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510(k) Data Aggregation

    K Number
    K062786
    Device Name
    MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
    Manufacturer
    GIVEN IMAGING LTD.
    Date Cleared
    2006-10-18

    (30 days)

    Product Code
    NEZ
    Regulation Number
    876.1300
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K010312,K020341,K022362,K022980,K031033,K032405,K040248,K052184,K060805
    Why did this record match?
    Reference Devices :

    K010312, K020341, K022362, K022980, K031033, K032405, K040248, K052184, K060805

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

    The Given® Diagnostic System with the PillCam™ SB Capsule is intended for visualization of the small bowel mucosa. It may be used as a tool in the detection of abnormalities of the small bowel in adults and children from 10 years of age and up

    The Suspected Blood Indicator (SBI) feature is intended to mark frames of the video suspected of containing blood or red areas

    Device Description

    The Given® Diagnostic System is comprised of three subsystems-PillCam™ Capsule (ESO or SB), Data Recorder Set, and RAPID® Workstation.

    The modifications to the Given® Diagnostic System, which are the subject of this Special 510(k), include (1) improved PillCam™ SB capsule; and (2) labeling change, which does not affect the intended use of the device, related to the Automatic Mode of the RAPID® Software Application.

    AI/ML Overview

    The provided text is a 510(k) summary for the Given® Diagnostic System, a medical device for visualizing the small bowel mucosa. The document focuses on regulatory approval and does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria.

    Therefore, I cannot provide the requested information about acceptance criteria and device performance based solely on the provided text. The document clearly states it's a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against defined acceptance criteria.

    The information sought, such as detailed performance metrics (sensitivity, specificity, etc.), sample sizes for training and test sets, expert qualifications, and ground truth establishment, would typically be found in a separate clinical study report or a more comprehensive technical and clinical data submission, which is not included in this 510(k) summary.

    The only performance-related statement is about the "Suspected Blood Indicator (SBI) feature" being "intended to mark frames of the video suspected of containing blood or red areas," which is an intended function, not a performance metric with acceptance criteria.

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