(85 days)
No
The description focuses on electrical stimulation and does not mention any AI/ML components or functionalities.
Yes
The device is indicated for the acute and ongoing treatment of urinary incontinence by improving urethral sphincter closure, strengthening pelvic floor muscles, and inhibiting the detrusor muscle, which are all therapeutic actions.
No
The device is described as a "Pelvic Floor Stimulation System" that "stimulates the muscles of the pelvic floor to achieve and maintain urinary continence." Its purpose is to treat urinary incontinence by improving urethral sphincter closure, strengthening pelvic floor muscles, and inhibiting the detrusor muscle, not to diagnose a condition.
No
The device description explicitly states the system is comprised of an "external stimulator and an electrode," which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Minnova Pelvic Floor Stimulation System is a therapeutic device that uses electrical stimulation applied externally or internally (via electrodes) to treat urinary incontinence. It directly interacts with the patient's body to achieve a therapeutic effect.
- Lack of Sample Analysis: The description does not mention any analysis of biological samples. The device's function is to deliver electrical impulses, not to analyze substances from the body.
Therefore, the Minnova Pelvic Floor Stimulation System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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 detruser muscle through reflective mechanisms.
Product codes
Not Found
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Empi, Inc. Innova Pelvic Floor Stimulation System, K9411911/B, Hollister Mycrogym II Stimulation Device, K891773, Utah Medical Liberty System, K960496
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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 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
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.
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 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.