The Slendertone Flex device is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the purpose of improving abdominal muscle tone.

The device is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.

Device Description

The Slendertone Flex Abdominal Training system is a two- channel battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It comprises two main components, namely, an electronic stimulator module which generates the required stimulation signals, and an abdominal electrode belt, which connects the signals from the stimulator to the skin electrodes located on the inner surface of the belt. In effect, the belt in this case takes the place of the lead-wires in most conventional muscle stimulators.

The product is supplied with a set of double- sided adhesive electrodes, an instruction manual, a set of batteries, and a carry pouch. Power is derived from three AAA cells located in a compartment protected by a removable battery cover.

Although a two- channel system, there are only three electrodes, since the central umbilical electrode is common to the each of the left and right stimulation circuits. The electrodes connect adhesively to studs on the inner surface of the belt. The user extends the belt and puts it on in a wrapping motion from front to back, closing it at the back using the hook and loop patches. When the belt is in place on the body the larger center electrode locates over the umbilicus and the two side electrodes locate on either side of the body towards the mid axillary line, between the pelvis and the ribcage. It has been found that this electrode positioning is particularly useful for stimulating the abdominal muscles.

The pulsed stimulation current passes between the side and center electrodes only. There is no current passed from side to side. Because the user has no access to the wiring or connectors within the belt, he/she cannot alter the current path and so the possibilities for mis-use are greatly reduced

AI/ML Overview

The provided text describes a 510(k) summary for the Slendertone FLEX Abdominal Training System, Type 515. This submission focuses on demonstrating substantial equivalence to a predicate device, not on validating novel performance claims through clinical studies against specific acceptance criteria. Therefore, much of the requested information (like acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth for training) is not present in this document.

Here's a breakdown of what can be extracted and what is not available from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified in the document. The submission focuses on substantial equivalence to a predicate device and compliance with safety standards rather than specific performance metrics (e.g., a certain percentage improvement in muscle tone) as acceptance criteria.	The "Non clinical Tests" section states: "Comparisons of electrical outputs for the two devices show similar results." This indicates that the new device's electrical output is comparable to the predicate device.
Compliance with specific safety and EMC standards.	The device has been designed and independently tested to the following requirements: - IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for safety.- IEC 60601-2-10- IEC 601-1-1 and appendices A1:1991,A2:1995- IEC 601-1-2: EMC requirements- IEC 61000-4-2:1995: Electromagnetic compatibility.- IEC 61000-4-3:1997: Electromagnetic compatibility- DD ENV 50204:1996: Electromagnetic compatibility- EN 55011:1998: radiated emissions.

Acceptance Criteria

Reported Device Performance

Not specified in the document. The submission focuses on substantial equivalence to a predicate device and compliance with safety standards rather than specific performance metrics (e.g., a certain percentage improvement in muscle tone) as acceptance criteria.

The "Non clinical Tests" section states: "Comparisons of electrical outputs for the two devices show similar results." This indicates that the new device's electrical output is comparable to the predicate device.

Compliance with specific safety and EMC standards.

The device has been designed and independently tested to the following requirements: - IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for safety.- IEC 60601-2-10- IEC 601-1-1 and appendices A1:1991,A2:1995- IEC 601-1-2: EMC requirements- IEC 61000-4-2:1995: Electromagnetic compatibility.- IEC 61000-4-3:1997: Electromagnetic compatibility- DD ENV 50204:1996: Electromagnetic compatibility- EN 55011:1998: radiated emissions.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned. The document describes non-clinical tests (electrical output comparisons and compliance with standards) and hazard/risk analyses, but not human subject testing with a defined test set.
Data Provenance: Not mentioned for any test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/not mentioned. No ground truth was established by experts in the context of a test set for performance claims.
Qualifications of Experts: Not applicable/not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication Method: Not applicable/not mentioned. No human subject test set or adjudication process is described.

5. 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

MRMC Study: No. This device is a muscle stimulator, not an AI-powered diagnostic tool, so an MRMC study is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable. This is not an algorithm-only device. The submission focuses on the safety and electrical performance of the physical muscle stimulator and its equivalence to a predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Type of Ground Truth: Not applicable. For the non-clinical tests described, the "ground truth" would be the specified parameters in the electrical output tests and the requirements of the international safety and EMC standards. There is no biological or clinical "ground truth" established for performance claims from human subjects in this document.

8. The sample size for the training set

Sample Size for Training Set: Not applicable/not mentioned. This device does not use machine learning, so there is no "training set."

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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Page 1 of 3 510(k) Summary

K030708

Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland

510 (k) Summary of Safety and Effectiveness.

This summary is submitted in accordance with 21 CFR 807.92

JUN 2 5 2003

a) 1 Submitted by	Bio-Medical Research LtdBMR HouseParkmore Business Park, WestGalwayRepublic of Ireland
Establishment Registration Number	8020867
Contact Person	Michelle Sawyer
Phone	+353 91 774361
Fax	+353 91 773302
e-mail	msawyer@des.bmr.ie
Title	Regulatory Affairs Manager
Date of Preparation	February 2003.
2 Trade Name of Device system. Type 515.	Slendertone FLEX Abdominal Training
Common Name	Muscle Stimulator
Classification name	Powered Muscle Stimulator
3 Identification of predicate device	Slendertone FLEX Abdominal training system.K010335

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Description of Device 4

5 Intended Use

The device is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for developing a firmer abdomen.

િ Technological Comparison

The Slendertone Flex device is similar to the original Slendertone FLEX abdominal training system , type 512 and delivers a stimulation signal which is identical .The device is restricted in its range of available stimulation parameters and is restricted in terms of electrode positioning , since the electrodes are integrated in the belt.

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510(k) Summary Page 3 of 3

7 Technological Comparison

The two Slendertone FLEX Abdominal training systems are the same in delivery of the stimulation signal and have similar parameter settings. There are similar restrictions between the two devices in that electrode positioning is governed by and integral to the garment. Both products utilise a LCD screen with user compliance logging.

Non clinical Tests

Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;

IEC 60601-1:1990 Medical electrical equipment Part 1: General requirements for . safety.
IEC 60601-2-10 .
IEC 601-1-1 and appendices A1:1991,A2:1995 ● IEC 601-1-2: EMC requirements
IEC 61000-4-2:1995: Electromagnetic compatibility .
. IEC 61000-4-3:1997: Electromagnetic compatibility
. DD ENV 50204:1996: Electromagnetic compatibility
EN 55011:1998: radiated emissions. .

Bio-Medical Research Ltd, (BMR), adheres to recognised and established industry practice, and all devices are subject to final performance testing.

A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 5 2003

Helen Gallagher Regulatory Affairs Bio-Medical Research Limited BMR House Parkmore Business Park, West Galway Republic of Ireland

Re: K030708

Trade/Device Name: FLEX, Type 515 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: May 20, 2003 Received: June 2, 2003

Dear Ms. Gallagher:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Mav 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 - Ms. Helen Gallagher

comply with all the Act`s requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological 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):

Not known

Device Name:

Slendertone Flex Abdominal Training system, type 515.

Sponsor Name:

Bio-Medical Research Ltd.

The device is intended for over the counter sale.

Indications for Use:

The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

Do Not Write Below This Line - Continue on Another Page if Needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Over-The-Counter Use

for Mark N. Milleson

vision of General, F astorative and Neurological Devices

510(k) Number K030708

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Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).