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510(k) Data Aggregation

    K Number
    K011667
    Device Name
    HORIZONS INTERNATIONAL POLYPECTOMY SNARES
    Manufacturer
    HORIZONS INTL. CORP.
    Date Cleared
    2001-08-16

    (78 days)

    Product Code
    FDI
    Regulation Number
    876.4300
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    HORIZONS POLYPECTOMY SNARES ARE INTENDED TO ELECTROSURGICALLY REMOVE POLYPS IN THE GI TRACT UNDER ENDOSCOPIC VISUALIZATION

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but this document contains no information about acceptance criteria or the study that proves whether the device meets those criteria. It is a 510(k) clearance letter for a medical device (Horizons Polypectomy Snares), indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

    The letter confirms that the device can be marketed but does not include details on:
    * Acceptance criteria for device performance
    * Specific study data or methodology
    * Sample sizes used
    * Ground truth establishment
    * Expert qualifications
    * Adjudication methods
    * Details of multi-reader multi-case (MRMC) comparative effectiveness studies
    * Standalone algorithm performance studies
    * Training set information

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