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    K Number
    K140562
    Device Name
    WIJAY EZ-VOID EXTERNAL CATHETER VALVE
    Manufacturer
    LEOMED, LLC
    Date Cleared
    2014-06-16

    (103 days)

    Product Code
    KNY
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    WIJAY EZ-VOID EXTERNAL CATHETER VALVE

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

    The Wijay EZ-Void™ External Catheter Valve is indicated for use, to aid in emptying the urinary bladder, for short-term (7 days or less) in adult patients with indwelling urethral or Suprapubic catheters and (1) who are capable of operating the device in accordance with its instructions for use, and (2) for whom normal bladder cycling is not contraindicated.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA to LeoMed, LLC regarding their "Wijay EZ-Void External Catheter Valve." This document confirms the device's substantial equivalence to a legally marketed predicate device.

    However, the letter does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for either training or test sets.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is solely an FDA clearance letter and does not include the technical study details you are asking for.

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