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510(k) Data Aggregation

    K Number
    K233275
    Device Name
    RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1)
    Manufacturer
    Gyrus ACMI, Inc
    Date Cleared
    2024-03-25

    (178 days)

    Product Code
    FGB,FET,NTN
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K153049
    Why did this record match?
    Device Name :

    RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope

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

    The RenaFlex™ Single-use Flexible Ureteroscope is intended to be used to visualize organs, cavities, and canals in the urinary tract (urethra. bladder, ureter, calvces and renal papillae) via transurethral or percutaneous access routes. It can also be used with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

    The Video System Center for Single Use Endoscopes is intended to provide illumination and receive, process, and output images from the compatible Olympus endoscope for diagnostics, treatment, and observation.

    Device Description

    The RenaFlex Single-use Flexible Ureteroscope System will provide visualization and access for diagnostic and therapeutic applications, including urinary system biopsy and kidney stone treatment and removal. The RenaFlex Single-use Flexible Ureteroscope and compatible Video System Center for Single-use Endoscopes provide a means for direct visualization, diagnosis, and treatment of various diseases in the urinary tract and kidneys. The ureteroscope component of the system is intended as a single-use device that works to access the anatomy and to guide accessory devices for diagnostic and therapeutic applications in the urinary tract and kidneys. The compatible Video System Center for Singleuse Endoscopes is a reusable software-driven device that provides illumination and receives, processes, and outputs images from the endoscope using field upgradable software for diagnosis, treatment, and observation.

    AI/ML Overview

    The provided text focuses on the 510(k) summary for the RenaFlex Single-use Flexible Ureteroscope System and does not describe acceptance criteria, performance data, or study designs for an AI/software device. The document states that "Clinical studies were not necessary for substantial equivalence determination," indicating that the submission primarily relied on bench testing and comparison to a predicate device.

    Therefore, I cannot provide the requested information about acceptance criteria, performance, or study details for an AI-powered device based on the given text. The device described is a physical medical instrument (ureteroscope) and its associated video system, not an AI software.

    The document does not contain the information required to answer the prompt.

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