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510(k) Data Aggregation

    K Number
    K223926
    Device Name
    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box
    Manufacturer
    Medimaging Integrated Solution Inc. (MiiS)
    Date Cleared
    2023-10-06

    (280 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K193095
    Why did this record match?
    Device Name :

    VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box

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

    The VersaVue™ Single-Use Flexible Cystoscope is a sterile, single-use, and flexible device intended to be operated with its compatible display system (VersaVue™ Tablet OR VersaVue™ Video Box). The device provides endoscopic procedure and surgical treatment within the lower urinary tract.

    The Cystoscope is intended to provide visualization via displaying unit.

    The Cystoscope is intended for use in a hospital environment or medical office environment. It is designed for use in adults.

    Device Description

    VersaVue™ Single-Use Flexible Cystoscope is a single-use, flexible, sterile cystoscope. The illumination LED locate at the tip of the distal end. There is a bending section near the region of distal end, which manipulated by the control lever on the handle part, can provide visions with more than one direction for the users. The signal captured was then transmitted to the cable-connected display system (VersaVue™ Tablet OR VersaVue™ Video Box). The working channel provide access for accessories to conduct surgical process.

    VersaVue™ Tablet is a tablet. The live imaging or snapshot will present directly on the tablet.

    VersaVue™ Video Box is a standalone imaging transfer system, it can be connected to computer to project live imaging. The function of VersaVueTM Single-Use Flexible Cystoscope is to provide live imaging of the lower urinary tract, including tissue appearance recording, snapshot, vertical flip and horizontal flip.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria for a device's performance that would require a study with a test set, expert adjudication, or MRMC studies. The document describes a 510(k) premarket notification for a cystoscope, focusing on substantial equivalence to a predicate device based on technical characteristics and nonclinical tests.

    Therefore, I cannot provide the requested information. The document states:

    "Clinical Tests
    No clinical studies were performed."

    This indicates that the submission did not include studies that would typically define acceptance criteria based on performance with a test set and ground truth. The listed nonclinical tests focus on safety, electrical compatibility, sterilization, and basic optical performance specifications, not on clinical performance metrics with a patient dataset.

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