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510(k) Data Aggregation

    K Number
    K142194
    Device Name
    CytoSure Urinary Access System
    Manufacturer
    Emmy Medical
    Date Cleared
    2014-12-19

    (130 days)

    Product Code
    FAJ,EZL
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K080560,K910486,K063442,K132686,K040390
    Why did this record match?
    Reference Devices :

    K080560, K910486, K063442, K132686

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

    The CystoSure™ Urinary Access System provides catheterization and visualization for the female urinary bladder.

    The CystoSure™ rigid metal scope is used to visualize the urinary bladder for diagnostic procedures. The CystoSure™ access catheter accessory provides urethral urinary catheterization and postoperative bladder irrigation/lavage with the addition of a sealed port for passage of the CystoSure™ scope.

    Device Description

    The Emmy Medical CystoSure Urinary Access System is intended for use in the diagnostic visualization of the female bladder. The CystoSure cystoscope is a reusable, rod lens optic that can be used with standard O.R. camera couplers and light guides. The length and field of view of the Emmy Medical cystoscope are optimized for inspection of the female bladder. The Emmy Medical cystoscope does not include the traditional outer sheath as those functions are provided by the access catheter accessory.

    The CystoSure Access Catheter accessory provides a single use access catheter with four ports: One for bladder drainage, one for bladder irrigation, one for balloon inflation and one for the CystoSure cystoscope. The access catheter encompasses only one balloon size (5 cc) and length (female only) and it does not include any hydrophilic or antimicrobial coatings or features to make it radiopaque.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the CystoSure™ Urinary Access System. It does not contain information about an AI-powered device or a study comparing AI with human readers. Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as these are not relevant to the content provided.

    The document focuses on demonstrating substantial equivalence of the CystoSure™ Urinary Access System to legally marketed predicate devices based on design, materials, construction, intended use, and technological characteristics, supported by nonclinical testing, biocompatibility, and sterilization validation.

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