SLENDERTONE GYMBODY, MODEL 512-01

{0}------------------------------------------------ K052969 ## Section 4: 510(k) Summary of Safety and Effectiveness This summary is submitted in accordance with 21 CFR 807.92 | 1. | Device Manufacturer:<br>Sponsor | Bio-Medical Research Ltd.<br>Parkmore Business Park West<br>Galway<br>Ireland | |----|---------------------------------|-------------------------------------------------------------------------------| | | 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 muscle<br>conditioning | | | Product Code | NGX | | 3. | Identification of Predicate: | Slendertone Flex, Type 512<br>Bio-Medical Research Ltd.<br>K010335 | #### 4. Description of Device: 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. {1}------------------------------------------------ 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. - 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. {2}------------------------------------------------ | | Material | Slendertone Flex<br>Type 512 | Slendertone Gymbody<br>Type 512-01 | |-----------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------| | Belt | Outer Material 100% Nylon<br>Binding: 82% Nylon/18% Elastene<br>Velcro: 100% Nylon<br>Foam: 100% Polyurethane | Outer Material: 100% Polyester<br>Binding: 82% Nylon, 18% Elastane<br>Velcro: 100% Nylon<br>Foam: 100% Polyurethane | | | Electrodes | Type 709/710<br>Hydrogel layer with conductive<br>polymer film<br>2 x 70mm x 100mm and<br>1 x 100mm x 100mm | Type 709/710<br>Hydrogel layer with conductive<br>polymer film<br>2 x 70mm x 100mm and<br>1 x 100mm x 100mm | | | Unit Housing | ABS | ABS | | | Key Mat | Silicon Rubber | Silicon Rubber | | | Status Indicator | Liquid Crystal Display | Light Emitting Diodes | | | Battery<br>Connection | Holster Pin Arrangement | Lead wire with through hole three-pin<br>connector providing both polarizing<br>and 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. - 6. 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. - 7. 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). - 8. 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. {3}------------------------------------------------ #### 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. {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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 {6}------------------------------------------------ #### 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 {7}------------------------------------------------ # 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_________________________________________________________________________________________________________________________________________________________________