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510(k) Data Aggregation

    K Number
    K122361
    Device Name
    T:CONNECT DATA MANAGEMENT SYSTEM
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Date Cleared
    2013-02-22

    (203 days)

    Product Code
    OUG, LZG
    Regulation Number
    880.6310
    Why did this record match?
    Product Code :

    OUG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The t.connect Diabetes Management Application is intended for use by individuals with diabetes mellitus who use Tandem Diabetes Care insulin pumps, their care givers, and their healthcare providers in home and clinical settings. The t:connect Application supports diabetes management through the display and analysis of information downloaded from Tandem Diabetes Care insulin pumps and specified blood glucose meters.
    Device Description
    The Tandem t:connect is a web based software system which allows pump users, care professionals to view data retrieved from a Tandem Ambulatory Insulin Pump and Blood Glucose meters. t:connect is comprised of a Data Uploader, a Web Application, a Secure Web and Database Server, and an Admin Web Application. The t:connect Data Uploader is a client based software application installed on the pump user's personal computer. Using a USB cable connecting the pump to a personal computer, the application uploads pump data to a secure online database server through a secure, encrypted, internet connection. The t.connect Data Uploader also uploads data from a limited set of Blood Glucose meters. The t:connect Web Application is a reporting application that provides users with the ability to view and print (to PDF) both tabular and graphical reports representing the data uploaded to the online database. The tconnect Web and Database Server is an application that runs on the secure server. Data displayed on the t:connect Web Application is retrieved from the secure Database "intermediary" providing an extra layer of security and restricted access to the Database Server. For both the Data Uploader and the Web Application, users are authenticated against a "or both the extir oploads to insure maximum security and secure access to only their data. The Admin Web Application is an application used to manage accounts. It also allows holders of certain types of accounts to Logon As User to the t.connect Web Application as other users. t:connect does not have the ability to modify any therapy provided by or parameters internal to the devices it communicates with. t:connect only reads data from these devices. The major functions of the device include: - Retrieve History Log data from the pump and transmit to the database server . - Retrieve History Log data from various BG meters and transmit to the database server . - Retrieve Diagnostic information from the pump and transmit to the database server . - Provide a means to view the pump's complete history log - Retrieve Pump Settings from the pump for easy viewing by the user - Display Therapy Data textually and graphically . - Manage User Accounts for retrieving and viewing pump data . - Generate Notifications for the user - Print reports to PDF . - Export data for use in generating customer reports using other software applications - Provision of user help . - Administrator functionality related to creation and managing user accounts
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