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510(k) Data Aggregation

    K Number
    K182122
    Device Name
    Ureteric Catheters
    Manufacturer
    Coloplast Corp
    Date Cleared
    2018-10-04

    (59 days)

    Product Code
    EYB
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K021856,K171043
    Predicate For
    K192183
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Ureteric catheters for retrograde ureteropyelography are intended for injection of contrast medium or saline during endourological procedures.

    Device Description

    The Ureteric Catheters for retrograde ureteropyelography are flexible tubular devices designed with open proximal and distal ends. The bulb shaped distal end permits the catheter to enter the lowest part of the ureter maintaining water tightness when injecting contrast or saline. The Ureteric Catheters are made from a polyvinyl chloride (PVC) material and have soft bulbous tip to help position the device in the ureter meatus. The devices are provided sterile and are intended for single use. The Ureteric Catheters have a Chevassu open tip, do not have side eyes, and range in diameter from 3 Fr to 7 Fr for the catheter body and 4 Fr to 10 FR for the Chevassu bulb. They are supplied with a metal stylet to facilitate insertion and a Luer-lock syringe connector. They are provided in two lengths, 69.5 and 73 cm. The longer version is intended to be compatible with a 0.035" guidewire. The shaft is marked at one centimeter increments along the length to aid in advancement and is radiopaque for fluoroscopic visualization.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Ureteric catheter) and does NOT contain information about acceptance criteria or a study proving that an AI/ML powered device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

    Therefore, I cannot extract the requested information from this document. The document details:

    • Device Name: Ureteric catheter
    • Regulation Number: 21 CFR § 876.5130 (Urological Catheter and Accessories)
    • Product Code: EYB
    • Predicate Devices: PORGES™ Ureteral Catheters (K021856) and Floppy Tip Hydro-Coated Ureteric Catheter (K171043)
    • Non-Clinical Performance Data: Biocompatibility testing (Cytotoxicity, Sensitization, Irritation), Performance testing (Visual Evaluation, Compatibility with Guidewire or Stylet, Compatibility with Connector, Compatibility with Liquid, Tensile Strength on Catheter Bulb, Tensile Strength on Catheter Tube, Flow Rate, Simulation of Use, Radiopacity), Sterilization, and Packaging and Distribution testing.
    • Absence of Clinical Studies: Explicitly states "No animal studies or clinical testing were provided to support substantial equivalence between the subject and predicate devices."

    No AI/ML software is mentioned, nor are any acceptance criteria or studies related to AI/ML performance.

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