(125 days)
Myo Plus is to be used exclusively for exoprosthetic fittings of the upper limbs.
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.
The provided text describes the Myo Plus device and its substantial equivalence to a predicate device, but it does not contain specific details about acceptance criteria or a study that proves the device meets those criteria in the context of a comparative effectiveness study involving AI assistance for human readers or standalone algorithm performance.
The document primarily focuses on demonstrating substantial equivalence based on:
- Identical Indications for Use
- Identical Principles of Operation
- Similar Technological Characteristics
- Compliance with recognized safety and performance standards (electrical safety, EMC, biocompatibility, battery safety)
- Results from general functional and performance tests.
There is no mention of an AI component, human readers, effect sizes, multi-reader multi-case studies, or the types of ground truth typically established for AI-driven diagnostic or assistive devices. The "Pattern recognition" mentioned refers to the device's ability to interpret muscle signals for prosthetic control, not image analysis or AI interpretation of medical data in a diagnostic context.
Therefore, I cannot extract the requested information from the provided text for the following reasons:
- Acceptance criteria and reported device performance related to AI/human reader studies: Not present. The acceptance criteria mentioned are related to functional performance (e.g., "Functional testing: Passed," "Pattern recognition: Passed") and compliance with safety standards.
- Sample size for test set and data provenance: Not mentioned.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method for test set: Not mentioned.
- MRMC comparative effectiveness study and effect size: No such study is described.
- Standalone (algorithm only) performance: No such performance evaluation is described. Myo Plus is a physical device (control unit for prosthetic limbs) that uses signal processing, not a standalone AI algorithm for medical image analysis.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the device's function would be the user's intended muscle movements and the device's accurate interpretation and execution of those movements, but this is not defined in terms of a clinical study or labeled dataset.
- Training set sample size and how ground truth was established for training: Not mentioned. The device "learns to assign muscle signals from the user to the various types of movement" through a calibration process via the Myo Plus App, which can be done by users themselves or with a professional. This is a user-specific calibration, not a large-scale AI model training process using a distinct training dataset.
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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
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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
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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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| Image: ottobock logo | PREMARKETNOTIFICATIONMYO PLUS | Project Report No.PD-PP00120325A-200Attachment X | Page1 of 4 |
|---|---|---|---|
| ---------------------- | --------------------------------------- | ---------------------------------------------------------- | ---------------- |
510(K) SUMMARY
1 Submitter Information
| 510(k) owner: | Otto Bock Healthcare Products GmbH |
|---|---|
| Establishment Registration: | 3005190268 |
| Address: | Brehmstraße 161110 ViennaAustria |
| Contact Person: | Rene UrtzRegulatory Affairs Managerrene.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.
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| ottobock. | PREMARKETNOTIFICATIONMYO PLUS | Project Report No.PD-PP00120325A-200Attachment X | Page2 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.
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| PREMARKET | Project Report No. | Page | |
|---|---|---|---|
| ottobock. | NOTIFICATIONMYO PLUS | PD-PP00120325A-200Attachment 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 withIBT Electrodes | |
| Manufacturer | Otto Bock HealthCareProducts GmbH | Infinite BiomedicalTechnologies, LLC | |
| Classification, Indications for Use and Intended Use | |||
| Classification ProductCode | GXY | GXY | Same |
| Subsequent ProductCode | IQZ | IQZ | Same |
| Indications for Use | Myo Plus is to be usedexclusively for exoprostheticfittings of the upper limbs. | Sense System with IBTElectrodes is to be usedexclusively for externalprosthetic fittings of upperlimbs. | Same |
| Principle of operation | Detect, process, andtransmit physiologicalsignals for use with aprosthesis. | Detect, process, andtransmit physiologicalsignals for use with aprosthesis. | Same |
| Environment of Use | Professional healthcarefacility and home use | Professional healthcarefacility and home use | Same |
| Assembling procedure | Components are assembledby a prosthetist. | Components are assembledby a prosthetist. | Same |
| Technological Characteristics - System | |||
| Signal acquisition | EMG electrode | EMG electrode | Same |
| Adjustment software | YesMyo Plus App | YesUser Interface Application | Same |
| Software/Firmware/Microprocessor Control? | Yes | Yes | Same |
| Input voltage | 5,5-12 VDC | 5 to 10 VDC (system) | Similar |
| Output signal | 0 - 4,5V digital and 0-8.2Vmotor (analog) | 0-3.3Vdigital and 0-7.4Vmotor | Similar |
| Terminal device (e.g.hand, wrist or elbow)included? | No | No | Same |
| Wireless Communication | YesBluetooth | YesBluetooth | Same |
| Component for trainingand capabilitiesassessment | YesMyo Cuff | No | Differs |
| Power source included? | Included in componentMyoCuff | 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 |
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| PREMARKETNOTIFICATIONMYO PLUS | Project Report No.PD-PP00120325A-200Attachment X | Page4 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 to104°F) | -10°C to +50°C (14°F to122°F) | Similar |
| Housing material | TECHNOMELT PA 638BLACKPolyamid | Plastics( ABS/PC Blend)Polycarbonate/AcrylonitrileButadien 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/suctionsocket | Suspension arms/suctionsocket | Same |
| Safety and Performance Testing | |||
| Electrical Safety | IEC 60601-1:2005/A1:2012IEC 60601-1-11:2015 | IEC 60601-1:2005/A1:2012IEC 60601-1-11:2010 | Similar |
| ElectromagneticCompatibility | IEC 60601-1-2:2012 | IEC 60601-1-2:2007 | Similar |
| Biocompatibility | ISO 10993-1:2009 | ISO 10993-1:2009 | Same |
| Battery Safety | IEC 62133-2:2017ST/SG/AC.10/11/Rev.5/Amend.2, Sub-section 38.3 | IEC 62133:2002ST/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.
§ 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).