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510(k) Data Aggregation

    K Number
    K963265
    Device Name
    PROSYS SAMEC LA
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
    Date Cleared
    1996-10-25

    (66 days)

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

    PROSYS SAMEC LA

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

    The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ SAMECTM LA under the ConvaTec ProSys™ product line of incontinence products.

    ProSys™ SAMEC™ LA is intended for use in the management of male urinary incontinence.

    Device Description

    ProSys™ SAMEC™ LA is a one-piece self-adhering male external catheter.

    AI/ML Overview

    This document is a 510(k) Premarket Notification for the ProSys™ SAMEC™ LA, a male external catheter. The document asserts substantial equivalence to a predicate device, the Mentor Urology, Inc.'s Freedom Cath® Self-Adhering Male External Catheter, based on indications, contraindications, and biocompatibility testing.

    However, the provided text does not contain any information about acceptance criteria for a device's performance that would typically be evaluated in a study with a test set, ground truth, experts, or sample sizes related to clinical efficacy or diagnostic accuracy.

    The information present focuses solely on the biocompatibility of the adhesive material and the latex rubber. It states:

    • Adhesive material: Non-toxic, non-sensitizing, Primary Irritation Index of 0.25 (acceptable range: 0-2 for mildly irritating).
    • Latex rubber: Non-toxic, non-irritating, non-sensitizing. Initially failed Cytotoxicity testing, but passed after a 1:32 dilution in the MEM Elution test.

    **Therefore, I cannot provide the requested table and study details because the provided text does not describe a study involving:

    • Acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy).
    • A test set of data (e.g., patient samples, images).
    • Ground truth established by experts.
    • Sample sizes for test or training sets for an AI/algorithm.
    • MRMC studies for human reader improvement.**

    The "study" referenced is exclusively about biocompatibility testing, which has different types of acceptance criteria (e.g., irritation indices, passage of cytotoxicity tests at certain dilutions) than those for clinical performance of a diagnostic or therapeutic device that would involve AI.

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