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510(k) Data Aggregation

    K Number
    K954215
    Device Name
    MINIGUARD
    Manufacturer
    ADVANCED SURGICAL INTERVENTION, INC.
    Date Cleared
    1996-05-08

    (243 days)

    Product Code
    MNG
    Regulation Number
    876.5160
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED SURGICAL INTERVENTION, INC.

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

    The Miniguard is an external female continence device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence occurs when intraabdominal pressure exceeds urethral resistance as a result of physical stress such as coughing, laughing, or lifting heavy objects. The Miniguard is designed for women who experience urine leakage under conditions of physical stress.

    Device Description

    The Miniguard female continence device consists of a small pad that is coated on one side with a biocompatible polymer adhesive. The Miniguard is an external management device that is applied to the urinary opening to prevent or decrease episodes of stress incontinence. The Miniguard's function is to provide occlusion of the urinary opening by creating a seal over the urinary opening. The foam pad backing is intended to facilitate application and removal and for user comfort.

    AI/ML Overview

    The Advanced Surgical Intervention (ASI) Miniguard Female Continence Device was evaluated for its safety and efficacy in decreasing urinary leakage episodes and improving quality of life in women with stress incontinence.

    1. Table of Acceptance Criteria & Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a pass/fail format per se, but rather presents the statistically significant improvements as the measure of effectiveness. I've re-framed the reported performance as meeting implied criteria for significant improvement.

    Hypothesis / Study EndpointImplied Acceptance Criterion (Significant Improvement)Reported Device Performance (Average % Improvement)Statistical Significance (Prob> T)
    Overall Efficacy (All participants)
    1. Decrease in No. of Leakage Episodes (per week)Statistically and clinically significant decrease65.5% decrease≤0.0001
    2. Reduction in Perceived Severity of LeakageStatistically and clinically significant reduction71.1% reduction
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