Contract analysis

I. Executive Summary The purpose of this memorandum is to provide Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc. (collectively, "Solstice") with a comprehensive legal and regulatory analysis of whether the Solstice Lumina™ CGM System — comprising the Lumina C14 implantable sensor and the Lumina R7 wearable reader/transmitter — qualifies for classification as an integrated continuous glucose monitoring

II. Background A. The Solstice Lumina™ CGM System The Solstice Lumina™ CGM System is a continuous glucose monitoring system designed for real-time measurement of glucose concentrations in persons aged eighteen (18) years and older who have been diagnosed with Type 1 or Type 2 diabetes mellitus. The system comprises two device variants and associated software components, which together constitute a single system inten

III. Regulatory Framework for iCGM Classification A. Historical Context: De Novo Classification Order DEN170088 The iCGM classification was established by FDA through a De Novo classification request, designated DEN170088, which was granted in 2018. The De Novo pathway, codified at 21 U.S.C. § 360c(f)(2) and 21 C.F.R. Part 860, Subpart D, permits FDA to classify novel medical devices of low to moderate risk for which

IV. Special Controls Applicable to iCGM Devices This Section provides a detailed analysis of each category of special controls applicable to iCGM devices and their application to the Solstice Lumina™ CGM System. The special controls established under De Novo classification order DEN170088, as updated by the March 2024 reclassification order, encompass the following categories: (A) analytical performance criteria; (B)

1. MARD (Mean Absolute Relative Difference) Requirement The Mean Absolute Relative Difference, commonly referred to as MARD, is the primary accuracy metric used to evaluate CGM device performance. MARD quantifies the average deviation between CGM glucose readings and paired reference glucose measurements (typically obtained via YSI laboratory-grade glucose analyzer), expressed as a percentage of the reference value.

2. Consensus Error Grid / Point Accuracy In addition to the overall MARD requirement, the iCGM special controls require that a device demonstrate high point accuracy as measured by the Clarke Error Grid Analysis or the Consensus Error Grid Analysis. Specifically, the iCGM special controls require that ≥ 99% of paired CGM-reference data points fall within Zones A and B of the Clarke or Consensus Error Grid. Zone A rep

3. Alarm/Alert Performance iCGM devices must demonstrate adequate hypoglycemia and hyperglycemia alert performance as part of the special controls assessment. Alert performance is clinically important because users and, in the iCGM context, secondary devices rely on the CGM system's alerts to detect and respond to dangerous glucose excursions. An iCGM device that fails to alert on a hypoglycemic event, or that genera

4. Sensor Reliability and Functional Life The iCGM special controls require demonstration that the sensor maintains reliable and consistent performance throughout its specified functional life. For the Lumina C14 sensor, the specified functional life is fourteen (14) days (336 hours), which aligns with the secondary predicate device (NovaSense GlucoTrack NX-700, K230489) and is within the range of currently marketed

V. Comparison: iCGM Classification vs. Standard 510(k) CGM Classification A. Pathway Options Solstice has two primary regulatory pathway options for the Lumina CGM System's U.S. market authorization, both of which involve a traditional 510(k) premarket notification submission under 21 C.F.R. Part 807, Subpart E: Option 1: Traditional 510(k) with Standard CGM Classification (Non-iCGM). Under this option, Solstice woul

1. Cite an additional iCGM predicate. Solstice could identify a legally marketed iCGM device (i.e., a device cleared under the iCGM classification established by DEN170088) as a predicate or reference device, in addition to the NovaSense devices. This would provide FDA with a clear classification basis for iCGM classification.

2. Pursue iCGM classification based on special controls compliance alone. Solstice could argue that iCGM classification is warranted based on the device's compliance with the iCGM special controls, even if the primary predicate is a non-iCGM device. This approach would require Solstice to demonstrate that the Lumina system meets all iCGM performance criteria and that iCGM classification is appropriate given the devic

3. File a De Novo classification request. As a last resort, if FDA determines that iCGM classification is not available through the 510(k) pathway given the non-iCGM status of the predicates, Solstice could file a De Novo classification request. However, this option is not preferred because the iCGM classification already exists — there is no need to establish a new classification — and the De Novo pathway would add