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510(k) Data Aggregation

    K Number
    K030170
    Device Name
    REUSABLE SMARTSTITCH SUTURE DEVICE, MODELS OM-8007, OM-8500
    Manufacturer
    OPUS MEDICAL, INC.
    Date Cleared
    2003-07-28

    (192 days)

    Product Code
    OCW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K062244
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Opus SmartStitch M-Connector is indicated for use with a OM-8000 Actuation Handle for placement of #2 Braided Polyester Suture through soft tissue in endoscopic and other limited access procedures.

    The Opus SmartStitch Actuation Handle is indicated for use with a OM-8007 M-Connector for placement of USP size #2 braided polyester suture (not supplied) through soft tissue in endoscopic and other limited access procedures.

    Device Description

    Reusable SmartStitch® Suture Device

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving a device meets them. The document is an FDA 510(k) clearance letter for the Reusable SmartStitch Suture Device, indicating that it has been determined substantially equivalent to a predicate device.

    While it mentions the device name, intended use, and regulatory classification, it does not include any information about:

    • Acceptance criteria
    • Device performance data
    • Details of any studies conducted (sample size, data provenance, ground truth, experts, adjudication methods, MRMC studies, standalone performance, training set details).

    Therefore, I cannot generate the table or provide the requested information based on this text.

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