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510(k) Data Aggregation

    K Number
    K221158
    Device Name
    Single-Use Video Flexible Ureterorenoscope System
    Manufacturer
    Guangzhou Red Pine Medical Instrument Co., Ltd.
    Date Cleared
    2023-03-06

    (319 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K172098
    Why did this record match?
    Device Name :

    Single-Use Video Flexible Ureterorenoscope System

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

    The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.

    Device Description

    The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.

    The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.

    Flexible Ureterorenoscope has the following physical and performance characteristics:

    • Flexible insertion portion
    • Camera and LED light source at the distal tip
    AI/ML Overview

    The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.

    However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.

    Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.

    Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.

    Based on the provided text, here is what can be inferred:

    1. A table of acceptance criteria and the reported device performance

    The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.

    CategoryAcceptance Criteria (Implied)Reported Device Performance
    Predicate ComparisonBe similar to or better than the predicate device in technological characteristics (indications for use, anatomical site, target population, environment, flexible scope, CMOS imager, LED light source, deflection (at least 270°), 0° direction of view, 120° field of view, 3-50mm depth of field, system composition, patient-contacting materials, single-use, EO sterilized) to not raise new questions of safety and effectiveness.Matches or is similar to the predicate device in all listed characteristics. Differences in deflection, insertion width, working length, and channel width are noted as either better or not raising new safety/effectiveness questions, confirmed by performance testing. For example, deflection is 275° (better), working length 670mm (longer).
    Electrical SafetyCompliance with IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014 and A1:2020.In compliance with the listed FDA recognized standards.
    Photobiological SafetyCompliance with IEC 62471:2006.Tested according to IEC 62471:2006.
    Mechanical & Optical PerformanceCompliance with ISO 8600-1:2015 (applicable parts), ISO 12233:2017, ISO 15739:2017, and internal specifications for water delivery, fatigue, stress of bending, tensile strength, insertion width, channel width, deflection, field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range, color performance.The device was designed to comply, and performance measurements were performed according to, the listed standards. Bench test results claim "same or similar image quality, optical performance and mechanical performance" compared to the predicate. Specific numerical performance values are not provided.
    BiocompatibilityCompliance with ISO 10993-1, -5, -10, -11 for "Surface – Mucosal Membrane" with "Limited (
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