SLENDERTONE CoreFit Abs 8, Type 734

{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. October 25, 2018 Bio-Medical Research Ltd Eoin Keating Quality Engineer Parkmore Business Park West Galway, H91 NHT7 Ireland Re: K180688 Trade/Device Name: SLENDERTONE CoreFit Abs 8, Type 734 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: September 12, 2018 Received: September 24, 2018 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, 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 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Vivek J. Pinto -S 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) K180688 Device Name SLENDERTONE® CoreFit Abs 8, Type 734 Indications for Use (Describe) The SLENDERTONE® CoreFit Abs 8, Type 734 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}------------------------------------------------ Image /page/3/Picture/1 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 side. To the right of the circles is the text "BIO-MEDICAL" in a light blue color, with the words "Research Limited" underneath in gray. 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: | September 21, 2018 | ## II. DEVICE | Trade Name of Device: | SLENDERTONE® CoreFit Abs 8, Type 734 | |-------------------------|------------------------------------------------------| | 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 (Primary Predicate) | |----------------|---------------------------------------------------| | Manufacturer: | Bio-Medical Research Ltd. | | Trade Name: | Slendertone System Ultra, Type 390, Model E70/X70 | {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The SLENDERTONE® CoreFit Abs 8, Type 734 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 ten 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 off and to increase or decrease the stimulation intensity. The SLENDERTONE® CoreFit Abs 8. Type 734 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® CoreFit Abs 8, Type 734 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® CoreFit Abs 8, Type 734 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen. SLENDERTONE® CoreFit Abs 8, Type 734 is intended for over-the-counter use. The Indications for Use statement for the SLENDERTONE® CoreFit Abs 8, Type 734 is identical to the predicate device {5}------------------------------------------------ #### VI. BIOCOMPATIBILITY EVALUATION The SLENDERTONE® CoreFit Abs 8, Type 734 uses the same adhesive gel pads (electrodes) as the predicate device Slendertone System Ultra. Biocompatibility testing of the SLENDERTONE® CoreFit Abs 8, Type 734 garment assembly was carried out. The four test studies conducted were as follows; - 1. Cytotoxicity Test: MTT Method MEM with 10% FBS Extract - 2. Cytotoxicity Test: MTT Method MEM Extract - 3. Skin sensitization: Buehler test in guinea pigs - 4. Skin irritation Test: Direct contact. A summary of the four biocompatibility tests carried out can be seen in the below table. | Test | Result | Toxicological Conclusion | |--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------| | Cytotoxicity Test: MTT<br>Method MEM with 10%<br>FBS Extract | Potential toxicity at extract<br>concentration >=75% | No toxicological risk to users. | | Cytotoxicity Test: MTT<br>Method MEM Extract | No potential cytotoxic potential | No toxicological risk to users. | | Skin sensitization:<br>Buehler test in guinea<br>pigs | Dermal scoring using the<br>Magnusson and Kligman scoring<br>system was graded as 0 (no<br>visible change) | No toxicological risk to users. | | Skin irritation Test: Direct<br>contact | No abnormal signs were observed<br>during the study. The response of<br>skin on test side did not exceed<br>that on the control side. | No toxicological risk to users. | # VII. 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 primary predicate device Slendertone System Ultra. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for BIO-MEDICAL Research Limited. The logo consists of a circular cluster of green and blue dots on the left. To the right of the dots, the words "BIO-MEDICAL" are written in a light blue font, with "Research Limited" written in gray underneath. | Table I | New Device | Predicate Device | |---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Basic Unit Characteristics | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Slendertone System Ultra,<br>Type 390, Model E70/X70 | | 1. 510(k) Number | (To be Assigned) | K100320 | | 2. Device Name, Model | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Slendertone System Ultra<br>Type 390, E70/X70 | | 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 | | 4. Power Source | 3.7V Lithium Polymer Single Cell<br>Rechargeable | 3.6V NiMh Battery Pack<br>Rechargeable | | - Method of line Isolation | No line connection possible when connected<br>to body | No line connection possible when connected<br>to body | | - Patient Leakage Current | Not applicable, no line connection, no AC<br>charger connection or operation. Connection<br>method does not allow AC charger<br>connection to Patient. | Not applicable, no line connection, no AC<br>charger connection or operation. Connection<br>method does not allow AC charger<br>connection to Patient. | | 5. No. of Output Modes | 1 (Symmetric, Pulsed, Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | | 6. Number of Output Channels | 2 | 2 | | - Synchronous/Alternating? | Synchronous | Synchronous | | - Method of channel isolation | Transistor | Transistor | | 7. Regulated Current or Regulated Voltage | Constant Current | Constant Current | | 8. Software/Firmware/Microprocessor Control? | Yes | Yes | | 9. Automatic overload Trip? | Yes | Yes | | 10. Automatic No-Load Trip? | Yes | Yes | | 11. Automatic Shut Off | Yes | Yes | | 12. Patient Override Control? | Yes, pause button stops treatment<br>immediately. | Yes, pause button stops treatment<br>immediately. | | 13. Indicator Display<br>- On/Off Status? | Yes OLED Display | Yes LCD | | | New Device | Predicate Device | | Table I<br>Basic Unit Characteristics | SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Slendertone System Ultra,<br>Type 390, Model E70/X70 | | - Low Battery? | Yes, OLED Display | Yes, LCD | | - Voltage/Current Level? | Yes, OLED Display | Yes, LCD | | 14. Timer range (minutes) | 20-40 minutes | 20-40 minutes | | 15. Compliance with Voluntary 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 (47 CFR Part 15, Subpart B) | IEC 60601-1:1988 & A1:1991, A2:1995<br>IEC 60601-2-10:1987 & A1 2001<br>IEC 60601-1-2:2001 (EN 60601-1-2:2001)<br>CISPR 22:2003/CFR 47 Part 15:2005<br>IEC 60601-1-6:2004 (EN 60601-1-6:2001)<br>Battery Charger: IEC 60950 and UL 1950<br>FCC Rules Subpart B | | 16. Compliance with CFR 21 898? | Yes | Yes | | 17. Weight (unit) | 37g (incl. batteries) | 116g (inc. batteries) | | 18. Dimensions (un.)<br>{W x H x D} | 57 x 57 x 15 mm approx. | 60 x 23 x 115mm approx. | | 19. Housing Materials and Construction | Injection moulded thermosetting plastic, with a thermoplastic elastomer (TPE) keypad | Injection moulded thermosetting plastic | | Table II<br>Output Characteristics | New Device<br>SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Predicate Device<br>Slendertone System Ultra,<br>Type 390, Model E70/X70 | | Waveform | Pulsed, Symmetrical, Biphasic | Pulsed, Symmetrical, Biphasic | | Shape | Rectangular, with interphase interval | Rectangular, with interphase interval | | Maximum Output Voltage (RMSV) (+/- 10%) | 7.58V @ 500Ω<br>14.4V @ 2kΩ<br>@ 10kΩ: no output for 10kΩ resistance | 7.4V @500Ω<br>15.4V@2kΩ<br>6.2V@10kΩ | | $\frac{Vp^2 x 2 x PW}{\sqrt{\frac{1}{freq}}}$ | | | | Maximum Output Current (RMSA) (+/- 10%) | 15.16mA @ 500Ω<br>7.2mA @ 2kΩ<br>@ 10kΩ: no output for 10kΩ resistance | 14.7mA@500Ω<br>7.7mA@2kΩ<br>620μA @ 10kΩ | | Pulse Width | 730 µs | 730 µs | | Baseline to peak current @500Ω | 72mA | 70mA | | Frequency (Hz) | 50-70 Hz | 50-70 Hz | | For interferential modes:<br>- Beat Frequency | N/A | N/A | | For multiphasic waveforms only:<br>- Symmetrical phases | Yes | Yes | | - Phase Duration | 200 - 315µs | 200/225/250/275/300/315 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) | 1 phase 22.8 µC @500Ω<br>2 phase 45.6 µC @500Ω | 1 phase 22 µC @500Ω<br>2 phase 44 µC @500Ω | | C= Ip*PW | | | | Maximum Current Density (mA/cm²) | 0.216 mA/cm² @500Ω | 0.21 mA/cm² @ 500Ω | | Table II<br>Output Characteristics | New Device<br>SLENDERTONE® CoreFit Abs 8,<br>Type 734 | Predicate Device<br>Slendertone System Ultra,<br>Type 390, Model E70/X70 | | Maximum Power Density (W/ cm²)<br>Using smallest electrode conductive<br>surface area | 1.64 mW/ cm² @500Ω | 1.59 mW/ cm² @500Ω | | Contraction Time | 1.0 - 5.5 s | 1.0 - 5.5 s | | Relaxation Time | 1.0 - 7.0 s | 1.0 - 7.0 s | | Burst Mode | N/A | N/A | | Additional Features (if applicable) | N/A | N/A | | Maximum Charge Current | 300mA @ 5V | 400 mA @ 6V | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ Image /page/10/Picture/1 description: The image is a company logo for Bio-Medical Research Limited. The logo consists of a cluster of green and blue circles on the left side. To the right of the circles, the words "BIO-MEDICAL" are written in a light blue font, with the words "Research Limited" written below in a gray font. ### 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 safety and essential performance | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-6:2010/A1:2013 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 60601-1-2:2007 | Medical electrical equipment - part 1-2: general requirements for safety -collateral standard: electromagnetic compatibility - requirements and tests | | IEC 60601-2-10:2012 | Medical Electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators | | IEC 60601-1-11:2015 | Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | 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® CoreFit Abs 8, Type 734 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® CoreFit Abs 8, . Type 734 is as safe and effective as the predicate device and is substantially equivalent.