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The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.

The Dexcom Glucose Program System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions for persons with diabetes who are not at significant risk of severe hypoglycemia. Interpretation of the Dexcom Glucose Program System results should be based on the glucose trends and sequential sensor readings over time. The Dexcom Glucose Program System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments.

The Dexcom Glucose Program System is also intended to autonomously communicate with digitally connected devices. The Dexcom Glucose Program System can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

The Dexcom G6 Glucose Program Continuous Glucose Monitoring System (Dexcom Glucose Program System) is a continuous glucose monitor (CGM) that offers an altered feature set versus the predicate Dexcom G6 CGM System.

The Dexcom Glucose Program System consists of three main components: a sensor/applicator delivery system, a transmitter, and a mobile application (app). The sensor is a small and flexible wire inserted into subcutaneous tissue where it converts glucose into electrical current. The transmitter is connected to the sensor and is worn on the body. It samples the electrical current produced by the sensor and converts these measurements into glucose readings using an onboard algorithm. The transmitter sends glucose data to the app. The app displays the current glucose reading (updated every 5 minutes) and glucose trends (up to 12 hours) from the transmitter. The app alerts users of important system conditions, when it enters an error state, or when requiring the user to enter information. The app also supports connectivity to Dexcom Share and Follow (DEN140016), however, the new app is a separate device from the Share and Follow apps.

The provided text is a U.S. FDA 510(k) summary for the Dexcom G6 Glucose Program Continuous Glucose Monitoring System. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain the detailed acceptance criteria for performance, the results of a specific study proving the device meets those criteria, or information on sample sizes, ground truth establishment, or expert involvement.

The document states that the device was "verified and validated according to Dexcom's internal design control process and in accordance with special controls for integrated continuous glucose monitors" and that "This testing demonstrated that the system performed according to its specifications and that the technological and performance criteria are comparable to the predicate device."

Nonetheless, specific quantitative acceptance criteria and detailed study results are not present in the provided text. To answer your request thoroughly, this information would need to be extracted from a separate clinical study report or a more detailed section of the 510(k) submission that is not included here.

Therefore, I cannot populate the table or provide detailed information for points 2 through 9 based solely on the provided text.

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