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

• K Number: K993411
• Device Name: FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR
• Manufacturer: MEGA ELECTRONICS LTD.
• Date Cleared: 2000-01-10 ( 90 days)
• Product Code: HIR
• Regulation Number: 884.1425

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 Description

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.

Predicate Devices

K974048, K961872, K930530, K960311, K891774

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a biofeedback device using EMG for pelvic floor muscle training and does not mention any AI or ML components in its description, intended use, or performance studies.

Therapeutic

Yes
The device is indicated for the treatment of stress and mixed female urinary incontinence, which is a therapeutic purpose.

Diagnostic

No

Explanation: The device is described as an aid for exercising and training pelvic floor muscles and is indicated in the treatment of stress and mixed female urinary incontinence, rather than for diagnosis. It uses an EMG vaginal probe for data collection, which is typically for monitoring muscle activity during treatment or training, not for pathological diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of a "palmsized measuring unit" and a "2 channel EMG vaginal probe," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the FemiScan™ device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for exercising and training pelvic floor muscles and treating urinary incontinence. This is a therapeutic and training purpose, not for diagnosing a condition based on in vitro examination of specimens.
• Device Description: The device uses a vaginal probe to measure EMG (electromyography) signals from the pelvic floor muscles. This is a physiological measurement taken directly from the body, not an analysis of a biological sample outside the body.
• Lack of IVD Characteristics: The description does not mention any analysis of biological specimens (like blood, urine, tissue, etc.) or any diagnostic claims based on such analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The FemiScan™ device's function falls outside this definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

78 KPI, 85 HIR

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

pelvic floor muscle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician office, clinic, hospital environment or prescription home use.

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

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.

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K974048, K961872, K930530, K960311, K891774

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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
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.

2

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

3

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