(271 days)
No
The summary describes a device that uses biofeedback and electrical stimulation for pelvic floor muscle treatment. It mentions firmware, software, and data recording, but there is no mention of AI, ML, or any algorithms that would learn or adapt based on data. The focus is on standard biofeedback and stimulation techniques.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the MyOnyx System is indicated for the treatment of urinary incontinence through electrical stimulation and biofeedback to strengthen pelvic floor muscles or inhibit the detrusor muscle.
Yes
The device uses EMG-based or pressure-based biofeedback, records RMS EMG signal and pressure data, and can acquire physiological data. While it also provides treatment, the biofeedback and data acquisition functions serve a diagnostic purpose by providing information about the patient's physiological state related to pelvic floor muscles.
No
The device description clearly states it includes a "palm-sized, multi-functional, 4-channel device with embedded firmware and accessories" and mentions hardware components like probes, a pneumatic pump, and a pressure sensor. While it utilizes software (MyOnyx Mobile App, BioGraph® Infiniti software), it is not solely software.
Based on the provided information, the MyOnyx System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of urinary incontinence through electrical stimulation and biofeedback, which are therapeutic and diagnostic (in the sense of monitoring physiological signals) procedures performed on the patient's body. IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device description details a system that interacts directly with the patient's body via electrodes and probes to deliver electrical stimulation and measure physiological signals (EMG and pressure). This is consistent with a therapeutic and biofeedback device, not an IVD device that analyzes samples.
- No mention of analyzing biological samples: The entire description focuses on the device's interaction with the patient's body and the signals it measures from the body. There is no mention of collecting or analyzing biological specimens.
Therefore, the MyOnyx System falls under the category of a therapeutic and biofeedback device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
KPI, HCC
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). ●
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvic floor muscles
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical supervision
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Biocompatibility of vaginal pressure probe:
Test Method / Standard: ISO 10993-1:2009/COR1:2010 (FR# 2-220)
Acceptance Criteria: Cytotoxicity: Noncytotoxic or Mildly cytotoxic (Grades 0-1) per ISO 10993-5; Sensitization: No delayed contact sensitization per ISO 10993-10; Irritation: Non-irritant per ISO 10993-10
Electrical safety:
Test Method / Standard: IEC 60601-1 / ES60601-1:2012 (FR# 19-4)
Acceptance Criteria: Conformity to applicable basic safety and performance requirements
EMC:
Test Method / Standard: IEC 60601-1-2:2014, 4th Ed. (FR# 19-8)
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 (FR# 17-16)
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, where appropriate, under single fault conditions.
Acceptance Criteria: Test results must meet or exceed hardware design specifications
Usability:
Test Method / Standard: IEC 60601-1-6:2010+A1:2013 (FR# 5-89) in conjunction with IEC 62366-1:2015 (FR# 5-114)
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 (FR# 13-79)
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 functionality was tested in autonomous mode (stimulation functions) and computerized mode (for biofeedback)
Acceptance Criteria: The device responds with expected outputs meeting software design specifications under anticipated use conditions and inputs
MyOnyx Mobile App verification testing:
Test Method / Standard: Device functionality was tested in remote control mode
Acceptance Criteria: The device responds with expected outputs meeting software design specifications when operated remotely under anticipated use conditions and inputs
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MyoTrac Infiniti™ System (K053434, Product codes: KPI, IPF, HCC)
Reference Device(s)
Pathway CTS2000 Pelvic Floor Training System (K023906, Product Code: KPI), Everyway Incontinence Stimulation Electrode (K122194, Product Code: KPI, HIR)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5320 Nonimplanted electrical continence device.
(a)
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).(b)
Classification. Class II (performance standards).
0
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Ltd. 510(k) Summary (K201014)
January 12, 2021
| Device Trade Name: | MyOnyx System |
|---|---|
| Regulation Number: | |
| Regulation Name: | |
| Product Code: | 21 CFR §876.5320 |
| Non-implanted electrical continence device | |
| KPI | |
| Regulation Number: | |
| Regulation Name: | |
| Product Code: | 21 CFR §882.5050 |
| Biofeedback device | |
| HCC | |
| Regulatory Class: | Class II |
| Manufacturer: | |
| Establishment Reg. No: | |
| Address: | Thought Technology Ltd. |
| 9680487 | |
| 5250 Ferrier, Suite 812 | |
| Montreal, Quebec H4P 1L3 | |
| CANADA | |
| Tel: +1 (514) 489-8251 Fax: +1 (514) 489-8255 | |
| Regulatory Contact: | Zena Butris, Regulatory Affairs Manager |
| E-mail: zbutris@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: 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). ●
4
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:
5
| Test | Test Method / Standard
(FDA Recognition No.) | Acceptance Criteria |
|------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility of
vaginal pressure probe | ISO 10993-1:2009/COR1:2010
(FR# 2-220) | Cytotoxicity: Noncytotoxic or Mildly
cytotoxic (Grades 0-1) per ISO 10993-5;
Sensitization: No delayed contact
sensitization per ISO 10993-10;
Irritation: Non-irritant per ISO 10993-10 |
| 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 |
| 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, where appropriate,
under single fault conditions. | 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 functionality was tested in
autonomous mode (stimulation functions)
and computerized mode (for biofeedback) | The device responds with expected outputs
meeting software design specifications
under anticipated use conditions and inputs |
| MyOnyx Mobile App
verification testing | Device functionality was tested in remote
control mode | The device responds with expected outputs
meeting software design specifications
when operated remotely under anticipated
use conditions and inputs |
6
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.
7
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Prescription use device for the treatment of
incontinence | Prescription use device for the treatment of
incontinence | -- | Same |
| Product Code | KPI, HCC | KPI, HCC (for the proposed intended use) | -- | Same |
| 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 MyoTrac Infiniti system is indicated
for acute and ongoing treatment of stress,
urge or mixed urinary incontinence and
where the following results may improve
urinary control: Inhibition of the detruser
muscle through reflexive mechanisms,
strengthening of pelvic floor muscle.
It is also indicated during incontinence
treatment for assessing EMG activity of the
pelvic floor and accessory muscles such as
the abdominal or gluteal muscles." | -- | Same |
| Biofeedback
Modalities | • EMG Biofeedback
• Pressure Biofeedback | • EMG Biofeedback | Pathway CTS2000 Pelvic
Floor Training System
(K023906, Product Code
KPI):
Offers EMG and pressure
biofeedback with similar
technological characteristics
for use in the treatment of
urinary incontinence | Different
The adjunct pressure
biofeedback modality
does not raise different
questions of safety &
effectiveness for the
intended use in the
treatment of urinary
incontinence. |
| EMG Biofeedback Specifications | | | | |
| EMG Signal
Processing | 16-bit ADC, Bipolar, 2048 samples/s;
±6250 µV raw signal, 12Hz - 1600Hz
(Hardware Filter, Notch filter at 50/60 Hz);
0 - 4420 µV RMS, 20Hz - 500Hz
(Band-Pass Filter) | 14-bit ADC, Bipolar, 2048 samples/s;
±2828 µV raw signal, 12Hz - 1600Hz
(Hardware Filter, Notch filter at 50/60 Hz);
0 - 2000 µV RMS, 20Hz - 500Hz
(Band-Pass Filter) | -- | Different, improved
range, resolution, and
accuracy. |
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
| CMMR | > 100 dB | > 100 dB | | The differences in
biofeedback signal
characteristics do not
raise different |
| Input
Impedance | > 10 ΜΩ | > 12 ΜΩ | | |
| Output EMG
Signal | 2048 samples/s raw signal or
20 samples/s RMS signal | 2048 samples/s raw signal or
20 samples/s RMS signal | | questions of safety &
effectiveness for the
intended use. |
| EMG Accuracy | ±3% | ±5% | | |
| Surface EMG
Electrodes | Uni-Gel™ Single Electrodes (Single Use),
Thought Technology Ltd, #T3425 | Uni-Gel™ Single Electrodes (Single Use),
Thought Technology Ltd, #T3425 | -- | Same |
| Anal EMG
Electrodes | Life-care Anal Probe, Model PR-13A
(Single patient, reusable) | Saint-Cloud Anal EMG/Stim Probe; or
Thought Technology, Anal EMG Probe
(Single patient, reusable) | Everyway Incontinence
Stimulation Electrodes
(K122194)
Life-care Anal Probe, Model
PR-13A | Different, currently
marketed device for
the same intended use |
| Vaginal EMG
Electrodes | Life-care Vaginal Probe, Model PR-02A
(Single patient, reusable) | Saint-Cloud Vaginal EMG/Stim Probe; or
Femelex EMG/Stim Probe; or
Thought Technology, Vaginal EMG Probe
(Single patient, reusable) | Everyway Incontinence
Stimulation Electrodes
(K122194)
Life-care Vaginal Probe,
Model PR-02A | Different, currently
marketed device for
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
(K023906) | The adjunct pressure
biofeedback option |
| Enclosure
material | Polycarbonate and ABS blend | Not available | Reference device with similar
technological characteristics | does not raise different
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
incontinence: | intended use.
The biocompatibility |
| Pressure range | 0 - 200 mmHg | | | of the vaginal pressure |
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
| Resolution | 0.1 mmHg | | | |
| Nominal pressure | 55 mmHg (± 10%), auto-set | | | |
| Vaginal
Pressure Probe | Single-patient use (reusable), pneumatically
inflatable vaginal probe with a silicon bulb
and communicating tubing for connection to
the Pressure Sensor (35 g, 105 mm x 33 mm) | | Pathway Anal Pressure Sensor
manufactured by DesChutes
Medical, K934552 | probe and the basic
safety and essential
performance of the
device have been
verified using current
consensus standards. |
| Electrical Stimulation | | | | |
| Electrical
Stimulation
Modalities | • Neuromuscular Electrical Stimulation
(NMES)
• EMG-Triggered Stimulation (ETS) using
NMES specifications for incontinence | • Neuromuscular Electrical Stimulation
(NMES)
• EMG-Triggered Stimulation (ETS) using
NMES specifications for incontinence | -- | Same |
| Stimulation
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
rest phase) for EMG-triggered stimulation | Synchronous | -- | Different
The waveform,
frequency and delivery
specification
differences do not
raise different
questions of safety &
effectiveness for the
intended use.
Safety features limit
max charge per pulse
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 | | |
| Max Charge per
Pulse @500 Ω | 80 µC | 80 µC | | |
| Max Power
Density @500 Ω | 0.11 W/cm² (with smallest electrode
conductive surface area on Anal Probe) | 0.19 W/cm² (with smallest electrode
conductive surface area on Anal Probe) | | |
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
| Preloaded
electrical
stimulation
programs | Stress incontinence:
- Pulse width: 200 μs
- Frequency: 45 Hz
- Repetitions: 80
- Work time: 6 s
- Rest time: 10 s
Urge incontinence: - Pulse width: 200 μs
- Frequency: 15 Hz
- Repetitions: 80
- Work time: 6 s
- Rest time: 10 s | Stress incontinence:
- Pulse width: 200 μs
- Frequency: 45 Hz
- Repetitions: 80
- Work time: 6 s
- Rest time: 10 s
Urge incontinence: - Pulse width: 200 μs
- Frequency: 10 Hz
- Repetitions: 80
- Work time: 5 s
- Rest time: 10 s | -- | Identical stress
incontinence programs
Comparable default
urge incontinence
programs
Basic safety and
essential performance
have been verified
with preloaded
programs |
| Preloaded ETS
programs | Stress incontinence ETS: - Pulse width: 200 μs
- Frequency: 45 Hz
- Repetitions: 63
- Work time: 6 s
- Rest time: 10 s | Stress incontinence ETS:
- Pulse width: 200 μs
- Frequency: 45 Hz
- Repetitions: 63
- Work time: 6 s
- Rest time: 10 s
Plus 3 additional preloaded editable
programs for stress incontinence, and
2 additional preloaded editable programs
for mixed incontinence | | One identical stress
incontinence ETS
program
MyOnyx has no
preloaded ETS
programs for urge or
mixed incontinence;
the stress incontinence
ETS program may
serve as template for
custom, user-defined
programs
Basic safety and
essential performance
have been verified
with preloaded
programs |
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
| Stimulation Electrodes/Probes | | | | |
| Anal
Stimulation
Probe | Life-care Anal Probe, Model PR-13A
(Single patient, reusable) | Saint-Cloud Anal EMG/Stim Probe
(Single patient, reusable) | Everyway Incontinence
Stimulation Electrodes
(K122194)
Life-care Anal Probe, Model
PR-13A | Different, currently
marketed device for
the same intended use |
| Vaginal
Stimulation
Probe | Life-care Vaginal Probe, Model PR-02A
(Single patient, reusable) | Saint-Cloud Vaginal EMG/Stim Probe; or
Femelex EMG/Stim Probe
(Single patient, reusable) | Everyway Incontinence
Stimulation Electrodes
(K122194)
Life-care Vaginal Probe,
Model PR-02A | Different, currently
marketed device for
the same intended use |
| Operating Characteristics | | | | |
| Operating
Modes | • Standalone using proprietary firmware
(autonomous mode via 3.5in LCD and
capacitive touch pad with haptic feedback
device controls);
• With the MyOnyx App running on a tablet
(remote control mode via Bluetooth®);
• With the BioGraph® Infiniti software
running on a personal computer
(computerized mode via Bluetooth®) | • Standalone using proprietary firmware
(autonomous mode via 8in LCD touch
screen);
• With the BioGraph® Infiniti software
running on a personal computer
(computerized mode via USB link) | -- | Different
The performance of
the device has been
verified and validated
with the new
firmware, user
interface, Mobile App
and specified
biofeedback software |
| Input / Output
Channels | 2 channels for EMG or pressure biofeedback,
electrical stimulation, and EMG-Triggered
stimulation
2 additional channels for electrical
stimulation only | 2 channels for EMG biofeedback, electrical
stimulation and EMG-Triggered stimulation | -- | Different
Basic safety and
essential performance
have been verified to
equivalent standards |
| Device
characteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ Infiniti
System (K053434) | Reference devices | Comparison / Brief
SE justification |
| Physical and Electronic Component Characteristics | | | | |
| Device Size | 155mm L x 83mm W x 20.95mm D | 102 mm x 152 mm x 51 mm | -- | Different |
| Weight | 272g | 330 g | | The changes to the |
| Enclosure
Materials | Polycarbonate and ABS blend;
Plexiglass tinted front panel, aluminum ring
for structural support | ABS | | electronic enclosure
and interface of the
device do not raise
different questions of
safety & effectiveness
for the intended use.
The device meets
current medical
electrical equipment
safety standards. |
| Data Display | 3.5in diagonal, 72mm x 54mm, 24-bit color,
backlit LCD (320 pixels x 240 pixels) | 8in diagonal, 75.5 mm x 72.5 mm, gray-
scale LED display (160 x 160 pixels) | | |
| Data Storage | Embedded Multi-Media Card (eMMC), 8GB | Compact Flash Card (User-supplied) | | |
| Communication | Bluetooth® v4.1 | USB | | |
| 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;
External 15W, 5V Medical Grade
(Class II Double Insulated) Power Supply /
Battery Charger | Internal Battery (user replaceable):
4 x AAA 1.5V Alkaline or rechargeable
NiMH Battery pack – up to 4 hours of
autonomous device operation;
External 15W, 6V Medical Grade
(Class II Double Insulated) Power Supply /
Battery Charger | -- | Different,
The changes to the
power source do not
raise different
questions of safety &
effectiveness. The
device meets current
medical electrical
equipment safety
standards. |
| Electrical
Safety & EMC
Standards | IEC/ES 60601-1 (Ed. 3.1)
IEC 60601-1-6
IEC 60601-2-10
IEC 60601-2-40
IEC 60601-1-2 (4th Ed.) | IEC/ES 60601-1 (Ed. 2)
IEC 60601-1-4
IEC 60601-1-2 (Ed. 2) | -- | Different,
Current recognized
consensus standards |
Side-by-side comparison of key MyOnyx System characteristics with predicate and reference devices that support substantial equivalence (SE)
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510(k) Summary (K201014): MyOnyx System
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510(k) Summary (K201014): MyOnyx System
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