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 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. 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called MyoWorx TM20, a powered muscle stimulator. It does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

The document is a regulatory submission for a powered muscle stimulator, focusing on demonstrating substantial equivalence to a predicate device based on design, technology, and performance, rather than providing the kind of detailed study data typically associated with AI/ML device validation.

Specifically, the document focuses on:

Device Description: What the MyoWorx TM20 is and how it works.
Intended Use: Muscle relaxation and increased local blood circulation.
Comparison to Predicate Device: A detailed side-by-side comparison of the MyoWorx TM20 with the Sys*Stim® 294 (ME294) across various technical specifications (e.g., number of output channels, power source, patient leakage current, electrical safety standards, operating conditions).
Substantial Equivalence Conclusion: Argument that the MyoWorx TM20 is substantially equivalent despite some differences, emphasizing that these differences do not raise new issues of safety or effectiveness.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text, as this information is not present. The document describes a "non-clinical performance study" in the "Substantial Equivalence Conclusion" section, but it does not provide details about the study design, sample size, ground truth, or specific acceptance criteria met. It merely states that "the data shows that the MyoWorx TM20 is substantially equivalent to the predicate."

Summary

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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

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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

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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)

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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.77 Westmount Road Suite 201Guelph, Ontario, N1H5J1
Contact Person/Prepared by:	Darren ReevesPresidentDP Distribution & Consulting, LLC(804) 307-7706dreeves@dpdconline.com7305 Hancock Village DriveSuite 109Chesterfield, Virginia 23832
Date:	10/13/2021
Subject Device:	Trade Name: MyoWorx TM20Common Name: Powered MuscleStimulatorClassification Name: Powered MuscleStimulator (21 CFR 878.5850, Product CodeIPF)
Predicate Device:	Mettler Electronics Corp., Sys*Stim® 294(ME294) (K984114)

Purpose and Device Description:

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

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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
1. External Power Supply for TM20
1. A main board for controlling and monitoring the generated output
1. 10 Individual output channels, and a stimulation circuit for each channel
1. Communication and stimulation cables
1. 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 ofComparison	Subject Device	Predicate Device(K984114)	Similarity
Device Name	MyoWorx TM20	Sys*Stim® 294(ME294)	N/A
510 (k) Number	Applying	K984114	N/A
Product Code	IPF	IPF, LIH and GZJ	Substantiallyequivalent
Regulation Number	882.5890	882.5890	Same
Intended Use
Intended Use	Muscle relaxationand increased localblood circulation.	1. Symptomatic reliefof chronic pain,acute post traumaticpain or acute post-surgical pain(interferential,Premodulated andMicrocurrentwaveforms).	Substantiallyequivalent
		2. Temporaryrelaxation of musclespasm, (allwaveforms exceptMicrocurrent).
		3. Prevention ofpost-surgical phlebo-thrombosis throughimmediatestimulation of calfmuscles, (allwaveforms exceptMicrocurrent).
		4. Increase of bloodflow in the treatmentarea (all waveformsexceptMicrocurrent).
		5. Prevention orretardation of disuseatrophy in post-injury typeconditions, (allwaveforms exceptMicrocurrent).
		6. Muscle re-education, (allwaveforms exceptMicrocurrent).
		7. Maintaining orincreasing range ofmotion, (allwaveforms exceptMicrocurrent).
Power Source	UL Listed MedicalGrade Power supplycable between 100-240VAC, 50/60Hz	Detachable U.L.Listed, hospital-grade line cord (ME7293) between 90-240 VAC, 50-60Hz	Substantiallyequivalent
Method of LineCurrent Isolation	External 60601 powersupply plus outputtransformers rated at4,000VAC	Yes	Same
Patient Leakagecurrent-Normal condition	< 100 uA	<100 uA	Same
-Single faultcondition	< 100 uA	<100 uA	Same
Number of OutputModes	1	6	Different
Number of OutputChannels	10	4	Different
AutomaticOverload Trip	Yes	Yes	Same
Automatic No-loadTrip	N/A	Yes	N/A
Automatic Shut Off	No	Yes	Different
Patient OverrideControl	No	No	Same
Compliance withCFR 898	No	No	Same
Housing Materialsand Construction	Aluminum. Twomachined, bent, andwelded parts. Onemachined part.Fastened by screws.	Aluminum. Stampedin a flat pattern,embossed, foldedinto a box shape andseams welded andground flush.	Substantiallyequivalent
For inferentialmodes only:Beat Frequency(Hz)	N/A	1-250Hz +/- 2Hz or10% whichever isgreater	N/A
For multiphasicwaveforms only:Symmetricalphases	Biphasic pulses aresymmetric	Biphasic pulses aresymmetric	Same
ElectrostaticDischarge (ESD)	±8 kV Contact±15 kV Air	±6 KV Contact±8 kV Air	Substantiallyequivalent
IEC 61000-4-2
Electrical fasttransient/bust	±2 kV for powersupply lines	±2 kV for powersupply lines	Same
IEC 61000-4-4		±1 kV forinput/output lines
SurgeIEC 61000-4-5	±0.5kV, ±1 kV Line to Line±0.5kV, ±1 kV, ±2 kV Line to Ground	±1 kV differential mode±2 kV common mode	Substantially equivalent
Voltage dips, shortinterruptions, andvoltage variationson power supplyinput linesIEC 61000-4-11	0% UT(100% dip in UT) for 0.5 cycle0% UT(100% dip in UT) for 1 cycles70% UT(30% dip in UT) for 30 cycles0% UT(100% dip in UT) for 5 seconds	<5% UT(>95% dip in UT) for 0.5 cycle40% UT(60% dip in UT) for 5 cycles70% UT(30% dip in UT) for 25 cycles<5% UT(>95% dip in UT) for 5 seconds	Substantially equivalent
Power frequency(50/60 Hz)magnetic fieldIEC 61000-4-8	30 A/m	3 A/m	Substantially equivalent
Conducted RFIEC 61000-4-6	3 Vrms, 150 kHz-80 MHz6 Vrms ISM/Amateur radio bands inside 150 kHz-80MHz	3 Vrms	Substantially equivalent
Radiated RFIEC 61000-4-3	3 V/m, 80 MHz-2.7GHzRF 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
OperatingTemperature	10 ℃ to 35℃	+50℉ to +104℉	Substantially equivalent
Humidity	Operating, Relative	Operating, 30% to	Substantially
	Humidity 30% to 75%Non-Condensing	75% RelativeHumidity at 104F	equivalent
	Storage, RelativeHumidity 10% to 90%Non-Condensing	Nonoperating, 5 to95% RelativeHumidity, non-condensing
StorageTemperature	-10 °C to 60°C	-40°F to 167°F	Substantiallyequivalent
Timer Accuracy	±25 parts per million(ppm)	±30 seconds	Different
Timer Range	30, 45, 60 and 90minutes	Maximum Time 60minutes	Different
Console Weight	5.2 pounds (withoutaccessories)	9.4 pounds	Substantiallyequivalent
Dimensions	3.45" (thickest point)and 1.26" (thinnestpoint) x14.000"x8.690"(HxWxD)-excludingfeet	5" (H) x 14.5" (W) x10" (D)	Substantiallyequivalent
Waveform	Biphasic orMonophasic,Rectangle	Interferential,Premodulated,Medium Frequency,SymmetricalBiphasic, High Volt,and Microcurrent,Square	Substantiallyequivalent
Maximum OutputVoltage (+/- 10%)	0V-75V +/-5% (peak),with 1kOhm loads	99 volts peak, 1Kohmload (SymmetricalBiphasic)	Different
Maximum OutputCurrent	0.120A, with 500Ohmload	7.2 mA	Different
Frequency Range	1-120Hz	1-120Hz	Same
Pulse Width Range	200µs	50-300µs	Substantiallyequivalent
Method of LineCurrent Isolation	External 60601 powersupply plus outputtransformers rated at4,000VAC	Yes	Substantiallyequivalent
Synchronous orAlternating	Synchronous	Unknown	Unknown
or RegulatedVoltage
Software/FirmwareMicroprocessorcontrol	Firmwaremicroprocessorcontrol	Microprocessorcontrol	Same
Indicator DisplayOn/Off Status	Yes	Yes	Same
Indicator DisplayLow Battery	N/A	N/A	Same
Indicator DisplayVoltage/CurrentLevel	Yes	Yes	Same
Net Charge	24ucoulombs perpulse	Unknown	Probablyequivalent
Maximum CurrentDensity	0.0032A/sqcm	0.0036A/sqcm	Substantiallyequivalent
Maximum PowerDensity	0.09W/sqcm	Unknown	Probablyequivalent
On Time	19.5 seconds	1-240 seconds	Different
Off Time	0.5 seconds	1-240 seconds	Different

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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

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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.

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
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.(b)
Classification. Class II (performance standards).