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510(k) Data Aggregation

    K Number
    K971597
    Device Name
    COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
    Manufacturer
    COLOPLAST CORP.
    Date Cleared
    1997-07-29

    (89 days)

    Product Code
    NAE,MGQ
    Regulation Number
    878.4022
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K926508
    Why did this record match?
    Device Name :

    COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)

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

    For use in the management of leg ulcers and pressure sores. The gel provides a moist wound healing environment which encourages natural autolytic debridement.

    Device Description

    Comfeel® Purilon Gel is an absorbent hydrogel wound dressing composed of calcium alginate, sodium carboxymethylcellulose and purified water. The product is supplied sterile in 15 g and 25 g plastic bellow tubes.

    AI/ML Overview

    The provided documents describe a 510(k) premarket notification for a wound dressing, Comfeel® Purilon Gel. This document does not describe a study involving an algorithm or artificial intelligence, nor does it present acceptance criteria or performance data for such a device.

    The 510(k) submission establishes substantial equivalence to a predicate device (IntraSite Gel) based on similarity in composition, intended use, and biocompatibility testing. The criteria for acceptance in a 510(k) often revolve around demonstrating this substantial equivalence, rather than specific performance metrics against pre-defined acceptance criteria with statistical rigor as would be expected for a novel AI/algorithm-driven device.

    Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert-established ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in the provided text. The document is for a traditional medical device (wound gel), not an AI device.

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