(261 days)
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.
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.
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. It is intended for use as a powered muscle stimulation device and for transcutaneous electrical nerve stimulation (TENS) and microcurrent electrical stimulation (MET).
Here's an overview of the acceptance criteria and the study performance for the MyOnyx System:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided details of verification and validation testing of system specifications, basic safety, and essential performance, conforming to recognized consensus standards.
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Conformity to applicable basic safety and performance requirements (IEC 60601-1 / ES60601-1:2012) | Demonstrated conformity |
| EMC (Electromagnetic Compatibility) | Conformity of device emissions and device immunity to EM disturbances for use in a professional healthcare facility (IEC 60601-1-2:2014, 4th Ed.) | Demonstrated conformity |
| Basic Safety and Essential Performance of Nerve and Muscle Stimulators | Conformity of electrical stimulation programs to applicable requirements (IEC 60601-2-10:2012+A1:2016) | Demonstrated conformity |
| Basic Safety and Essential Performance of Electromyographs and Electrical Stimulators | Conformity of electrical stimulation programs to applicable requirements for accuracy of controls and protection against hazardous stimulation output (IEC 60601-2-40:2016) | Demonstrated conformity |
| Verification of Hardware Device Controls and Interfaces | Test results must meet or exceed hardware design specifications | Met or exceeded hardware design specifications |
| Usability | Conformity of the Usability Engineering Process and related outputs. Acceptance of the modified device by representative end-users operating the device as per accompanying instructions for use (IEC 60601-1-6:2010+A1:2013 in conjunction with IEC 62366-1:2015) | Demonstrated conformity and user acceptance |
| Software Life-Cycle Processes | Firmware development in conformity with requirements for Class B software ('Moderate Level of Concern') (IEC 62304:2006+A1:2015) | Demonstrated conformity |
| Stimulation Firmware Unit Testing | The device responds with expected outputs meeting software design specifications when supplied with predefined test inputs | Responded with expected outputs meeting software design specifications |
| Firmware and System-Level Functional Verification Testing | The device responds with expected outputs meeting software design specifications under anticipated use conditions and inputs | Responded with expected outputs meeting software design specifications |
| Electrical Muscle Stimulation (EMS) Parameters: | ||
| Frequency | 5 – 80 Hz, 5 Hz/step | Measured within specified range (Comparison to predicate: 1 – 150 Hz) |
| Pulse Width | 150 – 400 μs, 5 μs/step | Measured within specified range (Comparison to predicate: 50 – 300 μs) |
| Ramp-up/down | 0 – 9.9 s, 100 ms/step | Measured within specified range (Comparison to predicate: 0 – 6 s) |
| Pulse Amplitude (Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | Measured within specified range (Same as predicate) |
| Max Current | 100 mA ± 20% @ 500 Ω; 39 mA ± 20% @ 2 kΩ | Measured within specified range (Comparison to predicate: 96 mA ± 20% @ 500 Ω; 105 mA ± 20% @ 1 kΩ) |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω; 78 Vpp ± 5% @ 2 kΩ | Measured within specified range (Comparison to predicate: 48 Vpp ± 20% @ 500 Ω) |
| Max Charge per Pulse @500 Ω | 80 μC | Measured within specified limit (Predicate not stated) |
| Max Power Density @500 Ω | 0.027 W/cm² | Measured within specified limit (Predicate not stated) |
| Surface EMG Specifications: | ||
| EMG Accuracy | ±3% | Measured within specified accuracy |
| Transcutaneous Electrical Nerve Stimulation (TENS) Parameters: | ||
| Frequency | 2 – 150 Hz, 1 Hz/step up to 20Hz, 5 Hz/step above 20 Hz | Measured within specified range (Comparison to predicate: 1 – 150 Hz) |
| Pulse Width | 50 – 250 µs, 5 µs/step | Measured within specified range (Comparison to predicate: 50 – 300 μs) |
| Pulse Amplitude (Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | Measured within specified range (Same as predicate) |
| Max Current | 100 mA ± 20% @ 500 Ω; 39 mA ± 20% @ 2 kΩ | Measured within specified range (Comparison to predicate: 96 mA ± 20% @ 500 Ω; 105 mA ± 20% @ 1 kΩ) |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω; 78 Vpp ± 5% @ 2 kΩ | Measured within specified range (Comparison to predicate: 48 Vpp ± 20% @ 500 Ω) |
| Max Charge per Pulse @500 Ω | 50 µC | Measured within specified limit (Predicate not stated) |
| Max Power Density @500 Ω | 0.031 W/cm² | Measured within specified limit (Predicate not stated) |
| Microcurrent Electrical Nerve Stimulation (MET) Parameters: | ||
| Frequency | 0.5 Hz (fixed) | Measured at fixed frequency (Comparison to predicate: 1 - 150 Hz) |
| Pulse Width | 500 ms (fixed) | Measured at fixed pulse width (Comparison to predicate: 2 - 200 ms) |
| Pulse Amplitude (Output Current) | 600 µA (Regulated) | Measured at fixed amplitude (Comparison to predicate: 0 - 700 µA) |
| Max Current | 600 μA ± 20% @1 kΩ | Measured within specified range (Comparison to predicate: 760 μA ± 20% @500 Ω) |
| Max Voltage | 0.30 Vpp ± 5% @ 500 Ω | Measured within specified range (Comparison to predicate: 0.36 Vpp ± 20% @ 500 Ω) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical or performance data for AI/ML algorithms. The performance data section refers to "verification and validation testing of system specifications, basic safety and essential performance" conducted in conformance with recognized consensus standards. These are typically engineering and bench tests, not evaluations involving human subjects or clinical data in the way a diagnostic AI might be.
The provenance of data for these non-clinical tests would typically be from the manufacturer's internal testing labs. The document does not provide details on country of origin for any data or whether it was retrospective or prospective, as these are not relevant for the type of testing described (which is not a clinical study on diagnostic accuracy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to the provided document. The evaluation of the MyOnyx System primarily focused on engineering and performance standards (e.g., electrical safety, EMC, software reliability, usability) rather than clinical accuracy or diagnostic capabilities requiring expert-established ground truth. No experts for ground truth establishment are mentioned.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in clinical studies or studies evaluating the accuracy of AI algorithms against a reference standard with human expert disagreement. The tests described are engineering validations against predefined specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. The document explicitly states: "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." Therefore, an MRMC comparative effectiveness study was not conducted or reported.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, in essence, the majority of the reported "Performance Data" represents a standalone evaluation of the device's technical specifications and compliance with standards. The tests such as "Electrical safety," "EMC," "Basic safety and essential performance of nerve and muscle stimulators," "Verification of hardware device controls and interfaces," "Software life-cycle processes," and "Stimulation firmware unit testing" are all evaluations of the device's inherent performance as an algorithm-driven system or hardware.
The usability testing (IEC 60601-1-6 / IEC 62366-1) involves human interaction but evaluates the device's interface and the safety of that interaction, not the diagnostic or therapeutic performance in a "human-in-the-loop" clinical decision-making context with an AI.
7. The Type of Ground Truth Used
For the engineering and performance tests, the "ground truth" is defined by the technical specifications outlined in the relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the internal hardware and software design specifications of the MyOnyx System. The device's outputs and functionalities are measured and compared against these established technical criteria and limits.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of AI/ML or a clinical study. The device contains "embedded firmware" and "pre-loaded programs," which implies pre-determined algorithms and settings rather than adaptive AI models that undergo continuous training with a dataset.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no mention of a "training set" for an AI/ML algorithm within the provided document. The device uses pre-programmed logic for its stimulation modes.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
June 15, 2022
| Device Trade Name: | MyOnyx System |
|---|---|
| Regulation Number:Regulation Name:Product Code: | 21 CFR §890.5850Powered muscle stimulatorIPF |
| Regulation Number:Regulation Name:Product Code: | 21 CFR §882.5890Transcutaneous electrical nerve stimulator for pain reliefGZJ |
| Regulatory Class: | Class II |
| Manufacturer: | Thought Technology Ltd. |
| Establishment Reg. No: | 9680487 |
| Address: | 5250 Ferrier, Suite 812Montreal, Quebec H4P 1L3CANADATel: +1 (514) 489-8251 Fax: +1 (514) 489-8255 |
| Regulatory Contact: | Suresh Sugirtharaja, Acting Regulatory Affairs ManagerE-mail: suresh@thoughttechnology.com |
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(FDA Recognition No.) | Acceptance Criteria |
|---|---|---|
| Electrical safety | IEC 60601-1 / ES60601-1:2012(FR# 19-4) | Conformity to applicable basic safety and performance requirements |
| EMC | IEC 60601-1-2:2014, 4th Ed.(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(FR# 17-16) | Conformity of electrical stimulation programs to applicable requirements |
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| Test | Test Method / Standard(FDA Recognition No.) | Acceptance Criteria |
|---|---|---|
| Basic safety andessential performanceof electromyographsand electricalstimulators | IEC 60601-2-40:2016 | Conformity of electrical stimulationprograms to applicable requirementsfor accuracy of controls and protectionagainst hazardous stimulation output |
| Verification ofhardware devicecontrols and interfaces | Each device circuit block was verifiedagainst hardware design specificationsunder normal use and single faultconditions, as appropriate. | Test results must meet or exceedhardware design specifications |
| Usability | IEC 60601-1-6:2010+A1:2013(FR# 5-89) in conjunction withIEC 62366-1:2015 (FR# 5-114) | Conformity of the UsabilityEngineering Process and relatedoutputs. Acceptance of the modifieddevice by representative end-usersoperating the device as peraccompanying instructions for use. |
| Software life-cycleprocesses | IEC 62304:2006+A1:2015(FR# 13-79) | Firmware development in conformitywith requirements for Class B software('Moderate Level of Concern') |
| Stimulation firmwareunit testing | The Class B (per IEC 62304)stimulation firmware functions andsafety features were tested with inputsthat verify the effectiveness of errorhandling and risk control measures | The device responds with expectedoutputs meeting software designspecifications when supplied withpredefined test inputs |
| Firmware and system-level functionalverification testing | Device functions were tested inautonomous mode and in remotecontrol mode with the MyOnyxMobile App | The device responds with expectedoutputs meeting software designspecifications under anticipated useconditions 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
| Devicecharacteristics | Subject device:MyOnyx System | Predicate device:Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
|---|---|---|---|
| Product Code | IPF, GZJ | IPF, GZJ | Same |
| Indicationsfor Use | The MyOnyx System is intended for use asa powered muscle stimulation device forrelaxation of muscle spasms and muscle re-education, prevention or retardation ofdisuse atrophy, maintaining or increasingrange of motion, increasing local bloodcirculation and immediate post-surgicalstimulation of calf muscles to preventvenous thrombosis.The MyOnyx System may also be used fortranscutaneous electrical nerve stimulation(TENS) and microcurrent electricalstimulation (MET) for the symptomaticrelief of acute and chronic intractable pain. | For TENS/IF/MIC mode:1. Symptomatic relief of chronic intractable pain2. Post traumatic pain3. Post surgical painFor EMS mode:1. Relaxation of muscle spasm2. Increase of local blood flow circulation3. Prevention or retardation of disuse atrophy4. Muscle re-education5. Maintaining or increasing range of motion6. Immediate post-surgical stimulation of calfmuscles to prevent venous thrombosis. | Same |
| OperatingModes | • Standalone (autonomous mode via 3.5inLCD and capacitive touch pad with hapticfeedback device controls);• With the MyOnyx App on a tablet(remote control mode via Bluetooth®) | • Standalone (autonomous mode via custom-segment LCD and control buttons) | DifferentThe optional remote control mode does not raisedifferent questions of safety & effectiveness.The safety, performance, and usability of the subjectdevice have been verified and validated for bothoperating modes using the same methods as thoseused for the reference MyOnyx device (K201014). |
| Input / OutputChannels | 4 channels (2 channels for either electricalstimulation or EMG input for ETS; and 2channels for electrical stimulation only) | 2 output channels for electrical stimulation | DifferentThe two additional channels do not raise differentquestions of safety & effectiveness.Both devices meet basic safety and essentialperformance standards. |
| Multi-channelStimulation | Yes (Synchronous or alternating) | Yes (Synchronous, alternating, or delayed) | Same |
| Devicecharacteristics | Subject device:MyOnyx System | Predicate device:Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Electrical Muscle Stimulation (EMS) | |||
| DeliveryMethod | Repeated cycles of work and rest phasesdelivered on one or two channels with oneof seven pre-loaded programs or userdefined programs | Repeated cycles of work and rest phasesdelivered on two channels with user definedprograms | DifferentDelivering stimulation using preloaded programs thatmay be adjusted by the clinician does not change theintended use or indications for use of the device anddoes not raise different questions of safety &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 stimulationparameters (stim time, rest time, ramp-up/down time,session time, pulse width, pulse frequency, and pulseamplitude/current).Built-in safety features keep the output current, maxcharge per pulse, and power density below safetythresholds.Both devices meet basic safety and essentialperformance standards considering worst casestimulation 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(Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | 0 – 100 mA, 1 mA/step (Regulated) | |
| Max Current | 100 mA ± 20% @ 500 Ω39 mA ± 20% @ 2 kΩ | 96 mA ± 20% @ 500 Ω105 mA ± 20% @ 1 kΩ | |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω andabove 4 kΩ load | Over-current trip; over-load trip | The subject device output was verified using the samemethods as those used for the reference MyOnyxdevice (K201014). |
| Max Charge perPulse @500 Ω | 80 μC | Not stated | |
| Max PowerDensity @500 Ω | 0.027 W/cm²(25 cm² electrode conductive surface area) | Not stated(min 16 cm² electrode conductive surface area) | |
| Surface EMG specifications | |||
| EMG SignalProcessing | 16-bit Analog to Digital Converter,Bipolar, 2048 samples/s;20 Hz - 500 Hz (Band-Pass Filter) | No EMG input | DifferentThe optional surface EMG input does not change theintended use or indications for use of the device and |
| CMMR | > 100 dB | ||
| Devicecharacteristics | Subject device:MyOnyx System | Predicate device:Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Input Impedance | ≥ 10 ΜΩ | does not raise different questions of safety &effectiveness. | |
| Digital Output | 20 samples/s RMS signal | The subject device meets current basic safety andessential performance standards. | |
| EMG Accuracy | ±3% | ||
| Surface EMGElectrodes | Uni-Gel™ Single Electrodes (Single Use),Thought Technology Ltd, #T3425 | The off-the-shelf surface electrodes and verificationmethods are the same as those used for the referenceMyOnyx device (K201014). | |
| Transcutaneous Electrical Nerve Stimulation (TENS) | |||
| DeliveryMethod | Continuous (no rest phase);Burst mode (2 bursts/s);Frequency modulation;Frequency and amplitude modulation(delivered via 2 pre-loaded programs foracute or chronic pain; or via user-definedprograms) | Continuous (no rest phase);Burst mode (0.5-5 bursts/s);Pulse rate modulation;Pulse width modulation(delivered via user-defined programs) | DifferentNon-significant differences in stimulation parametersdo not raise different questions of safety &effectiveness.Both devices allow for similar adjustable stimulationparameters (session time, pulse width, pulsefrequency, and pulse amplitude/current). |
| Waveform | Symmetrical, rectangular, bipolar, biphasic | Symmetrical, square, biphasic | Built-in safety features keep the output current, maxcharge per pulse, and power density below safetythresholds. |
| Frequency | 2 – 150 Hz, 1 Hz/step up to 20Hz,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(Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | 0 - 100 mA, 1 mA/step (Regulated) | performance standards considering worst casestimulation parameters. |
| Max Current | 100 mA ± 20% @ 500 Ω39 mA ± 20% @ 2 kΩNo stimulation above 4 kΩ load impedance | 96 mA ± 20% @ 500 Ω105 mA ± 20% @ 1 kΩ | The subject device output was verified using the samemethods as those used for the reference MyOnyxdevice (K201014). |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω andabove 4 kΩ load | Over-current trip; no load trip; over-load trip | |
| Devicecharacteristics | Subject device:MyOnyx System | Predicate device:Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Max Charge perPulse @500 Ω | 50 µC(accounting for bipolar pulse) | Not stated | |
| Max PowerDensity @500 Ω | 0.031 W/cm²(25 cm² electrode conductive surface area) | Not stated(min 16 cm² electrode conductive surface area) | |
| Microcurrent Electrical Nerve Stimulation (MET) | |||
| DeliveryMethod | Continuous (no rest phase)(delivered via pre-loaded program) | Continuous (no rest phase);Pulse rate modulation;Pulse width modulation(delivered via user-defined programs) | DifferentThe subject device does not offer adjustable waveformparameters for microcurrent stimulation but the defaultparameters are within the range of available optionswith the predicate device.Non-significant differences in stimulation parametersdo not raise different questions of safety &effectiveness.Both devices meet basic safety and essential |
| Waveform | Symmetrical, rectangular, bipolar,monophasic, polarity revesal | Symmetrical, square, monophasic | |
| Frequency | 0.5 Hz (fixed) | 1 - 150 Hz, 1 Hz/step | |
| Pulse Width | 500 ms (fixed) | 2 - 200 ms, 1 ms/step | |
| Pulse Amplitude(Output Current) | 600 µA (Regulated) | 0 - 700 µA, 10 µA/step (Regulated) | performance standards considering worst casestimulation parameters. |
| Max Current | 600 μA ± 20% @1 kΩ | 760 μA ± 20% @500 Ω | |
| Max Voltage | 0.30 Vpp ± 5% @ 500 Ω | 0.36 Vpp ± 20% @ 500 Ω | |
| Stimulation Electrodes (All Stimulation Modalities) | |||
| Cutaneous Stim.Electrodes | 5 cm x 5 cm PALS® NeurostimulationElectrodes (K132422) | 4 cm x 4 cm electrodes(minimum size, FDA cleared) | Similar off-the-shelf cutaneous electrodes |
| Physical and Electronic Component Characteristics | |||
| Device Size | 155 mm x 83 mm x 21 mm | 114 mm x 65 mm x 23 mm | Different |
| Weight | 272 g | 127 g | |
| EnclosureMaterials | Polycarbonate and ABS blend; | ABS | Differences in physical and electronic componentcharacteristics do not raise different questions ofsafety & effectiveness. |
| Devicecharacteristics | Subject device:MyOnyx System | Predicate device:Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Plexiglass tinted front panel, aluminum ringfor structural support | The subject device is designed consistent with FDAcybersecurity and wireless technology guidance formedical devices, and in conformity with current basicsafety and essential performance standards formedical electrical equipment. | ||
| Data Display | 3.5 in diagonal, 72 mm x 54 mm, 24-bitcolor, backlit LCD (320 x 240 pixels) | 2in diagonal, custom-segment LCD | |
| Data Storage | 8GB Embedded Multi-Media Card(eMMC) | No | |
| Communication | v4.1 Bluetooth® | No | |
| Electrical Safety Specifications | |||
| Power Source | Internal Battery (not user replaceable):Rechargeable (3200mAh) Li-ion Polymerbattery certified to IEC 62133 - up to 8hours of autonomous device operation; orExternal 15W, 5V Medical Grade(Class II Double Insulated) Power Supply /Battery Charger | Internal Battery (user replaceable): 9V Alkaline;orExternal medical grade power adapter (800 mA) | DifferentThe differences in power source characteristics andoptions do not raise different questions of safety &effectiveness.Both devices meet basic safety and essentialperformance standards for medical electricalequipment. |
| Safety &PerformanceStandards | IEC 60601-1:2005+A1:2012IEC 60601-2-10:2012+A1:2016IEC 60601-2-40:2016IEC 60601-1-2:2014IEC 60601-1-6:2013/IEC 62366-1:2015IEC 62304:2006+A1:2015IEC 62133:2012ISO 15223-1:2016 | IEC 60601-1IEC 60601-2-10IEC 60601-1-2IEC 62304 | DifferentThe differences in certain standards do not raisedifferent questions of safety & effectiveness.The subject device meets current basic safety andessential performance standards for medicalelectrical equipment as applicable for itstechnological characteristics and the intended useenvironment. |
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§ 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).