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510(k) Data Aggregation

    K Number
    K091795
    Device Name
    MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
    Manufacturer
    MEDTRADE PRODUCTS LTD.
    Date Cleared
    2009-11-20

    (156 days)

    Product Code
    QSY,FRO
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    K070175,K080097,K090026
    Why did this record match?
    Reference Devices :

    K070175

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

    CELOX Trauma Gauze is intended to be available Over The Counter for the following indication.
    Indications For OTC (Over The Counter) Use:
    CELOX Trauma Gauze is indicated for temporary external use to control bleeding of lacerations, minor cuts and abrasions.
    CELOX Trauma Gauze is indicated for temporary external use to control moderate to severe bleeding.

    Device Description

    CELOX Trauma Gauze Rx & OTC is identical in composition to Aquanova Super Absorbent Dressing Rx & OTC cleared in K070175 on July 25, 2007

    AI/ML Overview

    The provided document is a 510(k) summary for the MedTrade Products CELOX Trauma Gauze and CELOX Trauma Gauze OTC. It focuses on establishing substantial equivalence to predicate devices, rather than detailing a study that proves the device meets specific performance acceptance criteria.

    However, the document does mention one in vivo test:

    1. A table of acceptance criteria and the reported device performance

    The document does not specify quantitative acceptance criteria. It states:

    Performance MetricAcceptance CriteriaReported Device Performance
    Hemostasis in femoral artery wound modelNot specified (implied to be effective)"This data supports the effectiveness of the CELOX Trauma Gauze in achieving hemostasis in a femoral artery wound model."

    2. Sample size used for the test set and the data provenance

    • Sample Size: Not specified.
    • Data Provenance: Not specified (originating country, retrospective/prospective). The study is described as "in vivo testing," suggesting it was prospective.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable (the in vivo test likely involved direct observation of biological outcomes, not expert interpretation of results).

    4. Adjudication method for the test set

    Not applicable (no information on adjudication for the in vivo test).

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    Not applicable. This is not an AI/imaging device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Not applicable. This is not an AI/imaging device.

    7. The type of ground truth used

    The ground truth was likely direct observation of hemostasis in a "femoral artery wound model," which can be considered an outcome-based ground truth (the direct physiological response).

    8. The sample size for the training set

    Not applicable. This is not an AI/machine learning device requiring a training set.

    9. How the ground truth for the training set was established

    Not applicable.

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