Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

The Dexcom G7 Continuous Glucose Monitoring System and Dexcom G7 15 Day System are real-time CGM devices that continuously measure interstitial glucose levels and wirelessly transmit data to a display device (smartphone app or receiver). They are intended to replace fingerstick blood glucose testing for diabetes management in persons 2 years and older (G7) or 18 years and older (G7 15 Day), and can communicate with automated insulin dosing systems.

The subject devices have the same fundamental technological characteristics as their predicate devices (K240902 and K243214). The only design difference is the introduction of an alternate adhesive patch on the wearable sensor-transmitter component. All other system components, sensing mechanism, wireless communication protocols, and reportable glucose range (40–400 mg/dL) remain unchanged.

ISO 10993 (biocompatibility), AAMI TIR 28 and ANSI/AAMI/ISO 11135 (sterilization), accelerated aging testing (shelf life), mechanical functional testing (alternate adhesive patch), and a clinical study validating safe and effective use with the new adhesive patch.

The devices are substantially equivalent because they maintain identical indications for use and fundamental technological characteristics as their predicates; the alternate adhesive patch is a design difference that does not constitute a new intended use and does not raise different safety or effectiveness questions. Nonclinical and clinical testing demonstrated the devices meet acceptance criteria and are as safe and effective as the predicate devices.