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510(k) Data Aggregation

    K Number
    K960393
    Device Name
    SURESKIN BORDER
    Manufacturer
    EUROMED A/S
    Date Cleared
    1996-03-01

    (32 days)

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

    SURESKIN BORDER

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

    The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure sores and leg ulcers.

    Device Description

    The SureSkin® BORDER Hydrocolloid Wound Dressing manufactured by Euromed A/S is a wound dressing indicated for the management of lightly to heavily exudating pressure sores and leg ulcers. It is composed of a hydrocolloid material which is in contact with the wound, and an occlusive polyurethane backing. The dressing is similar in design, function, materials, and intended use to other hydrocolloid/occlusive dressings currently in commercial distribution, e.g., DuoDerm Dressing marketed by Convatec.

    AI/ML Overview

    The provided text describes a 510(k) Summary for the SureSkin® BORDER Hydrocolloid Wound Dressing. It details the device's description, classification, and comparison to predicate devices, focusing on its design, materials, and intended use for wound management. The document also mentions biocompatibility testing.

    However, the text does not contain any information regarding acceptance criteria or a study proving that the device meets such criteria. It lacks the specific details requested in the prompt, such as performance metrics, sample sizes for test or training sets, expert involvement, or statistical analysis.

    Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and a detailed study based solely on the provided input. The document focuses on regulatory submission information rather than a performance study report.

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