MyOnyx System

K201014 · Thought Technology , Ltd. · KPI · Jan 13, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K201014
• Device Name: MyOnyx System
• Applicant: Thought Technology , Ltd.
• Product Code: KPI · Gastroenterology, Urology
• Decision Date: Jan 13, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MyOnyx System subject to this 510(k) is intended for use in the treatment of incontinence.

Device Story

MyOnyx System is a 4-channel, palm-sized device for pelvic floor muscle treatment under medical supervision. Inputs include EMG signals via surface electrodes and pressure data via a pneumatic vaginal probe. Device transforms inputs into biofeedback (visual/audio/haptic) and provides neuromuscular electrical stimulation (NMES) or EMG-triggered stimulation (ETS). Operates in three modes: standalone (autonomous), remote control (via MyOnyx Mobile App on tablet), or computerized (via BioGraph Infiniti software on PC). Clinicians use output to guide patient pelvic floor strengthening or detrusor inhibition. Benefits include improved urinary control for incontinence patients. Device features Bluetooth connectivity, rechargeable Li-ion battery, and capacitive touch interface.

Clinical Evidence

Bench testing only. Verification and validation testing conducted per ISO 14971, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing for nerve/muscle stimulators (IEC 60601-2-10) and electromyographs (IEC 60601-2-40). Usability testing confirmed end-user acceptance. Firmware and software functional verification confirmed performance against design specifications.

Technological Characteristics

4-channel device; polycarbonate/ABS enclosure; 3.5-inch LCD; capacitive touch pad. EMG sensing: 16-bit ADC, 2048 samples/s, 12Hz-1600Hz bandwidth. Pressure sensing: pneumatic pump/sensor, 0-200 mmHg range. Stimulation: 0-100 mA, 5-80 Hz, 150-400 µs pulse width. Connectivity: Bluetooth v4.1. Power: 3200mAh Li-ion battery. Software: Class B (IEC 62304). Sterilization: N/A (single-patient use probes).

Indications for Use

Indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

Regulatory Classification

Identification

A nonimplanted electrical continence device is a device that consists of a pair of electrodes on a plug or a pessary that are connected by an electrical cable to a battery-powered pulse source. The plug or pessary is inserted into the rectum or into the vagina and used to stimulate the muscles of the pelvic floor to maintain urinary or fecal continence. When necessary, the plug or pessary may be removed by the user. This device excludes an AC-powered nonimplanted electrical continence device and the powered vaginal muscle stimulator for therapeutic use (§ 884.5940).

Predicate Devices

• MyoTrac Infiniti System (K053434)

Reference Devices

• Pathway CTS2000 Pelvic Floor Training System (K023906)
• Everyway Incontinence Stimulation Electrode (K122194)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 13, 2021

Thought Technology Ltd. Zena Butris Regulatory Affairs Manager 5250 Ferrier, Suite 812 Montreal, Quebec H4P 1L3 Canada

Re: K201014

> Trade/Device Name: MyOnyx System Regulation Number: 21 CFR§ 876.5320 Regulation Name: Nonimplanted Electrical Continence Device Regulatory Class: II Product Codes: KPI, HCC Dated: December 8, 2020 Received: December 14, 2020

Dear Zena Butris:

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.

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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 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-regulatoryinformation/postmarketing-safety-reporting-combination-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,

Sharon M. Andrews Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology 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) K201014

Device Name

MyOnyx System

#### Indications for Use (Describe)

The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

Type of Use (Select one or both, as applicable)

| <label><input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
|--------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# Ltd. 510(k) Summary (K201014)

January 12, 2021

| Device Trade Name: | MyOnyx System |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number:<br>Regulation Name:<br>Product Code: | 21 CFR §876.5320<br>Non-implanted electrical continence device<br>KPI |
| Regulation Number:<br>Regulation Name:<br>Product Code: | 21 CFR §882.5050<br>Biofeedback device<br>HCC |
| Regulatory Class: | Class II |
| Manufacturer:<br>Establishment Reg. No:<br>Address: | Thought Technology Ltd.<br>9680487<br>5250 Ferrier, Suite 812<br>Montreal, Quebec H4P 1L3<br>CANADA<br>Tel: [phone] Fax: [phone] |
| Regulatory Contact: | Zena Butris, 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: MyoTrac Infiniti™ System (K053434, Product codes: KPI, IPF, HCC)

# Reference Devices

- Pathway CTS2000 Pelvic Floor Training System (K023906, Product Code: KPI)
- Everyway Incontinence Stimulation Electrode (K122194, Product Code: KPI, HIR)

# Device Description

This 510(k) submission applies to the MyOnyx System, a re-engineered version of the multifunctional predicate MyoTrac™ Infiniti System (K053434), for use in the treatment of incontinence under medical supervision. The system's architecture, design and functionality are based largely on the currently marketed MyoTrac™ Infiniti System with the notable addition of the companion MyOnvx Mobile App for remote access and a pressure biofeedback modality for use in the treatment of incontinence.

The MyOnyx System includes a palm-sized, multi-functional, 4-channel device with embedded firmware and accessories designed for use under medical supervision to provide:

- . electromyographic (EMG) biofeedback;
- pressure biofeedback from pelvic floor muscles; ●
- electrical stimulation (ES); and
- ES with EMG biofeedback (EMG-triggered stimulation or ETS). ●

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Up to two stimulation programs may run simultaneously. The device can send a gentle, clinician-adjustable electrical current via surface electrodes on purpose-designed probes. The specified off-the-shelf probes are suitable for EMG biofeedback and electrical stimulation. A small electronic pneumatic pump and pressure sensor device is used with a vaginal provide biofeedback from pelvic floor muscles.

The MyOnyx device may be used in one of the following operating modes:

- as a standalone device for electrical stimulation only (autonomous mode); or ●
- . with the MyOnyx Mobile App running on an off-the-shelf tablet for biofeedback, electrical stimulation and EMG-triggered stimulation (remote control mode); or
- . with the company's BioGraph® Infiniti software running on a personal computer for biofeedback only (computerized 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 or personal computer is wireless, via Bluetooth". Visual, audio and voice feedback and prompts are provided to facilitate device operation on the standalone device, the MyOnyx Mobile App and the BioGraph® Infiniti software.

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

When used in computerized mode, up to 4 devices may be connected to a personal computer for physiological data acquisition and biofeedback. In this mode, the device can record on the PC raw EMG and pressure data at 2048 samples/s. For use in this mode with the BioGraph® Infiniti software the device must be configured through a firmware parameter setting ('extended' configuration).

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.

# Intended Use

The MyOnyx System subject to this 510(k) is intended for use in the treatment of incontinence.

# Indications for Use

The MyOnyx System is indicated for acute and ongoing treatment of stress, urge, or mixed urinary incontinence, where urinary control may be improved through electrical stimulation that strengthens the pelvic floor muscles or inhibits the detrusor muscle through reflexive mechanisms. The system also uses EMG-based or pressure-based biofeedback to help control and strengthen the pelvic floor muscles in the treatment of urinary incontinence.

The MyOnyx System is a Prescription Use device.

# Summary of Non-Clinical / Performance Testing

The re-engineered device 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 regulatory guidance and current consensus standards for this device type:

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| Test | Test Method / Standard<br>(FDA Recognition No.) | Acceptance Criteria |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility of<br>vaginal pressure probe | ISO 10993-1:2009/COR1:2010<br>(FR# 2-220) | Cytotoxicity: Noncytotoxic or Mildly<br>cytotoxic (Grades 0-1) per ISO 10993-5;<br>Sensitization: No delayed contact<br>sensitization per ISO 10993-10;<br>Irritation: Non-irritant per ISO 10993-10 |
| Electrical safety | IEC 60601-1 / ES60601-1:2012<br>(FR# 19-4) | Conformity to applicable basic safety and<br>performance requirements |
| EMC | IEC 60601-1-2:2014, 4th Ed.<br>(FR# 19-8) | Conformity of device emissions and device<br>immunity to EM disturbances for use in a<br>professional healthcare facility |
| Basic safety and essential<br>performance of nerve and<br>muscle stimulators | IEC 60601-2-10:2012+A1:2016<br>(FR# 17-16) | Conformity of electrical stimulation<br>programs to applicable requirements |
| Basic safety and essential<br>performance of<br>electromyographs and<br>electrical stimulators | IEC 60601-2-40:2016 | Conformity of electrical stimulation<br>programs to applicable requirements for<br>accuracy of controls and protection against<br>hazardous stimulation output |
| Verification of hardware<br>device controls and<br>interfaces | Each device circuit block was verified<br>against hardware design specifications<br>under normal use and, where appropriate,<br>under single fault conditions. | Test results must meet or exceed hardware<br>design specifications |
| Usability | IEC 60601-1-6:2010+A1:2013 (FR# 5-<br>89) in conjunction with<br>IEC 62366-1:2015<br>(FR# 5-114) | Conformity of the Usability Engineering<br>Process and related outputs. Acceptance of<br>the modified device by representative end-<br>users 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 with<br>requirements for Class B software<br>('Moderate Level of Concern') |
| Stimulation firmware unit<br>testing | The Class B (per IEC 62304) stimulation<br>firmware functions and safety features<br>were tested with inputs that verify the<br>effectiveness of error handling and risk<br>control measures | The device responds with expected outputs<br>meeting software design specifications<br>when supplied with predefined test inputs |
| Firmware and system-<br>level functional<br>verification testing | Device functionality was tested in<br>autonomous mode (stimulation functions)<br>and computerized mode (for biofeedback) | The device responds with expected outputs<br>meeting software design specifications<br>under anticipated use conditions and inputs |
| MyOnyx Mobile App<br>verification testing | Device functionality was tested in remote<br>control mode | The device responds with expected outputs<br>meeting software design specifications<br>when operated remotely under anticipated<br>use conditions and inputs |

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K201014 Page 4 of 10

# Comparison of Technological Characteristics

The appended table shows a side-by-side comparison of key device characteristics between the subject device and the predicate and reference devices that are used to demonstrate substantial equivalence.

# Substantial Equivalence Conclusion

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 devices for use in the treatment of incontinence. Furthermore, the results from the verification activities (non-clinical testing) support a finding of substantial equivalence, as they demonstrate that the subject device fulfills its design and risk management requirements, meets equivalent or more recent consensus standards, and it is therefore as safe and as effective for the intended use as the identified predicate devices.

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| Device<br>characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti<br>System (K053434) | Reference devices | Comparison / Brief<br>SE justification |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prescription use device for the treatment of<br>incontinence | Prescription use device for the treatment of<br>incontinence | -- | Same |
| Product Code | KPI, HCC | KPI, HCC (for the proposed intended use) | -- | Same |
| Indications for<br>Use | The MyOnyx System is indicated for acute<br>and ongoing treatment of stress, urge, or<br>mixed urinary incontinence, where urinary<br>control may be improved through electrical<br>stimulation that strengthens the pelvic floor<br>muscles or inhibits the detrusor muscle<br>through reflexive mechanisms. The system<br>also uses EMG-based or pressure-based<br>biofeedback to help control and strengthen<br>the pelvic floor muscles in the treatment of<br>urinary incontinence. | "The MyoTrac Infiniti system is indicated<br>for acute and ongoing treatment of stress,<br>urge or mixed urinary incontinence and<br>where the following results may improve<br>urinary control: Inhibition of the detruser<br>muscle through reflexive mechanisms,<br>strengthening of pelvic floor muscle.<br>It is also indicated during incontinence<br>treatment for assessing EMG activity of the<br>pelvic floor and accessory muscles such as<br>the abdominal or gluteal muscles." | -- | Same |
| Biofeedback<br>Modalities | • EMG Biofeedback<br>• Pressure Biofeedback | • EMG Biofeedback | Pathway CTS2000 Pelvic<br>Floor Training System<br>(K023906, Product Code<br>KPI):<br>Offers EMG and pressure<br>biofeedback with similar<br>technological characteristics<br>for use in the treatment of<br>urinary incontinence | Different<br>The adjunct pressure<br>biofeedback modality<br>does not raise different<br>questions of safety &<br>effectiveness for the<br>intended use in the<br>treatment of urinary<br>incontinence. |
| EMG Biofeedback Specifications | | | | |
| EMG Signal<br>Processing | 16-bit ADC, Bipolar, 2048 samples/s;<br>±6250 µV raw signal, 12Hz - 1600Hz<br>(Hardware Filter, Notch filter at 50/60 Hz);<br>0 - 4420 µV RMS, 20Hz - 500Hz<br>(Band-Pass Filter) | 14-bit ADC, Bipolar, 2048 samples/s;<br>±2828 µV raw signal, 12Hz - 1600Hz<br>(Hardware Filter, Notch filter at 50/60 Hz);<br>0 - 2000 µV RMS, 20Hz - 500Hz<br>(Band-Pass Filter) | -- | Different, improved<br>range, resolution, and<br>accuracy. |
| Device<br>characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti<br>System (K053434) | Reference devices | Comparison / Brief<br>SE justification |
| CMMR | > 100 dB | > 100 dB | | The differences in<br>biofeedback signal<br>characteristics do not<br>raise different |
| Input<br>Impedance | > 10 ΜΩ | > 12 ΜΩ | | |
| Output EMG<br>Signal | 2048 samples/s raw signal or<br>20 samples/s RMS signal | 2048 samples/s raw signal or<br>20 samples/s RMS signal | | questions of safety &<br>effectiveness for the<br>intended use. |
| EMG Accuracy | ±3% | ±5% | | |
| Surface EMG<br>Electrodes | Uni-Gel™ Single Electrodes (Single Use),<br>Thought Technology Ltd, #T3425 | Uni-Gel™ Single Electrodes (Single Use),<br>Thought Technology Ltd, #T3425 | -- | Same |
| Anal EMG<br>Electrodes | Life-care Anal Probe, Model PR-13A<br>(Single patient, reusable) | Saint-Cloud Anal EMG/Stim Probe; or<br>Thought Technology, Anal EMG Probe<br>(Single patient, reusable) | Everyway Incontinence<br>Stimulation Electrodes<br>(K122194)<br>Life-care Anal Probe, Model<br>PR-13A | Different, currently<br>marketed device for<br>the same intended use |
| Vaginal EMG<br>Electrodes | Life-care Vaginal Probe, Model PR-02A<br>(Single patient, reusable) | Saint-Cloud Vaginal EMG/Stim Probe; or<br>Femelex EMG/Stim Probe; or<br>Thought Technology, Vaginal EMG Probe<br>(Single patient, reusable) | Everyway Incontinence<br>Stimulation Electrodes<br>(K122194)<br>Life-care Vaginal Probe,<br>Model PR-02A | Different, currently<br>marketed device for<br>the same intended use |
| Pressure Biofeedback Specifications | | | | |
| Pressure Sensor | Electronic pneumatic pump and sensor | | Pathway CTS2000 Pelvic | Different |
| Size and Weight | 10 cm x 7 cm x 2 cm, 90 g | | Floor Training System<br>(K023906) | The adjunct pressure<br>biofeedback option |
| Enclosure<br>material | Polycarbonate and ABS blend | Not available | Reference device with similar<br>technological characteristics | does not raise different<br>questions of safety & |
| Power Source | Powered by the MyOnyx Device | | and equivalent accessory for | effectiveness for the |
| Power Rating | Max 140mA @ 5Vdc (700mW) | | use in the treatment of urinary<br>incontinence: | intended use.<br>The biocompatibility |
| Pressure range | 0 - 200 mmHg | | | of the vaginal pressure |
| Device<br>characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti<br>System (K053434) | Reference devices | Comparison / Brief<br>SE justification |
| Resolution | 0.1 mmHg | | | |
| Nominal pressure | 55 mmHg (± 10%), auto-set | | | |
| Vaginal<br>Pressure Probe | Single-patient use (reusable), pneumatically<br>inflatable vaginal probe with a silicon bulb<br>and communicating tubing for connection to<br>the Pressure Sensor (35 g, 105 mm x 33 mm) | | Pathway Anal Pressure Sensor<br>manufactured by DesChutes<br>Medical, K934552 | probe and the basic<br>safety and essential<br>performance of the<br>device have been<br>verified using current<br>consensus standards. |
| Electrical Stimulation | | | | |
| Electrical<br>Stimulation<br>Modalities | • Neuromuscular Electrical Stimulation<br>(NMES)<br>• EMG-Triggered Stimulation (ETS) using<br>NMES specifications for incontinence | • Neuromuscular Electrical Stimulation<br>(NMES)<br>• EMG-Triggered Stimulation (ETS) using<br>NMES specifications for incontinence | -- | Same |
| Stimulation<br>Programs | User configurable NMES / ETS programs | User configurable NMES / ETS programs | -- | Same |
| Neuromuscular Electrical Stimulation (NMES) specifications for Incontinence Treatments | | | | |
| Delivery | Synchronous or Alternating; Continuous (no<br>rest phase) for EMG-triggered stimulation | Synchronous | -- | Different<br>The waveform,<br>frequency and delivery<br>specification<br>differences do not<br>raise different<br>questions of safety &<br>effectiveness for the<br>intended use.<br>Safety features limit<br>max charge per pulse<br>and power density. |
| Current Output | 0 - 100 mA (Regulated) | 0 - 100 mA (Regulated) | | |
| Max Current | 100 mA ± 20% @500 Ω | 100 mA ± 10% @500 Ω | | |
| Waveform | Symmetrical, rectangular, bipolar, biphasic | Asymmetrical balanced pulsed current | | |
| Pulse Width | 150 - 400 µs | 50 – 400 µs | | |
| Frequency | 5 – 80 Hz | 2 - 100 Hz | |…