SmartGuard Technology; Predictive Low Glucose Technology

SmartGuard Technology is an Advanced Hybrid Closed Loop (AHCL) algorithm that automatically adjusts basal insulin delivery and delivers correction boluses based on continuous glucose monitor readings every 5 minutes, with user-selectable glucose targets of 100, 110, or 120 mg/dL. Predictive Low Glucose Technology (PLGM) is a software algorithm that automatically suspends insulin delivery when sensor glucose falls below or is predicted to fall below predefined thresholds. Both are intended for management of Type 1 diabetes in persons 7 years and older, and Type 2 diabetes in persons 18 years and older requiring insulin, for single patient use with a prescription.

Both subject devices are software-only interoperable automated glycemic controllers (iAGCs) embedded in compatible ACE pump firmware with no user interface. SmartGuard supports three target glucose setpoints and a temporary 150 mg/dL target; PLGM suspends insulin for 30 minutes to 2 hours. Both communicate with compatible CGMs/iCGMs via Bluetooth Low Energy and receive user inputs through an ACE pump or MiniMed App. The subject devices add compatibility with Type 2 diabetes patients and additional insulins (Fiasp, Lyumjev) but otherwise maintain the same design, architecture, features, and principles of operation as predicate devices.

ISO 14971:2019 (risk management), IEC 62304:2006/A1:2016 (software lifecycle), IEC 62366-1:2015 (human factors), HE75:2009 (human factors), 21 CFR 862.1356 (iAGC special controls). FDA guidances cited include content of premarket submissions for device software (June 2023), interoperable medical device design (September 2017), human factors and usability (February 2016), computational modeling credibility (November 2023), and predetermined change control plans (August 2024).

The subject devices have identical intended use, indications, and environment of use as their predicates with only minor technological differences that do not raise new safety or effectiveness questions. The algorithm design, architecture, features, logical flows, safeguards, and principles of operation remain unchanged from predicate K251217. Non-clinical and clinical performance data, including Virtual Patient Model simulations demonstrating equivalence to real patient studies, show both devices meet all iAGC Special Controls requirements and provide reasonable assurance of safety and effectiveness, establishing substantial equivalence to predicates for Product Codes QJI, QJS, and NDC.