Contract analysis

1. Introduction and Purpose 1.1 Purpose of This Section This document constitutes Section 4 of the Pre-Submission (Q-Sub) meeting package submitted by Solstice Biomedical Inc. ("Solstice" or the "Sponsor") to the United States Food and Drug Administration ("FDA"), Center for Devices and Radiological Health ("CDRH"), Office of Health Technology 2 ("OHT2"), Division of Chemistry and Toxicology Devices. The Pre-Submissi

2. Proposed Bench (Non-Clinical) Performance Testing 2.1 Overview of Bench Testing Scope The proposed bench (non-clinical) performance testing program has been designed to comprehensively evaluate the safety and performance of both the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter under simulated and actual use conditions. The testing program is organized into five principal categories,

3. Biocompatibility Testing Plan 3.1 General Approach and Applicable Standards The biocompatibility evaluation for the Solstice Lumina™ CGM System will be conducted in accordance with ISO 10993-1:2018, Biological evaluation of medical devices — Part 1: Evaluation and review within a risk management process. ISO 10993-1 provides the overarching framework for biological evaluation and directs the identification of appr