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510(k) Data Aggregation

    K Number
    K082415
    Device Name
    PRODIGY NPWT SYSTEM MODEL PRODIGY 800V
    Manufacturer
    PREMCO MEDICAL SYSTEMS, INC.
    Date Cleared
    2008-11-25

    (96 days)

    Product Code
    OMP
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K090258
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Prodigy™ NPWT System, Model: Prodigy™ 800V). It confirms the device's substantial equivalence to a legally marketed predicate device.

    Unfortunately, this document does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

    The letter focuses on regulatory approval based on equivalence, not on a detailed performance study report. Therefore, I cannot extract the requested information from this text.

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