Contract analysis

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 Registr

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 int

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 gluc

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 Cla

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 inten

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 pati

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 devi

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 ac

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

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 doe

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

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

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

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, Consensu

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

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 i

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]

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 mile

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, ope

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

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 t

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. Respe

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 throug