SLENDERTONE® Connect Abs, Type 570

K161974 · Bio-Medical Research, Ltd. · NGX · Nov 1, 2016 · Physical Medicine

Device Facts

• Record ID: K161974
• Device Name: SLENDERTONE® Connect Abs, Type 570
• Applicant: Bio-Medical Research, Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Nov 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable neuromuscular electrical stimulation (NMES) system; delivers electrical pulses to abdominal muscles via adhesive gel pads. System includes control unit, abdominal garment, and electrodes. Wireless communication via Bluegiga BLE113 Bluetooth module enables control and program management through iOS and Android mobile applications. User-operated; intended for home use. Device provides pre-installed toning program; users can download additional programs via app. Output parameters are strictly limited to ensure safety. Provides muscle stimulation to facilitate performance and improve tone. Benefits patient through non-invasive abdominal muscle conditioning.

Clinical Evidence

Bench testing only. Device performance evaluated against IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, IEC 60601-1-6, EN 60601-1-2, ISO 10993-5, ISO 10993-10, and IEC 62133. Wireless co-existence testing performed in environments with Bluetooth/Wi-Fi interference. No clinical data presented.

Technological Characteristics

Portable NMES system; 3.7V Lithium Polymer battery; 2 output channels; symmetric biphasic pulsed waveform. Housing: injection molded thermosetting plastic. Connectivity: Bluetooth (Bluegiga BLE113). Output: 10-80 Hz, 900 µs pulse width, constant current. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-11, ISO 10993, IEC 62133, FCC Part 15.247.

Indications for Use

Indicated for healthy individuals seeking to improve abdominal muscle tone, strengthen abdominal muscles, and develop a firmer abdomen.

Regulatory Classification

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.

Predicate Devices

• SLENDERTONE® Connect Abs, Type 570 (K151903)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 1, 2016

Bio-Medical Research Ltd Anne-Marie Keenan Regulatory Affairs Specialist Parkmore Business Park West Galway, H91 NHT7 Ireland

Re: K161974

Trade/Device 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 3, 2016 Received: October 5, 2016

Dear Anne-Marie 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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# 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

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# Indications for Use

510(k) Number (if known) K161974

Device Name SLENDERTONE® Connect Abs, Type 570

#### Indications for Use (Describe)

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 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)

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# 510k SUMMARY

| I. SUBMITTER | |
|-------------------------|------------------------------------------------------|
| Name: | Anne-Marie Keenan |
| Address: | Bio-Medical Research Ltd., |
| | Parkmore Business Park West, |
| | Galway, IRELAND |
| Telephone: | [phone] |
| Fax: | [phone] or [phone] |
| E-Mail: | [e-mail] |
| Prepared: | July 14, 2016 |
| 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: | K151903 |
| Manufacturer: | Bio-Medical Research Ltd. |
| Trade Name: | SLENDERTONE® Connect Abs, Type 570 |

The listed predicate has not been subject to a design-related recall.

# IV. DEVICE DESCRIPTION

The SLENDERTONE® Connect Abs, Type 570 is a portable, neuromuscular, electrical stimulation system intended to deliver electrical stimulation to the abdominal muscles. The system includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable, pouch and instructions for use. One toning program is pre-installed in the unit. Wireless communication is enabled by a Bluegiga BLE113 Bluetooth module. The modified Slendertone Connect Abs device supports a range of mobile devices via both iOS and android mobile applications.

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# 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.

# VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following tables summarizes the similarities and differences between the technological characteristics of the modified device versus the predicate device;

Table I Unit Characteristics

Table II Output Characteristics (values representing maximum power limit of 180mW)

Users may securely download additional treatment programs through the mobile application. The program parameters and resulting outputs for any such program are limited in accordance with the Table II.

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| Table I<br>Basic Unit Characteristics | Modified Device<br>Slendertone Connect Abs | Predicate Device<br>Slendertone Connect Abs | Justification |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K161974 | K151903 | N/A |
| 2. Device Name, Model | Slendertone® Connect<br>Abs,<br>Type 570 | Slendertone® Connect Abs,<br>Type 570 | Same |
| 3. Manufacturer (Contract) | JDI Electronics Factory<br>Cima Industrial Center<br>Chang Ping, Dongguan<br>Guangdong, CHINA<br><br>Owner Operator: Blue<br>Ocean Innovation Ltd<br>RM 1813, Fo Tan<br>Industrial Centre<br>26-28 Au Pui Wan Street<br>Fo Tan, Hong Kong | Blue Ocean Innovation Ltd<br>RM 1813, Fo Tan Industrial Centre<br>26-28 Au Pui Wan Street<br>Fo Tan, Hong Kong | |
| 4. Power Source | 3.7V Lithium Polymer<br>Single Cell Rechargeable | 3.7V Lithium Polymer Single Cell<br>Rechargeable | Same |
| - Method of line Isolation | No line connection<br>possible when connected<br>to body | No line connection possible when<br>connected to body | Same |
| - Patient Leakage Current | Not applicable, no line<br>connection, no AC<br>charger connection or<br>operation. Connection<br>method does not allow<br>AC charger connection to<br>Patient. | Not applicable, no line connection,<br>no AC charger connection or<br>operation. Connection method<br>does not allow AC charger<br>connection to Patient. | Same |
| 5. No. of Output Modes | 1 (Symmetric, Pulsed,<br>Biphasic) | 1 (Symmetric, Pulsed, Biphasic) | Same |
| 6. Number of Output<br>Channels | 2 | 2 | Same |
| - Synchronous/Alternating? | Synchronous | Synchronous | Same |
| - Method of channel<br>isolation | Transistor | Transistor | Same |
| 7. Regulated Current or<br>Regulated Voltage | Constant Current | Constant Current | Same |
| 8. Software/Firmware/Micro<br>processor Control? | Yes | Yes | Same |
| 9. Mobile Apps | iOS + Android | iOS only | Different, but does not<br>adversely impact the safety<br>and effectiveness of the<br>subject device |
| 10. Automatic overload<br>Trip? | Yes | Yes | Same |
| 11. Automatic No-Load | Yes | Yes | Same |
| Table I | Modified Device | Predicate Device | Justification |
| Basic Unit Characteristics<br>Trip? | Slendertone Connect Abs | Slendertone Connect Abs | |
| 12. Automatic Shut Off | Yes | Yes | Same |
| 13. Patient Override<br>Control? | Yes, pause button stops treatment immediately. | Yes, pause button stops treatment immediately. | Same |
| 14. Indicator Display<br>- On/Off Status?<br>- Low Battery?<br>- Voltage/Current Level? | Yes, Unit LED and Smart device<br>Yes, Unit LED and Smart device<br>Yes, via Smart device | Yes, Unit LED and Smart device<br>Yes, Unit LED and Smart device<br>Yes, via Smart device | Same |
| 15. Timer range (minutes) | 20-30 minutes | 20-30 minutes | Same |
| 16. Compliance with<br>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 Rule Part 15.247:2012 | 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 | Same |
| 17. Compliance with CFR<br>21 898? | Yes | Yes | Same |
| 18. Weight (unit) | 37g (including batteries) | 37g (including batteries) | Same |
| 19. Dimensions (un.)<br>{W x H x D} | 70 x 50 x 14 mm approx. | 70 x 50 x 14 mm approx. | Same |
| 20. Housing Materials and<br>Construction | Injection molded thermosetting plastic | Injection molded thermosetting plastic | Same |
| Table II | Modified Device | Predicate Device | Justification |
| Output Characteristics | Slendertone Connect Abs | Slendertone Connect Abs | |
| Waveform | Pulsed, Symmetrical, Biphasic | Pulsed, Symmetrical, Biphasic | Same |
| Shape | Rectangular, with interphase<br>interval | Rectangular, with interphase<br>interval | Same |
| Maximum Output<br>Voltage (RMSV) (+/-10%) | 9.47V @ 500Ω<br>17.5V @ 2kΩ<br>6.2V @ 10kΩ | 9.47V @ 500Ω<br>17.5V @ 2kΩ<br>6.2V @ 10kΩ | Same |
| $ Vp2x2xPW √1/freq $ | | | |
| Maximum Output<br>Current (RMSA) (+/-10%) | 18.9mA @ 500Ω<br>8.75mA @ 2kΩ<br>620µA @ 10kΩ | 18.9mA @ 500Ω<br>8.75mA @ 2kΩ<br>620µA @ 10kΩ | Same |
| Pulse Width | 900 µs | 900 µS | Same |
| Baseline to peak current<br>@500Ω | 80mA | 80mA | Same |
| Frequency (Hz) | 10 to 80 Hz | 10 to 80 Hz | Same |
| - Phase Duration | 100 - 400µS | 100 - 400µS | Same |
| Net Charge (µC per<br>pulse) | 0@500Ω<br>Symmetric, biphasic and<br>leading polarity alternates for<br>each successive pulse | 0@500Ω<br>Symmetric, biphasic and<br>leading polarity alternates for<br>each successive pulse | Same |
| Maximum Phase Charge<br>(µC)<br>C= Ip*PW | 1 phase 32 µC @500Ω<br>2 phase 64 µC @500Ω | 1 phase 32 µC @500Ω<br>2 phase 64 µC @500Ω | Same |
| Maximum Current<br>Density (mA/cm²) | 0.28 mA/cm² @500Ω | 0.28 mA/cm² @500Ω | Same |
| Maximum Power Density<br>(W/ cm²)<br>Using smallest electrode<br>conductive surface area | 2.57 mW/ cm² @500Ω | 2.57 mW/ cm² @500Ω | Same |
| Contraction Time | 0.5 - 5 sec | 0.5 - 5 sec | Same |
| Relaxation Time | 0.5 - 6 sec | 0.5 - 6 sec | Same |
| Additional Features (if<br>applicable) | N/A | N/A | Same |

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# 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

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- Medical electrical equipment Part 1-6: General IEC 60601-1-6:2010 requirements for basic safety and essential performance -Collateral standard: Usability Medical electrical equipment - part 1-2: general EN 60601-1-2:2007 requirements for 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 60601-1-11:2010 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
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- Biological evaluation of medical devices. Tests for irritation ISO 10993-10:2010 and skin sensitization

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.

# VIII. CONCLUSION

The modified SLENDERTONE® Connect Abs, Type 570 has

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- . The same principles of operation as the predicate device with no differences in technological characteristics.
- . The same Intended Use and Indications for Use as the predicate device.

Modifications to the SLENDERTONE® Connect Abs has not resulted in any new issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.