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510(k) Data Aggregation

    K Number
    K970416
    Device Name
    ACUFEX DOUBLE ARMED SUTURE NEEDLE
    Manufacturer
    SMITH & NEPHEW ENDOSCOPY, INC.
    Date Cleared
    1997-04-21

    (76 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K961853
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Acufex Double Armed Suture Needle is intended to be used to pass a suture through soft tissue which is need of repair. The Acufex Double Armed Suture Needle is intended to be used only with the Fast Pass Suture Punch. The Acufex Double Armed Suture Needle is indicated for use in open or arthroscopic Rotator Cuff and Bankart repairs.

    Device Description

    The Acufex Double Armed Suture Needle is a sterile, single-use device manufactured from braided polyester and stainless steel.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Acufex Double Armed Suture Needle) and does not contain information about acceptance criteria or a study proving device performance as it relates to AI/algorithm performance.

    The provided text describes a traditional medical device (a suture needle) and its substantial equivalence to a predicate device. It is focused on demonstrating that the new device is as safe and effective as a previously cleared device, not on the performance of a software algorithm or AI.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth related to AI/algorithm performance from this document.

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