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510(k) Data Aggregation

    K Number
    K080745
    Device Name
    GENADYNE A4 POWERED SUCTION PUMP
    Manufacturer
    GENADYNE BIOTECHNOLOGIES, INC.
    Date Cleared
    2008-07-30

    (135 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K051758
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Genadyne A4 Powered Suction Pump is intended for general suction use in hospitals or clinics.

    Device Description

    The Genadyne A4 powered suction pump is a portable suction device that is intended for general suction use in hospitals or clinics. The Genadyne A4 comes with a canister and a power adapter to charge the battery.

    AI/ML Overview

    The provided 510(k) summary for the Genadyne A4 Powered Suction Pump does not describe a study involving acceptance criteria or the performance of an AI device. This document is for a medical device that generates suction and is a standard 510(k) premarket notification for a Class II device.

    The information provided describes a comparison to a predicate device to establish substantial equivalence for regulatory approval, focusing on physical and performance characteristics of the suction pump itself, not on an AI system's diagnostic or predictive capabilities.

    Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI device. The document simply lists technical specifications and intended use of a physical suction pump.

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