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510(k) Data Aggregation

    K Number
    K000717
    Device Name
    SMITH & NEPHEW SUTURELOK, MODEL 7207321
    Manufacturer
    SMITH & NEPHEW, INC.
    Date Cleared
    2000-03-30

    (27 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K991500
    Predicate For
    K022394
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Smith & Nephew SutureLok is indicated for use in open and endoscopic procedures, including thoracoscopic surgery, laparoscopic procedures and general surgery. The device is not indicated for use in contraception tubal ligation.

    The Smith & Nephew SutureLok is intended for use in conjunction with USP size 0, 2-0 and 3-0 braided silk, nylon or polyester non-absorbable sutures in the management of soft vessel ligation and/or fixation of soft tissue structures during open and endoscopic procedures.

    Device Description

    The Smith & Nephew SutureLok comprises three main components:

    • The suture Lok implant (ring and pin) .
    • The disposable cartridge assembly with threader, and ●
    • The reusable delivery instrument
    AI/ML Overview

    This document is a 510(k) summary for the Smith & Nephew SutureLok device, which is a medical device for suture retention. It does not describe an AI/ML device or its performance criteria and studies. Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on this document.

    The document discusses the substantial equivalence of the new SutureLok device to a predicate device, focusing on design, materials, function, and intended use for suture retention in surgical procedures. It mentions comparative strength testing to demonstrate equivalence, which refers to physical properties of the device, not performance using AI.

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