BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P160007 · Decision Mar 8, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Guardian Connect system
    PMA Number
    P160007
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 8, 2018
    Date Received
    March 8, 2016
    Expedited Review
    N
    Docket Number
    18M-1371

    Advisory Committee Statement

    Approval for the Guardian Connect system.The Guardian Connect system is indicated for continuous or periodic monitoring of glucose levels in the interstitial fluid under the skin, in patients (14 to 75 years of age) with diabetes mellitus. The Guardian Connect system provides real-time glucose values and trends through a Guardian Connect app installed on a compatible consumer electronic mobile device. It allows users to detect trends and track patterns in glucose concentrations. The Guardian Connect app alerts if a Guardian Sensor (3) glucose level reaches, falls below, rises above, or is predicted to surpass set values. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on values provided by the Guardian Sensor (3).The Guardian Connect system is comprised of the following devices: Guardian Connect app, Guardian Sensor (3), and the Guardian Connect transmitter.Guardian Sensor (3):The Guardian Sensor (3) is intended for use with Medtronic Diabetes glucose-sensing systems, to continuously monitor glucose levels in persons with diabetes. The Guardian Sensor (3) is indicated for 7 days of continuous use. It is indicated for use as an adjunctive device to complement, not replace, information obtained from standard blood glucose monitoring devices. The sensor is intended for single use and requires a prescription. Guardian Connect Transmitter:The Guardian Connect transmitter is intended for use with the Guardian Connect system. The Guardian Connect transmitter powers the glucose sensor, collects and calculates sensor data, and sends the data via Bluetooth version 4.0 to the Guardian Connect app installed on a compatible mobile device. The transmitter is only compatible with the Guardian Sensor (3). The transmitter is indicated for multiple uses on a single patient as a component of the Guardian Connect system.The Guardian Connect transmitter requires a prescription. Guardian Connect App:The Guardian Connect app is intended for use only by patients using a compatible mobile device, and who have sufficient experience to adjust mobile device audio and notification settings. The app displays sensor glucose data, and also provides a user interface for sensor calibration, entering data such as exercise and meals, and uploading information to the CareLink Personal website. It allows users to detect trends and track patterns in glucose concentrations. The Guardian Connect app provides alerts if a Guardian Sensor (3) glucose level reaches, falls below, rises above, or is predicted to surpass set values.The Guardian Connect app is available over-the-counter (OTC) but requires the Guardian Sensor (3) and Guardian Connect transmitter to function.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MDS Sensor, Glucose, Invasive