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510(k) Data Aggregation

    K Number
    K112136
    Device Name
    TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE
    Manufacturer
    KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD.
    Date Cleared
    2011-09-29

    (65 days)

    Product Code
    KKX
    Regulation Number
    878.4370
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Disposable sterile drapes are intended for use for :

    • patient protective covering used to isolate incision sites and protect . against contamination during surgical procedures.
    • cover a variety of surgical and non-surgical equipment in various settings . throughout the clinical setting. These drapes are used protect surgical and non-surgical equipment from contamination during surgical procedures

    Drapes provided as sterile and non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 1135.

    Device Description

    The document lists the following disposable surgical drape types and model numbers included in the submission:

    MATERIALDRAPE STYLESTERILEDRAPE TYPEMODEL #
    SMSNon
    ReinforcedSterileTopJHSAD 150-240E
    BottomJHSAD 180-175E
    Non SterileTopJHSAD 150-240NS
    BottomJHSAD 180-175NS
    AI/ML Overview

    I am sorry but this document is a 510(k) premarket notification decision letter from the FDA to a medical device manufacturer. It certifies that the device, a surgical and equipment drape, is substantially equivalent to a legally marketed predicate device.

    The document does not contain information related to acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement for evaluating an AI-powered device. It is a regulatory approval document for a non-AI medical device.

    Therefore, I cannot provide the requested information based on the provided text.

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