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510(k) Data Aggregation

    K Number
    K143594
    Device Name
    VaPro Pocket
    Manufacturer
    Hollister Incorporated
    Date Cleared
    2015-01-09

    (22 days)

    Product Code
    GBM
    Regulation Number
    876.5130
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K141642
    Why did this record match?
    Device Name :

    VaPro Pocket

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

    VaPro™ Pocket 40cm intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.

    VaPro™ Pocket 20cm intermittent catheter is a flexible tubular device that is inserted through the urethra by female patients who need to drain urine from the bladder.

    Device Description

    The VaPro Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
    ∑ hydrophilic-coated PVC catheter (phthalate free)
    ∑ 2 smooth catheter eyelets
    ∑ protective sleeve
    ∑ protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
    ∑ color coded funnel
    The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter.
    This product does not utilize a collection bag.

    AI/ML Overview

    The provided document is a 510(k) premarket notification for a medical device called "VaPro™ Pocket intermittent catheter." It does not contain information about an AI-powered device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices.

    The document describes a urological catheter and its packaging. The "performance testing" section refers to:

    • Biocompatibility testing: Performed on the new packaging (not the device itself, as no change to the device was made).
    • Sterility testing: Performed using Gamma Irradiation.
    • Package integrity testing: To verify maintenance of the sterile barrier through shelf life.
    • Transportation testing: To verify no impact on catheter safety or efficacy.

    These are standard engineering and quality control tests for a physical medical device, not performance metrics for an AI algorithm.

    Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI-powered device because the provided text describes a physical, non-AI medical device and its packaging.

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