Contract analysis

I. Executive Summary This memorandum analyzes the proposed biocompatibility testing program for the Solstice Lumina™ Continuous Glucose Monitoring ("CGM") System, encompassing both the Lumina C14 implantable sensor (the "C14 Sensor") and the Lumina R7 wearable reader/transmitter (the "R7 Reader"), in support of Solstice's planned traditional 510(k) premarket notification submission covering both the C14 Sensor and R7

II. Regulatory Framework for Biocompatibility Assessment A. Applicable Standards and Guidance The biocompatibility evaluation of medical devices in the United States is governed by an interlocking framework of international standards and FDA-specific guidance. The following standards and guidance documents form the primary regulatory basis for the Lumina CGM System biocompatibility testing program: ISO 10993-1:2018 —

III. Proposed Biocompatibility Testing Scope — Lumina C14 Sensor A. Overview As discussed in Section II.B above, the C14 Sensor is classified as a subcutaneously implanted device with prolonged tissue and blood contact. This classification triggers the full battery of biological evaluation endpoints recommended under ISO 10993-1:2018 Table A.1 for implant devices with prolonged contact. The proposed Whitmore testing

I. Genotoxicity (ISO 10993-3) Test standard: ISO 10993-3:2014 — Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. Test method: The genotoxicity assessment typically includes a tiered battery of tests: • In vitro bacterial reverse mutation assay (Ames test): This test evaluates the mutagenic potential of device extracts using several strains of Salmon

IV. Proposed Biocompatibility Testing Scope — Lumina R7 Reader/Transmitter A. Overview The R7 Reader/Transmitter is an arm-worn external device with prolonged intact skin contact. As described in Section II.B above, this device is classified as a surface-contacting device (skin) with prolonged contact duration under ISO 10993-1:2018. The applicable biological evaluation endpoints for this device category are limited

V. Gap Analysis Against FDA Biocompatibility Guidance A. Methodology Calderwood & Harkness, in coordination with Pinnacle Regulatory Consulting Group LLC, conducted a gap analysis comparing the proposed Whitmore testing program against FDA's September 2020 guidance on the use of ISO 10993-1. This analysis identifies areas where the proposed testing program may fall short of FDA's current expectations or where supplem

VI. PtIr-4G Electrode Coating — Risk Assessment and Special Considerations A. Material Description The PtIr-4G designation refers to Solstice's fourth-generation enzymatic electrochemical biosensor electrode coating. This coating is composed of a platinum-iridium alloy deposited on the C14 Sensor's working electrode surface using a proprietary deposition process developed by Solstice's materials science team in Dubli

VII. Budget Analysis A. Total Testing Budget The total biocompatibility testing budget is $485,000, based on the formal quotation provided by Whitmore Laboratories Inc. on March 3, 2025. This amount is part of the broader estimated total external regulatory costs of $6,127,417 for the Lumina CGM System Pre-Submission through 510(k) clearance process, as documented in the overall regulatory budget workbook maintained