BionicGym Powered Muscle Stimulator

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. July 18, 2019 Medical Currents Ltd % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Srl Piazza Albania 10 Rome, 00153 It Re: K182794 Trade/Device Name: BionicGym Powered Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 14, 2019 Received: June 19, 2019 Dear Roger Gray: 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/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-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 Advice (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. Vivek Pinto, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182794 #### Device Name BionicGym Powered Muscle Stimulator #### Indications for Use (Describe) BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles. | 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/0 description: The image shows the logo for Medical Currents LTD and Bionic Gym. The text "MEDICAL CURRENTS LTD" is in black, all-caps font. Below that is the logo for Bionic Gym, with the word "bionic" in orange and the word "GYM" in black. ## 510(k) Summary ## I. General Information on Submitter | Submitter/Address: | Medical Currents Ltd<br>8 Cuffe Lane<br>Dublin 2<br>D02W840<br>Ireland | |--------------------|-------------------------------------------------------------------------------------------------------------------------------| | Contact person: | Dr. Louis Crowe | | Phone: | +353 87 239 3473 | | Correspondent: | Mr. Roger Gray<br>VP, Quality and Regulatory<br>Donawa Lifescience Consulting Srl<br>Piazza Albania 10<br>00153 Rome<br>Italy | | Phone: | +39 06 578 2665 | | Fax: | +39 06 574 3786 | | Email: | rgray@donawa.com | #### II. Date Prepared 17 July 2019 ## III. General Information on Device | Device Name: | BionicGym Powered Muscle Stimulator | |--------------------|------------------------------------------------------| | Common Name: | Powered Muscle Stimulator | | Regulation Number: | 21 CFR 890.5850 | | Regulation Name: | Stimulator, muscle, powered, for muscle conditioning | | Product Code: | NGX | | Regulatory Class: | II | ## IV. Predicate Devices PowerDot® PD-01 Muscle Stimulator (K150078). The predicate device has not been subject to any design related recalls. ## V. Device Description The BionicGym Powered Muscle Stimulator is a home use, wearable device in the form of a double thigh wrap garment. The electronics are housed in a control unit that is fitted into a pocket on the right thigh garment. The control unit generates electrical pulses which are distributed to hydrogel electrodes positioned within the thigh garments and in contact with the user's thighs. The control unit delivers pulses to the muscles via the electrodes in defined patterns, which cause controlled contractions of the legs. The program characteristics determine the leg muscle contractions, which may be tetanic or sub-tetanic, the latter of which can induce cardiovascular and aerobic demand, thus the user receives an exercise workout. The intensity of the workout can be selected from a suite available via a smart device (e.g. phone) based application ('App'). The workout can be paused or stopped from either the App or the control unit. The principle of operation of the BionicGym Powered Muscle Stimulator is that the pulse pattern delivered to the thigh electrodes is a composite of pulses shared between the electrode array. Repeating the pulse pattern induces contractions of the large muscle groups in the legs (quadriceps, hamstrings, gluteal and calf muscles), exercising the legs and raising the user's heart rate. {4}------------------------------------------------ MEDICAL CURREN Image /page/4/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the words. The logo is tilted slightly to the right. BionicGym can run a variety of training programs. However, there is a hard-limit in the firmware of 140 V and 200 mA maximum pulse amplitude, and the electrodes are large (≥150 x100 mm), so the pulse/current density is always low and the maximum amplitudes are always within allowable limits. Wireless communication is used to control the workout programs, utilizing Bluetooth for communications between the control unit, thigh wrap electrodes, and Smartphone App. The Smartphone App is available for both Android and iPhone operating systems. ## VI. Indications for Use BionicGym is intended to stimulate healthy muscles in order to exercise, improve or facilitate muscle performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the training programs or operational parameters are designed to target injured or ailing muscles. ## VII. Comparison of Intended Use and Technological Characteristics of the Subject and Predicate Devices The Indications for Use for BionicGym are very similar to those for the predicate device. While the predicate device is intended to be applied to a number of muscle groups, BionicGym is intended for application to the wearer's thighs. Both the subject and predicate devices are controlled via a Smartphone App, which communicates with the unit controller via low energy Bluetooth. Both subject and predicate devices use electronic pulses to stimulate the muscles to which they are applied, with a number of programmable variants. Differences exist between the subject and predicate device in relation to the nature, strength and duration of the stimulation pulses, but these differences are not significant in relation to the safety and effectiveness of the devices. | Table 1: Predicate device comparison table | | | | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|--| | Item | Subject device | Predicate Device (PD) | Similarity | | | Device name | BionicGym Powered Muscle<br>Stimulator | PowerDot® PD-01 Muscle<br>Stimulator | N/A | | | 510(k) Sponsor | Medical Currents Ltd, Ireland | Smartmissimo Technologies Pte Ltd,<br>Singapore | N/A | | | 510(k) Reference | Not yet assigned | K150078 | N/A | | | FDA Product Code | NGX | NGX | Same | | | FDA Classification<br>Name | Stimulator, muscle, powered, for<br>muscle conditioning | Stimulator, muscle, powered, for<br>muscle conditioning | Same | | | FDA Regulation<br>Number | 21 CFR 890.5850 | 21 CFR 890.5850 | Same | | | Device description | A wearable device in the form of a<br>two thigh wraps. The electronics are<br>housed in a control unit which<br>generates electrical pulses which<br>are distributed to hydrogel<br>electrodes positioned within the<br>thigh garments. Designed to be<br>used with the BionicGym Mobile<br>App. | The PD-01 Muscle Stimulator is a<br>battery-powered neuromuscular<br>stimulator intended to be used with<br>the PowerDot® Mobile Application.<br>PowerDot® electrodes can be<br>applied to multiple anatomical sites. | Substantially<br>Equivalent | | | Table 1: Predicate device comparison table | | | | | | Item | Subject device | Predicate Device (PD) | Similarity | | | Indications for Use | BionicGym is intended to stimulate<br>healthy muscles in order to exercise,<br>improve or facilitate muscle<br>performance. It is not intended to be<br>used in conjunction with therapy or<br>treatment of medical diseases or<br>medical conditions of any kind. None<br>of the training programs or<br>operational parameters are<br>designed to target injured or ailing<br>muscles. | The PowerDot PD-01 device, used<br>with PowerDot Mobile Application, is<br>intended for the stimulation of<br>healthy muscles in order to improve<br>or facilitate muscle performance.<br>The PowerDot PD-01 device and<br>PowerDot Mobile Application are not<br>intended to be used in conjunction<br>with therapy or treatment diseases<br>of medical or medical conditions of<br>any kind. | Substantially<br>Equivalent | | | Rx / OTC? | ОТС | ОТС | Same | | | Electrical safety | Complies with:<br>IEC 60601-1<br>IEC 60601-1-11<br>IEC 60601-2-10 | Complies with:<br>IEC 60601-1<br>IEC 60601-1-11<br>IEC 60601-2-10 | Same | | | Electromagnetic<br>compatibility | Complies with:<br>IEC 60601-1-2 | Complies with:<br>IEC 60601-1-2 | Same | | | Anatomical sites | Thighs | Multiple | Different | | | Power Source | 2 x Battery, Li-Po, rechargeable.<br>Not replaceable by user. | Battery, Li-Po, rechargeable.<br>Not replaceable by user. | Same | | | Method of Line Current<br>Isolation | N/A | N/A | Same | | | Patient Leakage<br>Current | Normal: < 25 µA<br>Single fault: < 25 µA | Normal: < 25 µA<br>Single fault: < 25 µA | Same | | | Average DC current<br>through electrodes<br>when device is on but<br>no pulses are being<br>applied | 0 µA | 0 µA | Same | | | Number of output<br>modes | One output mode, but with varying<br>stimulation parameters | One output mode, but with varying<br>stimulation<br>frequency, pulse width and<br>duty cycle ranges | Substantially<br>Equivalent | | | Number of output<br>channels | Any combination of 8 electrodes can<br>form a channel (synchronous) | 2 channels Synchronous (with<br>asynchronous support) | Different | | | Method of channel<br>isolation | Galvanic | Galvanic | Same | | | Regulated current or<br>voltage | Regulated current within allowable<br>voltage range | Regulated voltage | Different | | | Microprocessor<br>controlled | Yes | Yes | Same | | | Automatic overload trip | Yes | Yes | Same | | | Automatic no-load trip | Yes | Yes | Same | | | Automatic shut-off | Yes | Yes | Same | | | User over-ride control | Yes | Yes | Same | | | Indicator display:<br>- On/Off status<br>-Low battery<br>- Voltage/ current level | Yes<br>Yes<br>Yes (as 'intensity') | Yes<br>Yes<br>Yes | Same | | | Timer range | 0 - 120 mins max | 0 - 60 mins max | Different | | | Compliance with 21<br>CFR 898 | Yes | Yes | Same | | | Table 1: Predicate device comparison table | | | | | | Item | Subject device | Predicate Device (PD) | Similarity | | | Waveform | Biphasic rectangular symmetrical<br>with charge balancing second<br>phase, Zero net DC | Biphasic, close to rectangular,<br>asymmetrical, with<br>charge balancing second<br>phase, zero net DC | Different | | | Maximum Output<br>Voltage (+/- 15 %) | 140 V @ 500 Ω<br>140 V @ 2 kΩ<br>140 V @ 10 kΩ | 90 V @ 500 Ω<br>122 V @ 2 kΩ<br>138 V @ 10 kΩ | Substantially<br>Equivalent | | | Maximum Output<br>Current (+/- 15 %) | At pulse width of 400 µs:<br>200 mA @ 500 Ω<br>70 mA @ 2 kΩ<br>14 mA @ 10 kΩ | At pulse width of 400 µs:<br>136 mA @ 500 Ω<br>50 mA @ 2 kΩ<br>12.4 mA @ 10 kΩ | Substantially<br>Equivalent | | | Pulse width | 10 μs to 400 μs | 150-400 µs (for main<br>phase) | Substantially<br>Equivalent | | | Frequency | 1 - 99 Hz per channel | 1 - 120 Hz | Different | | | For interferential modes<br>only:<br>- Beat Frequency (Hz) | N/A | N/A | Same | | | For multiphasic<br>waveforms only:<br>- Symmetrical phases<br>- Phase duration(s) | Yes<br>1 μs to 400 μs for positive phase,<br>same for negative phase | No<br>150-400 μs for positive phase, same<br>for negative phase | Substantially<br>Equivalent | | | Net charge<br>How achieved | 0 µC at 500 Ω<br>Symmetrical pulses | 0 µC at 500 Ω<br>Capacitor coupling | Different | | | Maximum phase charge<br>(@ 500 Ω), μC per<br>pulse | 80 μC | 34.4 μC | Substantially<br>Equivalent | | | Maximum current<br>density (@ 500 Ω),<br>mA/cm² (rms) | 0.50 mA/cm² | 1.27 mA/cm² | Different | | | Maximum average<br>current, mA (@ 500 Ω)<br>(average absolute<br>value) | 9.9 mA | 2.7 mA | Different | | | Maximum average<br>power density, W/cm²<br>(@ 500 Ω) | 0.0100 W/cm² | 0.0177 W/cm² | Different | | | Burst mode:<br>a) Pulses per second<br>b) Bursts per second<br>c) Burst duration<br>d) Duty Cycle:<br>= (b) x (c) | N/A | a) 2<br>b) 120<br>c) 150-400 μs<br>d) 2-12 x 2-60 | Different | | | ON Time | Continuous or 0.1 to 24 sec | Continuous or 2-12 sec | Substantially<br>Equivalent | | | OFF Time | 0-120 sec | 0-60 sec | Substantially<br>Equivalent | | | Electrode type | Self adhesive | Self adhesive | Same | | | Electrode dimensions | 168 x 112 x 2.4 mm | 8 x 4 cm and 4.5 cm diameter | Different | | | Electrode weight | 57 g | Unknown | Different | | | Electrode conductive<br>surface area | 175 cm² | Approx 30 cm² and 15 cm² | Different | | | Table 1: Predicate device comparison table | | | | | | ltem | Subject device | Predicate Device (PD) | Similarity | | | Electrodes in use during<br>exercise session | 2 - 8 | 1 or 2 | Different | | | Electrode materials | · Silicone-coated PET release liner<br>· Hydrogel reference G607<br>· Conductive carbon film<br>· Printed silver pattern on the carbon<br>film | • MultiStick® MG-1500 hydrogel<br>• Other materials unknown | Different | | | Incorporated<br>electroconductive<br>media? | Yes | Yes | Same | | | Electrode hydrogel pH | 5.3 to 5.5 | Unknown | Probably<br>equivalent | | | Hydrogel formulation | Glycerine 60%<br>Polyacrylic acid 20%<br>Water 19%<br>Salt 1% | Unknown | Probably<br>equivalent | | | Skin-to-electrode<br>Impedance Range | 310 to 451 Ω | Unknown | Unknown | | | Maximum duration of<br>electrode use | 25 workout sessions | Single workout session | Different | | | Secondary electrode<br>support? | Yes - thigh wraps | No | Different | | | Wrap dimensions | Large – R Leg 647 x 376 x 20 mm<br>Large – L Leg 647 x 376 x 16 mm<br>Small - R Leg 567 x 347 x 20 mm<br>Small – L Leg 567 x 347 x 16 mm<br>Extension 225 x 130 x 1.5 mm | N/A | N/A | | | Wrap weight | Large - R Leg 284 g<br>Large - L Leg 266 g<br>Small - R Leg 242 g<br>Small - L Leg 234 g<br>Extension 67 g | N/A | N/A | | | Wrap material | Neoprene and nylon/spandex blend | N/A | N/A | | | Smartphone App? | Yes | Yes | Same | | Table 1 includes a detailed comparison between the subject and predicate devices. {5}------------------------------------------------ ## MEDICAL CURRENTS LTD Image /page/5/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three orange lines underneath the words. The logo is slightly blurry. {6}------------------------------------------------ ## MEDICAL CURRENTS LTD Image /page/6/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the word "GYM". {7}------------------------------------------------ ## MEDICAL CURRENTS Image /page/7/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the word "GYM". The subject device and the predicate devices have many identical or similar properties or features. The differences that exist with respect to device functionality are: - . BionicGym includes thigh wraps with predefined electrode positions, whereas the predicate device electrodes can be placed in many different locations. - The BionicGym electrodes are much larger, resulting in lower current density at maximum output. - . BionicGym incorporates an electrode check in the software to ensure all active electrodes are in appropriate contact with the skin; no such check is present in the predicate device. - . BionicGym has known electrode positions and does not allow the user to determine relative channel intensities and/or positions. The user picks from a suite of known and tested programs with predetermined channels and relative channel intensities. - BionicGym pulses are symmetrical biphasic, as opposed to asymmetrical biphasic in the predicate). - The user can choose a program lasting up to two hours, (as opposed to one hour in the predicate). - . BionicGym uses thigh wraps to allow correct positioning and support of the electrodes, whereas the predicate has no secondary means of support for the electrodes. With regard to these differences, the following paragraphs provide additional explanations: {8}------------------------------------------------ ## MEDICAL CURRENTS Image /page/8/Picture/1 description: The image shows the logo for Bionic Gym. The word "bionic" is in orange, and the word "GYM" is in black. There are three horizontal lines underneath the words. Anatomical sites: BionicGym can be used only on the thigh wraps cannot be fitted around the head, neck or torso, thus the possibility of inadvertent transcerebral, carotid sinus or transthoracic stimulation pathways is avoided by design. Number of output channels: The predicate device has only two channels, which limits the muscles it can target. For instance, from the website for the predicate, it appears the device can target only the quadriceps OR hamstring of only one leg at a time. By using more channels, BionicGym allows each muscle group to receive similar and balanced contractions and overall exercise times. Timer range: It is often the case that exercise sessions last for longer than an hour, as allowed by the predicate device. BionicGym allows sessions to last up to two hours, which is not significant in safety terms, because the current densities through the skin are low when compared with the predicate device. Regulated current or voltage: With regulated current, as used in BionicGym, the exact pulse put into the user body is known, with an assurance of there being no net DC. Furthermore, the output is limited to 140 V (substantially less than the 500 V maximal permissible voltage). Waveform: The BionicGym waveform is symmetrical, compared with the predicate device, which has an asymmetrical waveform. Having a symmetrical waveform helps ensure no net DC. Net Charge: how achieved: Symmetrical biphasic pulses are used in BionicGym, whereas capacitive coupling is used in the predicate device. In BionicGym, each phase balances each other in shape as well as intensity and duration. As a further safety feature, each pulse is 'reversed' every second time it is qiven. E.g. if pulse 1 has electrode A positive and electrode B negative (in the first phase of the biphasic pulse) the next time it is delivered it will lead with A negative and B positive, etc. Thus, if there is any imbalance in a given pulse, the Net Charge would still be minimized when averaged over two of the pulses. Maximum Current Density; Maximum Average Current; Maximum Average Power Density: These three parameters are closely related. BionicGym uses 8 electrodes that are each larger than the combined surface area of the 4 electrodes in the predicate device. This ensures that BionicGym delivers stimulation (up to the permissible level of 10 mA) while always maintaining a low current density and low power density. Burst Mode: BionicGym does not have a burst mode, whereas the predicate device does. Electrodes in use during exercise session: BionicGym has 8, while the predicate device has 4. BionicGym can contract both legs simultaneously, whereas the predicate can contract only a part of o…