Dexcom G7 15 Day Continuous Glucose Monitoring System

The Dexcom G7 15 Day Continuous Glucose Monitoring System is a wearable device that continuously measures glucose in interstitial fluid and wirelessly transmits readings every 5 minutes to a display device (mobile app or receiver). It is indicated for diabetes management in persons 18 years and older, can replace fingerstick testing, and communicates with automated insulin delivery systems.

The subject device shares the same fundamental technological characteristics, hardware, materials, chemical composition, principle of operation, and energy source as the predicate Dexcom G7 CGM System. Both use a wire-type sensing mechanism with a radio transmitter to wirelessly communicate glucose data. Design differences between the two devices do not constitute a new intended use.

IEC 62304 (medical device software lifecycle), IEC 62366-1:2015/AMD 1:2020 (usability engineering), ANSI/AAMI HE75:2009/(R) 2018 (human factors design), FDA Guidance for Device Software Functions (June 2023), and FDA Cybersecurity Guidance (September 2023).

The subject device differs from the predicate only in the age of the intended patient population (18+ years versus 2+ years) while maintaining identical intended use as a real-time continuous glucose monitoring device for diabetes management. Nonclinical testing on predicate and reference devices and clinical testing on the subject device demonstrate equivalent safety and effectiveness, with the subject device meeting iCGM special controls per 21 CFR 862.1355. Since design differences do not raise different safety or effectiveness questions and clinical performance is comparable to the predicate, substantial equivalence is established.