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510(k) Data Aggregation

    K Number
    K011757
    Device Name
    EXEL COMFORTPOINT INSULIN PEN NEEDLE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2002-01-23

    (231 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXEL COMFORTPOINT INSULIN PEN NEEDLE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    THIS DEVICE IS USED FOR INJECTIONOF INSULIN VIA PEN NEEDLE/DEVICE FOR USE BY DIABETIC PATIENTS .

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a US FDA 510(k) clearance letter for the Exel Comfortpoint Insulin Pen Needle. It confirms that the device is substantially equivalent to a legally marketed predicate device. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, ground truth, or any of the other specific details requested in your prompt.

    The letter is a regulatory approval document and focuses on:

    • Confirmation of substantial equivalence.
    • Instructions regarding general controls provisions of the Act (registration, listing, GMP, labeling, etc.).
    • Contact information for various FDA offices.
    • The "Indications for Use" for the device.

    Therefore, I cannot fulfill your request for information about acceptance criteria and the study proving the device meets those criteria based on the provided text. This type of information would typically be found in the 510(k) submission itself, or in supporting technical documentation, which is not included here.

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