Extract to table

As a Class II device, the Lumina CGM System is subject to the premarket notification (510(k)) pathway, and the 510(k) submission must include adequate biocompatibility data to support a determination of substantial equivalence to the identified predicate devices

The Lumina CGM System comprises two distinct components with fundamentally different contact profiles, which must be evaluated separately

Although iridium is generally considered to be a rare allergen, the combination of iridium with platinum and any proprietary surface treatments or processing aids used in the PtIr-4G deposition process must be evaluated

The test protocols must include appropriate positive controls to validate assay sensitivity and appropriate extraction conditions to ensure worst-case extractable levels are captured

Biocompatibility Risk Factors The biocompatibility risk assessment for the PtIr-4G electrode coating must consider each constituent element and the alloy as a whole: Platinum

Relationship to Freedom-to-Operate Analysis The biocompatibility testing strategy for the PtIr-4G electrode coating must be coordinated with Solstice's ongoing freedom-to-operate ("FTO") analysis, being conducted by Crestline IP Advisory LLC ("Crestline")