Contract analysis

1. Sponsor Information The sponsor and intended 510(k) holder for the Lumina CGM System is: Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 United States Tel: (617) 482-9100 Fax: (617) 482-9101 The following individuals are designated as principal contacts for this Pre-Submission request and all related regulatory correspondence: Primary Contact for Correspondence: Marcus Hale Vice Preside

2. Device Description Summary 2.1 Product Line Overview The Solstice Lumina™ CGM System is a next-generation, continuous glucose monitoring system designed to provide real-time, minimally invasive interstitial glucose measurement for the management of diabetes mellitus. The System is comprised of two hardware components — the Lumina C14 Sensor and the Lumina R7 Reader — together with supporting firmware, software, an

1. Lumina Firmware v3.4.2 — Embedded firmware on the C14 Sensor controlling electrochemical measurement acquisition, analog-to-digital conversion, signal conditioning, and BLE data transmission.

2. Lumina Reader OS v2.1.0 — Proprietary real-time embedded operating system on the R7 Reader managing BLE data reception, algorithm execution, display rendering, alert management, and mobile application pairing.

3. LuminaPredict Algorithm v2.1 — Proprietary glucose prediction and trend analysis algorithm executing on the R7 Reader. LuminaPredict employs an adaptive Kalman filter and machine learning-based signal processing to convert raw sensor current (nanoamperes) to calibrated glucose concentration (mg/dL) and to generate trend predictions and rate-of-change calculations.

4. Lumina Mobile App v1.0.3 — Companion mobile application for iOS (16.0+) and Android (13.0+) platforms providing extended data visualization, glucose data sharing with healthcare providers, retrospective analysis, and optional cloud data backup. The mobile application is intended to complement — not replace — the R7 Reader display, and the System is designed to function fully without the mobile application. 2.5 Int

3. Intended Regulatory Pathway Solstice intends to submit a traditional 510(k) premarket notification for the Lumina CGM System in accordance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360(k)) and the implementing regulations at 21 C.F.R. Part 807, Subpart E. The Lumina CGM System will be submitted as a single, integrated device system encompassing both the C14 Sensor and the R7 Read

4. Predicate Device Identification 4.1 Primary Predicate Device Solstice has identified the following device as the primary predicate for the Lumina CGM System's 510(k) substantial equivalence determination: NovaSense Medical Technologies Inc. GlucoTrack NX-500 CGM System • 510(k) Number: K211034 • Date of Clearance: June 18, 2022 • Product Code: QKQ • Classification: Class II • Regulation Number: 21 C.F.R. § 862.135

5. Regulatory History of Sponsor Solstice Biomedical Inc.'s parent company, Solstice Biomedical Devices Ltd. (Dublin, Ireland), has an established history of regulatory engagement with the U.S. Food and Drug Administration and with international regulatory authorities. The following summarizes the key elements of the sponsor's regulatory history relevant to this Pre-Submission request: • Prior FDA Clearance. Solstice

6. Pre-Submission Meeting Request Details In accordance with the FDA's Q-Submission Program guidance, Solstice provides the following details regarding the requested Pre-Submission meeting: Meeting Type Requested: Q-Submission (Pre-Sub) meeting pursuant to 21 C.F.R. Part 807 and the FDA guidance document Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (Revised January 2023)

1. Executive Summary — A concise overview of the Lumina CGM System, the proposed regulatory pathway, and the key topics and questions for discussion at the Pre-Submission meeting.

2. Detailed Device Description — Comprehensive technical description of the C14 Sensor, R7 Reader, associated firmware and software components, system architecture, and user interface design, supplemented with engineering drawings, system block diagrams, and photographs.

3. Predicate Comparison and Substantial Equivalence Discussion — A side-by-side comparison of the Lumina CGM System with the proposed primary predicate device (GlucoTrack NX-500, K211034) and secondary predicate device (GlucoTrack NX-700, K230489), including an analysis of intended use, technological characteristics, performance characteristics, and identification of differences with supporting rationale for substant

4. Proposed Performance Testing Plan — A summary of the bench testing, analytical performance testing, electrical safety and electromagnetic compatibility (EMC) testing, software verification and validation testing, biocompatibility testing, sterility/shelf-life testing, and wireless coexistence testing that Solstice proposes to conduct (or has already completed) in support of the 510(k) submission.

5. Proposed Clinical Study Protocol Summary — A summary of Protocol SBD-LUM-CL-001 ("LUMINA-US"), the prospective clinical study that Solstice proposes to conduct at U.S. clinical sites to generate clinical performance data for the 510(k) submission, including the study design, population, endpoints, sample size justification, statistical analysis plan, and site selection.

6. Specific Questions for FDA — The detailed questions that Solstice seeks the Division's feedback on at the Pre-Submission meeting, organized by topic area as summarized in Section 7 of this cover letter.

7. Summary of Topics and Questions for Discussion Solstice intends to present the following categories of questions and topics for discussion at the Pre-Submission meeting. Detailed, fully developed questions will be included in the Pre-Submission meeting package to be submitted by June 16, 2025. The following provides a summary of the question categories to assist the Division in identifying the appropriate reviewer

8. Proposed Attendee List Solstice proposes the following individuals to attend the Pre-Submission meeting on behalf of the sponsor, its legal counsel, and its regulatory consultant. Solstice respectfully requests that the Division identify the FDA attendees in advance of the meeting so that Solstice may tailor its presentation to the expertise and review responsibilities of the participating FDA staff. From Solstice

1. Dr. Niamh Tierney, RAC — Vice President, Regulatory Affairs, Solstice Biomedical Devices Ltd. (Dublin, Ireland). Dr. Tierney will serve as the lead regulatory presenter for the Pre-Submission meeting.

2. Marcus Hale — Vice President, U.S. Operations, Solstice Biomedical Inc. (Cambridge, MA). Mr. Hale will serve as the primary sponsor contact and administrative coordinator.

3. Dr. Aisling Burke — Chief Technology Officer, Solstice Biomedical Devices Ltd. (Dublin, Ireland). Dr. Burke will address technical questions regarding the C14 Sensor's PtIr-4G electrode technology, the R7 Reader hardware design, firmware and software architecture, and the LuminaPredict Algorithm.

4. Fiona Drennan — Quality Assurance Director, Solstice Biomedical Devices Ltd. (Dublin, Ireland). Ms. Drennan will address questions regarding quality system documentation, biocompatibility and sterilization validation, and manufacturing process controls. From Calderwood & Harkness LLP:

5. Miriam Calloway, Esq. — Partner, Healthcare & Life Sciences Regulatory Practice. Ms. Calloway will serve as lead legal counsel and will address regulatory strategy, IDE exemption analysis, and procedural questions.

6. Amy Whitfield, Esq. — Lead Associate, Healthcare & Life Sciences Regulatory Practice. Ms. Whitfield will provide supporting legal and regulatory analysis.

7. Sean Morrissey, Esq. — Associate, Healthcare & Life Sciences Regulatory Practice. Mr. Morrissey will provide supporting research and documentation. From Pinnacle Regulatory Consulting Group LLC:

8. Dr. Sandra Ellison — Managing Director. Dr. Ellison will provide subject-matter expertise on CGM device review expectations, performance testing, and clinical study design, drawing on her prior experience as a scientific reviewer in the Division of Chemistry and Toxicology Devices, CDRH.

9. Thomas Greenbaum — Senior Regulatory Specialist. Mr. Greenbaum will support the presentation of the predicate comparison and substantial equivalence analysis.

9. Enclosures The following document is enclosed with this Pre-Submission Meeting Request cover letter:

1. FDA Form 3514 — Pre-Submission Meeting Request Form, completed and signed by Marcus Hale, VP of U.S. Operations, Solstice Biomedical Inc., on behalf of the sponsor. Solstice notes that the complete Pre-Submission meeting package — including the executive summary, detailed device description, predicate comparison and substantial equivalence discussion, proposed performance testing plan, proposed clinical study prot

10. Contact and Correspondence Information All correspondence regarding this Pre-Submission request, including meeting scheduling communications, feedback letters, and any requests for additional information, should be directed to: Primary Contact: Marcus Hale Vice President, U.S. Operations Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Tel: (617) 482-9115 Fax: (617) 482-9101 Email: m.ha