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510(k) Data Aggregation

    K Number
    K253710

    Validate with FDA (Live)

    Device Name
    Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
    Manufacturer
    Dexcom, Inc.
    Date Cleared
    2025-12-17

    (23 days)

    Product Code
    QBJ
    Regulation Number
    862.1355
    Type
    Special
    Panel
    Clinical Chemistry
    Age Range
    2 - 120
    Reference & Predicate Devices
    K240902,K243214
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dexcom G7 15 Day System or G7 15 Day) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 18 years and older.

    The Dexcom G7 15 Day CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 15 Day CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 15 Day CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

    The Dexcom G7 15 Day CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 15 Day CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

    The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 CGM System or G7) is a real time, continuous glucose monitoring device indicated for the management of diabetes in persons 2 years and older.

    The Dexcom G7 CGM System is intended to replace fingerstick BG testing for diabetes treatment decisions. Interpretation of the Dexcom G7 CGM System results should be based on the glucose trends and several sequential sensor readings over time. The Dexcom G7 CGM System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.

    The Dexcom G7 CGM System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G7 CGM System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes.

    Device Description

    The Dexcom G7 Continuous Glucose Monitoring System (Dexcom G7 System) and the Dexcom G7 15 Day Continuous Glucose Monitoring System (Dexcom G7 15 Day System) are interoperable continuous glucose monitoring (CGM) systems intended to continuously measure the glucose in the interstitial fluid, calculate the glucose reading and make this available to the user. Both the Dexcom G7 System and the Dexcom G7 15 Day System are intended for single patient use at home and require a prescription.

    The Dexcom G7 System and the Dexcom G7 15 Day System consist of the following primary components: a wearable, consisting of a sensor and transmitter worn on the body and a display device, which can be a G7 Mobile Application (Mobile App) on an iOS or Android OS smart device or a G7 Receiver (Receiver).

    To achieve the intended functions and performance of both the Dexcom G7 System and the Dexcom G7 15 Day System, one sensor and at least one display device (App or Receiver) must be used together. The user must pair the display device(s) with each unique sensor to enable communication and start a sensor session. During an active session, the sensor reports new glucose data to the display device every 5 minutes. The display device then displays glucose data and provides alerts and information signals to the user. The reportable glucose range for both the Dexcom G7 System and the Dexcom G7 15 Day System is 40 mg/dL to 400 mg/dL. Glucose values below this range are reported as "LOW" and glucose values above this range are reported as "HIGH". The Dexcom G7 System sensor has an expected wear period of up to 10 days with an extended 12-hour grace period after the sensor session. The Dexcom G7 15 Day System sensor has an expected wear period of up to 15 days with an extended 12-hour grace period after the sensor session. The grace period allows additional time for the user to change the sensor at a convenient time.

    Both the Dexcom G7 System and the Dexcom G7 15 Day System are interoperable connected devices that can communicate glucose readings and other information wirelessly and securely to and from compatible electronic interfaces via the following secure wireless connections:

    • Wireless communication from the transmitter directly to an interoperable device communicating through the same protocol
    • The Mobile App communicates to another app on a single mobile platform
    • The Mobile App communicates through the cloud to another software device
      • Dexcom Partner Web APIs: The Dexcom Partner Web APIs enable secure and reliable communication of CGM data to authorized client software intended to receive the data through the cloud. The Partner Web APIs is not intended to be used by automated insulin delivery systems (AID).

    Principle of Operation:

    The principles of operation for the Dexcom G7 System and Dexcom G7 15 Day System remain the same as prior generations of Dexcom CGM Systems. The System uses a wire-type sensing mechanism that continuously measures interstitial glucose levels and uses a radio transmitter to wirelessly communicate glucose data to the display device for the user to see and use accordingly.

    AI/ML Overview

    N/A

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