(261 days)
No
The summary does not mention AI or ML, and the device description focuses on standard electrical stimulation and biofeedback functionalities.
Yes
The device is intended for therapeutic uses such as relaxation of muscle spasms, muscle re-education, prevention or retardation of disuse atrophy, maintaining or increasing range of motion, increasing local blood circulation, preventing venous thrombosis, and symptomatic relief of acute and chronic intractable pain. These are all therapeutic applications.
No.
The device description and intended use indicate it is an electrical stimulator for therapeutic purposes (e.g., muscle stimulation, pain relief), not for diagnosing medical conditions. While it can acquire EMG signals, this is for monitoring during stimulation, not for diagnostic interpretation.
No
The device description clearly states it is a "multi-functional, palm-sized, 4-channel device with embedded firmware and accessories" and is operated via an "LCD screen and a capacitive touch pad". This indicates it is a physical hardware device, not solely software.
Based on the provided text, the MyOnyx System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device that applies electrical stimulation to the body for therapeutic purposes (muscle stimulation, pain relief). This is an in vivo application, meaning it interacts with the living body.
- Device Description: The description details a device that delivers electrical current via surface electrodes and can acquire EMG signals. These are also in vivo interactions.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. This is the core definition of an IVD.
Therefore, the MyOnyx System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
IPF, GZJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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:
Tests included:
- Electrical safety (Test Method / Standard: IEC 60601-1 / ES60601-1:2012, Acceptance Criteria: Conformity to applicable basic safety and performance requirements)
- EMC (Test Method / Standard: IEC 60601-1-2:2014, 4th Ed., Acceptance Criteria: 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 (Test Method / Standard: IEC 60601-2-10:2012+A1:2016, Acceptance Criteria: Conformity of electrical stimulation programs to applicable requirements)
- Basic safety and essential performance of electromyographs and electrical stimulators (Test Method / Standard: IEC 60601-2-40:2016, Acceptance Criteria: Conformity of electrical stimulation programs to applicable requirements for accuracy of controls and protection against hazardous stimulation output)
- Verification of hardware device controls and interfaces (Test Method / Standard: Each device circuit block was verified against hardware design specifications under normal use and single fault conditions, as appropriate., Acceptance Criteria: Test results must meet or exceed hardware design specifications)
- Usability (Test Method / Standard: IEC 60601-1-6:2010+A1:2013 in conjunction with IEC 62366-1:2015, Acceptance Criteria: 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.)
- Software life-cycle processes (Test Method / Standard: IEC 62304:2006+A1:2015, Acceptance Criteria: Firmware development in conformity with requirements for Class B software ('Moderate Level of Concern'))
- Stimulation firmware unit testing (Test Method / Standard: The Class B (per IEC 62304) stimulation firmware functions and safety features were tested with inputs that verify the effectiveness of error handling and risk control measures, Acceptance Criteria: The device responds with expected outputs meeting software design specifications when supplied with predefined test inputs)
- Firmware and system-level functional verification testing (Test Method / Standard: Device functions were tested in autonomous mode and in remote control mode with the MyOnyx Mobile App, Acceptance Criteria: The device responds with expected outputs meeting software design specifications under anticipated use 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.
Key Metrics
Not Found
Predicate Device(s)
Combo Stimulator MT9000 (K171978, Product Codes: IPF, GZJ
Reference Device(s)
MyOnyx System (K201014, Product codes: KPI, HCC)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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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
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,
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
2
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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3
Image /page/3/Picture/0 description: The image contains the logo for Thought Technology Ltd. The logo consists of a stylized blue "T" on the left, followed by the words "Thought" and "Technology Ltd." stacked on top of each other. The text is also in blue and appears to be in a sans-serif font.
510(k) Summary
June 15, 2022
| Device Trade Name: | MyOnyx System |
|---|---|
| Regulation Number: | |
| Regulation Name: | |
| Product Code: | 21 CFR §890.5850 |
| Powered muscle stimulator | |
| IPF | |
| Regulation Number: | |
| Regulation Name: | |
| Product Code: | 21 CFR §882.5890 |
| Transcutaneous electrical nerve stimulator for pain relief | |
| GZJ | |
| Regulatory Class: | Class II |
| Manufacturer: | Thought Technology Ltd. |
| Establishment Reg. No: | 9680487 |
| Address: | 5250 Ferrier, Suite 812 |
| Montreal, Quebec H4P 1L3 | |
| CANADA | |
| Tel: +1 (514) 489-8251 Fax: +1 (514) 489-8255 | |
| Regulatory Contact: | Suresh Sugirtharaja, Acting Regulatory Affairs Manager |
| E-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.
4
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 |
5
| Test | Test Method / Standard
(FDA Recognition No.) | Acceptance Criteria |
|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Basic safety and
essential performance
of electromyographs
and electrical
stimulators | IEC 60601-2-40:2016 | Conformity of electrical stimulation
programs to applicable requirements
for accuracy of controls and protection
against hazardous stimulation output |
| Verification of
hardware device
controls and interfaces | Each device circuit block was verified
against hardware design specifications
under normal use and single fault
conditions, as appropriate. | Test results must meet or exceed
hardware design specifications |
| Usability | IEC 60601-1-6:2010+A1:2013
(FR# 5-89) in conjunction with
IEC 62366-1:2015 (FR# 5-114) | 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. |
| Software life-cycle
processes | IEC 62304:2006+A1:2015
(FR# 13-79) | Firmware development in conformity
with requirements for Class B software
('Moderate Level of Concern') |
| Stimulation firmware
unit testing | The Class B (per IEC 62304)
stimulation firmware functions and
safety features were tested with inputs
that verify the effectiveness of error
handling and risk control measures | The device responds with expected
outputs meeting software design
specifications when supplied with
predefined test inputs |
| Firmware and system-
level functional
verification testing | Device functions were tested in
autonomous mode and in remote
control mode with the MyOnyx
Mobile App | The device responds with expected
outputs meeting software design
specifications under anticipated use
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.
6
Side-by-side comparison with the predicate device
| Device
characteristics | Subject device:
MyOnyx System | Predicate device:
Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | IPF, GZJ | IPF, GZJ | Same |
| Indications
for 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. | For TENS/IF/MIC mode:
- Symptomatic relief of chronic intractable pain
- Post traumatic pain
- Post surgical pain
For EMS mode: - Relaxation of muscle spasm
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate post-surgical stimulation of calf
muscles to prevent venous thrombosis. | Same |
| Operating
Modes | • Standalone (autonomous mode via 3.5in
LCD and capacitive touch pad with haptic
feedback device controls);
• With the MyOnyx App on a tablet
(remote control mode via Bluetooth®) | • Standalone (autonomous mode via custom-
segment LCD and control buttons) | Different
The optional remote control mode does not raise
different questions of safety & effectiveness.
The safety, performance, and usability of the subject
device have been verified and validated for both
operating modes using the same methods as those
used for the reference MyOnyx device (K201014). |
| Input / Output
Channels | 4 channels (2 channels for either electrical
stimulation or EMG input for ETS; and 2
channels for electrical stimulation only) | 2 output channels for electrical stimulation | Different
The two additional channels do not raise different
questions of safety & effectiveness.
Both devices meet basic safety and essential
performance standards. |
| Multi-channel
Stimulation | Yes (Synchronous or alternating) | Yes (Synchronous, alternating, or delayed) | Same |
| Device
characteristics | Subject device:
MyOnyx System | Predicate device:
Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Electrical Muscle Stimulation (EMS) | | | |
| Delivery
Method | Repeated cycles of work and rest phases
delivered on one or two channels with one
of seven pre-loaded programs or user
defined programs | Repeated cycles of work and rest phases
delivered on two channels with user defined
programs | Different
Delivering stimulation using preloaded programs that
may be adjusted by the clinician does not change the
intended use or indications for use of the device and
does 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 stimulation
parameters (stim time, rest time, ramp-up/down time,
session time, pulse width, pulse frequency, and pulse
amplitude/current).
Built-in safety features keep the output current, max
charge per pulse, and power density below safety
thresholds.
Both devices meet basic safety and essential
performance standards considering worst case
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
(Output Current) | 0 – 100 mA, 1 mA/step (Regulated) | 0 – 100 mA, 1 mA/step (Regulated) | |
| Max Current | 100 mA ± 20% @ 500 Ω
39 mA ± 20% @ 2 kΩ | 96 mA ± 20% @ 500 Ω
105 mA ± 20% @ 1 kΩ | |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω
78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω and
above 4 kΩ load | Over-current trip; over-load trip | The subject device output was verified using the same
methods as those used for the reference MyOnyx
device (K201014). |
| Max Charge per
Pulse @500 Ω | 80 μC | Not stated | |
| Max Power
Density @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 Signal
Processing | 16-bit Analog to Digital Converter,
Bipolar, 2048 samples/s;
20 Hz - 500 Hz (Band-Pass Filter) | No EMG input | Different
The optional surface EMG input does not change the
intended use or indications for use of the device and |
| | | | |
| CMMR | > 100 dB | | |
| Device
characteristics | 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 and
essential performance standards. |
| EMG Accuracy | ±3% | | |
| Surface EMG
Electrodes | Uni-Gel™ Single Electrodes (Single Use),
Thought Technology Ltd, #T3425 | | The off-the-shelf surface electrodes and verification
methods are the same as those used for the reference
MyOnyx device (K201014). |
| Transcutaneous Electrical Nerve Stimulation (TENS) | | | |
| Delivery
Method | Continuous (no rest phase);
Burst mode (2 bursts/s);
Frequency modulation;
Frequency and amplitude modulation
(delivered via 2 pre-loaded programs for
acute or chronic pain; or via user-defined
programs) | Continuous (no rest phase);
Burst mode (0.5-5 bursts/s);
Pulse rate modulation;
Pulse width modulation
(delivered via user-defined programs) | Different
Non-significant differences in stimulation parameters
do not raise different questions of safety &
effectiveness.
Both devices allow for similar adjustable stimulation
parameters (session time, pulse width, pulse
frequency, and pulse amplitude/current). |
| Waveform | Symmetrical, rectangular, bipolar, biphasic | Symmetrical, square, biphasic | Built-in safety features keep the output current, max
charge per pulse, and power density below safety
thresholds. |
| 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 case
stimulation parameters. |
| Max Current | 100 mA ± 20% @ 500 Ω
39 mA ± 20% @ 2 kΩ
No stimulation above 4 kΩ load impedance | 96 mA ± 20% @ 500 Ω
105 mA ± 20% @ 1 kΩ | The subject device output was verified using the same
methods as those used for the reference MyOnyx
device (K201014). |
| Max Voltage | 50 Vpp ± 5% @ 500 Ω
78 Vpp ± 5% @ 2 kΩ | 48 Vpp ± 20% @ 500 Ω | |
| Safety Features | No stimulation below 200 Ω and
above 4 kΩ load | Over-current trip; no load trip; over-load trip | |
| Device
characteristics | Subject device:
MyOnyx System | Predicate device:
Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| Max Charge per
Pulse @500 Ω | 50 µC
(accounting for bipolar pulse) | Not stated | |
| Max Power
Density @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) | | |
| Delivery
Method | Continuous (no rest phase)
(delivered via pre-loaded program) | Continuous (no rest phase);
Pulse rate modulation;
Pulse width modulation
(delivered via user-defined programs) | Different
The subject device does not offer adjustable waveform
parameters for microcurrent stimulation but the default
parameters are within the range of available options
with the predicate device.
Non-significant differences in stimulation parameters
do 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 case
stimulation 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® Neurostimulation
Electrodes (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 | |
| Enclosure
Materials | Polycarbonate and ABS blend; | ABS | Differences in physical and electronic component
characteristics do not raise different questions of
safety & effectiveness. |
| Device
characteristics | Subject device:
MyOnyx System | Predicate device:
Combo Stimulator MT9000 (K171978) | Comparison to predicate / Brief SE justification |
| | Plexiglass tinted front panel, aluminum ring
for structural support | | The subject device is designed consistent with FDA
cybersecurity and wireless technology guidance for
medical devices, and in conformity with current basic
safety and essential performance standards for
medical electrical equipment. |
| Data Display | 3.5 in diagonal, 72 mm x 54 mm, 24-bit
color, 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 Polymer
battery certified to IEC 62133 - up to 8
hours of autonomous device operation; or
External 15W, 5V Medical Grade
(Class II Double Insulated) Power Supply /
Battery Charger | Internal Battery (user replaceable): 9V Alkaline;
or
External medical grade power adapter (800 mA) | Different
The differences in power source characteristics and
options do not raise different questions of safety &
effectiveness.
Both devices meet basic safety and essential
performance standards for medical electrical
equipment. |
| Safety &
Performance
Standards | IEC 60601-1:2005+A1:2012
IEC 60601-2-10:2012+A1:2016
IEC 60601-2-40:2016
IEC 60601-1-2:2014
IEC 60601-1-6:2013/IEC 62366-1:2015
IEC 62304:2006+A1:2015
IEC 62133:2012
ISO 15223-1:2016 | IEC 60601-1
IEC 60601-2-10
IEC 60601-1-2
IEC 62304 | Different
The differences in certain standards do not raise
different questions of safety & effectiveness.
The subject device meets current basic safety and
essential performance standards for medical
electrical equipment as applicable for its
technological characteristics and the intended use
environment. |
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8
9
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