(271 days)
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 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.
The provided document, a 510(k) summary for the MyOnyx System (K201014), primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It does not contain information about a clinical study involving human participants or a multi-reader multi-case (MRMC) comparative effectiveness study, which would typically involve human experts for ground truth and evaluation of AI assistance.
Therefore, many of the requested details, such as sample size for test and training sets, data provenance, number and qualifications of experts for ground truth, adjudication methods, and MRMC study effect sizes, are not present in this document because the device clearance was based on non-clinical engineering and performance testing rather than a clinical efficacy trial.
Here's an analysis based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
The document provides a table outlining acceptance criteria for various non-clinical tests. The "Reported Device Performance" is generally stated as "Conformity to applicable requirements" or meeting specific design specifications. While the table clearly lists the acceptance criteria, the detailed quantitative results of the tests themselves are not provided within this summary document, only the conclusion that they were met.
| Test | Acceptance Criteria | Reported Device Performance (as stated) |
|---|---|---|
| Biocompatibility of vaginal pressure probe | 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 | (Implicitly stated as conforming in "Comparison / Brief SE justification" column of table on page 7, "The biocompatibility of the vaginal pressure probe and the basic safety and essential performance of the device have been verified...") |
| Electrical safety (IEC 60601-1 / ES60601-1:2012) | Conformity to applicable basic safety and performance requirements | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| EMC (IEC 60601-1-2:2014, 4th Ed.) | Conformity of device emissions and device immunity to EM disturbances for use in a professional healthcare facility | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Basic safety and essential performance of nerve and muscle stimulators (IEC 60601-2-10:2012+A1:2016) | Conformity of electrical stimulation programs to applicable requirements | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "Basic safety and essential performance have been verified with preloaded programs" on pg 7) |
| 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 | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "Basic safety and essential performance have been verified with preloaded programs" on pg 7) |
| Verification of hardware device controls and interfaces | Test results must meet or exceed hardware design specifications | Meeting or exceeding hardware design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Usability (IEC 60601-1-6:2010+A1:2013, IEC 62366-1:2015) | 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. | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and "The performance of the device has been verified and validated with the new firmware, user interface, Mobile App and specified biofeedback software" on pg 7) |
| Software life-cycle processes (IEC 62304:2006+A1:2015) | Firmware development in conformity with requirements for Class B software ('Moderate Level of Concern') | Conformity (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Stimulation firmware unit testing | The device responds with expected outputs meeting software design specifications when supplied with predefined test inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| Firmware and system-level functional verification testing | The device responds with expected outputs meeting software design specifications under anticipated use conditions and inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
| MyOnyx Mobile App verification testing | The device responds with expected outputs meeting software design specifications when operated remotely under anticipated use conditions and inputs | Expected outputs meeting software design specifications (Implied by inclusion in "Summary of Non-Clinical / Performance Testing" and SE conclusion) |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a series of non-clinical performance tests conducted by the manufacturer, Thought Technology Ltd. These include electrical safety, electromagnetic compatibility (EMC), biocompatibility, hardware verification, usability, and software life-cycle processes, as detailed in the "Summary of Non-Clinical / Performance Testing" section on page 5.
2. Sample Size Used for the Test Set and the Data Provenance:
- Sample Size: Not applicable in the context of human patient data for an AI/ML device, as this summary describes engineering and performance testing of the device hardware and software, not a clinical trial with patient data. The "sample size" here refers to the number of units or components tested. This information is not specified in this summary document.
- Data Provenance: Not applicable in the context of patient data. The tests are general engineering and performance tests of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
- Not applicable as this is a non-clinical submission. Ground truth, in the AI/ML context, usually refers to labeled data for diagnostic tasks established by human experts. Here, "ground truth" for the device's technical performance is the expected behavior and measurements based on engineering specifications and international standards (e.g., IEC standards).
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert labeling of clinical data, which is not relevant for this type of non-clinical device clearance. The "adjudication" for these tests would be the comparison of test results against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No. The document makes no mention of an MRMC study or AI assistance. The device in question is a biofeedback and electrical stimulation system for incontinence, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable in the context of AI/ML algorithm performance. The "standalone" mode mentioned in the document (page 4) refers to the device's ability to operate for electrical stimulation only without being connected to a mobile app or computer. This is a functional description, not an AI/ML performance metric.
7. The Type of Ground Truth Used:
- The "ground truth" for this device's performance is established by engineering specifications, international consensus standards (e.g., ISO, IEC), and established medical device testing protocols. For example, for biocompatibility, the ground truth is "noncytotoxic, non-sensitizing, non-irritant" as defined by ISO standards. For electrical safety, the ground truth is "conformity to applicable basic safety and performance requirements" of IEC standards.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set of patient data. The "firmware development" mentioned (page 5) refers to traditional software engineering processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for it.
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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 (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
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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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Ltd. 510(k) Summary (K201014)
January 12, 2021
| Device Trade Name: | MyOnyx System |
|---|---|
| Regulation Number:Regulation Name:Product Code: | 21 CFR §876.5320Non-implanted electrical continence deviceKPI |
| Regulation Number:Regulation Name:Product Code: | 21 CFR §882.5050Biofeedback deviceHCC |
| Regulatory Class: | Class II |
| Manufacturer:Establishment Reg. No:Address: | Thought Technology Ltd.96804875250 Ferrier, Suite 812Montreal, Quebec H4P 1L3CANADATel: +1 (514) 489-8251 Fax: +1 (514) 489-8255 |
| Regulatory Contact: | Zena Butris, Regulatory Affairs ManagerE-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). ●
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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(FDA Recognition No.) | Acceptance Criteria |
|---|---|---|
| Biocompatibility ofvaginal pressure probe | ISO 10993-1:2009/COR1:2010(FR# 2-220) | Cytotoxicity: Noncytotoxic or Mildlycytotoxic (Grades 0-1) per ISO 10993-5;Sensitization: No delayed contactsensitization 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 andperformance requirements |
| EMC | IEC 60601-1-2:2014, 4th Ed.(FR# 19-8) | Conformity of device emissions and deviceimmunity to EM disturbances for use in aprofessional healthcare facility |
| Basic safety and essentialperformance of nerve andmuscle stimulators | IEC 60601-2-10:2012+A1:2016(FR# 17-16) | Conformity of electrical stimulationprograms to applicable requirements |
| Basic safety and essentialperformance ofelectromyographs andelectrical stimulators | IEC 60601-2-40:2016 | Conformity of electrical stimulationprograms to applicable requirements foraccuracy of controls and protection againsthazardous stimulation output |
| Verification of hardwaredevice controls andinterfaces | Each device circuit block was verifiedagainst hardware design specificationsunder normal use and, where appropriate,under single fault conditions. | Test results must meet or exceed hardwaredesign specifications |
| Usability | IEC 60601-1-6:2010+A1:2013 (FR# 5-89) in conjunction withIEC 62366-1:2015(FR# 5-114) | Conformity of the Usability EngineeringProcess and related outputs. Acceptance ofthe modified device by representative end-users operating the device as peraccompanying instructions for use. |
| Software life-cycleprocesses | IEC 62304:2006+A1:2015(FR# 13-79) | Firmware development in conformity withrequirements for Class B software('Moderate Level of Concern') |
| Stimulation firmware unittesting | The Class B (per IEC 62304) stimulationfirmware functions and safety featureswere tested with inputs that verify theeffectiveness of error handling and riskcontrol measures | The device responds with expected outputsmeeting software design specificationswhen supplied with predefined test inputs |
| Firmware and system-level functionalverification testing | Device functionality was tested inautonomous mode (stimulation functions)and computerized mode (for biofeedback) | The device responds with expected outputsmeeting software design specificationsunder anticipated use conditions and inputs |
| MyOnyx Mobile Appverification testing | Device functionality was tested in remotecontrol mode | The device responds with expected outputsmeeting software design specificationswhen operated remotely under anticipateduse 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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| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE justification |
|---|---|---|---|---|
| Intended Use | Prescription use device for the treatment ofincontinence | Prescription use device for the treatment ofincontinence | -- | Same |
| Product Code | KPI, HCC | KPI, HCC (for the proposed intended use) | -- | Same |
| Indications forUse | The MyOnyx System is indicated for acuteand ongoing treatment of stress, urge, ormixed urinary incontinence, where urinarycontrol may be improved through electricalstimulation that strengthens the pelvic floormuscles or inhibits the detrusor musclethrough reflexive mechanisms. The systemalso uses EMG-based or pressure-basedbiofeedback to help control and strengthenthe pelvic floor muscles in the treatment ofurinary incontinence. | "The MyoTrac Infiniti system is indicatedfor acute and ongoing treatment of stress,urge or mixed urinary incontinence andwhere the following results may improveurinary control: Inhibition of the detrusermuscle through reflexive mechanisms,strengthening of pelvic floor muscle.It is also indicated during incontinencetreatment for assessing EMG activity of thepelvic floor and accessory muscles such asthe abdominal or gluteal muscles." | -- | Same |
| BiofeedbackModalities | • EMG Biofeedback• Pressure Biofeedback | • EMG Biofeedback | Pathway CTS2000 PelvicFloor Training System(K023906, Product CodeKPI):Offers EMG and pressurebiofeedback with similartechnological characteristicsfor use in the treatment ofurinary incontinence | DifferentThe adjunct pressurebiofeedback modalitydoes not raise differentquestions of safety &effectiveness for theintended use in thetreatment of urinaryincontinence. |
| EMG Biofeedback Specifications | ||||
| EMG SignalProcessing | 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, improvedrange, resolution, andaccuracy. |
| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE justification |
| CMMR | > 100 dB | > 100 dB | The differences inbiofeedback signalcharacteristics do notraise different | |
| InputImpedance | > 10 ΜΩ | > 12 ΜΩ | ||
| Output EMGSignal | 2048 samples/s raw signal or20 samples/s RMS signal | 2048 samples/s raw signal or20 samples/s RMS signal | questions of safety &effectiveness for theintended use. | |
| EMG Accuracy | ±3% | ±5% | ||
| Surface EMGElectrodes | Uni-Gel™ Single Electrodes (Single Use),Thought Technology Ltd, #T3425 | Uni-Gel™ Single Electrodes (Single Use),Thought Technology Ltd, #T3425 | -- | Same |
| Anal EMGElectrodes | Life-care Anal Probe, Model PR-13A(Single patient, reusable) | Saint-Cloud Anal EMG/Stim Probe; orThought Technology, Anal EMG Probe(Single patient, reusable) | Everyway IncontinenceStimulation Electrodes(K122194)Life-care Anal Probe, ModelPR-13A | Different, currentlymarketed device forthe same intended use |
| Vaginal EMGElectrodes | Life-care Vaginal Probe, Model PR-02A(Single patient, reusable) | Saint-Cloud Vaginal EMG/Stim Probe; orFemelex EMG/Stim Probe; orThought Technology, Vaginal EMG Probe(Single patient, reusable) | Everyway IncontinenceStimulation Electrodes(K122194)Life-care Vaginal Probe,Model PR-02A | Different, currentlymarketed device forthe 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 pressurebiofeedback option | |
| Enclosurematerial | Polycarbonate and ABS blend | Not available | Reference device with similartechnological characteristics | does not raise differentquestions 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 urinaryincontinence: | intended use.The biocompatibility | |
| Pressure range | 0 - 200 mmHg | of the vaginal pressure | ||
| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE justification |
| Resolution | 0.1 mmHg | |||
| Nominal pressure | 55 mmHg (± 10%), auto-set | |||
| VaginalPressure Probe | Single-patient use (reusable), pneumaticallyinflatable vaginal probe with a silicon bulband communicating tubing for connection tothe Pressure Sensor (35 g, 105 mm x 33 mm) | Pathway Anal Pressure Sensormanufactured by DesChutesMedical, K934552 | probe and the basicsafety and essentialperformance of thedevice have beenverified using currentconsensus standards. | |
| Electrical Stimulation | ||||
| ElectricalStimulationModalities | • Neuromuscular Electrical Stimulation(NMES)• EMG-Triggered Stimulation (ETS) usingNMES specifications for incontinence | • Neuromuscular Electrical Stimulation(NMES)• EMG-Triggered Stimulation (ETS) usingNMES specifications for incontinence | -- | Same |
| StimulationPrograms | User configurable NMES / ETS programs | User configurable NMES / ETS programs | -- | Same |
| Neuromuscular Electrical Stimulation (NMES) specifications for Incontinence Treatments | ||||
| Delivery | Synchronous or Alternating; Continuous (norest phase) for EMG-triggered stimulation | Synchronous | -- | DifferentThe waveform,frequency and deliveryspecificationdifferences do notraise differentquestions of safety &effectiveness for theintended use.Safety features limitmax charge per pulseand 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 perPulse @500 Ω | 80 µC | 80 µC | ||
| Max PowerDensity @500 Ω | 0.11 W/cm² (with smallest electrodeconductive surface area on Anal Probe) | 0.19 W/cm² (with smallest electrodeconductive surface area on Anal Probe) | ||
| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE justification |
| Preloadedelectricalstimulationprograms | Stress incontinence:- Pulse width: 200 μs- Frequency: 45 Hz- Repetitions: 80- Work time: 6 s- Rest time: 10 sUrge 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 sUrge incontinence:- Pulse width: 200 μs- Frequency: 10 Hz- Repetitions: 80- Work time: 5 s- Rest time: 10 s | -- | Identical stressincontinence programsComparable defaulturge incontinenceprogramsBasic safety andessential performancehave been verifiedwith preloadedprograms |
| Preloaded ETSprograms | 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 sPlus 3 additional preloaded editableprograms for stress incontinence, and2 additional preloaded editable programsfor mixed incontinence | One identical stressincontinence ETSprogramMyOnyx has nopreloaded ETSprograms for urge ormixed incontinence;the stress incontinenceETS program mayserve as template forcustom, user-definedprogramsBasic safety andessential performancehave been verifiedwith preloadedprograms | |
| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE justification |
| Stimulation Electrodes/Probes | ||||
| AnalStimulationProbe | Life-care Anal Probe, Model PR-13A(Single patient, reusable) | Saint-Cloud Anal EMG/Stim Probe(Single patient, reusable) | Everyway IncontinenceStimulation Electrodes(K122194)Life-care Anal Probe, ModelPR-13A | Different, currentlymarketed device forthe same intended use |
| VaginalStimulationProbe | Life-care Vaginal Probe, Model PR-02A(Single patient, reusable) | Saint-Cloud Vaginal EMG/Stim Probe; orFemelex EMG/Stim Probe(Single patient, reusable) | Everyway IncontinenceStimulation Electrodes(K122194)Life-care Vaginal Probe,Model PR-02A | Different, currentlymarketed device forthe same intended use |
| Operating Characteristics | ||||
| OperatingModes | • Standalone using proprietary firmware(autonomous mode via 3.5in LCD andcapacitive touch pad with haptic feedbackdevice controls);• With the MyOnyx App running on a tablet(remote control mode via Bluetooth®);• With the BioGraph® Infiniti softwarerunning on a personal computer(computerized mode via Bluetooth®) | • Standalone using proprietary firmware(autonomous mode via 8in LCD touchscreen);• With the BioGraph® Infiniti softwarerunning on a personal computer(computerized mode via USB link) | -- | DifferentThe performance ofthe device has beenverified and validatedwith the newfirmware, userinterface, Mobile Appand specifiedbiofeedback software |
| Input / OutputChannels | 2 channels for EMG or pressure biofeedback,electrical stimulation, and EMG-Triggeredstimulation2 additional channels for electricalstimulation only | 2 channels for EMG biofeedback, electricalstimulation and EMG-Triggered stimulation | -- | DifferentBasic safety andessential performancehave been verified toequivalent standards |
| Devicecharacteristics | Subject device: MyOnyx System | Predicate device: MyoTrac™ InfinitiSystem (K053434) | Reference devices | Comparison / BriefSE 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 | |
| EnclosureMaterials | Polycarbonate and ABS blend;Plexiglass tinted front panel, aluminum ringfor structural support | ABS | electronic enclosureand interface of thedevice do not raisedifferent questions ofsafety & effectivenessfor the intended use.The device meetscurrent medicalelectrical equipmentsafety 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 Polymerbattery certified to IEC 62133 – up to 8hours 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 rechargeableNiMH Battery pack – up to 4 hours ofautonomous device operation;External 15W, 6V Medical Grade(Class II Double Insulated) Power Supply /Battery Charger | -- | Different,The changes to thepower source do notraise differentquestions of safety &effectiveness. Thedevice meets currentmedical electricalequipment safetystandards. |
| ElectricalSafety & EMCStandards | IEC/ES 60601-1 (Ed. 3.1)IEC 60601-1-6IEC 60601-2-10IEC 60601-2-40IEC 60601-1-2 (4th Ed.) | IEC/ES 60601-1 (Ed. 2)IEC 60601-1-4IEC 60601-1-2 (Ed. 2) | -- | Different,Current recognizedconsensus 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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§ 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).