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510(k) Data Aggregation

    K Number
    K231521
    Device Name
    Broncho Videoscope System
    Manufacturer
    Scivita Medical Technology Co., Ltd.
    Date Cleared
    2023-11-14

    (172 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    K210379
    Why did this record match?
    Reference Devices :

    K210379

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

    The Broncho videoscope system is designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs. The Broncho videoscope System is for use in a hospital environment.

    This Full HD Visualization Endoscopic Image Processor is used for endoscopic diagnosis and therapies. It connects to the electronic endoscopes, displaying the images on its LCD display and/or external monitor within the field of view from the body cavity.

    This Single-use Broncho Videoscope is intended to use in conjunction with endoscopic image processor to provide images through the video monitor for observation, diagnosis, photography and treatment of the respiratory system such as trachea, bronchi, and lungs.

    Device Description

    The subject device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and a Full HD Visualization Endoscopic Image Processor. The subject device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi, and lungs.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device called the "Broncho Videoscope System." It details the device's technical specifications and compares it to a predicate device to establish substantial equivalence. However, the document explicitly states that "No clinical study is included in this submission" (page 6, section 7).

    This means there is no information available in this document regarding acceptance criteria, reported device performance against those criteria, or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the provided input.

    However, I can extract information related to non-clinical testing and general device characteristics as described in the summary:

    Section 1-7: No information available as no clinical study was conducted.

    Section 8: Sample size for the training set - Not applicable, as no clinical study for AI model training is mentioned.

    Section 9: How the ground truth for the training set was established - Not applicable, as no clinical study for AI model training is mentioned.

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