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510(k) Data Aggregation

    K Number
    K181151
    Device Name
    GYNECARE TVT Abbrevo Continence System; GYNECARE TVT Obturator Continence System
    Manufacturer
    Ethicon Inc
    Date Cleared
    2018-08-10

    (101 days)

    Product Code
    PWJ
    Regulation Number
    884.4910
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K100936,K033568
    Predicate For
    K201686
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gynecare TVT ABBREVO™ Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT ABBREVO™ device.

    The Gynecare TVT™ Obturator Helical Passers and Atraumatic Winged Guide are intended to aid in the placement of the GYNECARE TVT™ Obturator device.

    Device Description

    The Helical Passers are two stainless steel, curved wire passers with plastic handles that are designed to deliver the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant. The Helical Passers are provided as left and right units, pre-assembled to the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly.

    The Winged Guide is a stainless steel accessory instrument that facilitates consistent passage of the GYNECARE TVT ABBREVO™ & GYNECARE TVT™ Obturator Implant Assembly through the dissection tract.

    AI/ML Overview

    The provided document is a 510(k) summary for surgical instrumentation and describes performance testing for those instruments, not for an AI/ML device. Therefore, it does not contain information about acceptance criteria or studies related to AI/ML device performance.

    The document discusses the following types of performance testing for the GYNECARE TVT ABBREVO™ and GYNECARE TVT™ Obturator Helical Passers and Atraumatic Winged Guide:

    • Sterilization validation: To demonstrate the devices are sterile to an SAL of 10^-6.
    • Package integrity: To ensure the sterility of the packaged devices.
    • Dimensional and mechanical performance: To confirm the instruments meet design specifications and can withstand intended use.
    • Biocompatibility: Including cytotoxicity, sensitization, and irritation tests to ensure the materials are safe for patient contact.
    • Shelf life: To validate the stability and performance of the devices over their intended storage period.

    The document concludes that the subject devices are substantially equivalent to their predicate devices and meet the special controls outlined in 21 CFR 884.4910.

    Since this document does not pertain to an AI/ML device, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to AI/ML performance.

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