(297 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of electromagnetic stimulation and its physiological effects, with no mention of AI or ML algorithms for control, analysis, or adaptation.
Yes
The device is intended for "rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women," which is a therapeutic purpose.
No
The device is described as a muscle stimulator system intended for rehabilitation and restoration of neuromuscular control, which are therapeutic functions. It does not perform any diagnostic functions like disease detection or identification.
No
The device description clearly outlines hardware components: a stimulator control unit and a treatment chair with a magnetic coil. The system generates a voltage signal and a magnetic field to induce muscle contractions, which are physical processes requiring hardware.
Based on the provided information, the NEOTONUS Model 1000 Muscle Stimulator System 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 NEOTONUS Model 1000 is a device that applies electromagnetic stimulation externally to the pelvic floor muscles. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use is for the rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence. This is a therapeutic application, not a diagnostic one.
Therefore, the NEOTONUS Model 1000 Muscle Stimulator System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NEOTONUS Model 1000 Muscle Stimulator System is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
Product codes
78 KPI
Device Description
The Model 1000 Muscle Stimulator System consists of a stimulator control unit and a treatment chair. The stimulator control unit is used to generate a voltage signal that periodically charges an "E" shaped magnetic coil located beneath the seat of the treatment chair. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-cycle "Rest" period (0-60 sec).
During treatment, the patient sits on the treatment chair with the pelvic floor area centered over the magnetic coil. The magnetic field emitted by the coil induces an electric field in the target tissue that causes contraction of the pelvic floor musculature. The patient is treated fully clothed and there is no need for an invasive electrode probe. Treatment is suggested as up to 30 minutes per sessions separated by at least 2 days.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor musculature
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
A clinical evaluation was conducted to compare the physiological effect of the Model 1000 to that of an electrical stimulator. Ten females received treatment with both the Model 1000 and an electrical stimulator. Treatment parameters were similar for both devices. Response was measured by evaluating the EMG activity of the urethral sphincter muscle and the pressure in the urethra during stimulation.
Urethral pressures were not affected by either magnetic or electrical stimulation. Muscle contractions in the urethral sphincter were visual and palpable for both types of stimulation. In all cases, the magnitude of the sphincter muscle activity produced by the magnetic stimulation was larger than that produced by the electrical stimulation. Most patients preferred the magnetic stimulation as more comfortable than the electrical stimulation. The results of this study support the substantial equivalence of the NEOTONUS Model 1000 Muscle Stimulator System to electrical stimulators for the treatment of urinary incontinence.
Key Metrics
Not Found
Predicate Device(s)
K961872, K963222, K960496, K970307
Reference Device(s)
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
K 973090
1 of 2
510(k) Summary
-- Neotonus, Inc. Model 1000 Muscle Stimulator System
Sponsor 1.
Neotonus, Inc. 810-A Franklin Court Marietta, GA 30067
Contact Person: Tony J. Morris President
May 28, 1998 Date Prepared:
Device Name 2.
| Proprietary Name: | NEOTONUS Model 1000 Muscle Stimulator System |
|---|---|
| Common/Usual Name: | Pelvic floor stimulator |
| Classification Name: | Nonimplanted electrical continence device |
3. Intended Use
The NEOTONUS Model 1000 Muscle Stimulator System is intended to provide entirely non-invasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
Device Description 4.
The Model 1000 Muscle Stimulator System consists of a stimulator control unit and a treatment chair. The stimulator control unit is used to generate a voltage signal that periodically charges an "E" shaped magnetic coil located beneath the seat of the treatment chair. Controls are available to vary the pulse frequency (1-55 Hz), pulse amplitude (0-100%), on-cycle "Duty" period (1-30 sec) and off-cycle "Rest" period (0-60 sec).
During treatment, the patient sits on the treatment chair with the pelvic floor area centered over the magnetic coil. The magnetic field emitted by the coil induces an electric field in the target tissue that causes contraction of the pelvic floor musculature. The patient is treated fully clothed and there is no need for an invasive electrode probe. Treatment is suggested as up to 30 minutes per sessions separated by at least 2 days.
1
K973096
2012
Basis For Substantial Equivalence 5.
The Model 1000 Muscle Stimulator System is substantially equivalent to electrical stimulators used for the treatment of incontinence, including the InCare Pelvic Floor Therapy System (K961872), the Hollister Microgyn Plus Stimulation Device (K963222), the Utah Medical Liberty System (K960496), and the Minnova Pelvic Floor Stimulation System (K970307).
A clinical evaluation was conducted to compare the physiological effect of the Model 1000 to that of an electrical stimulator. Ten females received treatment with both the Model 1000 and an electrical stimulator. Treatment parameters were similar for both devices. Response was measured by evaluating the EMG activity of the urethral sphincter muscle and the pressure in the urethra during stimulation.
Urethral pressures were not affected by either magnetic or electrical stimulation. Muscle contractions in the urethral sphincter were visual and palpable for both types of stimulation. In all cases, the magnitude of the sphincter muscle activity produced by the magnetic stimulation was larger than that produced by the electrical stimulation. Most patients preferred the magnetic stimulation as more comfortable than the electrical stimulation. The results of this study support the substantial equivalence of the NEOTONUS Model 1000 Muscle Stimulator System to electrical stimulators for the treatment of urinary incontinence.
2
Image /page/2/Picture/0 description: The image shows a partial document with a logo and a date. The logo on the left is for the Department of Health & Human Services. The date "JUN 12 1998" is printed below the logo, indicating the document was likely created or issued on that date.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neotonus, Inc. c/o Mr. James R. Veale Vice President, Regulatory Services Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
Re: K973096
Neotonus Model 1000 Muscle Stimulator System Dated: May 28, 1998 Received: May 29, 1998 Regulatory Class: II 21 CFR 876.5320/Procode: 78 KPI
Dear Mr. Veale:
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 Device Amendments, or to 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 Act. 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 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) 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 the Electronic Product 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/cdrf/dsmaldsmamain.html".
Sincerely vours.
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
Enclosure
3
510(k) Number (if known): K973096
Device Name: NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
Indications For Usc:
The NEOTONUS Model 1000 Muscle Stimulator System is intended to provide entirely noninvasive electromagnetic stimulation of pelvic floor musculature for the purpose of rehabilitation of weak pelvic muscles and restoration of neuromuscular control for the treatment of urinary incontinence in women.
(PLEASE DO NOT WRITE BISLOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
of CDRH, Office of Dovice Evaluation (ODE)
Prescription Use_ L (Per 21 CFR 801.109)
OR
Over-the-Counter Use_______
Robert Sattler/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devic 510(k) Number
(Üptional Format 1-2-96)