LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K022743
    Device Name
    REPROCESSED DISPOSABLE TROCARS
    Manufacturer
    MEDICAL DEVICE SERVICES
    Date Cleared
    2002-10-09

    (51 days)

    Product Code
    KAB
    Regulation Number
    874.4420
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    KAB

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

    Reprocessed trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures. Reprocessed trocars are single patient use devices.

    Device Description

    Reprocessed Disposable Trocars

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details, or ground truth establishment. The document is a 510(k) clearance letter from the FDA for "Reprocessed Disposable Trocars," which indicates that the device has been found substantially equivalent to a legally marketed predicate device.

    The letter does not include:

    • A table of acceptance criteria or reported device performance.
    • Details about any studies, including sample sizes, data provenance, or the number/qualifications of experts.
    • Information on adjudication methods.
    • Mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or how it was established for training or testing sets.

    The document primarily focuses on regulatory clearance, device classification, and general controls provisions.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1