(63 days)
Not Found
No
The document describes a standard electrical stimulation and EMG device with no mention of AI or ML capabilities.
Yes
The device is indicated for "acute and ongoing treatment of stress, urge or mixed urinary incontinence" and for improving "urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms," which are all therapeutic claims.
Yes
The device is indicated for "assessing EMG activity of the pelvic floor and accessory muscles" which is a diagnostic function to evaluate muscle activity.
No
The device description explicitly states it is comprised of external hardware components including a stimulator/electromyography reader, leadwires, electrodes, and is battery powered.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The InnoSense System directly interacts with the patient's body through electrodes to stimulate muscles and measure electrical activity (EMG). It is used for treatment and assessment of muscle function, not for analyzing biological samples.
The intended use and device description clearly indicate a therapeutic and diagnostic device that works in vivo (within the living body), not in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
The InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
Product codes (comma separated list FDA assigned to the subject device)
78 KPI, 85 HIR
Device Description
The InnoSense Pelvic Floor Stimulation and Electromyography (EMG) System is comprised of a external stimulator/electromyography reader, leadwires (for surface EMG only) and electrodes. The device has a one channel stimulation function and a two channel EMG function. It is battery powered by two 1.5 volt (AA) batteries, with a low battery indication shown on the LCD Panel. The electrodes used to stimulate the pelvic floor muscles consist of either a vaginal or rectal electrode. The EMG function uses two electrodes consisting at the most one Vaginal or Rectal electrode and/or one or two surface EMG electrodes. One electrode is used to sense pelvic floor muscle activity and one is to sense accessory muscle activity such as the abdominal or gluteal muscles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pelvic floor, urethral sphincter, abdominal, gluteal muscles
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)
Not Found
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.
K892649, K935213, K893220, K941911, K970307
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
JUN 30 1997
Image /page/0/Picture/1 description: The image shows the word "Empi" in a bold, stylized font. Above the word "Empi" is the number "K971527". To the right of the word "Empi" is the number "142" in a handwritten font. The image appears to be a product label or identifier.
Cost Effective Health Care Solutions
SUMMARY OF SAFETY AND EFFECTIVENESS InnoSense Pelvic Floor Stimulation and Electromyography System
Date of Summary June 17, 1997 Page 1 of 2
Empi, Inc. 599 Cardigan Road St. Paul. Minnesota 55126-3965 USA
612-415-9000 FAX 612-415-7305
General Provisions A.
| 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 | |
| Proprietary Name: | InnoSense Pelvic Floor Stimulation and |
| Electromyography System | |
| Common Name: | Pelvic Floor Stimulation and Biofeedback Device |
| Classification Name: | Non-Implanted Electrical Continence Device |
| Biofeedback Device |
Name of Predicate Devices B.
- Verimed Myoexerciser III, K892649 ◆
- Thought Technology InControl, K935213 �
- Verimed Veristim, K893220 �
- Innova Pelvic Floor Stimulation System, K941911 �
- Minnova Pelvic Floor Stimulation System, K970307 �
C. Device Description
List of Components
The InnoSense Pelvic Floor Stimulation and Electromyography (EMG) System is comprised of a external stimulator/electromyography reader, leadwires (for surface EMG only) and electrodes. The device has a one channel stimulation function and a two channel EMG function. It is battery powered by two 1.5 volt (AA) batteries, with a low battery indication shown on the LCD Panel. The electrodes used to stimulate the pelvic floor muscles consist of either a vaginal or rectal electrode. The EMG function uses two electrodes consisting at the most one Vaginal or Rectal electrode and/or one or two surface EMG electrodes. One electrode is used to sense pelvic floor muscle activity and one is to sense accessory muscle activity such as the abdominal or gluteal muscles.
Electrical Characterization
External Stimulator
The external stimulator function provides stimulus output to the electrode and can be adjusted to deliver stimulation at an peak pulse intensity range of 0 to 100mA.
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human figures, represented by flowing lines, suggesting a sense of community and support.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 30 1997
Re: K971527 InnoSense Pelvic Floor Stimulation and Electromyography System -- Dated: April 25, 1997 ------Received: April 28, 1997 Regulatory class: II 21 CFR §876.5320/Product code: 78 KPI 21 CFR §884.1425/Product code: 85 HIR
Ms. Carolyn M. Steele Husten Regulatory Affairs Manager Empi, Inc." 599 Cardigan Road St. Paul, Minnesota 55126-3965
Dear Ms. Husten:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address http://www.fda.gov/cdrl/dsmamain.html".
Sincerely yours,
h.J.Liau Yir
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
510(k) Number: (if known): K971527 Device Name: InnoSense Pelvic Floor Stimulation and Electromyography System Indications for Use:
The InnoSense System is indicated for acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Improvement of urethral sphincter closure, Strengthening of pelvic floor muscles, Inhibition of the detruser muscle through reflexive mechanisms. It is also indicated during incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal or gluteal muscles.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert D. Salling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K911527
Prescription Use
(Per 21 CFR 801.109)
OR Over-The Counter Use _________________________________________________________________________________________________________________________________________________________