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510(k) Data Aggregation

    K Number
    K973071
    Device Name
    TRI TALON RETRIEVAL FORCEPS
    Manufacturer
    MEDICAL ENGINEERING LABORATORY, INC.
    Date Cleared
    1997-10-24

    (67 days)

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

    THE MEDICAL ENGINEERING LABORATORIES, INC, TRI TALON RETRIEVAL FORCEPS (TRIPOD) IS INTENDED TO FOR USE IN THE FOLLOWING APPLICATIONS:

    GASTROSCOPE, SIGMOIDOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOOD IMPACTION OR FOREIGN OBJECTS FROM THE ESOPHAGUS OR STOMACH.

    COLONOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENTS CHANNEL FOR REMOVAL OF FOREIGN OBJECTS OR POLYPS FROM THE COLON.

    BRONCHOSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR REMOVAL OF FOREIGN OBJECTS FROM THE LUNG.

    URETEROSCOPE: USE THROUGH THE ACCESSORY/INSTRUMENT CHANNEL FOR THE REMOVAL OF STONES AND FOREIGN OBJECTS FROM THE URETER AND BLADDER.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is related to a 510(k) clearance letter for a medical device called "TRI TALON RETRIEVAL FORCEPS". This document indicates FDA clearance for marketing based on substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, device performance metrics, study design, sample size, ground truth establishment, or expert involvement typically found in a clinical performance study report.

    Therefore, I cannot fulfill your request for the detailed information as the provided text does not contain it. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than on new clinical performance data with specific acceptance criteria in the way you've described for AI/diagnostic devices.

    To provide the requested information, I would need a clinical study report or a different type of regulatory submission that details the performance evaluation of the device against specific criteria.

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