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    K Number
    K970566
    Device Name
    ARGLAES FILM DRESSING
    Manufacturer
    MAERSK MEDICAL, LTD.
    Date Cleared
    1997-07-29

    (166 days)

    Product Code
    FRO,MGP
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ARGLAES FILM DRESSING

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

    ARGLAES Film Dressings are sterile, transparent, and self-adherent dressings intended for the local management of pressure sores, incisions, donor sites, minor burns, abrasions and lacerations, superficial leg ulcers and other dermal ulcers. ARGLAES Film Dressings are also intended to help secure and protect intravenous catheters.

    Device Description

    ARGLAES-AB Antimicrobial Barrier Film Dressing

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a medical device (ARGLAES-AB Antimicrobial Barrier Film Dressing) from 1997. It outlines the regulatory classification, limitations on labeling, and general controls, as well as the device's intended use.

    However, it does not include any details about an acceptance criteria table, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established. This type of detailed study information is typically found in a separate clinical study report or a more comprehensive summary of safety and effectiveness, which is not part of this 510(k) clearance letter.

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