Complete Control System

K162891 · Coapt, LLC · GXY · Apr 14, 2017 · Neurology

Device Facts

• Record ID: K162891
• Device Name: Complete Control System
• Applicant: Coapt, LLC
• Product Code: GXY · Neurology
• Decision Date: Apr 14, 2017
• 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
Pattern Recognition for Myoelectric Prosthesis Control	Not specified	Passed	Not specified	Not specified

Indications for Use

The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.

Device Story

COMPLETE CONTROL System is an embedded myoelectric control solution for powered upper-limb prostheses. It acquires surface EMG signals via CO-AMP modules; processes and translates signals using pattern recognition technology in the CONTROLLER module; and enables intuitive control of prosthetic elbow, wrist, or hand components. The system is installed by a prosthetist; includes a CALIBRATE button for patient-led training/recalibration; and uses a COMMUNICATOR USB dongle for system provisioning. It functions as a plug-and-play add-on for existing prostheses, eliminating manual control switching. The system simplifies electrode placement and configuration via the COMPLETE CONTROLROOM software. By utilizing pattern recognition, it provides more intuitive, powerful control compared to traditional switching, potentially improving functional outcomes for amputees.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety, electromagnetic disturbance, and functional validation (cabling, power, wireless connectivity, calibration, pattern recognition, and feature extraction).

Technological Characteristics

Embedded system for myoelectric prostheses. Components: CO-AMP (EMG amplifier), CONTROLLER (main processor), CALIBRATE (patient interface), COMMUNICATOR (wireless USB). Power: 5.3-16.8 VDC. Connectivity: Wireless and USB. Software: Pattern recognition algorithm. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61000-4-3, IEC 61000-4-8, CISPR 11, FCC Part 15.

Indications for Use

Indicated for upper limb amputees requiring powered myoelectric prosthetic control. Suitable for unilateral or bilateral amputations starting at transradial or transhumeral levels, or dysmelia cases requiring forearm or upper arm fittings. Not for use in extreme sports or operation of motor vehicles/motor-driven equipment.

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

• Otto Bock Health Care Product GmbH Axon Bus Prosthetic System (K123795)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 14, 2017

Coapt, LLC % Carrie Hetrick Senior Consultant, Regulatory Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, Texas 78746

Re: K162891

Trade/Device Name: Complete Control System Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IOZ Dated: April 3. 2017 Received: April 6, 2017

Dear Carrie Hetrick:

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. 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. 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Carlos L. Pena -S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K162891

Device Name Complete Control System

Indications for Use (Describe)

The Complete Control System is to be used exclusively for external prosthetic fittings of the upper limbs.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

### COMPLETE CONTROL System

### K162891

#### 1. Submission Sponsor

Coapt, LLC

222 W. Ontario Street, Unit # 300

Chicago, IL 60654

Contact: Mr. Blair Lock, MScE, P.Eng

Title: Chief Executive Officer

#### 2. Submission Correspondent

Emergo Global Consulting, LLC

2500 Bee Cave Road

Building 1, Suite 300

Austin, TX 78746

Office Phone: [phone]

Contact: Carrie Hetrick

Title: Senior Consultant, RA

#### 3. Date Prepared

3 April 2017

#### 4. Device Identification

| Trade/Proprietary Name: | COMPLETE CONTROL System |
|-------------------------|--------------------------|
| Common/Usual Name: | Cutaneous Electrode |
| Classification Name: | Electrode, cutaneous |
| Regulation Number: | 21 CFR §882.1320 |
| Product Code: | GXY, Cutaneous electrode |

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Subsequent Product Code: IQZ, Hand, External Limb Component, Powered

Device Class: Class II

Classification Panel: Neurology

#### 5. Legally Marketed Predicate Device(s)

K123795, Otto Bock Health Care Product GmbH Axon Bus Prosthetic System

#### 6. Indication for Use Statement

The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.

#### 7. Device Description

The COMPLETE CONTROL System is an advanced control solution designed to enhance the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System employs Pattern Recognition technology to acquire, non-invasively, the rich information in muscle signals to enhance the control of industry standard upper extremity prostheses. Patients can achieve intuitive control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. COMPLETE CONTROL simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on. COMPLETE CONTROL does not require an additional battery.

The COMPLETE CONTROL System is an embedded system that is used in conjunction with an upper-limb prosthetic device. This device can include any combination of an elbow, wrist, hand or terminal device. It contains several modules, including one for processing surface EMG (CO-AMP), processing and translating the signals (CONTROLLER), along with a controlling training routine (CALIBRATE). Finally, a wireless adapter (COMMUNICATOR) is included with the system setup and is used to provision the entire system.

The COMPLETE CONTROL System contains the following components.

- 1. Device Interface Cable (clinician-specified termination type)
- 2. COMPLETE CONTROLLER main processor
- 3. COMPLETE CALIBRATE patient interface button
- 4. COMPLETE CO-AMP consolidated EMG amplifier
- 5. EMG Interface Cable
- 6. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
- 7. Socket cut-out template for the COMPLETE CALIBRATE button
- 8. COMPLETE COMMUNICATOR USB dongle
- 9. COMPLETE CONTROLROOM software installation USB dongle

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#### 8. Substantial Equivalence Discussion

The following table compares the COMPLETE CONTROL System to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

| Manufacturer | Coapt, LLC | Otto Bock Health Care<br>Product GmbH | Device Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Trade Name | COMPLETE CONTROL<br>System | Axon Bus Prosthetic<br>System | |
| 510(k) Number | To be determined | K123795 | Not applicable |
| Classification<br>Product Code | GXY | GXY | Same |
| Regulation Number | 21 CFR 890.3450 | 21 CFR 890.3450 | Same |
| Regulation Name | Cutaneous electrode | Cutaneous electrode | Same |
| Subsequent Product<br>Code | IQZ (Hand, External Limb<br>Component, Powered) | IQZ (Hand, External Limb<br>Component, Powered) | Same |
| Indications for Use | The COMPLETE CONTROL<br>System is to be used<br>exclusively for external<br>prosthetic fittings of the<br>upper limbs. | The Axon-Bus Prosthetic<br>System is to be used<br>exclusively for<br>exoprosthetic fittings of<br>the upper limbs. | Same |
| Use/Field of<br>Application | The COMPLETE CONTROL<br>System is suitable for<br>unilateral or bilateral<br>amputations starting with<br>the transradial/<br>transhumeral amputation<br>level or, in case of<br>dysmelia, for forearm or<br>upper arm fittings. | The Axon-Bus Prosthetic<br>System is suitable for<br>unilateral or bilateral<br>amputations starting with<br>the transradial/<br>transhumeral amputation<br>level or, in case of<br>dysmelia, for forearm or<br>upper arm fittings. | Same |
| Conditions of Use | The COMPLETE CONTROL<br>System was developed for<br>everyday use and must<br>not be used for unusual | The Axon-Bus Prosthetic<br>System was developed for<br>everyday use and must<br>not be used for unusual | Same |

| Table 5A – Comparison of Characteristics | |
|------------------------------------------|--|
|------------------------------------------|--|

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| Manufacturer | Coapt, LLC | Otto Bock Health Care<br>Product GmbH | Device Comparison |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Trade Name | COMPLETE CONTROL<br>System<br>activities. These activities<br>include, for example,<br>sports with excessive<br>strain and/or shocks to<br>the wrist unit (pushups,<br>downhill, mountain<br>biking) or extreme sports<br>(free climbing, paragliding,<br>etc.) Furthermore, the<br>COMPLETE CONTROL<br>System should not be<br>used for the operation of<br>motor vehicles or motor-<br>driven equipment. | Axon Bus Prosthetic<br>System<br>activities. These activities<br>include, for example,<br>sports with excessive<br>strain and/or shocks to<br>the wrist unit (pushups,<br>downhill, mountain<br>biking) or extreme sports<br>(free climbing, paragliding,<br>etc.) Furthermore, the<br>Axon-Bus Prosthetic<br>System should not be<br>used for the operation of<br>motor vehicles or motor-<br>driven equipment. | |
| Mechanism of Action | The components of the<br>COMPLETE CONTROL<br>System are assembled by<br>a prosthetist according to<br>the individual needs of the<br>amputee. | The components of the<br>Axon-Bus Prosthetic<br>System are assembled by<br>a prosthetist according to<br>the individual needs of the<br>amputee. | Same |
| Power Requirements | 5.3-16.8 VDC<br>115 mA at 7.4 V | Li-Ion Battery<br>Various (1150/1500) | Differs |
| Physical Dimensions | | | |
| Central Control Unit | COMPLETE CONTROL ler<br>W: 25.9 mm (1.02 in)<br>L: 66.1 mm (2.60 in)<br>H: 13.5 mm (0.53 in) | <i>AxonMaster</i><br>53 x 28 x 9 mm | Similar |
| | Complete Co-Amp<br>W: 21.4 mm (0.84 in)<br>L: 47.8 mm (1.88 in)<br>H: 9.6 mm (0.38 in) | | |
| Manufacturer | Coapt, LLC | Otto Bock Health Care<br>Product GmbH | Device Comparison |
| Trade Name | COMPLETE CONTROL<br>System | Axon Bus Prosthetic<br>System | |
| | Complete Calibrate<br>W: 17.8 mm (0.70 in)<br>L: 27.6 mm (1.09 in)<br>H: 11.7 mm (0.46 in)<br>Depth below socket face:<br>7.6 mm (0.30 in)<br>Protrusion above socket<br>face: 4.0 mm (0.16 in)<br>Socket mounting hole cut-<br>out size: 14 x 24 mm (0.55<br>x 0.94 in) | 27 x 18 x 9.5 mm | Similar |
| | Complete Communicator<br>W: 21.8 mm (0.86 in)<br>L: 69.2 mm (2.72 in)<br>including USB end-cap<br>H: 16.1 mm (0.63 in) | Not available | Assumed similar |
| Clinician Software<br>Tool | Yes<br>COMPLETE CONTROL<br>Room Software | Yes<br>Ottobock Software | Similar |
| Electrical Safety<br>Testing Passed | IEC 60601-1<br>IEC 61000-4-3<br>IEC 61000-4-3<br>IEC 61000-4-8<br>IEC 60601-1-2<br>CISPR 11<br>FCC Part 15 | IEC 60601-1<br>IEC 60601-1-2 | Similar |

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#### 9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the COMPLETE CONTROL System and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Coapt, LLC completed a number of non-clinical performance tests. The COMPLETE CONTROL System meets all the

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requirements for overall design and electrical safety results, confirming that the design output meets the design inputs and specifications for the device.

The COMPLETE CONTROL System passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:

- Electrical safety testing per IEC 60601-1
- . Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2

The COMPLETE CONTROL System was tested internally to ensure that it meets device specifications & requirements and operates as intended. The following validation testing was performed on the finished device:

| Test Name | Result |
|------------------------------------------|--------|
| Cabling Connection Test | Passed |
| Power On and Boot Test | Passed |
| Wireless Connectivity and Profile Test | Passed |
| Inputs Test | Passed |
| Outputs Test | Passed |
| Calibration and Pattern Recognition Test | Passed |
| Feature Extraction Test | Passed |
| File Save Test | Passed |

#### 10. Clinical Performance Data

There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

#### 11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

The COMPLETE CONTROL System, as designed and manufactured, is determined to be equivalent to the referenced predicate device.