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510(k) Data Aggregation

    K Number
    K992178
    Device Name
    BALLOON FOR ULTRASONIC ENDOSCOPES
    Manufacturer
    N.M. BEALE CO. INC.
    Date Cleared
    2000-05-12

    (319 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BALLOON FOR ULTRASONIC ENDOSCOPES

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

    For Endoscopic Ultrasound Applications using the Balloon Method in the Upper or Lower Gastrointestinal Tract.

    Device Description

    Endoscopic Ultrasound Balloon Device Name: Latex Free

    AI/ML Overview

    The provided text describes a 510(k) clearance letter for the "Endoscopic Ultrasound Balloon" device. It outlines the FDA's determination of substantial equivalence to a predicate device for the stated indications for use.

    Crucially, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

    The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through a detailed study report within this document. While the manufacturer would have submitted testing data to the FDA to support their claim of substantial equivalence, those details are not present in the provided letter.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given input.

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