Contract analysis

Section 5: Predicate Comparison and Substantial Equivalence Discussion Solstice Lumina™ CGM System Pre-Submission (Q-Sub) Sponsor: Solstice Biomedical Inc. 220 Westbrook Drive, Suite 400 Cambridge, MA 02142 Parent Company: Solstice Biomedical Devices Ltd. Unit 14, Liffey Innovation Park Chapelizod, Dublin D20 FX72, Ireland Prepared by: Calderwood & Harkness LLP 1401 K Street NW, Suite 900 Washington, D.C. 20005 On be

1. Purpose and Scope This Section 5 of the Solstice Lumina™ CGM System Pre-Submission (Q-Sub) meeting package presents the predicate device identification, substantial equivalence rationale, and detailed comparative analysis for the Solstice Lumina™ Continuous Glucose Monitoring (CGM) System. The purpose of this section is to provide the U.S. Food and Drug Administration ("FDA" or "Agency") with a comprehensive and t

2. Regulatory Background 2.1 Applicable Classification and Regulation The Solstice Lumina™ CGM System is a continuous glucose monitoring system intended for prescription use in adults with diabetes mellitus. Based on its intended use, technological characteristics, and device design, the Lumina CGM System falls within the following regulatory classification: • Product Code: QKQ — Electrode, Glucose, Subcutaneous • Re

3. Identification of Predicate Devices Solstice has identified two predicate devices — a primary predicate and a secondary predicate (reference device) — to support the substantial equivalence determination for the Solstice Lumina™ CGM System. In addition, Solstice's previously cleared device (K192847) is referenced solely for corporate pedigree purposes. Each device is described below. 3.1 Primary Predicate Device D

4. Subject Device Overview 4.1 Intended Use The Solstice Lumina™ CGM System is intended for continuous glucose monitoring in persons aged 18 years and older with Type 1 or Type 2 diabetes mellitus. The system is intended for prescription use only. The Solstice Lumina™ CGM System continuously measures glucose levels in interstitial fluid via a subcutaneously implanted enzymatic electrochemical sensor (the Lumina C14).

5. Substantial Equivalence Comparison Table 5.1 Side-by-Side Comparison Matrix The following comprehensive comparison table presents a detailed side-by-side comparison of the key characteristics and parameters of the subject device (Solstice Lumina™ CGM System), the primary predicate device (NovaSense GlucoTrack NX-500, K211034), and the secondary predicate device (NovaSense GlucoTrack NX-700, K230489). This comparis

6. Discussion of Technological Differences and Substantial Equivalence 6.1 Overview of Analytical Framework The legal standard for substantial equivalence is set forth in Section 513(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 360c(i), and implemented through the regulations at 21 C.F.R. § 807.100. Under this framework, a new device may be found substantially equivalent to a legally markete

1. Sensor wear duration (14 days vs. 10 days)

2. Electrode material (platinum-iridium PtIr-4G vs. platinum)

3. Wireless communication protocol version (BLE 5.2 vs. BLE 5.0)

4. Reader form factor (arm-worn vs. handheld)

5. Glucose prediction/processing algorithm (LuminaPredict v2.1 vs. NovaSense proprietary algorithm) Solstice respectfully submits that none of these differences raise new or different questions of safety or effectiveness that cannot be resolved through the proposed performance testing, biocompatibility testing, and clinical data. Each difference is analyzed individually in Sections 6.2 through 6.6 below. For each dif

7. Summary of Proposed Testing to Support Substantial Equivalence The following subsections provide a high-level summary of the testing program that Solstice proposes to conduct in support of the substantial equivalence determination for the Solstice Lumina™ CGM System. Detailed test protocols and study plans are presented in Section 6 (Proposed Performance Testing Plan) and Section 7 (Proposed Clinical Study Protoco

8. Substantial Equivalence Conclusion Based on the analysis presented in this Section 5 of the Pre-Submission meeting package, Solstice Biomedical Inc. respectfully submits the following conclusions regarding the substantial equivalence of the Solstice Lumina™ CGM System to the identified predicate devices: Same Intended Use. The Solstice Lumina™ CGM System has the same intended use as the primary predicate device (N