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510(k) Data Aggregation

    K Number
    K970443
    Device Name
    HOLLISTER RETRACTED PENIS POUCH
    Manufacturer
    HOLLISTER, INC.
    Date Cleared
    1997-02-25

    (20 days)

    Product Code
    EXI
    Regulation Number
    876.5250
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K862934
    Why did this record match?
    Device Name :

    HOLLISTER RETRACTED PENIS POUCH

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

    The Hollister Urine Collection Pouch is intended to collect urine from incontinent men by encompassing the penis

    Device Description

    The Hollister Urine Collection Pouch is a one-piece disposable system which collects urine by encompassing the penis. The pouch is made from odor-barrier film and features a synthetic skin barrier adhesive which aids in the protection of the skin. If required the precut opening in the barrier may be enlarged to accommodate the anatomy of the user. Strips of adhesive microporous tape may be used for additional security.

    AI/ML Overview

    The provided document is a 510(k) summary for the Hollister Urine Collection Pouch. It describes a medical device and compares it to a predicate device for regulatory approval. This document does not contain any information about a study with acceptance criteria, reported device performance, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device.

    The document discusses:

    • Device Description: A one-piece disposable system to collect urine from incontinent men.
    • Predicate Device: Hollister Female Urine Collection Pouch, K862934.
    • Technological Characteristics Comparison: A table comparing characteristics like intended use, barrier adhesive, barrier backing, barrier thickness, pouch film, drain valve, and drain valve tubing between the proposed and predicate devices.
    • Biocompatibility: Assessment based on ISO 10993, FDA guidelines (G95-1), and USP. Materials were found biocompatible.
    • Conclusion: The device is safe, effective, and substantially equivalent to the predicate device.

    Therefore, I cannot fulfill your request as the information you are asking for (acceptance criteria and study details for an AI/ML device) is not present in the provided text. This document is from 1997 and pertains to a physical medical device, not an AI/ML system.

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