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510(k) Data Aggregation

    K Number
    K992513
    Device Name
    THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF
    Manufacturer
    WISAP GESELLSCHAFT FUR WISSENSCHAFTL. APP. BAU MBH
    Date Cleared
    2000-03-17

    (235 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    THERME-PNEU COMPUTER, WISAP #7070C, #7070CF, #7070CM, #7070CMF

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

    This decice is restricted to use by authorized expert personnel / physicians!

    The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO .- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.

    Device Description

    Not Found

    AI/ML Overview

    The provided FDA document is a 510(k) clearance letter for the WISAP Therme Pneu Computer. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device. This type of document does not contain the detailed information required to answer your questions about acceptance criteria and performance studies.

    The letter states: "We have reviewed your Section 510k) notification of intent to market the device and we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

    This means that the device's clearance was likely based on a comparison to an existing device, rather than a new clinical performance study with specific acceptance criteria as you've outlined.

    Therefore, I cannot provide the requested information because it is not present in the given text.

    To answer your questions, one would need access to the full 510(k) submission document, which would detail any performance testing conducted, if applicable to this type of device and regulatory pathway. For many Class I and Class II devices cleared via the 510(k) pathway, extensive "acceptance criteria" and "study data" as you've described for AI/diagnostic devices are not typically required beyond demonstrating functional equivalence and safety to a predicate device.

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