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510(k) Data Aggregation

    K Number
    K974143
    Device Name
    KMC NEWSKIN
    Manufacturer
    KMC INTL. CO.
    Date Cleared
    1998-03-27

    (144 days)

    Product Code
    MDA
    Regulation Number
    878.4025
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K971482
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    KMC Ultra-Sil Scar Management System is a thin, soft silicone KMC ofera-SIF Scar handyement application for keloid and hypertrophic scar management.

    KMC Ultra-Sil Scar Management System is intended to be used only on healed scars.

    Device Description

    KMC Ultra-Sil Scar Management System is a thin, soft silicone sheet designed to be applied externally, in a non-invasive manner to healed keloid and hypertrophic scars. Scar area is to be washed and towel dried before application. KMC Ultra-Sil Scar Management System is applied to scar area with 1/2 inch overlap. Initial application to last 2-3 hours. Successive applications will increase contact by 1 hour each until 8 hour contact is reached. Application time of 20 hours is recommended.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance, or any studies with sample sizes, expert involvement, or statistical analysis. The document is a 510(k) summary for the "KMC Ultra-Sil Scar Management System," which primarily focuses on establishing substantial equivalence to a predicate device (Degania Silicone Sil-K, 510(k) No. K971482).

    The 510(k) summary outlines:

    • Device Description and Use: A thin, soft silicone sheet for external, non-invasive application to healed keloid and hypertrophic scars. It details application instructions (e.g., wash scar area, initial application of 2-3 hours, increasing to 8 hours, with 20 hours recommended).
    • Manufacturing: States it uses essentially the same silicone materials and manufacturing practices as the predicate device.
    • Substantial Equivalence: The core claim, stating it's substantially equivalent to the Degania Silicone Sil-K.

    Therefore, I cannot populate the requested table or provide details about a study that proves the device meets acceptance criteria. The document does not describe such a study or associated data points. The FDA's letter (Document {1}) confirms the substantial equivalence determination, allowing the device to be marketed, but does not refer to specific performance criteria or a study done by the applicant to prove these criteria were met, beyond the substantial equivalence argument.

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