← Product Code [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI) · K970307 # MINNOVA PELVIC FLOOR STIMULATION SYSTEM (K970307) _Empi · KPI · Apr 22, 1997 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970307 ## Device Facts - **Applicant:** Empi - **Product Code:** [KPI](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI.md) - **Decision Date:** Apr 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5320 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Indications for 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 detrusor muscle through reflective mechanisms. ## Device Story Minnova Pelvic Floor Stimulation System; battery-powered external electrical stimulator; used with vaginal or rectal electrodes to stimulate pelvic floor muscles; treats urinary incontinence; improves urethral sphincter closure; strengthens pelvic floor; inhibits detrusor muscle; non-programmable; no biofeedback; clinician-prescribed; patient-operated; provides intermittent or continuous stimulation; peak pulse intensity 0-100mA; frequency 12.5Hz or 50Hz; pulse width 300μs; duty cycle 5:10. ## Clinical Evidence Bench testing only. Verification of device specifications, software verification and validation, EMI testing, and FMECA performed to demonstrate substantial equivalence to predicate devices. ## Technological Characteristics Battery-powered electrical stimulator; output 0-100mA; frequency 12.5Hz or 50Hz; pulse width 300μs; duty cycle 5:10; ramp time 2s. Electrodes feature touchproof connectors. Non-programmable; no biofeedback. ## Regulatory 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). ## Predicate Devices - Empi, Inc. Innova Pelvic Floor Stimulation System (K9411911/B) - Hollister Mycrogym II Stimulation Device ([K891773](/device/K891773.md)) - Utah Medical Liberty System ([K960496](/device/K960496.md)) ## Reference Devices - Innova ComfortPulse Vaginal electrodes ([K964577](/device/K964577.md)) - Innova Vaginal Electrode ([K910081](/device/K910081.md)) - Innova Rectal Stimulation Electrode ([K954272](/device/K954272.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} APR 22 1997 Empi. Cost Effective Health Care Solutions SUMMARY OF SAFETY AND EFFECTIVENESS Minnova Pelvic Floor Stimulation System Date of Summary January 24, 1997 Page 1 of 2 K970307 A. General Provisions Submitter's Name: Empi, Inc. Submitter's Address: 599 Cardigan Road St. Paul, Minnesota 55126-3965 Contact Person: Carolyn M. Steele Husten Regulatory Affairs Manager Classification Name: Non-Implanted Electrical Continence Device 21 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 C. Device Description 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 soft-sided carrying case. Empi, Inc. 599 Cardigan Road St. Paul, Minnesota 55126-3965 USA 612-415-9000 FAX 612-415-7305 {1} 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 300μs. 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 detrusor 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. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970307](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KPI/K970307) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com