(125 days)
Not Found
Yes
The device description explicitly states that the control unit "learns to assign muscle signals from the user to the various types of movement" through calibration, which is a core concept of machine learning. The "Pattern recognition" functional test also supports this.
No
The device is a control unit for a myoelectric prosthetic, which aims to restore function rather than treat a disease or condition.
No
The device description indicates that MYO PLUS measures electromyographic control signals and assigns them to prosthetic movements. It is a control unit for a myoelectric prosthesis, learning to assign muscle signals to movement types through calibration. One component, the Myo Cuff, is used to "evaluate the muscle signals of a potential user" and for users to "practice" with a professional. While this evaluation might inform prosthetic fitting, the device's primary function described is control of the prosthesis, not diagnosis of a medical condition or disease. The evaluation of muscle signals seems to be for optimizing the use of the device itself rather than diagnosing a physiological state.
No
The device description clearly outlines multiple hardware components, including the "Myo Plus TR" control unit, "Remote Electrodes," and the "Myo Cuff," which are integral to the device's function. While there is a "Myo Plus App," it serves as an interface for the hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "exclusively for exoprosthetic fittings of the upper limbs." This clearly indicates a purpose related to controlling a prosthetic device, not diagnosing a medical condition.
- Device Description: The description focuses on measuring electromyographic control signals from the user's muscles to control the movements of a prosthesis. This is a functional control system, not a diagnostic test.
- Lack of Diagnostic Claims: There are no mentions of diagnosing, monitoring, or predicting any disease, condition, or physiological state. The device's function is to translate muscle signals into prosthetic movements.
- Myo Cuff: While the Myo Cuff is used to "evaluate the muscle signals of a potential user," this evaluation is for the purpose of determining suitability for using the Myo Plus controller and practicing, not for diagnosing a medical condition.
- Performance Studies: The performance studies focus on functional aspects like "Functional testing," "Adaptation to the user through calibration," "Pattern recognition," and "Product compatibility," which are relevant to the device's role in controlling a prosthesis, not diagnostic accuracy.
In summary, the Myo Plus system is designed to be a control unit for a myoelectric prosthesis, enabling users to control the prosthesis through their muscle signals. It does not perform any in vitro diagnostic testing on samples from the human body for the purpose of providing diagnostic information.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IQZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper limbs.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facility and home use
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)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1320 Cutaneous electrode.
(a)
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.(b)
Classification. Class II (performance standards).
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Construction (Permit, SEP, NOI, Other, Please Specify) | Post-Construction (Permit, SEP, NOI, Other, Please Specify) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
| Image: ottobock logo | PREMARKET
NOTIFICATION
MYO PLUS | Project Report No.
PD-PP00120325A-200
Attachment X | Page
1 of 4 |
| ---------------------- | --------------------------------------- | ---------------------------------------------------------- | ---------------- |
|---|
510(K) SUMMARY
1 Submitter Information
| 510(k) owner: | Otto Bock Healthcare Products GmbH |
|---|---|
| Establishment Registration: | 3005190268 |
| Address: | Brehmstraße 16 |
| 1110 Vienna | |
| Austria | |
| Contact Person: | Rene Urtz |
| Regulatory Affairs Manager | |
| rene.urtz@ottobock.com | |
| Telephone: | +43 1 523 37 86 707 |
| Fax Number: | +43 1 523 22 64 |
| 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
NOTIFICATION
MYO PLUS | Project Report No.
PD-PP00120325A-200
Attachment X | Page
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 | ||
| MYO PLUS | PD-PP00120325A-200 | ||
| 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 | |
| IBT Electrodes | |||
| Manufacturer | Otto Bock HealthCare | ||
| Products GmbH | Infinite Biomedical | ||
| Technologies, LLC | |||
| Classification, Indications for Use and Intended Use | |||
| Classification Product | |||
| Code | GXY | GXY | Same |
| Subsequent Product | |||
| Code | IQZ | IQZ | Same |
| Indications for Use | Myo Plus is to be used | ||
| exclusively for exoprosthetic | |||
| fittings of the upper limbs. | Sense System with IBT | ||
| Electrodes is to be used | |||
| exclusively for external | |||
| prosthetic fittings of upper | |||
| limbs. | Same | ||
| Principle of operation | Detect, process, and | ||
| transmit physiological | |||
| signals for use with a | |||
| prosthesis. | Detect, process, and | ||
| transmit physiological | |||
| signals for use with a | |||
| prosthesis. | Same | ||
| Environment of Use | Professional healthcare | ||
| facility and home use | Professional healthcare | ||
| facility and home use | Same | ||
| Assembling procedure | Components are assembled | ||
| by a prosthetist. | Components are assembled | ||
| by a prosthetist. | Same | ||
| Technological Characteristics - System | |||
| Signal acquisition | EMG electrode | EMG electrode | Same |
| Adjustment software | Yes | ||
| Myo Plus App | Yes | ||
| User Interface Application | Same | ||
| Software/Firmware/Micro | |||
| 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 | ||
| motor (analog) | 0-3.3V | ||
| digital and 0-7.4V | |||
| motor | Similar | ||
| Terminal device (e.g. | |||
| hand, wrist or elbow) | |||
| included? | No | No | Same |
| Wireless Communication | Yes | ||
| Bluetooth | Yes | ||
| Bluetooth | Same | ||
| Component for training | |||
| and capabilities | |||
| assessment | Yes | ||
| Myo Cuff | No | Differs | |
| Power source included? | Included in component | ||
| 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, | ||
| State switching | Pattern recognition | Similar | |
| Input Button | None | None | Same |
6
| | PREMARKET
NOTIFICATION
MYO PLUS | Project Report No.
PD-PP00120325A-200
Attachment X | Page
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 | ||
| 104°F) | -10°C to +50°C (14°F to | ||
| 122°F) | Similar | ||
| Housing material | TECHNOMELT PA 638 | ||
| BLACK | |||
| Polyamid | Plastics( ABS/PC Blend) | ||
| Polycarbonate/Acrylonitrile | |||
| 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 | ||
| socket | Suspension arms/suction | ||
| socket | Same | ||
| Safety and Performance Testing | |||
| Electrical Safety | IEC 60601-1:2005/A1:2012 | ||
| IEC 60601-1-11:2015 | IEC 60601-1:2005/A1:2012 | ||
| IEC 60601-1-11:2010 | Similar | ||
| Electromagnetic | |||
| 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 | ||
| ST/SG/AC.10/11/Rev.5/ | |||
| Amend.2, Sub-section 38.3 | IEC 62133:2002 | ||
| ST/SG/AC.10/11/Rev.5/ | |||
| 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.