SmartGuard technology; Predictive Low Glucose technology

SmartGuard technology is a software-only Advanced Hybrid Closed Loop (AHCL) algorithm that automatically adjusts basal insulin delivery and delivers correction boluses based on continuous glucose monitor readings. Predictive Low Glucose technology is a software-only Predictive Low Glucose Management (PLGM) algorithm that automatically suspends insulin delivery when glucose values fall below or are predicted to fall below predefined thresholds. Both are intended for managing Type 1 diabetes in persons 7 years and older and Type 2 diabetes in persons 18 years and older, requiring insulin, and are used with compatible pumps and continuous glucose monitors.

The subject devices have identical technological characteristics to their predicate devices (K251217). Both SmartGuard and PLGM algorithms are embedded software within compatible alternate controller enabled (ACE) pumps, communicate via Bluetooth Low Energy with compatible continuous glucose monitors, adjust insulin delivery at five-minute intervals, and include multiple safeguards against over- or under-delivery of insulin. No differences in design, materials, chemical composition, energy source, or manufacturing process exist between subject and predicate devices.

Software verification and validation performed per IEC 62304 and FDA's 2023 guidance on Device Software Functions. Human factors and usability engineering conducted per IEC 62366-1:2015, HE75:2009, and FDA guidance on Applying Human Factors and Usability Engineering to Medical Devices (February 2016). Risk management completed per ISO 14971:2019. Cybersecurity assessment and penetration testing conducted with software bill of materials provided.

The subject devices are substantially equivalent to their predicates because they have identical intended uses, indications for use, principle of operation, compatible hardware, and all technological characteristics. The devices are software-only with no differences in design or performance. Comprehensive non-clinical testing (software verification, cybersecurity, human factors) and clinical data from multiple studies demonstrate safety and effectiveness equivalent to predicates. Both devices meet all iAGC Special Controls requirements under 21 CFR 862.1356.