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510(k) Data Aggregation

    K Number
    K073579
    Device Name
    DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
    Manufacturer
    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
    Date Cleared
    2008-08-18

    (242 days)

    Product Code
    FTL,REG
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K792281,K922916,K991400,K031225,K061704,K930669,K002093,K070192
    Why did this record match?
    Reference Devices :

    K792281,K922916

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

    DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.

    Device Description

    The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material. DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements. FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes. The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags: - the inner transparent bag contains the device only - the outer transparent bag contains the inner bag and four adhesive labels for patient records. The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.

    AI/ML Overview

    The provided text does not describe acceptance criteria for a medical device or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for a surgical mesh (DynaMesh-PP) seeking substantial equivalence to predicate devices.

    The document focuses on comparing the DynaMesh-PP to existing legally marketed polypropylene meshes based on design, materials, manufacturing processes, and physical properties. It does not detail specific performance acceptance criteria or a study designed to demonstrate the device meets such criteria.

    The tables provided (pages 3 and 4 of the submission) show a technological comparison to predicate devices, listing various physical features and their measured values for both the subject device (DynaMesh-PP) and the predicate device (Sofradim Parietene Mesh). These are presented to demonstrate similarity, not necessarily to meet pre-defined acceptance criteria for performance in a clinical or simulated-use context.

    Therefore, I cannot populate the requested table or answer the questions as the information is not present in the provided text. The document is a regulatory submission for substantial equivalence based on comparison to existing devices, not a report on acceptance criteria and performance from an independent study.

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