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510(k) Data Aggregation

    K Number
    K181144
    Device Name
    Angled Tip Ureteral Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2018-06-28

    (58 days)

    Product Code
    KOD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K102527,K171600,K171662
    Why did this record match?
    Reference Devices :

    K102527, K171600, K171662

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

    These devices are intended for access and catheterization of the urinary tract, including the following applications:

    • Delivery of contrast media
    • Navigation of a tortuous ureter
    • Access, advancement, or exchange of wire guides
    Device Description

    The Angled Tip Ureteral Catheter is constructed from polyurethane tubing and is designed with a female Luer lock adapter. The catheter is available in 5 and 6 French diameters and a length of 70 centimeters. The distal tip of the catheter has an angle of 20°, sideports, and a taper. The female Luer lock adapter is constructed from polyamide. The subject device also includes a stainless steel wire guide coated with PTFE. The wire guide diameter is 0.035 inches and the length is 145 centimeters

    AI/ML Overview

    This document, K181144, is a 510(k) premarket notification for the Angled Tip Ureteral Catheter from Cook Incorporated. It determines the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information regarding studies for AI/ML based medical devices or their acceptance criteria. It pertains to a physical medical device (catheter) and its substantial equivalence based on performance testing of the device itself. Therefore, I cannot extract the requested information regarding:

    • A table of acceptance criteria and reported device performance for an AI/ML device.
    • Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details for an AI/ML test set or training set.

    The performance data listed in the document (Biocompatibility, Sterilization, Dimensional and Compatibility, Radiopacity, Kink Radius, Tensile, Blockage and leakage) are standard engineering and material tests for a physical catheter, not typically applicable to the validation of an AI/ML algorithm.

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