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510(k) Data Aggregation

    K Number
    K100006
    Device Name
    HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
    Manufacturer
    RIVERPOINT MEDICAL
    Date Cleared
    2010-05-10

    (126 days)

    Product Code
    GAT,GAP,GAR,GAS,GAW
    Regulation Number
    878.5000
    Type
    Abbreviated
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K063778,K021019,K982853,K050947,K001173
    Why did this record match?
    Reference Devices :

    K063778, K021019, K982853, K050947, K001173

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

    RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.

    HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

    Device Description

    Riverpoint Medical non-absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well).

    AI/ML Overview

    The provided text describes a 510(k) summary for Riverpoint Medical's non-absorbable surgical sutures. It outlines the device description, intended use, and states that the sutures are designed to meet specific safety and effectiveness criteria. However, it does not contain a study report with specific acceptance criteria or performance data in the format requested.

    The document states:
    "Riverpoint Medical non-absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. Testing is performed on each lot of product to verify that USP requirements have been met prior to release."

    This sentence indicates the acceptance criteria are based on USP 32 standards for these parameters. However, the document does not provide a table with these specific USP 32 requirements or the reported device performance against them. It also does not include information about sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth for training was established.

    Therefore, I cannot populate the table or provide the detailed study information as requested. The document confirms that testing is performed to verify compliance with USP 32, but it does not present the results of such testing or the study design in a way that allows for the extraction of the requested metrics.

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