Slendertone Gymbody is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.

Device Description

Slendertone Gymbody, Type 512-01 is a two-program battery operated muscle stimulation system specifically designed to exercise the abdominal muscles. It is a variant of Slendertone Flex, Type 512 abdominal training system and was developed to provide a lower cost alternative to the consumer.

It comprises of two main components, 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.

The product is supplied with a set of double-sided adhesive electrodes, an instruction manual and a set of batteries. Power is derived from 1 x 9volt battery located in a compartment protected by a removable battery cover.

The 3 pads are attached to the belt covering the 3 metal studs on the inner surface of the belt. The larger pad is placed in the middle, over the umbilicus, and the two side electrodes are located on either side of the body towards the mid axillary line, between the pelvis and the rib cage.

The pulsed stimulation current passes between the side and center electrodes only. There is no current passed from side to side.

AI/ML Overview

This document is a 510(k) premarket notification for the Slendertone Gymbody, Type 512-01, a muscle stimulator. It does not contain acceptance criteria or a study that proves the device meets specific performance criteria through empirical data.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Slendertone Flex, Type 512, K010335) based on technological comparison and the claim that the fundamental scientific technology has not changed.

Here's a breakdown based on your requested information, highlighting what is (and isn't) present in the provided text:

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

This information is not present in the provided text. The submission focuses on technological equivalence rather than performance metrics against specific acceptance criteria.

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

This information is not present. No new clinical study or test set data is described for the Slendertone Gymbody, Type 512-01. The submission references "original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)" for effectivity, implying reliance on the predicate device's 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)

This information is not present as no new clinical study or ground truth establishment for a test set is described.

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

This information is not present as no new clinical study or test set 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

This is not applicable to this device. The Slendertone Gymbody is a muscle stimulator, not an AI-powered diagnostic or interpretive device that would be subject to MRMC studies with human readers.

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

This is not applicable to this device. The Slendertone Gymbody is a physical muscle stimulator, not an algorithm.

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

This information is not explicitly stated for any studies. The submission mentions "effectivity of which is borne out in the original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)." Without access to the K010335 submission, the specific type of ground truth used in those original trials (e.g., muscle strength measurements, body circumference changes, user reported outcomes) is unknown.

8. The sample size for the training set

This information is not present as no new training set for the Slendertone Gymbody, Type 512-01 is described.

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

This information is not present as no new training set is described.

Summary of the Device's Claimed "Proof" of Meeting Criteria:

The core of this 510(k) submission for the Slendertone Gymbody, Type 512-01, is to demonstrate substantial equivalence to its predicate device, Slendertone Flex, Type 512 (K010335). The "study" that proves the device meets the (implied) acceptance criteria is essentially the comparison to the predicate device and the assertion that "The same technolgical platform and modus operandi is used for the new variant, effectivity of which is borne out in the original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335)."

The acceptance criteria are therefore implicitly the performance and safety demonstrated by the predicate device. The new device is argued to meet these because:

Its intended use and indications for use are identical to the predicate.
Its fundamental scientific technology does not differ.
Changes (e.g., fewer programs, different user interface, different battery type, single amplitude control) are assessed as not impacting on the safety or efficacy of the device.
Risk analysis conducted on the modified device aligned with ISO 14971 confirmed no new significant risks.

Essentially, the manufacturer is relying on the prior approval and demonstrated effectiveness of the predicate device, claiming all changes in the new device do not alter its safety or effectiveness profile.

Summary

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K052969

Section 4: 510(k) Summary of Safety and Effectiveness

This summary is submitted in accordance with 21 CFR 807.92

1.	Device Manufacturer:Sponsor	Bio-Medical Research Ltd.Parkmore Business Park WestGalwayIreland
	Contact Person:	Michael O'Sullivan
	Telephone:	+353 91 774300
	Fax:	+353 91 774301/302
	E-Mail:	mosullivan@bmr.ie
	Title:	Quality Systems Engineer
	Date of Preparation:	October 17, 2005
2.	Trade Name of Device:	Slendertone Gymbody, Type 512-01
	Common Name:	Muscle Stimulator
	Classification Name:	Stimulator, muscle, powered, for muscleconditioning
	Product Code	NGX
3.	Identification of Predicate:	Slendertone Flex, Type 512Bio-Medical Research Ltd.K010335

4. Description of Device:

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The pulsed stimulation current passes between the side and center electrodes only. There is no current passed from side to side.

న. Technological Comparison
Slendertone Gymbody is a variant of the Slendertone Flex Abdominal Training System and is a lower cost alternative to the consumer. It has been designed to differ visually from the original device while remaining compliant with all necessary legislative and performance standards. The device's intended use or fundamental scientific technology does not differ from Slendertone Flex, Type 512 (K010335).

Design

Slendertone Gymbody, Type 512-01, is a two channel, three electrode, battery operated muscle stimulation system comprising of two main components, the electronic stimulator module and the electrode belt. The device uses a set of adhesive electrodes to transfer stimulation signals to the skin. This is the same as Slendertone Flex, Type 512.

Slendertone Gymbody, Type 512-01 is a 2 program device whereas Slendertone Flex, Type 512 is a 4 program device. The 2 program levels (1 & 2) are the same as levels 2 and 4 in Slendertone Flex, Type 512.

Slendertone Gymbody, Type 512-01 contains a different user interface from its predicate device Slendertone Flex, Type 512. The LCD user interface present in Slendertone Flex, Type 512 has been changed to a series of LEDS. There is no significant change to the internal control mechanism and principles of operation remain the same. Visual indication of status and functionality are different however and are reflected in the instructions for use. The changes do not impact on the safety or efficacy of the device.

Slendertone Gymbody, Type 512-01 contains a different housing and keypad format from Slendertone Flex, Type 512 . The changes do not impact upon safety or efficacy of the device nor do they impact on indications for use. The fundamental operating principle remains the same.

Material

There are no fundamental changes to materials of construction that could impact on use. Comparative details are outlined in the table below.

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	Material	Slendertone FlexType 512
Belt	Outer Material 100% NylonBinding: 82% Nylon/18% ElasteneVelcro: 100% NylonFoam: 100% Polyurethane	Outer Material: 100% PolyesterBinding: 82% Nylon, 18% ElastaneVelcro: 100% NylonFoam: 100% Polyurethane
Electrodes	Type 709/710Hydrogel layer with conductivepolymer film2 x 70mm x 100mm and1 x 100mm x 100mm	Type 709/710Hydrogel layer with conductivepolymer film2 x 70mm x 100mm and1 x 100mm x 100mm
Unit Housing	ABS	ABS
Key Mat	Silicon Rubber	Silicon Rubber
Status Indicator	Liquid Crystal Display	Light Emitting Diodes
BatteryConnection	Holster Pin Arrangement	Lead wire with through hole three-pinconnector providing both polarizingand latching mechanism

Chemical Composition Not applicable

Energy Source

No change in energy type, however Slendertone Gymbody, Type 512-01 utilizes 1 x 9v battery in comparison to 3 x 1.5v batteries in Slendertone Flex, Type 512.

1. Statement of Intended Use and Indications Compared to Predicate The Slendertone Gymbody, Type 512-01 device that is the subject of this 510(k) Special premarket notification has the same identical intended use and indications for use as the above predicate. It 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, strength and firmness.
1. Clinical Studies

The same technolgical platform and modus operandi is used for the new variant, effectivity of which is borne out in the original clinical trial data submitted for review along with Slendertone Flex, Type 512 (K010335).

1. Safety and Effectiveness Slendertone Gymbody was designed and evaluated with the BMR Design Control System (Ref: D180). There were no issues regarding the Safety and Effectiveness of the device.

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Section 8: Design Control

Risk Management.

A risk analysis was carried out during the design phase of the previously marketed device, Slendertone Flex, Model 512. Since then, the procedure for Risk Management in the company has been upgraded to reflect the requirements of ISO 14971. This new procedure has now been applied to the proposed modified device Slendertone Gymbody Model 512-01 and the full analysis is on file.

Summary of Changes

In this summary we highlight the modifications to the product from the standpoint of risk.

Replacement of LCD by LEDs

All major display functions of the LCD are implemented on the LEDs, except;

The treatment is digitally timed however the time is not displayed. No safety or efficacy issue is raised since the timer display is a convenience indicator to inform the user on the remaining treatment time.

The stimulus intensity is not digitally displayed, instead 3 LEDs are used to represent 4 levels of stimulation. The stimulus intensity is incremented in 1% steps with each keypress, as it was on the previously marketed device. No safety or efficacy issue is raised here because the stimulus intensity setting is determined by the user's comfort and tolerance level, not by prescription of any particular intensity level. The digital display is a convenience indicator to inform the user about the intensity level they have reached.

Removal of Audible feedback.

The audio indicator was used in the predicate device to provide audio feedback beeps with each keypress and to alert the user when the load sense circuit detected no load. This is a convenience issue with no safety issue since the intensity is reduced to effectively zero when no load is detected. In any case, there was an audio mute function on the predicate model.

Removal of EEPROM

The EEPROM only stored user statistics and preferences on the predicate device, not treatment data. No safety or efficacy issue arises with its removal.

Change to a single amplitude control.

The predicate device has a separate left and right intensity control. however the new device has a single control which controls both left and right. The product is intended to stimulate the abdominal muscles symmetrically, that is, approximately equally on the left and right sides. The predicate device already had a software control which prevented the user selecting gross asymmetry in left and right intensity. No safety or efficacy issue is raised by this change.

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Change of battery type.

No safety or efficacy issue arises.

Removal of two programs.

The main working program of the new product, program 2 is identical to program 4 of the predicate device. The other programs have been included to introduce users to the sensation of EMS, with slightly shorter contraction times. No safety or efficacy issue arises.

Change to style of Belt

The spacing, size and design of electrodes are identical so no safety or efficacy issue arises.

Change to Connector linking Controller and Belt

The connector design has changed from an audio jack and socket to an industrial wire to board connector. The connector in the new product is perhaps less convenient to use however it provides the same or greater protection. The arrangement also been certified for compliance to the ISO 60601 standards. Furthermore, since the leadwires are integrated within a belt, the risk is negligible.

A declaration of conformity to design control is included in Appendix 3

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Public Health Service

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Michael O'Sullivan Quality Systems Engineer Bio-Medical Research Limited BMR House Parkmore Business Park, West Galway Republic of Ireland

Re: K052969

Trade/Device Name: Slendertone Gymbody, Type 512-01 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: October 18, 2003 Received: October 21, 2003

Dear Mr. O'Sullivan:

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 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) 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, 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 (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

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Page 2 - Mr. Michael O'Sullivan

or any Federal statutes and regulations administered by other Federal agencies. You must 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), please contact the Office of Compliance at (240) 276- . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Sor Mark N. Melkerson Acting 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

510(k) Number (if known):

KC052969

Device Name:

Slendertone Gymbody, Type 512-01

Indications for Use:

Slendertone Gymbody is indicated for the improvement of abdominal muscle tone, for strengthening of the abdominal muscles and for the development of a firmer abdomen.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

× Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign=Off) CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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).