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510(k) Data Aggregation

    K Number
    K111821
    Device Name
    BIOPSY VALVE
    Manufacturer
    ENDOCHOICE, INC.
    Date Cleared
    2011-07-28

    (30 days)

    Product Code
    OCX
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    K122417,K133734,K152140
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Biopsy valves are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.

    Device Description

    The EndoChoice biopsy valve can be manufactured with a choice of two types – regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets such criteria. Instead, it is a 510(k) summary for a medical device (EndoChoice Biopsy Valves) which focuses on demonstrating substantial equivalence to a predicate device.

    Here's why the requested information cannot be extracted from this document:

    • No performance standards: The text explicitly states, "No performance standards exist for this device." This implies there are no pre-defined quantitative acceptance criteria that the device needs to meet through a specific performance study.
    • Substantial Equivalence: The entire submission is based on showing "substantial equivalence" of the EndoChoice Biopsy Valve to a predicate device (US Endoscopy - Bioshield - ERCP Biopsy Valve). This means the focus is on comparing technological characteristics and overall performance to an already legally marketed device, rather than proving performance against new, independent acceptance criteria.
    • Lack of detailed study data: The document mentions "Performance Data" but does not elaborate on any specific study, its design, sample size, ground truth, or statistical analysis. It only concludes that based on technological characteristics and overall performance, the device is substantially equivalent, and differences are minor without new safety or effectiveness issues.

    Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies because this information is not present in the provided 510(k) summary.

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