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510(k) Data Aggregation

    K Number
    K022000
    Device Name
    POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
    Manufacturer
    SPIRE BIOMEDICAL INC
    Date Cleared
    2002-07-19

    (30 days)

    Product Code
    MSD
    Regulation Number
    876.5540
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K013160,K021212,K002902
    Predicate For
    K022620,K022644,K041559,K043292,K060288
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Spire Biomedical, Inc.'s Pourchez RetrO™ Silicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque silicone catheter designed for percutaneous insertion or insertion via a cutdown.

    Device Description

    The Pourchez RetrO™ Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque silicone catheter. The distal end has two tips separated over a predetermined distance. The distal arterial and venous lumens are round and are staggered to reduce recirculation. The body is oval, and the proximal end, which is connected to the catheter body by color-coded extension adapters, has two distinctive lumens with color-coded adapters (red for arterial and blue for venous). The catheter is available in five different implant lengths. It is also available with and without side holes on the distal ends. The catheter has a polyester cuff located at one of five different implant lengths from the distal end. A RetrO catheter repair kit will also be offered to replace damaged extensions and/or extension adapters.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device (Pourchez RetrO™ Twin Lumen Chronic Hemodialysis Catheter) and a subsequent FDA clearance letter. It does not describe or refer to any algorithm, AI, or software.

    Therefore, I cannot provide information on acceptance criteria and a study proving device conformance based on the input text for an AI/algorithm-based device as requested in the prompt.

    The document states: "A series of tests were performed to demonstrate substantial equivalence to predicate devices or conformation to established ISO standards for hemodialysis catheters. In all cases, the Pourchez RetrO™ catheter demonstrated equivalent performance to the predicate devices and acceptance criteria established by the appropriate standard." However, it does not provide specific details about these tests, acceptance criteria, reported performance, sample sizes, or ground truth establishment relevant to an AI/algorithm study.

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