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

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Neotonus Model 1000 Muscle Stimulator System, extracting the requested information:

Understanding the Device and its Context:

The Neotonus Model 1000 Muscle Stimulator System is a non-invasive device designed for the electromagnetic stimulation of pelvic floor muscles to treat urinary incontinence in women. The submission is a 510(k) premarket notification, meaning it seeks to demonstrate substantial equivalence to previously marketed devices, rather than proving novel efficacy.

Acceptance Criteria and Device Performance

The provided document describes a clinical evaluation to demonstrate substantial equivalence, not a study against pre-defined acceptance criteria in the traditional sense of a performance goal (e.g., target sensitivity/specificity). Instead, the "acceptance criteria" here are implied by the desired outcome of the study: to show that the Model 1000 has a physiological effect at least equivalent or superior to existing electrical stimulators for the treatment of incontinence.

The study aims to show that the Model 1000 works similarly or better physiologically, and is preferred by patients, which would support its claim of substantial equivalence.

Table of "Acceptance Criteria" and Reported Performance (inferred):

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Model 1000 vs. Electrical Stimulator)
Produce muscle contractions in the urethral sphincter.	Achieved: Muscle contractions in the urethral sphincter were visual and palpable for both types of stimulation (Model 1000 and electrical stimulator).
Magnitude of sphincter muscle activity.	Superior: In all cases, the magnitude of the sphincter muscle activity produced by the magnetic stimulation (Model 1000) was larger than that produced by the electrical stimulation.
Impact on urethral pressures.	Equivalent: Urethral pressures were not affected by either magnetic (Model 1000) or electrical stimulation.
Patient comfort.	Superior: Most patients preferred the magnetic stimulation (Model 1000) as more comfortable than the electrical stimulation.
Overall physiological effect.	Equivalent/Superior: The clinical evaluation concludes that the results support the substantial equivalence of the NEOTONUS Model 1000 Muscle Stimulator System to electrical stimulators, citing larger muscle activity and improved comfort.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: Ten (10) females.
- Data Provenance: Not explicitly stated, but clinical evaluations for 510(k)s are typically conducted in the country where the device is being submitted for regulatory approval (in this case, presumably the US). The study design (clinical evaluation comparing two devices) suggests it was a prospective study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The study design focuses on physiological measurements (EMG activity, urethral pressure) and observable/palpable muscle contractions, along with patient preference. It does not describe a process where "experts" establish a ground truth in the sense of labeling data.
- The "ground truth" here is the physiological response as measured by objective instruments and subjective patient feedback, reported by the study investigators. The qualifications of these investigators are not provided.
Adjudication method for the test set:
- Not applicable. This study does not involve image interpretation or diagnostic labeling that would require an adjudication method like 2+1 or 3+1. The outcomes are physiological measurements and direct observation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is a muscle stimulator, not an AI-powered diagnostic tool requiring human reader interpretation of data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable. The Model 1000 is a physical medical device, not an algorithm, and it directly delivers therapeutic stimulation. It doesn't perform "standalone" diagnostic tasks apart from human interaction.
The type of ground truth used:
- The ground truth was based on physiological measurements (EMG activity of the urethral sphincter muscle, pressure in the urethra) and direct observation (visual and palpable muscle contractions). Patient preference (comfort) also served as a qualitative outcome. This is akin to physiologic response data.
The sample size for the training set:
- This concept is not applicable to this submission. The Model 1000 is a hardware device, not an AI/ML algorithm that requires a "training set." The clinical evaluation served as empirical evidence for its performance and substantial equivalence.
How the ground truth for the training set was established:
- This question is not applicable as there is no training set for a hardware device.

Summary

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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

Device Description 4.

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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.

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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

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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)

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)

Regulation Number and Section

§ 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).