Myo Plus

K191179 · Otto Bock Healthcare Products GmbH · GXY · Sep 4, 2019 · Neurology

Device Facts

• Record ID: K191179
• Device Name: Myo Plus
• Applicant: Otto Bock Healthcare Products GmbH
• Product Code: GXY · Neurology
• Decision Date: Sep 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: AI/ML, Therapeutic

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Myoelectric Prosthesis Control (Pattern Recognition)	Passed internal requirements and international standards for functional performance.	Passed	Not specified	Internal non-clinical performance testing including functional testing, adaptation to user through calibration, and pattern recognition testing.

Indications for Use

Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.

Device Story

Myo Plus is a central control unit for myoelectric upper limb prostheses. It measures electromyographic (EMG) signals from the user's skin surface via remote electrodes; these signals are processed by the control unit to trigger movements in prosthetic components like hands or rotation units. The system includes a Myo Cuff for temporary signal evaluation and training, and a Myo Plus App for calibration and monitoring. Calibration allows the system to learn and assign specific muscle signal patterns to movements, a process performable by the user. The device is used in professional healthcare facilities and home settings, operated by prosthetists for assembly and by patients for daily use. By translating physiological signals into prosthetic motion, the device enables functional control of the prosthesis, improving user mobility and independence.

Clinical Evidence

Bench testing only. Performance was validated through functional testing, calibration adaptation, user commissioning, pattern recognition accuracy, wireless data transmission, product compatibility, product lifetime, and battery life. Electrical safety and EMC testing were conducted per IEC 60601-1 and IEC 60601-1-2 standards. Biocompatibility was assessed per ISO 10993-1.

Technological Characteristics

System includes central control unit (Myo Plus TR), remote electrodes, and Myo Cuff. Electrodes feature titanium (grade 2) contact areas and TECHNOMELT PA 638 polyamide housing. Signal processing is digital (80-500 Hz bandwidth). Connectivity via Bluetooth for mobile app interface. Powered by 5.5-12 VDC. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and IEC 62133-2.

Indications for Use

Indicated for patients requiring exoprosthetic fittings of the upper limbs.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Sense System with IBT Electrodes (K182112)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

September 27, 2019

Otto Bock Healthcare Products GmbH % Rene Urtz Regulatory Affairs Manager Otto Bock Healthcare Products GmbH Brehmstrabe 16 1110 Wien Vienna, AT

### Re: K191179

Trade/Device Name: Myo Plus Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: August 6, 2019 Received: August 9, 2019

Dear Rene Urtz:

This letter corrects our substantially equivalent letter of September 4, 2019.

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

{1}------------------------------------------------

Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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.

# Heather L. Dean -S

For: Vivek Pinto, Ph.D. Acting Division Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K191179

Device Name Myo Plus

Indications for Use (Describe)

Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.

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

| <div> <input checked="true" type="checkbox"/> <span>Construction (Permit, SEP, NOI, Other, Please Specify)</span> </div> | <div> <input type="checkbox"/> <span>Post-Construction (Permit, SEP, NOI, Other, Please Specify)</span> </div> |
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| Image: ottobock logo | PREMARKET<br>NOTIFICATION<br>MYO PLUS | Project Report No.<br>PD-PP00120325A-200<br>Attachment X | Page<br>1 of 4 |
|----------------------|---------------------------------------|----------------------------------------------------------|----------------|
|----------------------|---------------------------------------|----------------------------------------------------------|----------------|

## 510(K) SUMMARY

## 1 Submitter Information

| 510(k) owner: | Otto Bock Healthcare Products GmbH |
|-----------------------------|-------------------------------------------------------------------|
| Establishment Registration: | 3005190268 |
| Address: | Brehmstraße 16<br>1110 Vienna<br>Austria |
| Contact Person: | Rene Urtz<br>Regulatory Affairs Manager<br>[e-mail] |
| Telephone: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | September 03, 2019 |

## 2 Device Information

| Trade Name: | Myo Plus |
|------------------------------|------------------------------------------------|
| Common or Usual Name: | Powered, External Upper Limb Prosthetic System |
| Classification Name: | Cutaneous Electrode (21 CFR 882.1320) |
| Classification Product Code: | GXY (Electrode, Cutaneous) |
| Subsequent Product Code: | IQZ (Hand, External Limb Component, Powered) |

## 3 Predicate Devices

| 510(k) Number: | K182112 |
|----------------|----------------------------------|
| Device Name: | Sense System with IBT Electrodes |

## 4 Indications for Use

Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.

{4}------------------------------------------------

| ottobock. | PREMARKET<br>NOTIFICATION<br>MYO PLUS | Project Report No.<br>PD-PP00120325A-200<br>Attachment X | Page<br>2 of 4 |
|-----------|---------------------------------------|----------------------------------------------------------|----------------|
|-----------|---------------------------------------|----------------------------------------------------------|----------------|

## 5 Device Description

MYO PLUS measures the electromyographic control signals of the user and assigns them to the movements of the prosthesis, such as the hand or rotation unit. The product is the central control unit of a myoelectric prosthesis. By calibrating via the Myo Plus App, the control unit learns to assign muscle signals from the user to the various types of movement. This calibration can be performed by the users themselves, and repeated at regular intervals if necessary.

#### Description of the components:

### Myo Plus TR

The central control unit is installed in the forearm of the prosthesis and is supplied with energy by the battery system of the prosthesis. Up to 8 remote electrodes can be connected. The electronics handles the signal processing of the electrode signals and controls the compatible prosthesis components.

### Remote Electrode

The remote electrodes take the muscle signal from the skin surface and transmit it to MyoPlus TR. The electrode contacts are located on a flexible cable and are individually screwed into the socket by the prosthesist.

#### Myo Plus App

The Myo Plus App is the central interface for the user and/or professionals to make settings on the control system or monitor operating states. The data transfer to mobile setting systems on Android or mobile iOS devices shall be carried out by a wireless connection according to the state of the art.

### Mvo Cuff

The Myo Cuff is used to evaluate the muscle signals of a potential user of a Myo Plus controller. The Myo Cuff forms a flexible wristband which is temporarily applied to the user's forearm. Thus, the signal patterns of the user can be evaluated with the help of the app without the preparation of a complex test socket. If a user has problems separating the patterns at the beginning, he can also use the Myo Cuff for practicing with an professional.

### Myo Plus trial kit

The Myo Plus trial kit provides the components of Myo Plus as a loaner kit for the prosthesist.

{5}------------------------------------------------

| PREMARKET | Project Report No. | Page | |
|-----------|--------------------------|------------------------------------|--------|
| ottobock. | NOTIFICATION<br>MYO PLUS | PD-PP00120325A-200<br>Attachment X | 3 of 4 |

## 6 Substantial Equivalence

The following table compares Myo Plus to the predicate device with respect to indications for use, principle of operation, technological characteristics and safety and performance testing.

| | Myo Plus | Predicate device | Comparison |
|-------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------|
| 510k number | To be determined | K182112 | |
| Device name, Model | Myo Plus | Sense System with<br>IBT Electrodes | |
| Manufacturer | Otto Bock HealthCare<br>Products GmbH | Infinite Biomedical<br>Technologies, LLC | |
| | Classification, Indications for Use and Intended Use | | |
| Classification Product<br>Code | GXY | GXY | Same |
| Subsequent Product<br>Code | IQZ | IQZ | Same |
| Indications for Use | Myo Plus is to be used<br>exclusively for exoprosthetic<br>fittings of the upper limbs. | Sense System with IBT<br>Electrodes is to be used<br>exclusively for external<br>prosthetic fittings of upper<br>limbs. | Same |
| Principle of operation | Detect, process, and<br>transmit physiological<br>signals for use with a<br>prosthesis. | Detect, process, and<br>transmit physiological<br>signals for use with a<br>prosthesis. | Same |
| Environment of Use | Professional healthcare<br>facility and home use | Professional healthcare<br>facility and home use | Same |
| Assembling procedure | Components are assembled<br>by a prosthetist. | Components are assembled<br>by a prosthetist. | Same |
| | Technological Characteristics - System | | |
| Signal acquisition | EMG electrode | EMG electrode | Same |
| Adjustment software | Yes<br>Myo Plus App | Yes<br>User Interface Application | Same |
| Software/Firmware/Micro<br>processor Control? | Yes | Yes | Same |
| Input voltage | 5,5-12 VDC | 5 to 10 VDC (system) | Similar |
| Output signal | 0 - 4,5V digital and 0-8.2V<br>motor (analog) | 0-3.3V<br>digital and 0-7.4V<br>motor | Similar |
| Terminal device (e.g.<br>hand, wrist or elbow)<br>included? | No | No | Same |
| Wireless Communication | Yes<br>Bluetooth | Yes<br>Bluetooth | Same |
| Component for training<br>and capabilities<br>assessment | Yes<br>Myo Cuff | No | Differs |
| Power source included? | Included in component<br>MyoCuff | No | Differs |
| Technological Characteristics - Processing unit | | | |
| Dimensions | 67 x 27 x 9.2 mm | 59 x 27.8 x 9.8 mm | Similar |
| Control Options | Pattern recognition,<br>State switching | Pattern recognition | Similar |
| Input Button | None | None | Same |

{6}------------------------------------------------

| | PREMARKET<br>NOTIFICATION<br>MYO PLUS | Project Report No.<br>PD-PP00120325A-200<br>Attachment X | Page<br>4 of 4 |
|----------------------|---------------------------------------|----------------------------------------------------------|----------------|
| Image: ottobock logo | | | |

| Technological Characteristics - Electrode | | | |
|-------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------|---------|
| Dimensions | 40.8 x 13.8 x 5.3 mm | 28.8 x 16.8 x 6.7mm | Similar |
| Temperature range (use) | +5°C to +40°C (41°F to<br>104°F) | -10°C to +50°C (14°F to<br>122°F) | Similar |
| Housing material | TECHNOMELT PA 638<br>BLACK<br>Polyamid | Plastics( ABS/PC Blend)<br>Polycarbonate/Acrylonitrile<br>Butadien Styrol | Differs |
| Contact area | Titanium (grade 2) | Titanium (grade 1) | Similar |
| Signal processing | Digital | Digital | Same |
| Frequency bandwidth | 80 - 500 Hz | 90-500Hz | Similar |
| Adjustment | none | Digital gain 1-7 | Differs |
| Installation | Suspension arms/suction<br>socket | Suspension arms/suction<br>socket | Same |
| Safety and Performance Testing | | | |
| Electrical Safety | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-11:2015 | IEC 60601-1:2005/A1:2012<br>IEC 60601-1-11:2010 | Similar |
| Electromagnetic<br>Compatibility | IEC 60601-1-2:2012 | IEC 60601-1-2:2007 | Similar |
| Biocompatibility | ISO 10993-1:2009 | ISO 10993-1:2009 | Same |
| Battery Safety | IEC 62133-2:2017<br>ST/SG/AC.10/11/Rev.5/<br>Amend.2, Sub-section 38.3 | IEC 62133:2002<br>ST/SG/AC.10/11/Rev.5/<br>Amend.2, Sub-section 38.3 | Similar |

The following table shows a brief summary of additional non-clinical performance testing conducted to support substantial equivalence.

| Test | Result |
|--------------------------------------------|--------|
| Functional testing | Passed |
| Adaptation to the user through calibration | Passed |
| Commissioning by user | Passed |
| Pattern recognition | Passed |
| Wireless data transmission | Passed |
| Product compatibility | Passed |
| Product lifetime | Passed |
| Battery life | Passed |

Myo Plus passed all the safety and performance testing in accordance with internal requirements and international standards, including those shown herein to demonstrate its ability to achieve its intended use and to support the substantial equivalence.

## 7 Conclusions

Myo Plus has the same indications for use, the same principle of operation and similar technological characteristics as the predicated device cleared under 510(k) no. K182112.

Based on the supporting data and the discussion provided herein, Otto Bock Healthcare GmbH considers its Myo Plus to be substantially equivalent to the predicate device.