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510(k) Data Aggregation

    K Number
    K202208
    Device Name
    BeneHold Surgical Incise Drape with CHG antimicrobial
    Manufacturer
    Avery Dennison Belgie BVBA
    Date Cleared
    2021-07-30

    (358 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

    The BeneHold™ Surgical Incise Drape with CHG is indicated for use as an incise drape with continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes.

    It is intended for external use only. Correlation between in vitro results and any clinical event has not been tested.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a medical device called "BeneHold™ Surgical Drape with CHG". This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets them in the context of a performance study (e.g., for an AI/ML powered device).

    Instead, this document confirms that the device is substantially equivalent to a legally marketed predicate device and outline general regulatory requirements. It does not include performance data, expert qualifications, sample sizes for test/training sets, or details about comparative effectiveness studies.

    The "Indications for Use" section mentions "continuous antibacterial activity (in vitro) from 2.5 to 4 hours against the following organisms; S. epidermidis, E. faecalis, E. coli, P. aeruginosa and E. aerogenes." This refers to laboratory testing of the antimicrobial properties of the drape, not a clinical study involving human patients or a performance study for an AI-powered device.

    Therefore, I cannot extract the requested information from this document.

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