MyOnyx System

K213197 · Thought Technology , Ltd. · IPF · Jun 17, 2022 · Physical Medicine

Device Facts

• Record ID: K213197
• Device Name: MyOnyx System
• Applicant: Thought Technology , Ltd.
• Product Code: IPF · Physical Medicine
• Decision Date: Jun 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

Device Story

Multi-functional, 4-channel, palm-sized device for physical therapy and rehabilitation; operates in standalone mode or via MyOnyx Mobile App on tablet (Bluetooth). Inputs: clinician-defined or pre-loaded programs for EMS, TENS, and MET; surface EMG signals (20 samples/s RMS). Outputs: electrical current to nerves/muscles via surface electrodes; visual/audio/haptic feedback via LCD and touch pad. Used by clinicians to manage muscle/nerve stimulation; output informs therapy adjustments. Benefits: muscle relaxation, atrophy prevention, pain relief, and circulation improvement.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), nerve/muscle stimulator performance (IEC 60601-2-10), electromyograph performance (IEC 60601-2-40), usability (IEC 62366-1), and software life-cycle (IEC 62304).

Technological Characteristics

4-channel stimulator; Polycarbonate/ABS enclosure; 3.5" LCD; capacitive touch interface; Bluetooth v4.1; 3200mAh Li-ion battery. Stimulation: Symmetrical, rectangular, biphasic waveforms. EMG: 16-bit ADC, 2048 samples/s, 20-500Hz band-pass filter. Standards: IEC 60601-1, 60601-2-10, 60601-2-40, 60601-1-2, 62304, 62133. Software Class B (Moderate Level of Concern).

Indications for Use

Indicated for patients requiring muscle stimulation for spasm relaxation, re-education, atrophy prevention, range of motion maintenance, blood circulation increase, or post-surgical calf stimulation to prevent venous thrombosis. Also indicated for patients requiring TENS or MET for symptomatic relief of acute and chronic intractable pain.

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

• Combo Stimulator MT9000 (K171978)

Reference Devices

• MyOnyx System (K201014)
• PALS® Neurostimulation Electrodes (K132422)

Submission Summary (Full Text)

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June 17, 2022

Thought Technology Ltd. Suresh Sugirtharaja Acting Regulatory Affairs Manager 5250 Ferrier, Suite 812 Montreal, Quebec H4P 1L3 Canada

## Re: K213197

Trade/Device Name: MyOnyx System Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: IPF, GZJ Dated: June 6, 2022 Received: June 7, 2022

### Dear Suresh Sugirtharaja:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K213197

Device Name

MyOnyx System

Indications for Use (Describe)

The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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510(k) Summary

June 15, 2022

| Device Trade Name: | MyOnyx System |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Regulation Number:<br>Regulation Name:<br>Product Code: | 21 CFR §890.5850<br>Powered muscle stimulator<br>IPF |
| Regulation Number:<br>Regulation Name:<br>Product Code: | 21 CFR §882.5890<br>Transcutaneous electrical nerve stimulator for pain relief<br>GZJ |
| Regulatory Class: | Class II |
| Manufacturer: | Thought Technology Ltd. |
| Establishment Reg. No: | 9680487 |
| Address: | 5250 Ferrier, Suite 812<br>Montreal, Quebec H4P 1L3<br>CANADA<br>Tel: [phone] Fax: [phone] |
| Regulatory Contact: | Suresh Sugirtharaja, Acting Regulatory Affairs Manager<br>E-mail: [e-mail] |

This 510(k) Summary has been prepared in accordance with 21 CFR §807.92. It summarizes device safety and effectiveness information to provide an understanding of the basis for a determination of substantial equivalence.

| Predicate Device: | Combo Stimulator MT9000 (K171978, Product Codes: IPF, GZJ |
|-------------------|-----------------------------------------------------------|
| Reference Device: | MyOnyx System (K201014, Product codes: KPI, HCC) |

### Indications for Use / Intended Use

The MyOnyx System is intended for use as a powered muscle stimulation device for relaxation of muscle spasms and muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

The MyOnyx System may also be used for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET) for the symptomatic relief of acute and chronic intractable pain.

Caution: US Federal law restricts this device to sale by or on the order of a licensed health-care practitioner.

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## Device Description

The MyOnyx System is a multi-functional, palm-sized, 4-channel device with embedded firmware and accessories designed for use in physical therapy and rehabilitation under medical supervision. The system that is subject to this 510(k) provides pre-loaded programs and allows users to define programs for electrical muscle stimulation (EMS), transcutaneous electrical nerve stimulation (TENS), and microcurrent stimulation (MET).

Biofeedback and incontinence-related indications for use of the device have been cleared under K201014.

The device can send a gentle, clinician-adjustable electrical current to underlying nerves and muscles via off-the-shelf surface electrodes cleared by the FDA for this purpose. EMG signals may also be acquired using off-the-shelf, FDA-cleared surface EMG electrodes.

The device may be used for muscle and nerve stimulation in one of the following operating modes:

- . As a standalone device (autonomous mode); or
- . With the MyOnyx Mobile App running on an off-the-shelf tablet (remote control mode).

The device is operated via a graphical interface on an LCD screen and a capacitive touch pad with haptic and audio feedback. The connection to a tablet is wireless, via Bluetooth®. Visual, audio and voice feedback and prompts are provided to facilitate device operation.

Stimulation data are not recorded. When used in remote control mode, the device can record on the tablet root-mean-square (RMS) EMG signal data at 20 samples/s.

The device is powered by an internal rechargeable Li-ion polymer battery or via a medical grade power supply / battery charger. The internal battery offers up to 8 hours of autonomous device operation.

## Performance Data

The MyOnyx System was evaluated using a risk management process in accordance with ISO 14971. Verification and validation testing of system specifications, basic safety and essential performance was conducted in conformance with current recognized consensus standards for this device type considering regulatory guidance for powered muscle stimulators, wireless technology, and cybersecurity:

| Test | Test Method / Standard<br>(FDA Recognition No.) | Acceptance Criteria |
|------------------------------------------------------------------------|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Electrical safety | IEC 60601-1 / ES60601-1:2012<br>(FR# 19-4) | Conformity to applicable basic safety and performance requirements |
| EMC | IEC 60601-1-2:2014, 4th Ed.<br>(FR# 19-8) | Conformity of device emissions and device immunity to EM disturbances for use in a professional healthcare facility |
| Basic safety and essential performance of nerve and muscle stimulators | IEC 60601-2-10:2012+A1:2016<br>(FR# 17-16) | Conformity of electrical stimulation programs to applicable requirements |

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| Test | Test Method / Standard<br>(FDA Recognition No.) | Acceptance Criteria |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic safety and<br>essential performance<br>of electromyographs<br>and electrical<br>stimulators | IEC 60601-2-40:2016 | Conformity of electrical stimulation<br>programs to applicable requirements<br>for accuracy of controls and protection<br>against hazardous stimulation output |
| Verification of<br>hardware device<br>controls and interfaces | Each device circuit block was verified<br>against hardware design specifications<br>under normal use and single fault<br>conditions, as appropriate. | Test results must meet or exceed<br>hardware design specifications |
| Usability | IEC 60601-1-6:2010+A1:2013<br>(FR# 5-89) in conjunction with<br>IEC 62366-1:2015 (FR# 5-114) | Conformity of the Usability<br>Engineering Process and related<br>outputs. Acceptance of the modified<br>device by representative end-users<br>operating the device as per<br>accompanying instructions for use. |
| Software life-cycle<br>processes | IEC 62304:2006+A1:2015<br>(FR# 13-79) | Firmware development in conformity<br>with requirements for Class B software<br>('Moderate Level of Concern') |
| Stimulation firmware<br>unit testing | The Class B (per IEC 62304)<br>stimulation firmware functions and<br>safety features were tested with inputs<br>that verify the effectiveness of error<br>handling and risk control measures | The device responds with expected<br>outputs meeting software design<br>specifications when supplied with<br>predefined test inputs |
| Firmware and system-<br>level functional<br>verification testing | Device functions were tested in<br>autonomous mode and in remote<br>control mode with the MyOnyx<br>Mobile App | The device responds with expected<br>outputs meeting software design<br>specifications under anticipated use<br>conditions and inputs |

Clinical testing was not required to demonstrate substantial equivalence for this device type. The clinical literature supports the safety and clinical utility of the stimulation modes for the stated indications for use.

## Substantial Equivalence Comparison & Conclusion

The appended table shows the side-by-side comparison of the subject device to the predicate device for key device characteristics and safety and performance standards used to demonstrate substantial equivalence.

The assessment of device differences shows that the MyOnyx System does not raise new or different questions of safety and effectiveness as compared to the predicate device for the stated indications for use. The results from verification and validation activities (non-clinical testing) support a finding of substantial equivalence as they demonstrate that the subject device fulfills its design and risk management requirements by meeting safety and performance standards that are equivalent to those met by the identified predicate and reference devices.

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# Side-by-side comparison with the predicate device

| Device<br>characteristics | Subject device:<br>MyOnyx System | Predicate device:<br>Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | IPF, GZJ | IPF, GZJ | Same |
| Indications<br>for Use | The MyOnyx System is intended for use as<br>a powered muscle stimulation device for<br>relaxation of muscle spasms and muscle re-<br>education, prevention or retardation of<br>disuse atrophy, maintaining or increasing<br>range of motion, increasing local blood<br>circulation and immediate post-surgical<br>stimulation of calf muscles to prevent<br>venous thrombosis.<br>The MyOnyx System may also be used for<br>transcutaneous electrical nerve stimulation<br>(TENS) and microcurrent electrical<br>stimulation (MET) for the symptomatic<br>relief of acute and chronic intractable pain. | For TENS/IF/MIC mode:<br>1. Symptomatic relief of chronic intractable pain<br>2. Post traumatic pain<br>3. Post surgical pain<br>For EMS mode:<br>1. Relaxation of muscle spasm<br>2. Increase of local blood flow circulation<br>3. Prevention or retardation of disuse atrophy<br>4. Muscle re-education<br>5. Maintaining or increasing range of motion<br>6. Immediate post-surgical stimulation of calf<br>muscles to prevent venous thrombosis. | Same |
| Operating<br>Modes | • Standalone (autonomous mode via 3.5in<br>LCD and capacitive touch pad with haptic<br>feedback device controls);<br>• With the MyOnyx App on a tablet<br>(remote control mode via Bluetooth®) | • Standalone (autonomous mode via custom-<br>segment LCD and control buttons) | Different<br>The optional remote control mode does not raise<br>different questions of safety & effectiveness.<br>The safety, performance, and usability of the subject<br>device have been verified and validated for both<br>operating modes using the same methods as those<br>used for the reference MyOnyx device (K201014). |
| Input / Output<br>Channels | 4 channels (2 channels for either electrical<br>stimulation or EMG input for ETS; and 2<br>channels for electrical stimulation only) | 2 output channels for electrical stimulation | Different<br>The two additional channels do not raise different<br>questions of safety & effectiveness.<br>Both devices meet basic safety and essential<br>performance standards. |
| Multi-channel<br>Stimulation | Yes (Synchronous or alternating) | Yes (Synchronous, alternating, or delayed) | Same |
| Device<br>characteristics | Subject device:<br>MyOnyx System | Predicate device:<br>Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Electrical Muscle Stimulation (EMS) | | | |
| Delivery<br>Method | Repeated cycles of work and rest phases<br>delivered on one or two channels with one<br>of seven pre-loaded programs or user<br>defined programs | Repeated cycles of work and rest phases<br>delivered on two channels with user defined<br>programs | Different<br>Delivering stimulation using preloaded programs that<br>may be adjusted by the clinician does not change the<br>intended use or indications for use of the device and<br>does not raise different questions of safety &<br>effectiveness. |
| Waveform | Symmetrical, rectangular, bipolar, biphasic | Symmetrical, square wave, biphasic | |
| Frequency | 5 – 80 Hz, 5 Hz/step | 1 – 150 Hz, 1 Hz/step | Both devices allow for similar adjustable stimulation<br>parameters (stim time, rest time, ramp-up/down time,<br>session time, pulse width, pulse frequency, and pulse<br>amplitude/current).<br>Built-in safety features keep the output current, max<br>charge per pulse, and power density below safety<br>thresholds.<br>Both devices meet basic safety and essential<br>performance standards considering worst case<br>stimulation parameters. |
| Pulse Width | 150 – 400 μs, 5 μs/step | 50 – 300 μs, 10 μs/step | |
| Ramp-up/down | 0 – 9.9 s, 100 ms/step | 0 – 6 s, 1 s/step | |
| Pulse Amplitude<br>(Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | 0 – 100 mA, 1 mA/step (Regulated) | |
| Max Current | 100 mA ± 20% @ 500 Ω<br>39 mA ± 20% @ 2 kΩ | 96 mA ± 20% @ 500 Ω<br>105 mA ± 20% @ 1 kΩ | |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω<br>78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω and<br>above 4 kΩ load | Over-current trip; over-load trip | The subject device output was verified using the same<br>methods as those used for the reference MyOnyx<br>device (K201014). |
| Max Charge per<br>Pulse @500 Ω | 80 μC | Not stated | |
| Max Power<br>Density @500 Ω | 0.027 W/cm²<br>(25 cm² electrode conductive surface area) | Not stated<br>(min 16 cm² electrode conductive surface area) | |
| Surface EMG specifications | | | |
| EMG Signal<br>Processing | 16-bit Analog to Digital Converter,<br>Bipolar, 2048 samples/s;<br>20 Hz - 500 Hz (Band-Pass Filter) | No EMG input | Different<br>The optional surface EMG input does not change the<br>intended use or indications for use of the device and |
| | | | |
| CMMR | > 100 dB | | |
| Device<br>characteristics | Subject device:<br>MyOnyx System | Predicate device:<br>Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Input Impedance | ≥ 10 ΜΩ | | does not raise different questions of safety &<br>effectiveness. |
| Digital Output | 20 samples/s RMS signal | | The subject device meets current basic safety and<br>essential performance standards. |
| EMG Accuracy | ±3% | | |
| Surface EMG<br>Electrodes | Uni-Gel™ Single Electrodes (Single Use),<br>Thought Technology Ltd, #T3425 | | The off-the-shelf surface electrodes and verification<br>methods are the same as those used for the reference<br>MyOnyx device (K201014). |
| Transcutaneous Electrical Nerve Stimulation (TENS) | | | |
| Delivery<br>Method | Continuous (no rest phase);<br>Burst mode (2 bursts/s);<br>Frequency modulation;<br>Frequency and amplitude modulation<br>(delivered via 2 pre-loaded programs for<br>acute or chronic pain; or via user-defined<br>programs) | Continuous (no rest phase);<br>Burst mode (0.5-5 bursts/s);<br>Pulse rate modulation;<br>Pulse width modulation<br>(delivered via user-defined programs) | Different<br>Non-significant differences in stimulation parameters<br>do not raise different questions of safety &<br>effectiveness.<br>Both devices allow for similar adjustable stimulation<br>parameters (session time, pulse width, pulse<br>frequency, and pulse amplitude/current). |
| Waveform | Symmetrical, rectangular, bipolar, biphasic | Symmetrical, square, biphasic | Built-in safety features keep the output current, max<br>charge per pulse, and power density below safety<br>thresholds. |
| Frequency | 2 – 150 Hz, 1 Hz/step up to 20Hz,<br>5 Hz/step above 20 Hz | 1 – 150 Hz, 1 Hz/step | Both devices meet basic safety and essential |
| Pulse Width | 50 – 250 µs, 5 µs/step | 50 – 300 μς, 10 µs/step | Both devices meet basic safety and essential |
| Pulse Amplitude<br>(Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | 0 - 100 mA, 1 mA/step (Regulated) | performance standards considering worst case<br>stimulation parameters. |
| Max Current | 100 mA ± 20% @ 500 Ω<br>39 mA ± 20% @ 2 kΩ<br>No stimulation above 4 kΩ load impedance | 96 mA ± 20% @ 500 Ω<br>105 mA ± 20% @ 1 kΩ | The subject device output was verified using the same<br>methods as those used for the reference MyOnyx<br>device (K201014). |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω<br>78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω and<br>above 4 kΩ load | Over-current trip; no load trip; over-load trip | |
| Device<br>characteristics | Subject device:<br>MyOnyx System | Predicate device:<br>Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Max Charge per<br>Pulse @500 Ω | 50 µC<br>(accounting for bipolar pulse) | Not stated | |
| Max Power<br>Density @500 Ω | 0.031 W/cm²<br>(25 cm² electrode conductive surface area)…