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510(k) Data Aggregation

    K Number
    K243045
    Device Name
    “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002)
    Manufacturer
    BRAXX Biotech Co. Ltd
    Date Cleared
    2024-11-19

    (53 days)

    Product Code
    JAQ,JAO
    Regulation Number
    892.5700
    Type
    Special
    Panel
    Radiology
    Reference & Predicate Devices
    K183332
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Esophageal Brachytherapy Applicator is intended for use with commercially available afterloader during brachytherapy. The purpose of the device is for delivery of radioactive source to the esophagus. This device is sterile, disposable and single-use.

    Device Description

    [BKMI2001]
    The device has 6 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #6 valve corresponds with the proximal balloon. There is an indication balloon on each valve unit, which can indicate the inflated balloon. The distance between first marker printed on the main catheter and the distal tip is 19.8 cm. This device is disposable and designed for sterile and single use.

    [BKMI2002]
    The device has 8 independently balloons. Each balloon corresponds to a specified needle free connector (valve). The #1 valve is connected to the most distal balloon and the #8 valve corresponds with the proximal balloon. The distance between first marker printed on the main catheter and the distal tip is 40 cm. This device is disposable and designed for sterile and single use.

    AI/ML Overview

    The provided text is a 510(k) summary for the "BRAXX" Esophageal Brachytherapy Applicator. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not describe a study involving an AI/software device that requires acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance improvement.

    The "Performance Testing" section refers to mechanical tests for the physical device (Balloon Burst, Balloon Fatigue, Balloon Diameter and Volume, Leakage, Tensile Strength). These are not related to an AI algorithm's performance on a test set of data.

    Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study proving device meets criteria for an AI/software device. The provided text is solely for a physical medical device.

    To answer your request, if this were an AI/software device, the information would typically be found in a section detailing clinical performance studies or algorithm validation studies.

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