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    K Number
    K172298
    Device Name
    OLYMPUS URF-P6/P6R
    Manufacturer
    Olympus Medical Systems Corp.
    Date Cleared
    2018-03-29

    (241 days)

    Product Code
    FGB
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K912120
    Predicate For
    K181451
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This instrument has been designed to be used with an Olympus light source, documentation equipment, monitor, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and hepatic duct).

    Device Description

    This endoscope is composed from eyepiece section, control section and flexible insertion tube, and equipped light fiber bundle for image transfer system. Besides, it has eyepiece frame on eyepiece section for eyepiece and video camera connection for endoscope.

    URF-P6R has Identification marking for opposite bending direction on the control section and the bending section of the URF-P6R moves in the direction opposite to the conventional endoscopes, such as the URF-P6. This is the only different point between URF-P6 and URF-P6R.

    AI/ML Overview

    The provided document is a 510(k) premarket notification from Olympus Medical Systems Corp. for their URF-P6/P6R uretero-reno fiberscope. This document does not describe an AI/ML-driven device or study that proves the device meets acceptance criteria related to AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olympus URF Type P2) through non-clinical testing for safety and effectiveness.

    Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment, as the document does not contain this type of content.

    The information in the document pertains to:

    • Device identification: Ureter-reno fiberscope, Regulation Number 876.1500, Class II.
    • Indications for Use: Endoscopic diagnosis and treatment within the ureter, kidney, and biliary tract.
    • Comparison to predicate device (K912120 URF Type P2): Discusses minor changes in physical properties, patient-contact material, sterilization method (addition of hydrogen peroxide), and internal structure for durability.
    • Non-clinical testing: Risk analysis (ISO 14971), biocompatibility (ISO 10993), performance testing, reprocessing validation, and electrical safety (IEC 60601 standards).

    The document concludes that the Olympus URF-P6/P6R is substantially equivalent to the predicate device, with no significant changes affecting safety or effectiveness.

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