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510(k) Data Aggregation

    K Number
    K213195
    Device Name
    Balloon BS-3
    Manufacturer
    FUJIFILM Corporation
    Date Cleared
    2021-10-29

    (30 days)

    Product Code
    FDA
    Regulation Number
    876.1500
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K143556
    Why did this record match?
    Device Name :

    Balloon BS-3

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

    Balloon BS-3 is intended to be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract at medical facilities under the management of physicians.

    Do not use this product for any other purpose. It is not intended for use for any neonates, infants or children.

    Device Description

    Balloon BS-3 is a pre-sterilized, single-use accessory used for fixing the endoscope in the body cavity. The device is fixed at the tip or bending portion of the endoscope and is inflated by filling air from the operation part of the endoscope with a special pump. The device is used for a natural opening of the human body to perform enlargement of a lumen, coelom or body cavity in order to enable and facilitate insertion of the endoscope.

    AI/ML Overview

    This is a 510(k) summary for a medical device called "Balloon BS-3," an endoscopic accessory. The document does not describe an AI/ML device, therefore, the requested information about acceptance criteria and studies for an AI/ML device is not applicable.

    The document primarily focuses on demonstrating substantial equivalence to a predicate device (Balloon BS-2) through comparison of technological characteristics and performance data related to sterility, biocompatibility, and inflation rate.

    Here's an overview of the information provided in the document:

    • Device Name: Balloon BS-3
    • Intended Use: To be used in combination with FUJIFILM double balloon endoscopes to assist with insertion inside the upper or lower digestive tract. Not for neonates, infants, or children.
    • Predicate Device: Balloon BS-2 (K143556)

    Performance Data and Conclusions:

    The document states that the following tests were conducted:

    • Sterility: Evaluated using ISO 11135:2014 and ASTM F1980-16.
    • Biocompatibility: Evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010.
    • Comparative bench testing: Conducted on the subject and predicate devices to evaluate the rate of inflation.
    • Additional evaluation: The subject device was additionally evaluated against ISO 8600-1:2015.

    The overall conclusion is that "Bench testing demonstrates that the subject device is as safe and effective as the predicate device. Thus, Balloon BS-3 is substantially equivalent to the listed predicate device."

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