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510(k) Data Aggregation

    K Number
    K022777
    Device Name
    MANUAL TOUCHE SYSTEM
    Manufacturer
    ONUX MEDICAL, INC.
    Date Cleared
    2002-11-19

    (90 days)

    Product Code
    GAQ,GAO,HCF
    Regulation Number
    878.4495
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MANUAL TOUCHE SYSTEM

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

    The Manual Touché Suturing System has applications in gynecological, orthopaedic, and general abdominal; endoluminal, open and thoracic endoscopic surgical wound closure procedures (e.g. creation of anastomosis, hernia repair, ligation and hemostasis).

    Device Description

    A single-use, surgical instrument for placing stainless steel sutures.

    AI/ML Overview

    The provided text is related to a 510(k) submission for the Manual Touché Suturing System. However, it does not contain information about acceptance criteria, device performance testing, or study details (like sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

    The document primarily focuses on:

    • Identifying the device (Manual Touché Suturing System).
    • Claiming substantial equivalence to predicate devices (Powered Touché Suturing System and Salute Fixation System).
    • Describing the subject device and comparing its technical aspects to predicate devices.
    • Stating its intended use and indications.
    • Providing the FDA's clearance letter for the device.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance from this document, nor can I provide information on the study design elements you asked for. The document does not describe the specific testing or studies conducted to prove the device meets performance criteria.

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