FEMISCAN CLINIC SYSTEM, MODEL FS-ICTRA AND FEMISCAN PERSONAL SYSTEM, MODEL FS-HMTR by MEGA ELECTRONICS LTD.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the FemiScan™ Clinic System and FemiScan™ Personal System, focusing on acceptance criteria and supporting studies:

Based on the provided K993411 document, the information regarding study details for establishing performance criteria is limited. The document focuses more on substantial equivalence to predicate devices and general safety/performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance in a numerical format. It broadly states that the device was subjected to safety and performance tests to ensure compliance with applicable recognized standards and to establish performance and reliability characteristics.

Therefore, a table of specific acceptance criteria and reported device performance cannot be created from the given text.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document mentions a "user study conducted under the direction of Kuopio University Hospital" for evaluating the FemiScan™ Personal System for suitability as a prescription home use device. However, the specific sample size for this user study is not provided.
Data Provenance:
- Country of Origin: Kuopio University Hospital is located in Finland.
- Retrospective or Prospective: The description "user study conducted" suggests a prospective study design.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth for the user study or their qualifications. The study was conducted under the "direction of Kuopio University Hospital," implying medical oversight, but details about individual expert contributions are absent.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the user study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study to evaluate how human readers improve with AI vs. without AI assistance. The FemiScan™ is a biofeedback monitoring device, not an imaging interpretation or diagnostic AI device in the typical sense that would necessitate such a study design.

6. Standalone (Algorithm Only) Performance Study

The document does not explicitly describe a standalone (algorithm only without human-in-the-loop) performance study in terms of diagnostic accuracy or similar metrics. While "system level tests, integration tests, data calculations, display results" were conducted, these describe internal validation steps rather than an independent performance study of the FemiScan™'s biofeedback algorithm against predetermined clinical outcomes or a gold standard without human interaction. The description of the user study implies human interaction for home use.

7. Type of Ground Truth Used

For the "user study conducted under the direction of Kuopio University Hospital," the ground truth implicitly relates to the suitability and safety for home use, and potentially the effectiveness of the device in aiding "exercising and training pelvic floor muscle activation and control" and "treatment of stress and mixed female urinary incontinence." The document notes "No adverse events occurred during the study," which is a safety outcome. Specific objective clinical outcomes or a "gold standard" for the effectiveness of training are not detailed as ground truth.

8. Sample Size for the Training Set

The document makes no mention of a training set or any machine learning/AI development process that would typically involve a separate training set. The FemiScan™ operates on electromyography (EMG) monitoring technology and biofeedback principles, which are well-established, rather than relying on a complex AI model trained on large datasets.

9. How the Ground Truth for the Training Set Was Established

Since there is no mention of a training set, there is no information on how its ground truth would have been established.

Summary

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K993411
Page 1 of 2

'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: 413.525.1999 Tel:
  This summary was prepared on September 30, 1999
1. 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 electricalcontinence device
884.1425 85 HIR, II	Perineometer

1. 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).
1. 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.
1. 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.
1. The subject FemiScan™ Clinic and Personal System and the predicate Hollister devices both operate using the same

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K993411
Page 2 of 2

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.

1. 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 (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/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)

Over-The-Counter Use

Signature

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).