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    K Number
    K102581
    Device Name
    DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305
    Manufacturer
    BYRNE MEDICAL INC.
    Date Cleared
    2010-11-08

    (61 days)

    Product Code
    ODC,FDF
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K001241
    Why did this record match?
    Device Name :

    DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305

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

    The DEFENDO™ Disposable Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

    Device Description

    The DEFENDO™ Disposable Suction Valve is a disposable device that attaches to the suction cylinder of an endoscope. When the valve is depressed, the suction function on the endoscope is activated, allowing for the suctioning of fluid through the stem of the valve where it flows into the Suction Pump Canister.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the DEFENDO™ Disposable Suction Valve, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device PerformanceResult
    Connection to the endoscope: The valve must connect to the endoscope by aligning valve with port and pressing down. Must not be cumbersome to attach.The force required to connect the BMI suction valve (100305) and the ease of installation was similar to the predicate (Olympus® MH-443). Alignment with the port notches was comparable. Test results showed "Smooth" for all 10 tests of the BMI 100305, matching the "Smooth" results of the predicate.Pass
    Priming time to Suction Canister: The device must be comparable to the predicate device in terms of being able to supply water within a reasonable time frame (priming time).The average priming time for the BMI 100305 was 3.92 seconds (SD 0.163) over 10 tests, compared to the predicate's average of 4.16 seconds (SD 0.147) over 8 tests. The results indicate no significant difference between the two units.Pass
    Material Quantity Removed: The device must be comparable to the predicate device in terms of the amount of water removed in the defined time frame.The average material removed for the BMI Suction Valve was 512.2 grams (SD 11.25) over 8 samples (10 tests each), compared to the predicate's average of 528.5 grams (SD 13.61) over 8 samples (10 tests each). The difference was
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