MyoWorx TM20

{0}------------------------------------------------ October 19, 2021 Image /page/0/Picture/1 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 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. MyoWorx Inc. % Darren Reeves President DP Distribution & Consulting, LLC. 12240 Hunting Horn Lane Rockville, Virginia 23146 ## Re: K192746 Trade/Device Name: MyoWorx TM20 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF Dated: July 15, 2021 Received: July 15, 2021 ### Dear Darren Reeves: 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. 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 {1}------------------------------------------------ 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 mediation-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, for CDR Jitendra Virani, MS Assistant Director 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K192746 Device Name MyoWorx TM20 Indications for Use (Describe) Muscle relaxation and increased local blood circulation. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) 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}------------------------------------------------ In accordance with 210 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MyoWorx TM20 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005. | Sponsor: | MyoWorx Inc.<br>77 Westmount Road Suite 201<br>Guelph, Ontario, N1H5J1 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person/Prepared by: | Darren Reeves<br>President<br>DP Distribution & Consulting, LLC<br>(804) 307-7706<br>dreeves@dpdconline.com<br>7305 Hancock Village Drive<br>Suite 109<br>Chesterfield, Virginia 23832 | | Date: | 10/13/2021 | | Subject Device: | Trade Name: MyoWorx TM20<br>Common Name: Powered Muscle<br>Stimulator<br>Classification Name: Powered Muscle<br>Stimulator (21 CFR 878.5850, Product Code<br>IPF) | | Predicate Device: | Mettler Electronics Corp., Sys*Stim® 294<br>(ME294) (K984114) | ### Purpose and Device Description: The TM20 is a device used for muscle relaxation. It sends biphasic pulses to targeted distressed muscles, and by delivering a specified sequence of timed and abrupt electrical frequency pulses, the device can be used to decrease the tension of the muscle fibers and leads to greater blood flow. The user operates the device by means of a keypad overlay. The overlay allows for the user to adjust the treatment length, adjust intensity of each stimulation output, adjust maximum power of stimulation, and start, pause, and stop {4}------------------------------------------------ treatment. The values being set and current stage of treatment is displayed to the user by means of an LCD display, alpha numeric displays, and LEDs. Future revisions of the product are intended to be controlled by means of a Laptop or Tablet which will rest on the surface of the enclosure and connect to the device by means of a Slave USB cable. This capability will be implemented in hardware but not firmware. The TM20 device consists of the following: - 1. User Interface Overlay - 2. External Power Supply for TM20 - 3. A main board for controlling and monitoring the generated output - 4. 10 Individual output channels, and a stimulation circuit for each channel - 5. Communication and stimulation cables - 6. A custom bent metal enclosure The TM20 device is designed, assembled, and tested to medical device standards of a Class 2 device which meets all safety and regulatory requirements for Health Canada and the FDA. The device is designed to operate from 10-35 degrees Celsius. ### Intended Use and Indication for Use: Muscle relaxation and increased local blood circulation. # Comparison of Predicate Device: The MyoWorx TM20 is substantially equivalent in intended use, design, technology/principles of operation, materials, and performance to the Sys*Stem ® 294 (ME294) (K984114). Differences between the devices cited in this section do not raise any new issue of substantial equivalence. Side by Side Device Comparison Table: Predicate Device, Sys*Stim® 294 (ME294) and Proposed Device, MyoWorx TM20 | Elements of<br>Comparison | Subject Device | Predicate Device<br>(K984114) | Similarity | |---------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Device Name | MyoWorx TM20 | Sys*Stim® 294<br>(ME294) | N/A | | 510 (k) Number | Applying | K984114 | N/A | | Product Code | IPF | IPF, LIH and GZJ | Substantially<br>equivalent | | Regulation Number | 882.5890 | 882.5890 | Same | | Intended Use | | | | | Intended Use | Muscle relaxation<br>and increased local<br>blood circulation. | 1. Symptomatic relief<br>of chronic pain,<br>acute post traumatic<br>pain or acute post-<br>surgical pain<br>(interferential,<br>Premodulated and<br>Microcurrent<br>waveforms). | Substantially<br>equivalent | | | | 2. Temporary<br>relaxation of muscle<br>spasm, (all<br>waveforms except<br>Microcurrent). | | | | | 3. Prevention of<br>post-surgical phlebo-<br>thrombosis through<br>immediate<br>stimulation of calf<br>muscles, (all<br>waveforms except<br>Microcurrent). | | | | | 4. Increase of blood<br>flow in the treatment<br>area (all waveforms<br>except<br>Microcurrent). | | | | | 5. Prevention or<br>retardation of disuse<br>atrophy in post-<br>injury type<br>conditions, (all<br>waveforms except<br>Microcurrent). | | | | | 6. Muscle re-<br>education, (all<br>waveforms except<br>Microcurrent). | | | | | 7. Maintaining or<br>increasing range of<br>motion, (all<br>waveforms except<br>Microcurrent). | | | Power Source | UL Listed Medical<br>Grade Power supply<br>cable between 100-<br>240VAC, 50/60Hz | Detachable U.L.<br>Listed, hospital-<br>grade line cord (ME<br>7293) between 90-<br>240 VAC, 50-60Hz | Substantially<br>equivalent | | Method of Line<br>Current Isolation | External 60601 power<br>supply plus output<br>transformers rated at<br>4,000VAC | Yes | Same | | Patient Leakage<br>current<br>-Normal condition | < 100 uA | <100 uA | Same | | -Single fault<br>condition | < 100 uA | <100 uA | Same | | Number of Output<br>Modes | 1 | 6 | Different | | Number of Output<br>Channels | 10 | 4 | Different | | Automatic<br>Overload Trip | Yes | Yes | Same | | Automatic No-load<br>Trip | N/A | Yes | N/A | | Automatic Shut Off | No | Yes | Different | | Patient Override<br>Control | No | No | Same | | Compliance with<br>CFR 898 | No | No | Same | | Housing Materials<br>and Construction | Aluminum. Two<br>machined, bent, and<br>welded parts. One<br>machined part.<br>Fastened by screws. | Aluminum. Stamped<br>in a flat pattern,<br>embossed, folded<br>into a box shape and<br>seams welded and<br>ground flush. | Substantially<br>equivalent | | For inferential<br>modes only:<br>Beat Frequency<br>(Hz) | N/A | 1-250Hz +/- 2Hz or<br>10% whichever is<br>greater | N/A | | For multiphasic<br>waveforms only:<br>Symmetrical<br>phases | Biphasic pulses are<br>symmetric | Biphasic pulses are<br>symmetric | Same | | Electrostatic<br>Discharge (ESD) | ±8 kV Contact<br>±15 kV Air | ±6 KV Contact<br>±8 kV Air | Substantially<br>equivalent | | IEC 61000-4-2 | | | | | Electrical fast<br>transient/bust | ±2 kV for power<br>supply lines | ±2 kV for power<br>supply lines | Same | | IEC 61000-4-4 | | ±1 kV for<br>input/output lines | | | Surge<br>IEC 61000-4-5 | ±0.5kV, ±1 kV Line to Line<br>±0.5kV, ±1 kV, ±2 kV Line to Ground | ±1 kV differential mode<br>±2 kV common mode | Substantially equivalent | | Voltage dips, short<br>interruptions, and<br>voltage variations<br>on power supply<br>input lines<br>IEC 61000-4-11 | 0% UT<br>(100% dip in UT) for 0.5 cycle<br><br>0% UT<br>(100% dip in UT) for 1 cycles<br><br>70% UT<br>(30% dip in UT) for 30 cycles<br><br>0% UT<br>(100% dip in UT) for 5 seconds | <5% UT<br>(>95% dip in UT) for 0.5 cycle<br><br>40% UT<br>(60% dip in UT) for 5 cycles<br><br>70% UT<br>(30% dip in UT) for 25 cycles<br><br><5% UT<br>(>95% dip in UT) for 5 seconds | Substantially equivalent | | Power frequency<br>(50/60 Hz)<br>magnetic field<br>IEC 61000-4-8 | 30 A/m | 3 A/m | Substantially equivalent | | Conducted RF<br>IEC 61000-4-6 | 3 Vrms, 150 kHz-80 MHz<br>6 Vrms ISM/Amateur radio bands inside 150 kHz-80MHz | 3 Vrms | Substantially equivalent | | Radiated RF<br>IEC 61000-4-3 | 3 V/m, 80 MHz-2.7GHz<br>RF communication equipment inside 80 MHz-6GHz | 3 V/m | Substantially equivalent | | Input | 100-240V 1.4A, 50/60Hz | 90-240VAC, 50-60Hz, 2.3 Amp Nom. | Substantially equivalent | | Operating<br>Temperature | 10 ℃ to 35℃ | +50℉ to +104℉ | Substantially equivalent | | Humidity | Operating, Relative | Operating, 30% to | Substantially | | | Humidity 30% to 75%<br>Non-Condensing | 75% Relative<br>Humidity at 104F | equivalent | | | Storage, Relative<br>Humidity 10% to 90%<br>Non-Condensing | Nonoperating, 5 to<br>95% Relative<br>Humidity, non-<br>condensing | | | Storage<br>Temperature | -10 °C to 60°C | -40°F to 167°F | Substantially<br>equivalent | | Timer Accuracy | ±25 parts per million<br>(ppm) | ±30 seconds | Different | | Timer Range | 30, 45, 60 and 90<br>minutes | Maximum Time 60<br>minutes | Different | | Console Weight | 5.2 pounds (without<br>accessories) | 9.4 pounds | Substantially<br>equivalent | | Dimensions | 3.45" (thickest point)<br>and 1.26" (thinnest<br>point) x<br>14.000"x8.690"<br>(HxWxD)-excluding<br>feet | 5" (H) x 14.5" (W) x<br>10" (D) | Substantially<br>equivalent | | Waveform | Biphasic or<br>Monophasic,<br>Rectangle | Interferential,<br>Premodulated,<br>Medium Frequency,<br>Symmetrical<br>Biphasic, High Volt,<br>and Microcurrent,<br>Square | Substantially<br>equivalent | | Maximum Output<br>Voltage (+/- 10%) | 0V-75V +/-5% (peak),<br>with 1kOhm loads | 99 volts peak, 1Kohm<br>load (Symmetrical<br>Biphasic) | Different | | Maximum Output<br>Current | 0.120A, with 500Ohm<br>load | 7.2 mA | Different | | Frequency Range | 1-120Hz | 1-120Hz | Same | | Pulse Width Range | 200µs | 50-300µs | Substantially<br>equivalent | | Method of Line<br>Current Isolation | External 60601 power<br>supply plus output<br>transformers rated at<br>4,000VAC | Yes | Substantially<br>equivalent | | Synchronous or<br>Alternating | Synchronous | Unknown | Unknown | | or Regulated<br>Voltage | | | | | Software/Firmware<br>Microprocessor<br>control | Firmware<br>microprocessor<br>control | Microprocessor<br>control | Same | | Indicator Display<br>On/Off Status | Yes | Yes | Same | | Indicator Display<br>Low Battery | N/A | N/A | Same | | Indicator Display<br>Voltage/Current<br>Level | Yes | Yes | Same | | Net Charge | 24ucoulombs per<br>pulse | Unknown | Probably<br>equivalent | | Maximum Current<br>Density | 0.0032A/sqcm | 0.0036A/sqcm | Substantially<br>equivalent | | Maximum Power<br>Density | 0.09W/sqcm | Unknown | Probably<br>equivalent | | On Time | 19.5 seconds | 1-240 seconds | Different | | Off Time | 0.5 seconds | 1-240 seconds | Different | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # Substantial Equivalence Conclusion: After performing non-clinical performance studies, the data shows that the MyoWorx TM20 is substantially equivalent to the predicate in its sole function as a powered muscle stimulator for temporary relief of muscle spasms. The subject device has fewer functions than the predicate and the differences between it and the predicate device do not raise new issues of safety or effectiveness. Regarding any differences, the following paragraphs provide additional explanations: Number of output modes: The predicate device has six different output modes versus one output mode in the MyoWorx TM20. The single output mode in the subject device is the same as the "Biphasic" output mode in the predicate device. Not having the same number of output modes as the predicate does not raise new issues of safety or effectiveness and simplifies the function and operation of the subject device. Number of output channels: The predicate device has four channels and the MyoWorx TM20 device has 10 channels. This difference allows the TM20 device to apply the intended effect to more muscles at one time as compared with {10}------------------------------------------------ predicate device. As demonstrated through clinical validation, this difference does not impact upon safety or effectiveness. Automatic shut-off: The MyoWorx TM20 does not automatically shut-off but rather goes into a sleep mode with all outputs turned off other than an indicator LED light. Timer Accuracy: The timer in the MyoWorx TM20 has greater accuracy than the predicate. Timer Range: The minimum time of 30 minutes and maximum time of 90 minutes for the TM20 versus a selectable range of up to 60 minutes for the predicate device does not affect safety or effectiveness as current delivery in the MyoWorx TM20 is applied for a maximal allowable duration, which is greater than 10 times less the allowable duration of the predicate. Maximum Output Voltage: The predicate device has a maximum output voltage of 99 volts (output mode same as subject device) and the MyoWorx TM20 has a maximum voltage of 75 volts. The TM20 device is substantially as safe as the predicate due to the lesser maximum voltage output and substantially as effective as the voltage level is well within the physiological range to produce the intended effect of muscle relaxation and increased local blood circulation. Maximum Output Current: The predicate device has a lower maximum output current than the subject device, however safety or effectiveness is not affected as current delivery in the MyoWorx TM20 is applied for a maximal allowable duration, which is greater than 10 times less the allowable duration of the predicate. On-Time: Selectable for the predicate and preset for the subject device, controlling safe delivery of the stimulus. Off-Time: Selectable for the predicate and preset for the subject device. None of the above-identified differences have any adverse effect on the safety or effectiveness of the subject device when compared with the predicate.