Slendertone connect Abs

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized human face in profile, with three curved lines representing the hair or head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 6, 2015 Bio-Medical Research Ltd. Attn: Ms. Anne-Marie Keenan Regulatory Affairs Specialist Parkmore Business Park West. Galway, IRELAND > Re: K151903 Trade Name: Slendertone® connect Abs, Type 570 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: October 6, 2015 Received: October 9, 2015 Dear Ms. Keenan: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code 27f 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Michael J. Hoffmann -A for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K151903 Device Name SLENDERTONE connect Abs, Type 570 #### Indications for Use (Describe) The SLENDERTONE connect Abs is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. | Type of Use (Select one or both, as applicable) | |------------------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:inline-block; vertical-align:middle;"><input type="checkbox"/>Prescription Use (Part 21 CFR 201 Subpart D)</div> | | <div style="display:inline-block; vertical-align:middle;"><input checked="" type="checkbox"/>Over-The-Counter Use (21 CFR 201 Subpart G)</div> | _ | Prescription Use (Part 21 CFR 801 Subpart D) |X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for bio-medical research Itd. The logo has the letters "bmr" in blue, with a gray line going through the "b". The words "bio-medical research Itd." are in gray below the letters. Bio-Medical Research Ltd. Parkmore Business Park West, Galway, Ireland This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. ## I. SUBMITTER | Name: | Anne-Marie Keenan,<br>Regulatory Affairs Specialist | |------------|-------------------------------------------------------------------------------| | Address: | Bio-Medical Research Ltd.,<br>Parkmore Business Park West,<br>Galway, IRELAND | | Telephone: | +353 91 774316 | | Fax: | +353 91 774301 or +353 91 774302 | | E-Mail: | akeenan@bmr.ie | | Prepared: | October 6, 2015 | ## II. DEVICE | Trade Name of Device: | SLENDERTONE® Connect Abs, Type 570 | |-------------------------|------------------------------------------------------| | Common Name: | Powered muscle stimulator | | Regulation Number: | 21 CFR 890.5850 | | Regulation Description: | Stimulator, muscle, powered, for muscle conditioning | | Product Code: | NGX | | Device Class: | 2 | ## III. PREDICATE DEVICES | 510(k) Number: | K100320 | |----------------|---------------------------------------------------| | Manufacturer: | Bio-Medical Research Ltd. | | Trade Name: | Slendertone System Ultra, Type 390, Model E70/X70 | | 510(k) Number: | K143551 | | Manufacturer: | DJO LLC. | | Trade Name: | Compex Wireless USA | {4}------------------------------------------------ These predicates have not been subject to a design-related recall. #### IV. DEVICE DESCRIPTION The SLENDERTONE® Connect Abs, Type 570 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains one pre-installed program called 'Essential Toning'. The SLENDERTONE® Connect Abs incorporates a Bluegiga BLE113 Bluetooth module to enable wireless communication and can be paired with a Bluetooth enabled iOS smart device running a Slendertone Connect iOS App, available from the Apple App store. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user. The control unit is connected to the abdominal belt garment via an 8-pin interface. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. These controls remain active while the control unit is wirelessly paired with a smart device and can be used in the event of loss of Bluetooth connection. The SLENDERTONE® connect Abs contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and bluetooth activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable. The SLENDERTONE® Connect Abs, Type 570 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual. ### V. INDICATIONS FOR USE The SLENDERTONE® connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. The SLENDERTONE® connect Abs, Type 570 is intended for over-thecounter use. {5}------------------------------------------------ The Indications for Use statement for the SLENDERTONE® connect Abs, Type 570 is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following tables summarizes the similarities and differences between the technological characteristics of the new device versus the listed predicate devices; | Table I | Unit Characteristics of new vs. predicate devices, Slendertone System Ultra<br>and Compex Wireless USA | |----------|-----------------------------------------------------------------------------------------------------------------------------------------| | Table II | Output Characteristics of new vs. predicate device Compex Wireless USA<br>(new device values representing maximum power limit of 180mW) | In future, users may securely download additional treatment programs through the mobile app. The program parameters and resulting outputs for any such program are limited in accordance with the Table II. {6}------------------------------------------------ | Table I<br>Basic Unit Characteristics | New Device<br>Slendertone Connect Abs | Predicate Device<br>Slendertone System Ultra | Predicate Device -<br>Compex Wireless USA | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. 510(k) Number | To be assigned | K100320 | K143551 | | 2. Device Name, Model | Slendertone Connect Abs, Type 570 | Slendertone System Ultra<br>Type 390, E70/X70 | Compex Wireless USA | | 3. Manufacturer (Contract) | Blue Ocean Innovation Ltd<br>RM 1813, Fo Tan Industrial Centre<br>26-28 Au Pui Wan Street<br>Fo Tan, Hong Kong | China Turnkey Solutions Logistics<br>(Shenzhen) Co.,<br>Futian Free Trade Zone<br>CHINA 518038 | DJO LLC | | 4. Power Source | 3.7V Lithium Polymer Single Cell<br>Rechargeable | 3.6V NiMh Battery Pack<br>Rechargeable | 3.7V Lithium Polymer Single Cell. | | - Method of line Isolation | No line connection possible when<br>connected to body | No line connection possible when<br>connected to body | No line connection possible when<br>connected to body | | - Patient Leakage Current | Not applicable, no line connection, no<br>AC charger connection or operation.<br>Connection method does not allow AC<br>charger connection to Patient. | Not applicable, no line connection, no<br>AC charger connection or operation.<br>Connection method does not allow AC<br>charger connection to Patient. | Not applicable, no line connection, no<br>AC charger connection or operation.<br>Connection method does not allow AC<br>charger connection to Patient. | | 5. No. of Output Modes | 1 (Symmetric, Pulsed, Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | | 6. Number of Output Channels | 2 | 2 | 2 | | - Synchronous/Alternating? | Synchronous | Synchronous | Synchronous | | - Method of channel isolation | Transistor | Transistor | Transistor | | 7. Regulated Current or Regulated<br>Voltage | Constant Current | Constant Current | Constant Current | | 8. Software/Firmware/Microprocessor<br>Control? | Yes | Yes | Yes, with Wireless control | | 9. Automatic overload Trip? | Yes | Yes | Yes | | 10. Automatic No-Load Trip? | Yes | Yes | Yes | | 11. Automatic Shut Off | Yes | Yes | Yes | | 12. Patient Override Control? | Yes, pause button stops treatment<br>immediately. | Yes, pause button stops treatment<br>immediately. | Yes, pause button stops treatment<br>immediately. | | 13. Indicator Display<br>- On/Off Status? | Yes, Unit LED and Smart device | Yes, LCD | Yes, LCD | | Table I<br>Basic Unit Characteristics | New Device<br>Slendertone Connect Abs | Predicate Device<br>Slendertone System Ultra | Predicate Device -<br>Compex Wireless USA | | - Low Battery? | Yes, Unit LED and Smart device | Yes, LCD | Yes, LCD | | - Voltage/Current Level? | Yes, via Smart device | Yes, LCD | Yes, LCD | | 14. Timer range (minutes) | 20-30 minutes | 20-40 minutes | 20-40 minutes | | 15. Compliance with Voluntary<br>Standards? | IEC 60601-1: 2005 & A1:2012<br>IEC 60601-2-10:2012<br>EN 60601-1-2: 2007<br>IEC 60601-1-11:2010<br>IEC 60601-1-6:2010<br>IEC 62133:2012<br>FCC Rule Part 15.247:2012 | IEC 60601-1:1988 & A1:1991,<br>A2:1995<br>IEC 60601-2-10:1987 & A1 2001<br>IEC 60601-1-2:2001 (EN 60601-1-<br>2:2001)<br>CISPR 22:2003/CFR 47 Part 15:2005<br>IEC 60601-1-6:2004 (EN 60601-1-<br>6:2001)<br>Battery Charger: IEC 60950 and UL<br>1950<br>CC Rules Subpart B | | | 16. Compliance with CFR 21 898? | Yes | Yes | Yes | | 17. Weight (unit) | 37g (inc batteries) | 116g (inc. batteries) | 2x60g | | 18. Dimensions (un.)<br>{W x H x D} | 70 x 50 x 14 mm approx. | 60 x 23 x 115mm approx. | 65 x 20mm | | 19. Housing Materials and Construction | Injection moulded thermosetting plastic | Injection moulded thermosetting plastic | plastic | {7}------------------------------------------------ {8}------------------------------------------------ | Table II<br>Output Characteristics | New Device<br>Slendertone Connect Abs | Predicate Device<br>Compex Wireless USA | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Waveform | Pulsed, Symmetrical, Biphasic | Pulsed, Symmetrical, Biphasic | | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | | Maximum Output Voltage (RMSV) (+/-<br>10%)<br>$\frac{Vp^2 x 2 x PW}{\sqrt{\frac{1}{freq}}}$ | 9.47V @ 500Ω<br>17.5V @ 2kΩ<br>6.2V @ 10kΩ | 15.5V @500Ω<br>62.0V @2kΩ<br>unknown | | Maximum Output Current (RMSA) (+/-<br>10%) | 18.9mA @ 500Ω<br>8.75mA @ 2kΩ<br>620μA @ 10kΩ | 31mA@ 500Ω (estimated)<br>31mA@ 2kΩ (estimated)<br>unknown | | Pulse Width | 900 μs | 900μs | | Baseline to peak current @500Ω | 80mA | 120mA | | Frequency (Hz) | 10 to 80 Hz | 1 to 120 Hz | | - Phase Duration | 100 - 400μS | 300 to 400 μS | | Net Charge (µC per pulse) | 0@500Ω<br>Symmetric, biphasic and leading polarity alternates<br>for each successive pulse | 0@500Ω<br>Symmetric, biphasic and leading polarity alternates<br>for each successive pulse | | Maximum Phase Charge (μC)<br>C= Ip*PW | 1 phase 32 µC @500Ω<br>2 phase 64 µC @500Ω | 1 phase 48 µC @500Ω<br>2 phase 96 µC @500Ω | | Maximum Current Density (mA/cm²) | 0.28 mA/cm² @500Ω | 1.49 mA/cm² @500Ω<br>Electrode 50mm square | | Maximum Power Density (W/ cm²)<br>Using smallest electrode conductive<br>surface area | 2.57 mW/ cm² @500Ω | 27.6 mW/cm² @500Ω | | Contraction Time | 0.5 - 5 sec | 4.5 - 11.0 sec | | Table II<br>Output Characteristics | New Device<br>Slendertone Connect Abs | Predicate Device<br>Compex Wireless USA | | Relaxation Time | 0.5 - 6 sec | 4.5 - 31 secs | | Additional Features (if applicable) | N/A | N/A | {9}------------------------------------------------ {10}------------------------------------------------ #### VII. PERFORMANCE DATA Performance testing was conducted in accordance with the following international standards for safety: | IEC 60601-1: 2005/A1:2012 | Medical electrical equipment. General requirements for basic<br>safety and essential performance | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-6:2010 | Medical electrical equipment - Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability | | EN 60601-1-2:2007 | Medical electrical equipment - part 1-2: general requirements<br>for safety -collateral standard: electromagnetic compatibility<br>- requirements and tests | | IEC 60601-2-10:2012 | Medical Electrical equipment - Part 2-10: Particular<br>requirements for the safety of nerve and muscle stimulators | | IEC 60601-1-11:2010 | Medical electrical equipment - Part 1-11: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Requirements for medical electrical<br>equipment and medical electrical systems used in the home<br>healthcare environment | | ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity | | ISO 10993-10:2010 | Biological evaluation of medical devices. Tests for irritation<br>and skin sensitization | In addition, the performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band i.e. Bluetooth and Wi-Fi devices, cellphones, cordless phones etc.. The device met all specified requirements. BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013. Safety of Technology Equipment and FCC Rule Part 15.247:2012. Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications. {11}------------------------------------------------ ## VIII. CONCLUSION - . The SLENDERTONE® connect Abs, Type 570 has the same principles of operation as it's predicate devices and any differences in technological characteristics do not raise new issues of safety or effectiveness. - . The Indications for Use statement is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device. - . Performance data has demonstrated that the SLENDERTONE® Connect Abs, Type 570 is as safe and effective as the predicate devices and is substantially equivalent.