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510(k) Data Aggregation

    K Number
    K202921
    Device Name
    Uro-G Cystoscope
    Manufacturer
    UroViu Corporation
    Date Cleared
    2021-05-04

    (217 days)

    Product Code
    FAJ
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology-Urology (GU)
    Reference & Predicate Devices
    K132384,K171500
    Why did this record match?
    Reference Devices :

    K132384

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

    The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.

    Device Description

    The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.

    AI/ML Overview

    The provided text describes the 510(k) summary for the Uro-G Cystoscope. This document primarily focuses on establishing substantial equivalence to a predicate device (Uro-V Cystoscope) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.

    The "acceptance criteria" for a medical device like a cystoscope typically refer to the performance standards and safety requirements it must meet to be considered safe and effective, often demonstrated through engineering bench testing, biocompatibility, and electrical safety. The "study that proves the device meets the acceptance criteria" in this context refers to these non-clinical tests.

    There is no mention of AI/ML components in the Uro-G Cystoscope from the provided text, nor are there any acceptance criteria, sample sizes, or ground truth establishment relevant to AI/ML or comparative effectiveness studies with human readers. The device is a physical endoscope.

    Therefore, I will interpret "acceptance criteria" and "study" in the context of a medical device submission focused on equivalence for a non-AI physical device.

    Here's the breakdown based on the provided document:

    Acceptance Criteria and Study for Uro-G Cystoscope (Non-AI Device)

    The Uro-G Cystoscope is a physical medical device. The "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Uro-V Cystoscope) and compliance with relevant safety and performance standards through non-clinical testing.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Criterion (Implicit/Explicit)Reported Device Performance/Comparison
    Predicate EquivalenceIntended Use: "The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra."EXACTLY THE SAME as predicate (Uro-V Cystoscope).
    Indications for Use: Symptomatic voiding dysfunction, Hematuria, Bladder tumor surveillance, Recurrent lower urinary tract infection, Pelvic pain syndromes.EXACTLY THE SAME as predicate.
    Route of Advancement: Advanced to the bladder via the urethra.SAME as predicate.
    Site of Use: Hospitals and physician offices.SAME as predicate.
    Components: Reusable handle with video screen; Attachable cannula with working channel, illumination source, and camera at tip.**SAME** as predicate (handle is identical, cannula has modifications but core components are the same).
    Image Transmission/Display: Image transmitted from video camera at tip to video monitor on handle; 3.5-inch LCD Display.SAME as predicate.
    Field of View: 140 degrees.SAME as predicate.
    Direction of View: 0 degrees (forward viewing).SAME as predicate.
    Operational Characteristics: Adjustable illumination brightness, capture still images/video, cleaning/disinfection protocol, frequency/duration of use.SAME as predicate for these operational aspects.
    Tissue Contact Materials: Compliant with ISO 10993.SAME as predicate, and cannula materials passed all applicable biocompatibility tests (see details below).
    Differences and Rationale: Changes in Outer Diameter (5.5mm vs 4.2mm); Working Length (380mm vs 254mm); Working Channel ID (2.2mm); Flexible Tip Deflection (up to 210° up and 130° down); Focal Length (5-50mm vs 3-50mm). Rationale provided for each difference to demonstrate no new safety/effectiveness issues.Acceptable; Differences are addressed and do not raise new issues of safety or effectiveness. For example, increased OD is still within anatomical limits for patients, increased working length allows better access, improved tip deflection enhances ease of use without compromising safety due to continuous imaging.
    Performance Data (Bench/Non-Clinical)Design Verification & Validation: Ensure device performs as intended and meets specifications.Conducted with successful results.
    Packaging & Shelf-Life: Maintain sterility and integrity over time.Conducted for the sterile cannula, confirming labeled shelf life compliance.
    Biocompatibility: Meet ISO 10993 Part 1 requirements for short-duration (
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