SLENDERTONE Evolve Abs, Type 735

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 10, 2021 Bio-Medical Research Ltd. Eoin Keating Official Correspondent Parkmore Business Park West Galway, H91 NHT7 Ireland Re: K203513 Trade/Device Name: SLENDERTONE Evolve Abs, Type 735 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: November 25, 2020 Received: November 30, 2020 Dear Eoin Keating: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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 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 comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K203513 Device Name SLENDERTONE® Evolve Abs, Type 735 Indications for Use (Describe) The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen. Type of Use (Select one or both, as applicable)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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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}------------------------------------------------ Bio-Medical Research Limited, Parkmore Business Park West, Galway, Ireland. Tel: +353 (0)91 774300 Fax: +353 (0)91 774301 Image /page/3/Picture/2 description: The image shows the logo for BIO-MEDICAL Research Limited. The logo consists of a cluster of green and blue circles on the left, arranged in a pattern that resembles a molecule or a cell structure. To the right of the circles, the words "BIO-MEDICAL" are written in a large, sans-serif font, with "BIO-" in blue and "MEDICAL" in gray. Below "BIO-MEDICAL", the words "Research Limited" are written in a smaller, gray, sans-serif font. This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92. ### I. SUBMITTER | Name: | Mike Kilkelly | |------------|-------------------------------------------------------------------------------| | Address: | Bio-Medical Research Ltd.,<br>Parkmore Business Park West,<br>Galway, IRELAND | | Telephone: | +353 91 774395 | | Fax: | +353 91 774301 or +353 91 774302 | | E-Mail: | mkilkelly@bmr.ie | | Prepared: | November 25, 2020 | #### II. DEVICE | Trade Name of Device: | SLENDERTONE® Evolve Abs, Type 735 | |-------------------------|------------------------------------------------------| | 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: | K180688 | | Manufacturer: | Bio-Medical Research Limited. | | Trade Name: | SLENDERTONE® Corefit Abs8, Type 734 | This predicate has not been subject to a design-related recall. {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The SLENDERTONE® Evolve Abs, Type 735 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 twelve pre-installed programs. The control unit is connected to the abdominal belt garment via three magnetic connectors. 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. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. 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® Evolve Abs, Type 735 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® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen. The Indications for Use statement for the SLENDERTONE® Evolve Abs, Type 735 is identical to the predicate device. ### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE The following table summarizes the similarities and differences between the technological characteristics of the new device and predicate device SLENDERTONE® Corefit Abs8, Type 734. {5}------------------------------------------------ # 10.2 Output Specifications | Table I | New Device | Predicate Device | Comparison | |-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Basic Unit Characteristics | SLENDERTONE® Evolve Abs,<br>Type 735 | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | | | 1. 510(k) Number | (To be Assigned) | K180688 | N/A | | 2. Device Name, Model | SLENDERTONE® Evolve Abs,<br>Type 735 | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | N/A | | 3. Manufacturer (Contract) | China Turnkey Solutions Logistics<br>(Shenzhen) Co.,<br>Futian Free Trade Zone<br>CHINA 518038 | China Turnkey Solutions Logistics<br>(Shenzhen) Co.,<br>Futian Free Trade Zone<br>CHINA 518038 | Identical | | 4. Power Source | 3.7V Lithium Polymer Single Cell<br>Rechargeable | 3.7V Lithium Polymer Single Cell<br>Rechargeable | Identical | | - Method of line Isolation | No line connection possible when<br>connected to body | No line connection possible when<br>connected to body | Identical | | - 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,<br>no AC charger connection or<br>operation. Connection method does<br>not allow AC charger connection to<br>Patient. | Identical | | 5. No. of Output Modes | 1 (Symmetric, Pulsed, Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | Identical | | 6. Number of Output Channels | 2 | 2 | Identical | | - Synchronous/Alternating? | Synchronous | Synchronous | Identical | | - Method of channel isolation | Transistor | Transistor | Identical | | 7. Regulated Current or<br>Regulated Voltage | Constant Current | Constant Current | Identical | | 8.<br>Software/Firmware/Microproce<br>ssor Control? | Yes | Yes | Identical | | Table I | New Device | Predicate Device | | | Basic Unit Characteristics | SLENDERTONE® Evolve Abs,<br>Type 735 | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Comparison | | 9. Automatic overload Trip? | Yes | Yes | Identical | | 10. Automatic No-Load Trip? | Yes | Yes | Identical | | 11. Automatic Shut Off | Yes | Yes | Identical | | 12. Patient Override Control? | Yes, pause button stops treatment<br>immediately. | Yes, pause button stops treatment<br>immediately. | Identical | | 13. Indicator Display<br>- On/Off Status?<br>- Low Battery?<br>- Voltage/Current Level? | Yes, OLED Display<br>Yes, OLED Display<br>Yes, OLED Display | Yes, OLED Display<br>Yes, OLED Display<br>Yes, OLED Display | Identical | | 14. Timer range (minutes) | 2 - 45 minutes | 20-40 minutes | Different but no impact on safety<br>or effectiveness. | | 15. Compliance with Voluntary<br>Standards? | IEC 60601-1<br>IEC 60601-2-10<br>EN 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-1-6<br>IEC 62133<br>FCC (47 CFR Part 15, Subpart B) | IEC 60601-1<br>IEC 60601-2-10<br>EN 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-1-6<br>IEC 62133<br>FCC (47 CFR Part 15, Subpart B) | Identical | | 16. Compliance with CFR 21<br>898? | Yes | Yes | Identical | | 17. Weight (unit) | 37g (incl. batteries) | 37g (incl. batteries) | Identical | | 18. Dimensions (un.)<br>{W x H x D} | 57 x 57 x 15 mm approx. | 57 x 57 x 15 mm approx. | Identical | | 10.2 Output Specifications | | | | | The following information has been compiled using the “Guidance Document on Powered Muscle Stimulator 510(k)s, 1999”. | | | | | Table I<br>Basic Unit Characteristics | New Device<br>SLENDERTONE® Evolve Abs,<br>Type 735 | Predicate Device<br>SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Comparison | | 19. Housing Materials and<br>Construction | Injection moulded thermosetting plastic,<br>with a thermoplastic elastomer (TPE) keypad | Injection moulded thermosetting plastic,<br>with a thermoplastic elastomer (TPE) keypad | Identical | {6}------------------------------------------------ # 10.2 Output Specifications {7}------------------------------------------------ {8}------------------------------------------------ # 10.2 Output Specifications | Tabel II<br>Output Characteristics | New Device<br>SLENDERTONE® Evolve Abs,<br>Type 735 | Predicate Device<br>SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Comparison | |---------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Waveform<br>Shape | Pulsed, Symmetrical, Biphasic<br>Rectangular, with interphase interval | Pulsed, Symmetrical, Biphasic<br>Rectangular, with interphase interval | Identical<br>Identical | | Maximum Output Voltage (RMSV)<br>(+/-10%) | 8.36V @ 500Ω<br>15.56V @ 2kΩ<br>@ 10kΩ: no output for 10kΩ<br>resistance | 7.58V @ 500Ω<br>14.4V @ 2kΩ<br>@ 10kΩ: no output for 10kΩ<br>resistance | Different but no impact on<br>safety or effectiveness.<br>*See note below re<br>Maximum output current | | $Vp2x2xPW$ $\sqrt{\frac{1}{freq}}$ | | | | | Maximum Output Current (RMSA)<br>(+/-10%) | 16.72mA @ 500Ω<br>7.78mA @ 2kΩ<br>@ 10kΩ: no output for 10kΩ<br>resistance | 15.16mA @ 500Ω<br>7.2mA @ 2kΩ<br>@ 10kΩ: no output for 10kΩ<br>resistance | Different but no impact on<br>safety or effectiveness<br>*The values are well<br>below safety limits of<br>Table 201.101 “Pulse<br>frequency versus applied<br>current limits” of IEC<br>60601-2-10. | | Pulse Width | 800 μs | 730 μs | Different but no impact on<br>safety or effectiveness. | | Baseline to peak current @500Ω | 72mA | 72mA | Identical | | Frequency (Hz) | 50-75 Hz | 50-70 Hz | Identical | | For interferential modes:<br>- Beat Frequency | N/A | N/A | Identical | | Tabel II | New Device | Predicate Device | | | Output Characteristics | SLENDERTONE® Evolve Abs, | SLENDERTONE® CoreFit Abs 8, | Comparison | | | Type 735 | Type 734 | | | For multiphasic waveforms only:<br>- Symmetrical phases | Yes | Yes | Identical | | - Phase Duration | 200 - 350μs | 200 - 315μs | Different but no impact on<br>safety or effectiveness. | | Net Charge (µC per pulse) | 0@500Ω<br>Symmetric, biphasic and leading polarity<br>alternates for each successive pulse | 0@500Ω<br>Symmetric, biphasic and leading polarity<br>alternates for each successive pulse | Identical | | Maximum Phase Charge (µC)<br>C= Ip*PW | 1 phase 25.2 µC @500Ω | 1 phase 22.8 µC @500Ω<br>2 phase 45.6 µC @500Ω | Different but no impact on<br>safety or effectiveness. | | Maximum Current Density (mA/cm²) | 0.279 mA/cm² @500Ω | 0.216 mA/cm² @500Ω | Different but no impact on<br>safety or effectiveness<br>The values are well below the<br>2mA/cm2 value stated in<br>Clause 201.7.9.2.101 item (g) of<br>IEC 60601-2-10. | | Maximum Power Density (W/ cm2) | 2.33 mW/ cm² @500Ω<br>Using smallest electrode conductive<br>surface area | 1.64 mW/ cm² @500Ω | Different but no impact on<br>safety or effectiveness.<br>The value is well below the<br>maximum power density of<br>0.25 Watts/cm2 to reduce risk<br>of thermal burns. ** **FDA<br>Guidance document<br>Reference FDA Guidance<br>Document for Powered Muscle<br>Stimulator 510(k)s | | Tabel II<br>Output Characteristics | New Device<br>SLENDERTONE® Evolve Abs,<br>Type 735 | Predicate Device<br>SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Comparison | | Contraction Time | 1.0 - 60.0 s | 1.0 - 5.5 s | Different but no impact on<br>safety or effectiveness. | | Relaxation Time | 1.0 - 10.0 s | 1.0 – 7.0 s | Different but no impact on<br>safety or effectiveness. | | Burst Mode | N/A | N/A | Identical | | Additional Features (if applicable) | N/A | N/A | Identical | | Maximum Charge Current | 300mA @ 5V | 300mA @ 5V | Identical | {9}------------------------------------------------ # 10.2 Output Specifications {10}------------------------------------------------ # 10.2 Output Specifications {11}------------------------------------------------ ### VII. PERFORMANCE DATA Performance testing was conducted in accordance with the following international standards for safety: | IEC 60601-1 | Medical electrical equipment. General requirements for basic<br>safety and essential performance | |----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-6 | Medical electrical equipment - Part 1-6: General requirements<br>for basic safety and essential performance - Collateral<br>standard: Usability | | IEC 60601-1-2 | Medical electrical equipment - part 1-2: general requirements<br>for safety -collateral standard: electromagnetic compatibility<br>- requirements and tests | | IEC 60601-2-10 | Medical Electrical equipment - Part 2-10: Particular<br>requirements for the safety of nerve and muscle stimulators | | IEC 60601-1-11 | 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 | Battery testing was conducted in accordance with IEC 62133 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. {12}------------------------------------------------ ### VIII. CONCLUSION - The SLENDERTONE® Evolve, Type 735 has the same principles of operation as . it's predicate device and any differences in technological characteristics do not raise new issues of safety or effectiveness. - . The Indications for Use statement is identical to the predicate device. - Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type . 735 is as safe and effective as the predicate device and is substantially equivalent.