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510(k) Data Aggregation

    K Number
    K040519
    Device Name
    SLIP UROLOGY CATHETER
    Manufacturer
    PERCUTANEOUS SYSTEMS, INC.
    Date Cleared
    2004-05-20

    (83 days)

    Product Code
    EZD
    Regulation Number
    876.5130
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SLIP UROLOGY CATHETER

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

    The SLIP Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device is indicated for providing increased lubricity during the catheter's advancement.

    Device Description

    The SLIP Urology Catheter consists of a catheter, a sheath, a snap ring, and a guide ring. The catheter is pre-loaded with a membrane sheath for increased lubricity.

    AI/ML Overview

    1. Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Substantial Equivalence to Predicate DeviceThe SLIP Urology Catheter is identical to the Memcath Urology Catheter (except for the trade name). It has the same intended use, indications for use, technological characteristics, and principles of operation. Therefore, it is considered substantially equivalent.

    2. Sample Size Used for the Test Set and Data Provenance

    No specific test set or data provenance (country of origin, retrospective/prospective) is mentioned in the provided text, as no performance data was provided for clinical testing of the device itself. The primary argument for clearance is substantial equivalence to a predicate device.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

    Not applicable. No direct performance data or test set requiring expert ground truth establishment was conducted for the SLIP Urology Catheter, as its clearance was based on substantial equivalence.

    4. Adjudication Method for the Test Set

    Not applicable. No direct performance data or test set requiring adjudication was conducted for the SLIP Urology Catheter.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

    No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission relies on substantial equivalence to a predicate device.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

    Not applicable. This is a medical device (urology catheter), not an algorithm or AI-driven system.

    7. The Type of Ground Truth Used

    Not applicable. The clearance is based on substantial equivalence to a predicate device, not on specific performance metrics established against a ground truth.

    8. The Sample Size for the Training Set

    Not applicable. This is a medical device, not an AI or algorithm-driven system that would require a training set.

    9. How the Ground Truth for the Training Set was Established

    Not applicable. This is a medical device, not an AI or algorithm-driven system that would require a ground truth for a training set.

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