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510(k) Data Aggregation

    K Number
    K062723
    Device Name
    HALO90 COAGULATION CATHETER
    Manufacturer
    BARRX MEDICAL, INCORPORATED
    Date Cleared
    2006-11-09

    (58 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    HALO90 COAGULATION CATHETER

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

    The HALO® Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

    Device Description

    The HALO90 Coagulation System consists of the HALO90 Coagulation Generator with a disposable single-use HALO90 Coagulation Catheter model 90-9100, output cable, and an optional footswitch. The HALO90 Coagulation System performance and mode of operation is substantially equivalent to the already cleared HALO90 Coagulation System (with catheter model 1520F).

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the HALO® Coagulation System, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance data against pre-defined acceptance criteria.

    Therefore, I cannot populate the table or provide details for the requested questions as the necessary information is not present in the given text.

    The document indicates:

    • The device is substantially equivalent to the already cleared HALO®90 Coagulation System (with catheter model 1520F).
    • The purpose of the 510(k) is to secure clearance to market based on this substantial equivalence, not based on meeting specific quantitative performance acceptance criteria from a new study.

    There is no mention of:

    • Specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds).
    • A formal study designed to demonstrate performance against such criteria.
    • Sample sizes for test or training sets in the context of performance evaluation.
    • Expert involvement, adjudication methods, or ground truth establishment for a performance study.
    • MRMC studies or standalone algorithm performance.
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