(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.
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SUMMARY OF SAFETY AND EFFECTIVENESS Minnova Pelvic Floor Stimulation System
Date of Summary January 24, 1997
Page 1 of 2 K970307
Empi. Inc. 599 Cardigan Road St. Paul. Minnesota 55126-3965 USA
612-415-9000 FAX 612-415-7305
| A. | General Provisions | |
|---|---|---|
| Submitter's Name: | Empi, Inc. | |
| Submitter's Address: | 599 Cardigan RoadSt. Paul, Minnesota 55126-3965 | |
| Contact Person: | Carolyn M. Steele HustenRegulatory Affairs Manager | |
| Classification Name: | Non-Implanted Electrical Continence Device21 CFR Part 876.5320 | |
| Proprietary Name: | Minnova Pelvic Floor Stimulation System | |
| Common Name: | Pelvic Floor Stimulation Device |
B. Name of Predicate Devices
- Empi, Inc. Innova Pelvic Floor Stimulation System, K9411911/B �
- Hollister Mycrogym II Stimulation Device, K891773 �
- Utah Medical Liberty System, K960496
Device Description C.
List of Components
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.
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SUMMARY OF SAFETY AND EFFECTIVENESS Minnova Pelvic Floor Stimulation System
Date of Summary January 24, 1997 Page 2 of 2
Electrical Characterization
External Stimulator
The Minnova is a battery powered electrical stimulator which provides stimulus output to the electrode and can be adjusted to deliver intermittent or continuous stimulation at an peak pulse intensity range of 0 to 100mA. The ramp up/down time is 2 seconds. The stimulator is capable of providing electrical impulses at frequencies of either 12.5Hz or 50 Hz. The pulse width is 300us. The work to rest ratio (duty cycle) is 5:10 (5 seconds on/10 seconds off). The ComfortPulse Electrodes and Innova Rectal Electrode are fully compatible with the stimulator with the touchproof connector. The device is not programmable by the patient or the clinician and there are not any biofeedback components.
D. Intended Use
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.
E. Non-Clinical and Clinical Test Summary
Non-clinical tests were performed to establish that the device when used with the ComfortPulse, Innova Vaginal and Innova Rectal electrodes meet specifications, thus providing evidence that the device when used with the electrodes are substantially equivalent to predicate devices and do not introduce new safety or effectiveness issues. Non-Clinical Tests consisted of verification of the specifications listed in the Table of Similarities and Differences, software verification and validation testing described in Section II, Part D, EMI Testing described in Section II, Part B and an FMECA test.
§ 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).