FOOD AND DRUG ADMINISTRATION
PRE-SUBMISSION MEETING REQUEST FORM
(FDA Form 3514)
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Center for Devices and Radiological Health
OMB Control Number: 0910-0756
Date of Submission: June 2, 2025
Section 1: Submission Type
Type of Pre-Submission: Q-Submission (Q-Sub)
Q-Sub Subtype: Pre-Submission for a planned 510(k)
This request is submitted pursuant to FDA guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" (Revision, January 2023) to obtain formal written feedback from the Agency and, if appropriate, an interactive meeting with the review division prior to the filing of a Traditional 510(k) premarket notification for the Solstice Lumina™ CGM System.
Request for a formal meeting with written FDA feedback Request for written FDA feedback only (no meeting)
The Applicant respectfully requests that the Agency schedule a formal Pre-Submission meeting and provide written feedback on the specific questions set forth in this request form and in the accompanying Pre-Submission meeting package, which will be submitted in accordance with the timeline described in Section 9 below.
Section 2: Applicant / Sponsor Information
Applicant Name: Solstice Biomedical Inc.
Entity Type: Corporation, organized and existing under the laws of the State of Delaware (Delaware Division of Corporations File No. 7834291)
Principal Place of Business:
Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States
Applicant Telephone: (617) 555-0194
Applicant Email: regulatory@solsticebiomedical.com
Applicant Contact Person (Primary):
Marcus Hale Vice President of U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: (617) 555-0194
Email: marcus.hale@solsticebiomedical.com
Regulatory Contact:
Dr. Niamh Tierney Vice President of Regulatory Affairs Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72 Ireland Telephone: +353 1 555 8821
Email: niamh.tierney@solsticedevices.ie
Note Regarding Corporate Structure: Solstice Biomedical Inc. is the wholly owned U.S. subsidiary of Solstice Biomedical Devices Ltd., an Irish private limited company registered with the Companies Registration Office of Ireland (CRO No. 648231). Solstice Biomedical Inc. is the intended 510(k) holder and the U.S. initial distributor of the Solstice Lumina™ CGM System. All regulatory correspondence regarding this Pre-Submission and any subsequent 510(k) filing should be directed to Solstice Biomedical Inc. at the address listed above, with copies to the Authorized Representative identified in Section 3 below. Dr. Niamh Tierney, as Vice President of Regulatory Affairs for the parent entity, will serve as the lead regulatory contact for all substantive discussions with the Agency and will participate in the requested Pre-Submission meeting on behalf of the Applicant.
Section 3: Authorized Representative Information
Authorized Representative (Law Firm): Calderwood & Harkness LLP
Address:
Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 United States
Primary Contact:
Miriam Calloway, Esq. Partner, Healthcare & Life Sciences Practice Calderwood & Harkness LLP Telephone: (202) 555-0733
Email: miriam.calloway@calderwoodharkness.com
Additional Contact:
Amy Whitfield, Esq. Associate, Healthcare & Life Sciences Practice Calderwood & Harkness LLP Telephone: (202) 555-0741
Email: amy.whitfield@calderwoodharkness.com
Authorization Statement: Calderwood & Harkness LLP has been duly authorized by Solstice Biomedical Inc. to act on behalf of the Applicant in all communications with the U.S. Food and Drug Administration regarding this Pre-Submission (Q-Sub) request, including the scheduling of meetings, receipt and dissemination of written feedback, and the filing of any supplementary materials relating to this request. A signed authorization letter from Marcus Hale, VP of U.S. Operations, Solstice Biomedical Inc., dated May 28, 2025, is available upon request and will be included in the Pre-Submission meeting package.
Section 4: Device Identification
Device Trade/Proprietary Name: Solstice Lumina™ CGM System
Device Components:
The Solstice Lumina™ CGM System consists of the following two principal hardware components, which together constitute a single, integrated continuous glucose monitoring system:
The system also includes associated software components, including embedded firmware in the C14 sensor and R7 reader, a predictive glucose algorithm (LuminaPredict), and a companion mobile application (Solstice Lumina™ Mobile App) for iOS and Android platforms. A detailed description of all hardware and software components is provided in Section 5 below.
Common/Usual Name: Continuous Glucose Monitoring System
Product Code (Anticipated): QKQ — Electrode, Glucose, Subcutaneous
Device Classification: Class II (Special Controls)
Applicable Regulation Number: 21 C.F.R. § 862.1355 — Glucose test system
Planned Submission Type: Traditional 510(k) — The Applicant intends to file a single Traditional 510(k) premarket notification covering both the Lumina C14 sensor and the Lumina R7 reader/transmitter as an integrated continuous glucose monitoring system. The Applicant does not intend to submit separate 510(k) notifications for individual system components.
Establishment Registration Number: Solstice Biomedical Inc. is registered with FDA as a medical device establishment pursuant to 21 C.F.R. Part 807. The establishment registration number will be provided in the formal 510(k) submission. As of the date of this request, the Applicant's establishment registration is current and in good standing.
Section 5: Device Description Summary
5.1 System Overview
The Solstice Lumina™ CGM System is a prescription-use, real-time continuous glucose monitoring system intended to measure interstitial glucose levels in persons aged 18 years and older with Type 1 or Type 2 diabetes mellitus. The system provides continuous, real-time glucose readings, trend information, and configurable alerts to assist patients and healthcare providers in the management of diabetes. The system is designed to be used by patients in home and ambulatory settings and does not require confirmatory fingerstick blood glucose testing for treatment decisions.
The system operates by means of a subcutaneously placed electrochemical glucose sensor (Lumina C14) that wirelessly transmits glucose data to an arm-worn reader/transmitter device (Lumina R7), which in turn communicates with the companion Solstice Lumina™ mobile application on the patient's smartphone.
5.2 Lumina C14 — Subcutaneous Continuous Glucose Monitoring Sensor
The Lumina C14 is a disposable, subcutaneously implantable continuous glucose monitoring sensor with the following key characteristics:
• Sensor Technology: Fourth-generation enzymatic electrochemical biosensor utilizing glucose oxidase (GOx) immobilized on a proprietary platinum-iridium electrode coating (PtIr-4G technology). The PtIr-4G electrode coating provides enhanced signal stability, reduced interference from acetaminophen and ascorbic acid, and improved sensor longevity over the 14-day wear period.
• Wear Duration: 14 days (single-use, disposable)
• Insertion Site: Posterior upper arm (subcutaneous insertion via integrated single-use applicator)
• Measurement Range: 40–400 mg/dL
• Warm-Up Time: ≤ 60 minutes from insertion to first glucose reading
• Sampling Interval: Every 1 minute (continuous)
• Data Transmission: Wireless Bluetooth Low Energy (BLE) 5.2 to the Lumina R7 reader/transmitter
• Transmission Range: Up to 6 meters (line of sight)
• Power Source: Integrated lithium coin cell battery (non-rechargeable, 14-day operational life)
• Sterilization: Ethylene oxide (EO) sterilized; supplied in individual sterile packaging
• Biocompatibility: Patient-contacting materials include medical-grade silicone, platinum-iridium alloy, polyurethane membrane, and medical-grade adhesive (ISO 10993-compliant)
• Embedded Software: Lumina Firmware v3.4.2
5.3 Lumina R7 — Wearable Reader/Transmitter Device
The Lumina R7 is a reusable, arm-worn reader/transmitter device with the following key characteristics:
• Form Factor: Compact, lightweight, arm-worn device secured via a medical-grade adhesive patch and adjustable elastic band; designed for continuous wear on the upper arm
• Display: 1.4-inch AMOLED touchscreen display; displays real-time glucose values (mg/dL), trend arrows (rate of change), and 8-hour trend graphs
• Alerts: Configurable hypo- and hyperglycemia alerts with audible, vibration, and visual notification modes; configurable glucose threshold settings; alert latency ≤ 5 minutes
• Data Transmission (Inbound): Receives glucose data from Lumina C14 sensor via BLE 5.2
• Data Transmission (Outbound): Transmits glucose data and alert information to the Solstice Lumina™ mobile application (iOS and Android) via BLE 5.2
• Data Storage: On-device storage of up to 90 days of glucose data
• Power Source: Rechargeable lithium-polymer battery; battery life ≥ 7 days per charge; USB-C charging
• Water Resistance: IP67 rated
• Embedded Software: Lumina Reader OS v2.1.0
• Algorithm: LuminaPredict Algorithm v2.1 — a proprietary predictive algorithm that provides prospective glucose trend analysis and predictive low-glucose and high-glucose alerts based on rate of change and historical pattern analysis
• Reusable Life: Designed for a minimum of 2 years of continuous use
5.4 Software Components Summary
5.5 Intended Use
The Solstice Lumina™ CGM System is a prescription-use, real-time continuous glucose monitoring system intended for the continuous monitoring of interstitial glucose levels in persons aged 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 insulin dosing. The system is not intended for use in critically ill patients, in persons under 18 years of age, or as a sole basis for diagnosing diabetes.
5.6 Prescription Use
Prescription Use: Yes. The Solstice Lumina™ CGM System is intended for prescription use only, in accordance with 21 C.F.R. § 801.109.
Section 6: Predicate Device Information
6.1 Primary Predicate Device
The NovaSense GlucoTrack NX-500 CGM System is a continuous glucose monitoring system consisting of a subcutaneously placed electrochemical glucose sensor with a 10-day wear duration and a handheld reader/transmitter device. The NX-500 system employs a third-generation enzymatic electrochemical sensor with a platinum electrode, BLE 4.2 wireless communication, and provides real-time glucose values and trend information. The NX-500 was cleared via the Traditional 510(k) pathway under product code QKQ and 21 C.F.R. § 862.1355. The Applicant has selected the NX-500 as the primary predicate device because it shares the same intended use, technological characteristics, and product classification as the Solstice Lumina™ CGM System.
6.2 Secondary Predicate / Reference Device
The NovaSense GlucoTrack NX-700 CGM System is the successor to the NX-500 and features a 14-day wear duration sensor, BLE 5.0 wireless communication, an arm-worn reader with OLED display, and an updated predictive glucose algorithm. The NX-700 was cleared via the Traditional 510(k) pathway, citing the NX-500 (K211034) as its predicate device. The Applicant references the NX-700 as a secondary predicate and reference device to support the substantial equivalence analysis, particularly with respect to the 14-day sensor wear duration, arm-worn reader form factor, and BLE 5.x wireless communication protocol, each of which represents a feature shared between the Lumina CGM System and the NX-700 but not present in the primary predicate NX-500.
6.3 Additional Reference Device (Corporate Pedigree)
Note: The Solstice GlucoStrip RX-200 Test Strip Reader is referenced solely for the purpose of establishing the Applicant's corporate pedigree and prior history of FDA interactions. The RX-200 is a fingerstick blood glucose test strip reader and is not a continuous glucose monitoring system. The Applicant does not cite the RX-200 as a predicate device for the purposes of establishing substantial equivalence of the Solstice Lumina™ CGM System. The RX-200 is classified under a different product code (NBW) and is technologically distinct from the subject device.
Section 7: Regulatory History of the Applicant
Solstice Biomedical Inc. has the following regulatory history with the U.S. Food and Drug Administration and other regulatory authorities relevant to this Pre-Submission request:
1. Prior FDA Clearance — GlucoStrip RX-200 Test Strip Reader. 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). The RX-200 is a Class II fingerstick blood glucose test strip reader classified under product code NBW and 21 C.F.R. § 862.1345. The RX-200 is currently marketed in the United States and remains in good standing with the Agency. No FDA enforcement actions, warning letters, recalls, or post-market safety reports of significance have been associated with the RX-200.
2. Solstice Lumina™ CGM System — No Existing U.S. Clearance or Approval. The Solstice Lumina™ CGM System has not been the subject of any prior FDA premarket submission, and the device does not hold any existing FDA clearance, approval, or De Novo authorization. This Pre-Submission meeting request represents the Applicant's first formal engagement with the Agency regarding the Lumina CGM System.
3. EU MDR CE Certificate. The Solstice Lumina™ CGM System holds an EU Medical Device Regulation (MDR 2017/745) CE certificate issued by Meridian Conformity Assessment GmbH, a Notified Body designated under EU MDR (Notified Body Identification No. NB 0483). The certificate details are as follows:
• Certificate Number: MCA-2024-07319
• Date of Issue: September 12, 2024
• Device Classification (EU MDR): Class IIb (Rule 11, Annex VIII)
• Scope: Solstice Lumina™ CGM System (Lumina C14 sensor and Lumina R7 reader/transmitter)
• Commercial Availability in EU: The Lumina CGM System has been commercially available in EU Member States since September 2024.
4. ISO 13485:2016 Certification. Solstice Biomedical Devices Ltd. (parent company) holds ISO 13485:2016 certification for the design, development, manufacture, and servicing of continuous glucose monitoring systems and blood glucose monitoring devices. The ISO 13485 certificate is issued by BSI Group (Certificate No. MD 734822) and covers the manufacturing facility located at Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland.
5. No Outstanding FDA Enforcement Actions. As of the date of this submission, neither Solstice Biomedical Inc. nor Solstice Biomedical Devices Ltd. is the subject of any pending FDA warning letter, consent decree, import alert, or other enforcement action.
Section 8: Review Division Identification
Center: Center for Devices and Radiological Health (CDRH)
Office: Office of Health Technology 2 (OHT2)
Division: Division of Chemistry and Toxicology Devices
Rationale for Division Assignment: The Solstice Lumina™ CGM System is classified under product code QKQ (Electrode, Glucose, Subcutaneous) and regulated under 21 C.F.R. § 862.1355 (Glucose test system). Based on the FDA Product Classification database and the organizational structure of CDRH, devices classified under product code QKQ and the applicable regulatory provisions fall within the review jurisdiction of the Division of Chemistry and Toxicology Devices, Office of Health Technology 2 (OHT2). The Applicant has confirmed this assignment by reference to the FDA Product Classification database (accessed May 20, 2025) and the CDRH organizational chart. In the event that the Agency determines that a different review division has primary jurisdiction over this device, the Applicant respectfully requests that this Pre-Submission be routed to the appropriate division and that the Applicant be notified of any reassignment.
Section 9: Meeting Request Details
9.1 Type of Meeting Requested
The Applicant hereby requests a Q-Submission (Pre-Submission) meeting with the review division responsible for the planned Traditional 510(k) submission for the Solstice Lumina™ CGM System.
Purpose of Meeting: The purpose of the requested Pre-Submission meeting is to obtain FDA feedback on key regulatory, clinical, and technical questions relating to the planned Traditional 510(k) submission for the Solstice Lumina™ CGM System prior to formal submission of the 510(k) premarket notification. The Applicant seeks to discuss topics including, but not limited to, predicate acceptance and the substantial equivalence framework, clinical study design and endpoints, the applicability of IDE exemption, software documentation and level of concern, cybersecurity documentation expectations, biocompatibility testing scope, and the potential applicability of the integrated continuous glucose monitor (iCGM) classification pathway. A detailed enumeration of topics and specific questions is provided in Section 10 below.
9.2 Preferred Meeting Format
Preferred Format: Teleconference (video or audio)
The Applicant's preferred meeting format is a teleconference, as several key attendees will be participating from international locations (Dublin, Ireland). The Applicant is prepared to use the Agency's preferred teleconference platform.
Alternative Format: In the event that the review division prefers an in-person meeting, the Applicant is prepared to attend an in-person meeting at the FDA White Oak Campus, 10903 New Hampshire Avenue, Silver Spring, MD 20993. The Applicant respectfully requests advance notice of at least 21 days if an in-person meeting format is preferred, to allow international attendees to arrange travel.
9.3 Requested Meeting Date
The Applicant respectfully requests that the Pre-Submission meeting be scheduled during the month of August 2025, with a target date of August 14, 2025 (Thursday).
To ensure compliance with the recommended 60-day lead time for submission of the Pre-Submission meeting package prior to the requested meeting date, the Applicant intends to submit the complete Pre-Submission meeting package no later than June 16, 2025. The Applicant understands that the Agency will endeavor to schedule the meeting within 75 days of receipt of the complete meeting package, consistent with the Q-Submission guidance.
The Applicant is flexible with respect to the specific meeting date and is prepared to accommodate the review division's scheduling preferences within the August 2025 timeframe. If August 2025 is not feasible, the Applicant would welcome scheduling during the first two weeks of September 2025 as an alternative.
9.4 Estimated Meeting Duration
The Applicant requests a meeting duration of 60 minutes. The Applicant anticipates that a brief introductory presentation (approximately 10–15 minutes) will be followed by a discussion of the specific questions submitted in the Pre-Submission meeting package (approximately 40–45 minutes), with time reserved for closing remarks and identification of any action items (approximately 5 minutes).
9.5 Proposed Attendees (Applicant Side)
The following individuals are expected to attend the Pre-Submission meeting on behalf of the Applicant:
The Applicant reserves the right to modify the attendee list prior to the meeting date and will provide an updated list to the Agency at least 5 business days before the scheduled meeting.
Section 10: Summary of Topics and Questions for Discussion
The Applicant intends to discuss the following key topics during the Pre-Submission meeting. Detailed questions for each topic area will be set forth in the Pre-Submission meeting package to be submitted by June 16, 2025. The following is a brief enumeration of the key topics for the Agency's planning purposes:
Topic 1: Predicate Acceptance and Substantial Equivalence Framework
The Applicant seeks FDA confirmation that the NovaSense GlucoTrack NX-500 CGM System (K211034) is an acceptable primary predicate device and that the NovaSense GlucoTrack NX-700 CGM System (K230489) is an acceptable secondary predicate / reference device for the Solstice Lumina™ CGM System. The Applicant intends to discuss the proposed substantial equivalence framework, including identification and analysis of five key technological differences between the subject device and the primary predicate: (1) sensor wear duration (14 days vs. 10 days); (2) electrode material (PtIr-4G platinum-iridium coating vs. platinum); (3) wireless communication protocol (BLE 5.2 vs. BLE 4.2); (4) reader form factor (arm-worn vs. handheld); and (5) predictive glucose algorithm (LuminaPredict v2.1 vs. NovaSense TrendIQ). The Applicant will present a detailed predicate comparison and substantial equivalence discussion in the meeting package.
Topic 2: Clinical Study Design and Endpoints
The Applicant seeks FDA feedback on the acceptability of the proposed clinical study design for the Solstice Lumina™ CGM System. The planned study (Protocol No. SBD-LUM-CL-001, titled "LUMINA-US") is a prospective, single-arm, multicenter clinical study enrolling approximately 350 subjects at 6 clinical sites in the United States. The proposed primary endpoint is Mean Absolute Relative Difference (MARD) ≤ 9.0%, evaluated against Adriatic Partners LLC (YSI) reference glucose values under controlled conditions and against self-monitoring blood glucose (SMBG) reference values under home-use conditions. The Applicant seeks feedback on acceptability of the MARD threshold, study population, sample size, study duration, and glucose challenge protocol.
Topic 3: IDE Exemption Applicability
The Applicant seeks confirmation from the Agency as to whether the LUMINA-US clinical study (Protocol SBD-LUM-CL-001) qualifies for exemption from the Investigational Device Exemption (IDE) requirements under 21 C.F.R. § 812.2(c)(3), as a non-significant risk (NSR) diagnostic device study. The Applicant's preliminary assessment is that the study qualifies for IDE exemption because the Lumina CGM System is a diagnostic device that is not invasive (the subcutaneous sensor insertion is a minimally invasive procedure consistent with cleared predicate CGM devices), the device is used in accordance with its intended use, and the study does not pose a significant risk to study subjects. The Applicant seeks FDA concurrence with this assessment or, alternatively, guidance on the information required to support an IDE application if the Agency determines that IDE exemption is not applicable.
Topic 4: Software Documentation Requirements and Level of Concern
The Applicant seeks confirmation of the appropriate software Level of Concern designation for the Solstice Lumina™ CGM System. The Applicant has preliminarily designated the software Level of Concern as Major, based on the device's intended use for diabetes treatment decisions (including insulin dosing) and the potential for patient harm in the event of software failure or erroneous glucose readings. The Applicant intends to submit software documentation in accordance with the FDA guidance on "Content of Premarket Submissions for Device Software Functions" (November 2023) and the requirements of IEC 62304:2006/AMD 1:2015 (Medical device software — Software life cycle processes). The Applicant seeks feedback on the adequacy of the proposed software documentation approach and the appropriateness of the Major Level of Concern designation.
Topic 5: Cybersecurity Premarket Submission Expectations
The Applicant seeks FDA feedback on the adequacy of the proposed cybersecurity documentation for the Solstice Lumina™ CGM System, prepared in accordance with the FDA guidance entitled "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" (September 2023). The Applicant's cybersecurity documentation will include, among other elements: (a) a comprehensive Software Bill of Materials (SBOM) for all software components; (b) a threat model developed using the STRIDE (Spoofing, Tampering, Repudiation, Information Disclosure, Denial of Service, Elevation of Privilege) methodology; (c) a cybersecurity risk assessment; (d) documentation of security controls for BLE 5.2 wireless communications, including encryption, authentication, and pairing protocols; (e) vulnerability management and software update plans; and (f) a cybersecurity management plan. The Applicant seeks feedback on the scope and depth of documentation expected for a Class II CGM system with BLE connectivity.
Topic 6: Biocompatibility Testing Scope
The Applicant seeks FDA confirmation that the proposed ISO 10993 biocompatibility testing scope is adequate for the Solstice Lumina™ CGM System. The Applicant's proposed testing scope is as follows:
Lumina C14 Sensor (subcutaneous implant, ≤ 30-day contact duration, tissue/bone contact): 8 test categories
(i) Cytotoxicity (ISO 10993-5) (ii) Sensitization (ISO 10993-10) (iii) Irritation / Intracutaneous Reactivity (ISO 10993-10 / ISO 10993-23) (iv) Acute Systemic Toxicity (ISO 10993-11) (v) Subacute / Subchronic Systemic Toxicity (ISO 10993-11) (vi) Genotoxicity (ISO 10993-3) (vii) Implantation (ISO 10993-6) (viii) Hemocompatibility (ISO 10993-4)
Lumina R7 Reader/Transmitter (external device, prolonged skin contact): 3 test categories
(i) Cytotoxicity (ISO 10993-5) (ii) Sensitization (ISO 10993-10) (iii) Irritation (ISO 10993-10 / ISO 10993-23)
The Applicant seeks confirmation that the proposed testing scope aligns with the Agency's expectations and that no additional biological endpoint evaluations are required.
Topic 7: iCGM Classification Pathway
The Applicant seeks FDA guidance on whether the Solstice Lumina™ CGM System should pursue classification as an integrated continuous glucose monitor (iCGM) under the De Novo classification order DEN170088 and applicable special controls, rather than (or in addition to) a Traditional 510(k) submission under product code QKQ. The Applicant understands that iCGM classification (product code QQB) offers certain regulatory and interoperability advantages, including the ability to integrate with compatible automated insulin dosing (AID) systems and insulin pumps without requiring additional premarket review. The Applicant seeks feedback on: (a) whether the Lumina CGM System meets the performance criteria and special controls associated with iCGM classification; (b) whether the Applicant should pursue iCGM classification via a De Novo request or whether a 510(k) submission under product code QKQ with a path toward subsequent iCGM classification would be more appropriate; and (c) the additional performance data or testing that would be required to support iCGM classification.
Section 11: Pre-Submission Meeting Package Contents (Planned)
The Applicant intends to submit the complete Pre-Submission meeting package no later than June 16, 2025, which is at least 60 days prior to the requested meeting date of August 14, 2025. The Pre-Submission meeting package will include the following documents and materials:
1. Executive Summary. A concise summary of the device, the regulatory strategy, and the purpose of the Pre-Submission meeting request.
2. Detailed Device Description (Lumina C14 and Lumina R7). A comprehensive description of both hardware components and all software components of the Solstice Lumina™ CGM System, including device specifications, materials, operating principles, block diagrams, and photographs.
3. Predicate Comparison and Substantial Equivalence Discussion. A detailed comparison of the Solstice Lumina™ CGM System with the primary predicate (NovaSense GlucoTrack NX-500, K211034) and the secondary predicate / reference device (NovaSense GlucoTrack NX-700, K230489), including tabular comparison of intended use, technological characteristics, performance specifications, and identification and discussion of differences.
4. Proposed Performance Testing Plan (Bench Testing, Biocompatibility, EMC, Software V&V). A summary of the Applicant's proposed bench testing program, including analytical performance testing, biocompatibility testing (ISO 10993), electromagnetic compatibility testing (IEC 60601-1-2), electrical safety testing (IEC 60601-1), wireless coexistence testing, sterilization validation, shelf life/stability testing, and software verification and validation (V&V) testing.
5. Proposed Clinical Study Protocol Summary (Protocol SBD-LUM-CL-001). A summary of the proposed LUMINA-US clinical study protocol, including study objectives, study design, inclusion/exclusion criteria, study endpoints, sample size justification, statistical analysis plan, and study sites.
6. Specific Questions for FDA (Organized by Topic Area). A comprehensive list of specific questions for FDA, organized by the seven topic areas identified in Section 10 of this form, with relevant background information and the Applicant's preliminary position on each question.
7. Supporting Appendices. The following supporting materials will be appended to the meeting package:
(a) Predicate comparison tables (detailed side-by-side comparison) (b) Device diagrams and engineering drawings (Lumina C14 and Lumina R7) (c) Software architecture overview and data flow diagrams (d) Summary of EU MDR clinical evaluation and post-market data (if available) (e) ISO 13485:2016 certificate (Solstice Biomedical Devices Ltd.) (f) EU MDR CE certificate (Certificate No. MCA-2024-07319) (g) Authorization letter from Solstice Biomedical Inc. to Calderwood & Harkness LLP
The Applicant will submit the Pre-Submission meeting package electronically via FDA eSTAR or eCopy, consistent with the submission instructions set forth in Appendix A of this form.
Section 12: Declaration and Signature block
I certify that the information provided in this Pre-Submission meeting request is true, accurate, and complete to the best of my knowledge. I understand that any materially false, fictitious, or fraudulent statement or representation may subject the person making such statement to criminal penalties under 18 U.S.C. § 1001. I further certify that Solstice Biomedical Inc. is the applicant and intended 510(k) holder for the Solstice Lumina™ CGM System and that Calderwood & Harkness LLP has been duly authorized to act on behalf of Solstice Biomedical Inc. in all communications with the Food and Drug Administration relating to this Pre-Submission request.
Applicant Signature:
SOLSTICE BIOMEDICAL INC.
By: ________
Name: Marcus Hale
Title: Vice President of U.S. Operations
Date: June 2, 2025
Authorized Representative Signature:
CALDERWOOD & HARKNESS LLP
By: ________
Name: Miriam Calloway
Title: Partner, Healthcare & Life Sciences Practice
Date: June 2, 2025
Appendix A: Correspondence Address and Submission Instructions
A.1 Submission Address
This Pre-Submission meeting request and the accompanying Pre-Submission meeting package should be submitted to:
Food and Drug Administration Center for Devices and Radiological Health (CDRH) Document Control Center (DCC) 10903 New Hampshire Avenue WO66-G609 Silver Spring, MD 20993-0002
A.2 Electronic Submission
The Applicant intends to submit this Pre-Submission meeting request and the accompanying meeting package electronically via FDA eSTAR or eCopy, in accordance with FDA guidance on electronic submissions. If an eCopy is submitted, it will be provided on a single CD/DVD or USB flash drive in a format compliant with CDRH electronic submission requirements, accompanied by a paper cover letter.
A.3 Correspondence Copy
A courtesy copy of this Pre-Submission meeting request and all correspondence relating to this request should be directed to:
Office of Health Technology 2 (OHT2) Division of Chemistry and Toxicology Devices Center for Devices and Radiological Health (CDRH) Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
A.4 Return Address
All correspondence from the Agency regarding this Pre-Submission request should be directed to the Applicant at:
Solstice Biomedical Inc.
Attn: Marcus Hale, VP of U.S. Operations
220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Telephone: (617) 555-0194
Email: regulatory@solsticebiomedical.com
A.5 Copy to Authorized Representative
The Applicant requests that the Agency copy all correspondence relating to this Pre-Submission request to the Authorized Representative at:
Calderwood & Harkness LLP
Attn: Miriam Calloway, Partner
1401 K Street NW, Suite 900 Washington, D.C. 20005 Telephone: (202) 555-0733
Email: miriam.calloway@calderwoodharkness.com
Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-0756. The time required to complete this information collection is estimated to average 10 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Public Reporting Burden Disclosure: Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing burden, to the Food and Drug Administration, CDRH, PRAStaff@fda.hhs.gov.
| Component Designation | Description | Form Factor | |
| Lumina C14 | Subcutaneously implantable continuous glucose monitoring sensor | Disposable sensor with integrated applicator | |
| Lumina R7 | Wearable reader/transmitter device | Arm-worn reusable electronic device | |
| Software Component | Version | Platform | Function |
| Lumina Firmware | v3.4.2 | Embedded (C14 sensor) | Sensor control, signal processing, BLE transmission |
| Lumina Reader OS | v2.1.0 | Embedded (R7 reader) | Device control, display, alerts, data management |
| LuminaPredict Algorithm | v2.1 | Embedded (R7 reader) | Predictive glucose trend analysis, predictive alerts |
| Lumina Mobile App | v1.0.3 | iOS 16+ / Android 13+ | Data display, reporting, cloud sync, sharing |
| Field | Details | ||
| Device Name | NovaSense GlucoTrack NX-500 CGM System | ||
| 510(k) Number | K211034 | ||
| Date Cleared | June 18, 2022 | ||
| Product Code | QKQ | ||
| Classification | Class II | ||
| Manufacturer | NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 | ||
| Field | Details | ||
| Device Name | NovaSense GlucoTrack NX-700 CGM System | ||
| 510(k) Number | K230489 | ||
| Date Cleared | March 7, 2024 | ||
| Product Code | QKQ | ||
| Classification | Class II | ||
| Manufacturer | NovaSense Medical Technologies Inc., 4800 Innovation Parkway, San Diego, CA 92121 | ||
| Field | Details | ||
| Device Name | Solstice GlucoStrip RX-200 Test Strip Reader | ||
| 510(k) Number | K192847 |
| Date Cleared | November 14, 2019 | |
| Product Code | NBW | |
| Classification | Class II | |
| Manufacturer | Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142 | |
| Name | Title / Affiliation | Role |
| Dr. Niamh Tierney | VP of Regulatory Affairs, Solstice Biomedical Devices Ltd. | Lead Presenter; Regulatory Strategy |
| Marcus Hale | VP of U.S. Operations, Solstice Biomedical Inc. | Applicant Representative |
| Dr. Aisling Burke | Chief Technology Officer, Solstice Biomedical Devices Ltd. | Device Technology & Engineering |
| Fiona Drennan | Quality Assurance Director, Solstice Biomedical Devices Ltd. | Quality Systems & Biocompatibility |
| Miriam Calloway, Esq. | Partner, Calderwood & Harkness LLP | Authorized Representative; Legal |
| Amy Whitfield, Esq. | Associate, Calderwood & Harkness LLP | Authorized Representative; Legal |
| Dr. Sandra Ellison | Managing Director, Pinnacle Regulatory Consulting Group LLC | Regulatory Consulting |
| Thomas Greenbaum | Senior Regulatory Specialist, Pinnacle Regulatory Consulting Group LLC | Regulatory Consulting |