(85 days)
The Minnova Pelvic Floor Stimulation System is indicated for acute and ongoing treatment of urinary incontinence in cases where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflective mechanisms.
The Minnova Pelvic Floor Stimulation System is comprised of a external stimulator and an electrode. The device when used with the Innova® ComfortPulse® Vaginal electrodes (ComfortPulse Electrodes) (K964577 currently under review at the FDA), Innova Vaginal Electrode (K910081), and Innova® Rectal Stimulation Electrode (Innova Rectal Electrode) (K954272), stimulates the muscles of the pelvic floor to achieve and maintain urinary continence. The electrodes are identical to those previously submitted except for the addition of touchproof connectors to comply with "Medical Devices; Performance Standards for Electrode Lead Wires and Banning of Unprotected Electrode Lead Wires; Proposed Rule." There is no adapter required to connect the electrodes to the device. The components of the system are placed in a softsided carrying case.
This document does not contain information about acceptance criteria or a study that proves the device meets those criteria. It primarily describes the device's components, technical specifications, intended use, and the types of non-clinical tests performed to demonstrate substantial equivalence to predicate devices. There is no mention of clinical studies, sample sizes, expert involvement, ground truth, or MRMC studies.
§ 876.5320 Nonimplanted electrical continence device.
(a)
Identification. A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).(b)
Classification. Class II (performance standards).