MiniMed Go App

The MiniMed Go App is a software-only mobile application that connects with compatible continuous glucose monitors (Simplera and Instinct sensors) and the InPen smart insulin injector to help people with diabetes manage their therapy. It provides data visualization, insulin dose calculation based on glucose values and carbohydrate intake, event logging, and alerts/reminders for glucose and insulin dosing.

Compared to the predicate InPen System App, the MiniMed Go App adds direct Bluetooth and NFC connectivity to compatible CGMs (Simplera and Instinct sensors) for real-time glucose display and trend arrows, whereas the predicate obtained glucose values from cloud servers. Both apps support the same insulin dose calculator functionality, therapy settings ranges (with minor differences in carb ratio and insulin sensitivity ranges), and alert types. The subject device also runs on a dedicated durable handheld medical device (App Manager) in addition to standard smartphones.

Testing conducted per EN IEC 62304:2015 (software life cycle processes), IEC 62368-1 (electromagnetic compatibility), IEC 62366-1:2015 and HE75:2009 (human factors/usability), ISO 10993-1 (biocompatibility), ISO 14971:2019 (risk management), and FDA guidance on human factors engineering.

The MiniMed Go App is substantially equivalent to the InPen System App (K242775) because both are Class II software devices with the same manufacturer, product code, regulation, and intended use for diabetes management via insulin dose calculation and logging. Although the subject device adds CGM connectivity and expanded patient populations, the core insulin dosing algorithm and therapeutic function remain unchanged, all technological differences were tested and shown not to raise safety concerns, and comprehensive performance validation demonstrates safe and effective operation.