FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR

K993411 · Mega Electronics , Ltd. · HIR · Jan 10, 2000 · Obstetrics/Gynecology

Device Facts

• Record ID: K993411
• Device Name: FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
• Applicant: Mega Electronics , Ltd.
• Product Code: HIR · Obstetrics/Gynecology
• Decision Date: Jan 10, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1425
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FemiScan™ devices are intended as an aid for exercising and training pelvic floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.

Device Story

FemiScan Clinic and Personal Systems are biofeedback monitoring devices using a 2-channel vaginal EMG probe to measure pelvic floor muscle activity. The system consists of a palm-sized measuring unit with a computer-based user interface for data acquisition and transfer. Used in clinics, hospitals, or home settings (prescription), the device provides visual or auditory feedback to patients to aid in exercising and training pelvic floor muscle activation and control. Healthcare providers use the output to monitor patient progress and guide therapy. The device benefits patients by facilitating targeted muscle training to treat urinary incontinence.

Clinical Evidence

Bench testing included system-level tests, integration tests, data calculation verification, and safety/risk analysis. A clinical user study for the FemiScan™ Personal System was conducted at Kuopio University Hospital to evaluate suitability for prescription home use. No adverse events were reported during the study.

Technological Characteristics

Palm-sized measuring unit with computer-based user interface; 2-channel vaginal EMG probe; electrical EMG sensing technology; data acquisition and transfer capabilities. Operates as a biofeedback monitoring system for pelvic floor muscle training.

Indications for Use

Indicated for female patients with stress or mixed urinary incontinence requiring pelvic floor muscle training under physician supervision.

Regulatory Classification

Identification

A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.

Predicate Devices

• InCare Pelvic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872, K930530)
• InCare Contimed Biofeedback devices (K960311, K891774)

Submission Summary (Full Text)

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K993411
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## 'JAN 1 0 2000

10.0 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92.

- 1. The submitter of this premarket notification is: David Mahoney Mahoney Enterprises 200 North Main Street, South Building, Suite 6 East Longmeadow, MA 01028 413.525.6313, Fax: [phone] Tel:
This summary was prepared on September 30, 1999

- 2. The name of this device is the FemiScan™ Clinic System and the FemiScan™ Personal System. The common name is Biofeedback Monitoring device with vaginal EMG probe. Classification names are as follows:

| Regulation Number | Classification Name |
|---------------------|----------------------------------------------|
| 876.5320 78 KPI, II | Nonimplanted electrical<br>continence device |
| 884.1425 85 HIR, II | Perineometer |

- 3. The FemiScan™ Clinic System is substantially equivalent to the following Hollister Incorporated predicate devices: InCare Pelvic Floor Therapy System with Desktop Computer PRS 9300 (K974048, K961872 and K930530) and the InCare Contimed Biofeedback devices for treatment of urinary incontinence (K960311 and K891774).
- 4. The FemiScan™ Clinic and Personal Systems consist of a palmsized measuring unit with a computer-based user interface and data acquisition system for data collection and data transfer. The devices feature a 2 channel EMG vaginal probe.
- 5. Apart from electrical stimulation and male uriniary incontinence applications, the FemiScan™ Clinic and Personal System has the same intended use as the legally marketed predicate device system. When used in the physician office, clinic or hospital environment, the FemiScan™ Clinic and Personal System is intended as an aid for exercising and training pelvic floor muscle activation and control. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician in the physician office, clinic, hospital environment or prescription home use.
- 6. The subject FemiScan™ Clinic and Personal System and the predicate Hollister devices both operate using the same

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K993411
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electromyography monitoring technology. However, the predicate devices use pressure EMG while the subject device uses electrical EMG. The measurement technology and the transmission of EMG signals are similar and therefore the technological characteristics are essentially the same as those of the legally marketed predicate devices.

- 7. The FemiScan™ Clinic and Personal System were subjected to safety and performance tests for compliance against applicable recognized standards. Additionally, verification, validation and testing activities were conducted to establish the performance and reliability characteristics of the FemiScan™ Clinic and Personal System. Testing involved system level tests, integration tests, data calculations, display results, FemiScan™ Personal System HomeTrainer communications, and safety testing from risk analysis. The FemiScan™ Personal System was evaluated for suitability as a prescription home use device in a user study conducted under the direction of Kuopio University Hospital. No adverse events occurred during the study.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 0 2000

Mega Electronics Ltd. c/o Mr. David Mahonev Mahonev Enterprises 200 North Main Street South Building, Suite 6 East Longmeadow, MA 01028 Re: K993411

Mega Electronics Femiscan™ Clinic System and Femiscan™ Personal System Dated: October 5, 1999 Received: October 12, 1999 Requlatory Class: II 21 CFR 884.1425/Procode: 85 HIR 21 CFR 876.5320/Procode: 78 KPI

Dear Mr. Mahoney:

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 legally marketed predicate 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 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 requirements, as set forth in the Quality System Regulation (QS) 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 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(t) 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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## Indications for Use Statement

510 (k) Number (if known)

The Mega Electronics Ltd., FemiScan™ Clinic Device Name System and FemiScan™ Personal System

K 993411

The FemiScan™ devices are intended Indications: Indications for as an aid for exercising and training pelvic Use floor muscle activation, control and optionally coordination with the abdominal muscle group. It is indicated in the treatment of stress and mixed female urinary incontinence under the supervision of a physician. The FemiScan™ Clinic System is used in the physician office, clinic, or hospital environment. The FemiScan™ Personal System is used to supplement these exercises in the home environment.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

.

OR

Over-The-Counter Use

Signature