) and accelerated and real-time shelf life stability data

13. Biocompatibility — Test reports prepared in accordance with the ISO 10993 series of standards for biological evaluation of medical devices. Biocompatibility testing was performed by Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01, accredited to ISO/IEC 17025) and covers cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility evaluations for all patient-contacting materials

14. Software Documentation including software description, software requirements specification overview, software architecture overview, IEC 62304 software development lifecycle documentation (Level of Concern: Major), Software Bill of Materials (SBOM), hazard analysis, software verification and validation reports, and cybersecurity documentation prepared in accordance with the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 2023), including Threat Modeling, Security Risk Assessment, Cybersecurity Bill of Materials (CBOM), and Software Architecture Diagrams

15. Electromagnetic Compatibility (EMC) and Electrical Safety Data including test reports for compliance with IEC 60601-1 (general requirements for safety), IEC 60601-1-2 (electromagnetic disturbances), and applicable wireless coexistence testing per FDA guidance

16. Performance Testing Data — Bench Testing including analytical accuracy (sensor accuracy vs. YSI reference), linearity, precision (repeatability and reproducibility), interference testing (common interferents including acetaminophen, ascorbic acid, uric acid, and others), temperature performance, altitude performance, and response time testing

17. Clinical Data — Results from Protocol SBD-LUM-CL-001 ("LUMINA-US"), a prospective, single-arm, multicenter clinical study enrolling three hundred fifty (350) adult subjects (175 with Type 1 diabetes and 175 with Type 2 diabetes) at six (6) U.S. clinical sites. The study was conducted by Veltrano Clinical Research Organization Inc. Clinical data include accuracy analysis (MARD, Clarke Error Grid Analysis, Consensus Error Grid Analysis), safety analysis (adverse events, device-related adverse events, serious adverse events), and sensor survival analysis. The clinical study report is included in its entirety.

18. Risk Analysis including a comprehensive risk management file prepared in accordance with ISO 14971:2019, encompassing hazard identification, risk estimation, risk evaluation, risk control, evaluation of residual risk, and risk management review. The risk analysis covers all identified hazards associated with the Lumina C14 sensor, Lumina R7 reader, sensor applicator, mobile application, and the integrated system.

8. Regulatory History and International Certifications

Solstice Biomedical Devices Ltd. (the parent company of the applicant) maintains a certified quality management system in compliance with ISO 13485:2016 ("Medical devices — Quality management systems — Requirements for regulatory purposes"). The ISO 13485:2016 certificate was issued by Meridian Conformity Assessment GmbH, a Notified Body designated under Notified Body Identification Number 0483, with offices at Landsberger Allee 44, 10249 Berlin, Germany. The current certificate covers the design, development, manufacture, and distribution of continuous glucose monitoring systems and in vitro diagnostic glucose monitoring devices, including the Solstice Lumina™ CGM System. A copy of the current ISO 13485:2016 certificate is included in the enclosed Declarations of Conformity.

The Solstice Lumina™ CGM System has received CE certification under the European Union Medical Device Regulation (EU MDR 2017/745). The EU MDR CE certificate was issued by Meridian Conformity Assessment GmbH (NB 0483) under Certificate No. MCA-2024-07319, dated September 12, 2024. The Lumina CGM System has been commercially available in the European Union since September 2024 and, as of the date of this submission, is marketed and distributed in fourteen (14) EU member states. No field safety corrective actions, recalls, or safety alerts have been issued in connection with the Lumina CGM System in any jurisdiction.

The applicant further notes its prior regulatory history with the U.S. Food and Drug Administration. Solstice Biomedical Inc. previously obtained 510(k) clearance for the Solstice GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019). While the RX-200 is not cited as a predicate for the present submission, this prior clearance demonstrates the applicant's established track record of successful FDA regulatory engagement and compliance with U.S. medical device regulatory requirements.

9. User Fee Information

In accordance with the Medical Device User Fee Amendments (MDUFA), the applicant has submitted the applicable 510(k) standard review user fee for fiscal year 2025. The relevant user fee details are as follows:

FY2025 510(k) Standard Review User Fee: $22,417

Payment Method: Submitted via Pay.gov

Payment Confirmation Number: [To be inserted upon confirmation of payment]

Date of Payment: [To be inserted]

The applicant notes that Solstice Biomedical Inc. does not qualify for the small business user fee exemption or reduced fee under MDUFA. The consolidated global revenue of the applicant's parent entity, Solstice Biomedical Devices Ltd., for the most recently completed fiscal year was approximately €187.4 million (equivalent to approximately $204.3 million at an exchange rate of €1.00 = $1.09), which exceeds the applicable revenue threshold for small business qualification under the MDUFA user fee provisions. Accordingly, the full standard review fee has been remitted.

10. Establishment Registration

Solstice Biomedical Inc. (Delaware corporation, File No. 7834291) is registered as a medical device establishment with the U.S. Food and Drug Administration in accordance with the requirements of 21 C.F.R. Part 807, Subpart B. The establishment registration is maintained through the FDA Unified Registration and Listing System (FURLS).

Establishment Registration Number: [To be inserted]

FURLS Owner/Operator Number: [To be inserted]

Registration Status: Active

The applicant's establishment registration and device listing information will be updated to include the Solstice Lumina™ CGM System upon receipt of 510(k) clearance, in accordance with applicable regulatory requirements.

11. Pre-Submission History

The applicant engaged in a Pre-Submission (Q-Sub) interaction with FDA's Center for Devices and Radiological Health prior to the preparation and filing of this 510(k) submission. The Pre-Submission was directed to the Office of Health Technology 2 (OHT2), Division of Chemistry and Toxicology Devices, which is the reviewing division for devices classified under Product Code QKQ.

The key milestones of the Pre-Submission interaction are summarized below:

• Pre-Submission Meeting Request Submitted: June 2, 2025

• Pre-Submission Meeting Package Submitted: June 16, 2025

• Pre-Submission Meeting Held: August 14, 2025 (teleconference with FDA review team)

During the Pre-Submission meeting, the applicant presented its proposed regulatory strategy for the Solstice Lumina™ CGM System, including the selection of predicate devices, the proposed indications for use, the clinical study design (Protocol SBD-LUM-CL-001), the approach to software documentation and cybersecurity, and the proposed analytical performance testing plan. The applicant received feedback from the FDA review team on each of these topics.

This 510(k) submission has been prepared consistent with the feedback and recommendations received from FDA during the August 14, 2025 Pre-Submission meeting. The Pre-Submission meeting minutes, as issued by FDA, are referenced in the submission package for the convenience of the reviewing division.

12. Software Version Information

The following software and firmware versions are the subject of this 510(k) submission:

All software verification, validation, and lifecycle documentation enclosed in this submission correspond to the software versions identified above. The Software Bill of Materials (SBOM) and Cybersecurity Bill of Materials (CBOM) enclosed herein reflect the complete list of software components, open-source libraries, and third-party software modules incorporated in the above-listed software versions.

13. Authorized Representative / Contact for FDA Correspondence

All FDA correspondence regarding this 510(k) submission, including Requests for Additional Information (AI), deficiency letters, determination letters, and other communications, should be directed to the following contacts:

Primary Contact:

Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: [To be inserted]

Email: [To be inserted]

With a copy to:

Miriam Calloway, Partner Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: [To be inserted]

Email: [To be inserted]

And to:

Dr. Niamh Tierney Vice President of Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72, Ireland Telephone: [To be inserted]

Email: [To be inserted]

The applicant requests that all correspondence be sent to each of the three contacts identified above to ensure timely receipt and response. The applicant further consents to the receipt of correspondence via electronic mail at the email addresses listed above, in addition to any correspondence sent by U.S. mail or courier.

14. Truthful and Accurate Statement

In accordance with the requirements of 21 C.F.R. § 807.87(j), the undersigned hereby certifies, on behalf of the applicant Solstice Biomedical Inc., that the applicant believes, to the best of its knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted. The undersigned further certifies that the applicant is aware that any material misstatement, misrepresentation, or omission of a material fact in a premarket notification may subject the person or entity making such statement to criminal and/or civil liability under federal law, including but not limited to 18 U.S.C. § 1001 and 21 U.S.C. § 331.

15. Signature block

We respectfully request that the Center for Devices and Radiological Health review this submission and issue a determination of substantial equivalence for the Solstice Lumina™ CGM System. We are available to provide any additional information that may be required to facilitate the review and welcome the opportunity to discuss this submission with the review team at the Agency's convenience.

Respectfully submitted,

SOLSTICE BIOMEDICAL INC.

By: ________

Name: Marcus Hale

Title: Vice President of U.S. Operations

Date: ________

SOLSTICE BIOMEDICAL DEVICES LTD.

By: ________

Name: Dr. Niamh Tierney

Title: Vice President of Regulatory Affairs

Date: ________

16. Enclosures

The following enclosures accompany this 510(k) submission. The submission is organized into four (4) bound volumes and one (1) electronic copy (eCopy), as indicated below:

Total Physical Volumes: 4

eCopy: One (1) electronic copy (eCopy) of the complete submission is enclosed on USB flash drive, formatted in accordance with FDA eCopy guidance. The eCopy contains the complete contents of Volumes I through IV in searchable PDF format, with a submission-level table of contents and hyperlinked bookmarks.

CONFIDENTIAL — This cover letter and the accompanying submission materials contain confidential business information and trade secrets of Solstice Biomedical Inc. and Solstice Biomedical Devices Ltd. The applicant requests that such information be treated as confidential in accordance with 21 C.F.R. Part 20 and applicable exemptions under the Freedom of Information Act, 5 U.S.C. § 552. Any public disclosure of the contents of this submission should be limited to the 510(k) Summary prepared in accordance with 21 C.F.R. § 807.92.

DRAFT — Prepared by Calderwood & Harkness LLP for Solstice Biomedical Inc. — Engagement Reference No. 1037-00002 — Subject to Revision

Parameter	Specification
Measurement Range	40–400 mg/dL
Sensor Wear Duration	14 days (336 hours)
Warm-Up Time	≤ 60 minutes
Alert Latency	≤ 5 minutes
Wireless Protocol	Bluetooth Low Energy (BLE) 5.2
Calibration	Factory calibrated (no user calibration required)
Classification Parameter	Detail
Product Code	QKQ
Product Code Description	Electrode, Glucose, Subcutaneous
Regulation Number	21 C.F.R. § 862.1355
Regulation Description	Glucose test system
Device Class	Class II
Review Panel	Clinical Chemistry
Component	Software/Firmware Version
Lumina C14 Sensor Firmware	v3.4.2
Lumina R7 Reader Operating System	v2.1.0
LuminaPredict Glucose Estimation Algorithm	v2.1
Lumina Mobile Application (iOS and Android)	v1.0.3
Enclosure No.	Description	Volume
1	CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)	I
2	Indications for Use Statement (FDA Form 3881)	I
3	510(k) Summary (per 21 C.F.R. § 807.92)	I
4	Truthful and Accurate Statement (21 C.F.R. § 807.87(j))	I
5	Class III Summary and Certification — N/A (Class II device)	I

6	Financial Certification / Disclosure Statement (21 C.F.R. Part 54)	I
7	Declarations of Conformity and Summary Reports	I
8	Executive Summary	I
9	Device Description	II
10	Substantial Equivalence Comparison	II
11	Proposed Labeling (IFU, Package Labeling, Physician Labeling, Quick Start Guide, Mobile App Screenshots)	II
12	Sterilization and Shelf Life Documentation	II
13	Biocompatibility — ISO 10993 Test Reports (Whitmore Laboratories Inc., A2LA Cert. No. 3847.01)	III
14	Software Documentation (IEC 62304 Lifecycle, SBOM, Cybersecurity per FDA Sept. 2023 Guidance)	III
15	Electromagnetic Compatibility (EMC) and Electrical Safety Data	III
16	Performance Testing Data — Bench Testing (Accuracy, Linearity, Precision, Interference)	IV
17	Clinical Data — Protocol SBD-LUM-CL-001 ("LUMINA-US"), 350 Subjects, 6 U.S. Sites (Veltrano CRO Inc.)	IV
18	Risk Analysis (ISO 14971:2019)	IV

CALDERWOOD & HARKNESS LLP Attorneys at Law
1401 K Street NW, Suite 900 Washington, D.C. 20005
Telephone: (202) 555-7100 Facsimile: (202) 555-7199 www.calderwoodharkness.com
Document Reference: 1037-00002
April 30, 2026
[Date to be confirmed upon final submission]
Food and Drug Administration Center for Devices and Radiological Health (CDRH) Document Mail Center — WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Re: 510(k) Premarket Notification — Solstice Lumina™ CGM System (Lumina C14 Implantable Sensor and Lumina R7 Wearable Reader/Transmitter)
Submission Type: Traditional 510(k)
Dear Sir or Madam:
On behalf of Solstice Biomedical Inc., we respectfully submit the enclosed Traditional 510(k) Premarket Notification for the Solstice Lumina™ Continuous Glucose Monitoring (CGM) System, consisting of the Lumina C14 Implantable Sensor and the Lumina R7 Wearable Reader/Transmitter, seeking clearance to market the device in the United States. The following cover letter provides a summary of the key information contained in this submission and is organized in accordance with FDA guidance on the content and format of 510(k) submissions.
1. Identification of Applicant
The applicant and intended 510(k) holder for this submission is:
Solstice Biomedical Inc. A Delaware corporation (File No. 7834291) 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States of America
Solstice Biomedical Inc. is the wholly owned U.S. subsidiary of Solstice Biomedical Devices Ltd., a private limited company incorporated under the laws of Ireland (Companies Registration Office No. 648231), with its principal offices located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland. Solstice Biomedical Inc. serves as the U.S. agent for the device and, upon clearance, will be the entity of record as the 510(k) holder and the entity responsible for marketing, distribution, and post-market activities related to the Solstice Lumina™ CGM System in the United States.
Contact Person for FDA Correspondence (Primary):
Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: [To be inserted]
Email: [To be inserted]
Regulatory Affairs Contact:
Dr. Niamh Tierney Vice President of Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72, Ireland Telephone: [To be inserted]
Email: [To be inserted]
Authorized Representative and Legal Counsel:
Miriam Calloway, Partner Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: [To be inserted]
Email: [To be inserted]
Ms. Calloway is authorized to act on behalf of Solstice Biomedical Inc. in all matters pertaining to this 510(k) submission, including receipt and response to communications from the Center for Devices and Radiological Health.
2. Device Identification
Trade/Proprietary Name: Solstice Lumina™ CGM System
Common/Usual Name: Continuous Glucose Monitoring System
The Solstice Lumina™ CGM System is a two-component continuous glucose monitoring system designed to provide real-time, continuous measurement of interstitial glucose concentrations. Both device variants described below are submitted under a single 510(k) premarket notification as an integrated system. The system is intended for use only when the two components are used together as described in the proposed labeling.
Device Variants Covered by This Submission:
a. Lumina C14 — Implantable Continuous Glucose Monitoring Sensor
The Lumina C14 is a subcutaneously implantable continuous glucose monitoring sensor designed for a maximum wear duration of fourteen (14) days (336 hours). The sensor employs a fourth-generation enzymatic electrochemical biosensor architecture incorporating Solstice Biomedical's proprietary platinum-iridium electrode coating, designated as PtIr-4G technology. The PtIr-4G electrode coating is engineered to enhance signal stability and reduce electrode fouling over the extended fourteen-day wear period. The C14 sensor is inserted into the subcutaneous tissue of the posterior upper arm via a single-use, spring-loaded applicator device (included in the sensor kit). Once inserted, the sensor continuously measures glucose concentrations in the interstitial fluid and transmits measurement data wirelessly to the Lumina R7 reader/transmitter via Bluetooth Low Energy (BLE) 5.2 protocol. The sensor is factory calibrated and does not require fingerstick blood glucose calibration by the user during normal operation.
b. Lumina R7 — Wearable Reader/Transmitter
The Lumina R7 is a compact, wearable reader/transmitter device designed to be worn on the upper arm in close proximity to the implanted C14 sensor. The R7 receives real-time glucose data from the C14 sensor via BLE 5.2 wireless communication. The device features an integrated display screen capable of presenting real-time glucose values, directional trend arrows indicating the rate and direction of glucose change, and eight (8)-hour trend graphs. The R7 is equipped with configurable audible and vibratory alerts for hypoglycemia and hyperglycemia threshold excursions, as well as rapid rate-of-change alerts. In addition to its standalone display functionality, the R7 communicates glucose data to the Solstice Lumina™ mobile application, which is compatible with both iOS (version 15.0 and later) and Android (version 12.0 and later) operating systems. The mobile application provides extended data visualization, glucose history, reporting features, and optional data sharing with healthcare providers.
Key System Specifications:
Both the Lumina C14 Implantable Sensor and the Lumina R7 Wearable Reader/Transmitter are submitted together as a single integrated CGM system under this Traditional 510(k) submission. The system is not intended for use with any third-party sensor or reader components.
3. Device Classification
The Solstice Lumina™ CGM System is classified as follows:
The applicant notes that the applicable classification for subcutaneous continuous glucose monitoring electrodes (Product Code QKQ) was established pursuant to a reclassification order issued by FDA, the final rule for which became effective in March 2024. This reclassification confirmed the classification of integrated continuous glucose monitoring systems as Class II devices subject to Special Controls, enabling review under the Traditional 510(k) pathway. The special controls applicable to devices classified under Product Code QKQ include, among other things, clinical performance testing demonstrating analytical and clinical accuracy, biocompatibility evaluation, software verification and validation, wireless technology performance testing, electromagnetic compatibility testing, and appropriate labeling. The applicant has addressed each of the applicable special controls in the body of this submission, as summarized in Section 7 below and detailed in the enclosed submission volumes.
4. Predicate Devices
4.1 Primary Predicate Device
The primary predicate device for purposes of this 510(k) submission is the NovaSense GlucoTrack NX-500 CGM System, identified as follows:
Device Name: NovaSense GlucoTrack NX-500 CGM System 510(k) Number: K211034 Date of Clearance: June 18, 2022 Manufacturer: NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 Product Code: QKQ Device Class: Class II
The NovaSense GlucoTrack NX-500 is a continuous glucose monitoring system consisting of a subcutaneous enzymatic electrochemical sensor with a ten (10)-day wear duration and a handheld receiver that communicates with the sensor via Bluetooth Low Energy wireless transmission. The NX-500 was cleared for use by adults (age 18 and older) with Type 1 or Type 2 diabetes mellitus for diabetes treatment decisions, including insulin dosing, without the need for confirmatory fingerstick blood glucose testing. The NX-500 shares the same product code (QKQ), regulatory classification (21 C.F.R. § 862.1355), and intended use as the subject Solstice Lumina™ CGM System. The applicant has identified the NX-500 as the primary predicate because it most closely represents the same type of device with the same intended use, employing a substantially equivalent technological architecture (enzymatic electrochemical glucose sensing with BLE wireless data transmission to an external reader device).
4.2 Secondary Predicate (Reference Device)
The applicant identifies the following device as a secondary predicate (reference device) for purposes of supporting the substantial equivalence comparison, particularly with respect to the extended fourteen (14)-day sensor wear duration and enhanced wireless communication features:
Device Name: NovaSense GlucoTrack NX-700 CGM System 510(k) Number: K230489 Date of Clearance: March 7, 2024 Manufacturer: NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 Product Code: QKQ Device Class: Class II
The NovaSense GlucoTrack NX-700 is the successor model to the NX-500, cleared for the same intended use population and indications. The NX-700 features an extended fourteen (14)-day sensor wear duration (compared to the NX-500's ten-day wear duration), enhanced BLE 5.0 wireless transmission, and an updated glucose estimation algorithm. The applicant references the NX-700 to demonstrate that the fourteen-day wear duration and enhanced BLE communication featured in the Solstice Lumina™ CGM System are consistent with characteristics already reviewed and cleared by FDA in a device sharing the same product code and intended use.
4.3 Additional Reference (Corporate Pedigree)
Device Name: Solstice GlucoStrip RX-200 Test Strip Reader 510(k) Number: K192847 Date of Clearance: November 14, 2019 Manufacturer: Solstice Biomedical Inc., Cambridge, MA Product Code: NBW Device Class: Class II
The Solstice GlucoStrip RX-200 is referenced herein solely for purposes of establishing Solstice Biomedical Inc.'s prior history of successful FDA regulatory interaction and the company's corporate regulatory pedigree in the glucose monitoring device space. The RX-200 is not cited as a predicate device for purposes of the substantial equivalence determination for the Solstice Lumina™ CGM System, as it is a point-of-care blood glucose test strip reader (Product Code NBW) and does not share the same technological characteristics or product code as the subject device.
5. Intended Use / Indications for Use
The intended use and indications for use of the Solstice Lumina™ CGM System are as follows:
The Solstice Lumina™ CGM System is a prescription-use (Rx only) continuous glucose monitoring system intended for the continuous monitoring of glucose levels in the interstitial fluid of persons aged eighteen (18) years and older with Type 1 or Type 2 diabetes mellitus. The system is intended to replace fingerstick blood glucose testing for diabetes treatment decisions, including but not limited to insulin dosing decisions. The system measures glucose concentrations over a measurement range of 40 to 400 mg/dL.
The Lumina C14 sensor is designed for a maximum wear duration of fourteen (14) days (336 hours) per sensor. After the fourteen-day wear period, the sensor must be removed and replaced with a new sensor.
The Solstice Lumina™ CGM System is intended for use by patients as an aid in the management of diabetes. The system is not intended for use in critically ill patients, during surgical procedures, or as a substitute for laboratory glucose testing for the diagnosis of diabetes. The system is not intended for use in pediatric patients (under 18 years of age).
A completed FDA Form 3881 (Indications for Use Statement) is enclosed with this submission as part of the submission package. The indications for use set forth on Form 3881 are consistent with the indications described in this cover letter and the enclosed proposed labeling.
6. Summary of Substantial Equivalence Argument
The applicant submits that the Solstice Lumina™ CGM System is substantially equivalent to the primary predicate device, the NovaSense GlucoTrack NX-500 CGM System (510(k) No. K211034), and the secondary predicate device, the NovaSense GlucoTrack NX-700 CGM System (510(k) No. K230489). The subject device and the predicate devices share the same intended use, the same patient population, the same general technological characteristics (enzymatic electrochemical subcutaneous glucose sensing with wireless data transmission to an external reader device), and the same product code and regulatory classification.
The applicant has identified the following five (5) key technological differences between the Solstice Lumina™ CGM System and the primary predicate device (K211034):
1.  Sensor Wear Duration. The Lumina C14 sensor supports a fourteen (14)-day wear duration, compared to the ten (10)-day wear duration of the primary predicate (NovaSense NX-500). The applicant notes that the secondary predicate device (NovaSense NX-700, K230489) has been cleared with an equivalent fourteen-day wear duration, confirming that this extended duration has been reviewed and found acceptable by FDA for devices of the same type and intended use.
2.  Electrode Material. The Lumina C14 sensor employs a proprietary platinum-iridium (PtIr-4G) electrode coating, whereas the primary predicate utilizes a platinum electrode. The platinum-iridium alloy provides enhanced signal stability and extended electrode longevity without altering the fundamental electrochemical sensing mechanism. Biocompatibility testing of the PtIr-4G electrode material has been conducted in accordance with the ISO 10993 series, and results are enclosed in this submission.
3.  Bluetooth Low Energy (BLE) Version. The Lumina System utilizes BLE 5.2 for wireless communication between the C14 sensor and the R7 reader, whereas the primary predicate utilizes BLE 5.0. BLE 5.2 is a backwards-compatible evolution of the BLE standard offering improved power efficiency and connection stability. The upgrade in BLE version does not alter the fundamental method of wireless data transmission or raise new safety or effectiveness concerns. Wireless performance testing data, including electromagnetic compatibility (EMC) testing, is enclosed.
4.  Reader Form Factor. The Lumina R7 reader/transmitter is designed as an arm-worn wearable device, whereas the primary predicate employs a handheld receiver. Both devices perform the same function of receiving, processing, and displaying glucose data transmitted from the implanted sensor. The change in form factor does not alter the technological characteristics related to glucose measurement or data display and does not raise new questions of safety or effectiveness.
5.  Proprietary Glucose Estimation Algorithm. The Lumina System uses Solstice Biomedical's proprietary LuminaPredict algorithm (version 2.1) for glucose estimation and trend prediction, whereas the primary predicate uses NovaSense's proprietary algorithm. Both algorithms perform the same function of converting raw electrochemical sensor signals into glucose concentration values. Software verification, validation, and lifecycle documentation for the LuminaPredict algorithm are enclosed, prepared in accordance with IEC 62304 and applicable FDA guidance.
The applicant submits that none of the above-identified technological differences raise new questions of safety or effectiveness that cannot be resolved through the data and information provided in this submission. The enclosed performance data demonstrates that the Solstice Lumina™ CGM System meets or exceeds the analytical and clinical accuracy performance of the predicate devices. Specifically, the clinical study data demonstrate a Mean Absolute Relative Difference (MARD) of ≤ 9.0% across the measurement range (40–400 mg/dL), and ≥ 99% of paired data points fall within Zones A and B of the Clarke Error Grid Analysis. These results confirm that the Solstice Lumina™ CGM System provides glucose measurement accuracy that is at least as good as that demonstrated by the predicate devices.
A detailed Substantial Equivalence Comparison Table, providing a feature-by-feature comparison of the subject device against both the primary and secondary predicate devices, is enclosed in the submission package.
7. Summary of Submission Contents
The following documents and materials are enclosed as part of this 510(k) submission:
1.  CDRH Premarket Review Submission Cover Sheet (FDA Form 3514)
2.  Indications for Use Statement (FDA Form 3881)
3.  510(k) Summary prepared in accordance with 21 C.F.R. § 807.92
4.  Truthful and Accurate Statement in accordance with 21 C.F.R. § 807.87(j)
5.  Class III Summary and Certification — Not Applicable. The Solstice Lumina™ CGM System is a Class II device (Product Code QKQ). This section is included in the submission index for completeness and is marked as not applicable.
6.  Financial Certification / Disclosure Statement prepared in accordance with 21 C.F.R. Part 54, including financial disclosure information for all clinical investigators participating in Protocol SBD-LUM-CL-001 ("LUMINA-US")
7.  Declarations of Conformity and Summary Reports for applicable recognized consensus standards, including but not limited to ISO 10993, IEC 62304, IEC 60601-1, IEC 62133, and ISO 14971
8.  Executive Summary providing an overview of the device, its intended use, the substantial equivalence rationale, and a summary of testing and clinical data
9.  Device Description including detailed technical specifications, drawings, photographs, principles of operation, system architecture diagrams, and descriptions of the Lumina C14 sensor, Lumina R7 reader, sensor applicator, and Lumina mobile application
10.  Substantial Equivalence Comparison including detailed feature-by-feature comparison tables mapping the subject device against the primary predicate (K211034) and secondary predicate (K230489), with analysis of similarities and differences
11.  Proposed Labeling including Instructions for Use (IFU), package labeling, physician labeling (prescribing information), Quick Start Guide, and screenshots of the Lumina mobile application user interface
12.  Sterilization and Shelf Life documentation, including sterilization validation reports for the Lumina C14 sensor (ethylene oxide sterilization) and accelerated and real-time shelf life stability data
13.  Biocompatibility — Test reports prepared in accordance with the ISO 10993 series of standards for biological evaluation of medical devices. Biocompatibility testing was performed by Whitmore Laboratories Inc. (A2LA Certificate No. 3847.01, accredited to ISO/IEC 17025) and covers cytotoxicity, sensitization, irritation, acute systemic toxicity, subchronic toxicity, genotoxicity, implantation, and hemocompatibility evaluations for all patient-contacting materials
14.  Software Documentation including software description, software requirements specification overview, software architecture overview, IEC 62304 software development lifecycle documentation (Level of Concern: Major), Software Bill of Materials (SBOM), hazard analysis, software verification and validation reports, and cybersecurity documentation prepared in accordance with the FDA Guidance "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 2023), including Threat Modeling, Security Risk Assessment, Cybersecurity Bill of Materials (CBOM), and Software Architecture Diagrams
15.  Electromagnetic Compatibility (EMC) and Electrical Safety Data including test reports for compliance with IEC 60601-1 (general requirements for safety), IEC 60601-1-2 (electromagnetic disturbances), and applicable wireless coexistence testing per FDA guidance
16.  Performance Testing Data — Bench Testing including analytical accuracy (sensor accuracy vs. YSI reference), linearity, precision (repeatability and reproducibility), interference testing (common interferents including acetaminophen, ascorbic acid, uric acid, and others), temperature performance, altitude performance, and response time testing
17.  Clinical Data — Results from Protocol SBD-LUM-CL-001 ("LUMINA-US"), a prospective, single-arm, multicenter clinical study enrolling three hundred fifty (350) adult subjects (175 with Type 1 diabetes and 175 with Type 2 diabetes) at six (6) U.S. clinical sites. The study was conducted by Veltrano Clinical Research Organization Inc. Clinical data include accuracy analysis (MARD, Clarke Error Grid Analysis, Consensus Error Grid Analysis), safety analysis (adverse events, device-related adverse events, serious adverse events), and sensor survival analysis. The clinical study report is included in its entirety.
18.  Risk Analysis including a comprehensive risk management file prepared in accordance with ISO 14971:2019, encompassing hazard identification, risk estimation, risk evaluation, risk control, evaluation of residual risk, and risk management review. The risk analysis covers all identified hazards associated with the Lumina C14 sensor, Lumina R7 reader, sensor applicator, mobile application, and the integrated system.
8. Regulatory History and International Certifications
Solstice Biomedical Devices Ltd. (the parent company of the applicant) maintains a certified quality management system in compliance with ISO 13485:2016 ("Medical devices — Quality management systems — Requirements for regulatory purposes"). The ISO 13485:2016 certificate was issued by Meridian Conformity Assessment GmbH, a Notified Body designated under Notified Body Identification Number 0483, with offices at Landsberger Allee 44, 10249 Berlin, Germany. The current certificate covers the design, development, manufacture, and distribution of continuous glucose monitoring systems and in vitro diagnostic glucose monitoring devices, including the Solstice Lumina™ CGM System. A copy of the current ISO 13485:2016 certificate is included in the enclosed Declarations of Conformity.
The Solstice Lumina™ CGM System has received CE certification under the European Union Medical Device Regulation (EU MDR 2017/745). The EU MDR CE certificate was issued by Meridian Conformity Assessment GmbH (NB 0483) under Certificate No. MCA-2024-07319, dated September 12, 2024. The Lumina CGM System has been commercially available in the European Union since September 2024 and, as of the date of this submission, is marketed and distributed in fourteen (14) EU member states. No field safety corrective actions, recalls, or safety alerts have been issued in connection with the Lumina CGM System in any jurisdiction.
The applicant further notes its prior regulatory history with the U.S. Food and Drug Administration. Solstice Biomedical Inc. previously obtained 510(k) clearance for the Solstice GlucoStrip RX-200 Test Strip Reader (510(k) No. K192847, cleared November 14, 2019). While the RX-200 is not cited as a predicate for the present submission, this prior clearance demonstrates the applicant's established track record of successful FDA regulatory engagement and compliance with U.S. medical device regulatory requirements.
9. User Fee Information
In accordance with the Medical Device User Fee Amendments (MDUFA), the applicant has submitted the applicable 510(k) standard review user fee for fiscal year 2025. The relevant user fee details are as follows:
FY2025 510(k) Standard Review User Fee: $22,417
Payment Method: Submitted via Pay.gov
Payment Confirmation Number: [To be inserted upon confirmation of payment]
Date of Payment: [To be inserted]
The applicant notes that Solstice Biomedical Inc. does not qualify for the small business user fee exemption or reduced fee under MDUFA. The consolidated global revenue of the applicant's parent entity, Solstice Biomedical Devices Ltd., for the most recently completed fiscal year was approximately €187.4 million (equivalent to approximately $204.3 million at an exchange rate of €1.00 = $1.09), which exceeds the applicable revenue threshold for small business qualification under the MDUFA user fee provisions. Accordingly, the full standard review fee has been remitted.
10. Establishment Registration
Solstice Biomedical Inc. (Delaware corporation, File No. 7834291) is registered as a medical device establishment with the U.S. Food and Drug Administration in accordance with the requirements of 21 C.F.R. Part 807, Subpart B. The establishment registration is maintained through the FDA Unified Registration and Listing System (FURLS).
Establishment Registration Number: [To be inserted]
FURLS Owner/Operator Number: [To be inserted]
Registration Status: Active
The applicant's establishment registration and device listing information will be updated to include the Solstice Lumina™ CGM System upon receipt of 510(k) clearance, in accordance with applicable regulatory requirements.
11. Pre-Submission History
The applicant engaged in a Pre-Submission (Q-Sub) interaction with FDA's Center for Devices and Radiological Health prior to the preparation and filing of this 510(k) submission. The Pre-Submission was directed to the Office of Health Technology 2 (OHT2), Division of Chemistry and Toxicology Devices, which is the reviewing division for devices classified under Product Code QKQ.
The key milestones of the Pre-Submission interaction are summarized below:
•  Pre-Submission Meeting Request Submitted: June 2, 2025
•  Pre-Submission Meeting Package Submitted: June 16, 2025
•  Pre-Submission Meeting Held: August 14, 2025 (teleconference with FDA review team)
During the Pre-Submission meeting, the applicant presented its proposed regulatory strategy for the Solstice Lumina™ CGM System, including the selection of predicate devices, the proposed indications for use, the clinical study design (Protocol SBD-LUM-CL-001), the approach to software documentation and cybersecurity, and the proposed analytical performance testing plan. The applicant received feedback from the FDA review team on each of these topics.
This 510(k) submission has been prepared consistent with the feedback and recommendations received from FDA during the August 14, 2025 Pre-Submission meeting. The Pre-Submission meeting minutes, as issued by FDA, are referenced in the submission package for the convenience of the reviewing division.
12. Software Version Information
The following software and firmware versions are the subject of this 510(k) submission:
All software verification, validation, and lifecycle documentation enclosed in this submission correspond to the software versions identified above. The Software Bill of Materials (SBOM) and Cybersecurity Bill of Materials (CBOM) enclosed herein reflect the complete list of software components, open-source libraries, and third-party software modules incorporated in the above-listed software versions.
13. Authorized Representative / Contact for FDA Correspondence
All FDA correspondence regarding this 510(k) submission, including Requests for Additional Information (AI), deficiency letters, determination letters, and other communications, should be directed to the following contacts:
Primary Contact:
Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: [To be inserted]
Email: [To be inserted]
With a copy to:
Miriam Calloway, Partner Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: [To be inserted]
Email: [To be inserted]
And to:
Dr. Niamh Tierney Vice President of Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72, Ireland Telephone: [To be inserted]
Email: [To be inserted]
The applicant requests that all correspondence be sent to each of the three contacts identified above to ensure timely receipt and response. The applicant further consents to the receipt of correspondence via electronic mail at the email addresses listed above, in addition to any correspondence sent by U.S. mail or courier.
14. Truthful and Accurate Statement
In accordance with the requirements of 21 C.F.R. § 807.87(j), the undersigned hereby certifies, on behalf of the applicant Solstice Biomedical Inc., that the applicant believes, to the best of its knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted. The undersigned further certifies that the applicant is aware that any material misstatement, misrepresentation, or omission of a material fact in a premarket notification may subject the person or entity making such statement to criminal and/or civil liability under federal law, including but not limited to 18 U.S.C. § 1001 and 21 U.S.C. § 331.
15. Signature block
We respectfully request that the Center for Devices and Radiological Health review this submission and issue a determination of substantial equivalence for the Solstice Lumina™ CGM System. We are available to provide any additional information that may be required to facilitate the review and welcome the opportunity to discuss this submission with the review team at the Agency's convenience.
Respectfully submitted,
SOLSTICE BIOMEDICAL INC.
By: ________
Name: Marcus Hale
Title: Vice President of U.S. Operations
Date: ________
SOLSTICE BIOMEDICAL DEVICES LTD.
By: ________
Name: Dr. Niamh Tierney
Title: Vice President of Regulatory Affairs
Date: ________
16. Enclosures
The following enclosures accompany this 510(k) submission. The submission is organized into four (4) bound volumes and one (1) electronic copy (eCopy), as indicated below:
Total Physical Volumes: 4
eCopy: One (1) electronic copy (eCopy) of the complete submission is enclosed on USB flash drive, formatted in accordance with FDA eCopy guidance. The eCopy contains the complete contents of Volumes I through IV in searchable PDF format, with a submission-level table of contents and hyperlinked bookmarks.
CONFIDENTIAL — This cover letter and the accompanying submission materials contain confidential business information and trade secrets of Solstice Biomedical Inc. and Solstice Biomedical Devices Ltd. The applicant requests that such information be treated as confidential in accordance with 21 C.F.R. Part 20 and applicable exemptions under the Freedom of Information Act, 5 U.S.C. § 552. Any public disclosure of the contents of this submission should be limited to the 510(k) Summary prepared in accordance with 21 C.F.R. § 807.92.
DRAFT — Prepared by Calderwood & Harkness LLP for Solstice Biomedical Inc. — Engagement Reference No. 1037-00002 — Subject to Revision
Parameter | Specification
Measurement Range | 40–400 mg/dL
Sensor Wear Duration | 14 days (336 hours)
Warm-Up Time | ≤ 60 minutes
Alert Latency | ≤ 5 minutes
Wireless Protocol | Bluetooth Low Energy (BLE) 5.2
Calibration | Factory calibrated (no user calibration required)
Classification Parameter | Detail
Product Code | QKQ
Product Code Description | Electrode, Glucose, Subcutaneous
Regulation Number | 21 C.F.R. § 862.1355
Regulation Description | Glucose test system
Device Class | Class II
Review Panel | Clinical Chemistry
Component | Software/Firmware Version
Lumina C14 Sensor Firmware | v3.4.2
Lumina R7 Reader Operating System | v2.1.0
LuminaPredict Glucose Estimation Algorithm | v2.1
Lumina Mobile Application (iOS and Android) | v1.0.3
Enclosure No. | Description | Volume
1 | CDRH Premarket Review Submission Cover Sheet (FDA Form 3514) | I
2 | Indications for Use Statement (FDA Form 3881) | I
3 | 510(k) Summary (per 21 C.F.R. § 807.92) | I
4 | Truthful and Accurate Statement (21 C.F.R. § 807.87(j)) | I
5 | Class III Summary and Certification — N/A (Class II device) | I
6 | Financial Certification / Disclosure Statement (21 C.F.R. Part 54) | I
7 | Declarations of Conformity and Summary Reports | I
8 | Executive Summary | I
9 | Device Description | II
10 | Substantial Equivalence Comparison | II
11 | Proposed Labeling (IFU, Package Labeling, Physician Labeling, Quick Start Guide, Mobile App Screenshots) | II
12 | Sterilization and Shelf Life Documentation | II
13 | Biocompatibility — ISO 10993 Test Reports (Whitmore Laboratories Inc., A2LA Cert. No. 3847.01) | III
14 | Software Documentation (IEC 62304 Lifecycle, SBOM, Cybersecurity per FDA Sept. 2023 Guidance) | III
15 | Electromagnetic Compatibility (EMC) and Electrical Safety Data | III
16 | Performance Testing Data — Bench Testing (Accuracy, Linearity, Precision, Interference) | IV
17 | Clinical Data — Protocol SBD-LUM-CL-001 ("LUMINA-US"), 350 Subjects, 6 U.S. Sites (Veltrano CRO Inc.) | IV
18 | Risk Analysis (ISO 14971:2019) | IV

CALDERWOOD & HARKNESS LLP Attorneys at Law

SOLSTICE BIOMEDICAL INC.

SOLSTICE BIOMEDICAL DEVICES LTD.

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