(243 days)
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.
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.
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 Endpoint | Implied 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 decrease | 65.5% decrease | ≤0.0001 |
| 2. Reduction in Perceived Severity of Leakage | Statistically and clinically significant reduction | 71.1% reduction |
§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.