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)
1. COMPLETE CONTROLLER main processor
1. COMPLETE CALIBRATE patient interface button
1. COMPLETE CO-AMP consolidated EMG amplifier
1. EMG Interface Cable
1. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
1. Socket cut-out template for the COMPLETE CALIBRATE button
1. COMPLETE COMMUNICATOR USB dongle
1. COMPLETE CONTROLROOM software installation USB dongle

AI/ML Overview

This document, a 510(k) summary for the "COMPLETE CONTROL System" by Coapt, LLC, outlines the device's characteristics and its comparison to a predicate device to establish substantial equivalence for regulatory clearance. It focuses on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., accuracy, precision, latency) for the device's core function (pattern recognition for myoelectric control). Instead, the "acceptance criteria" are implied to be conformance to various standards and the successful completion of internal validation tests.

Acceptance Criteria (Implied)	Reported Device Performance
I. Conformance to Standards
Electrical safety per IEC 60601-1	Passed
Electromagnetic Disturbance (EMD) per IEC 60601-1-2	Passed
II. Internal Validation Testing
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
Meets device specifications and requirements and operates as intended	Confirmed (through internal testing)
Meets design inputs and specifications	Confirmed (through internal testing and electrical safety)

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a test set with a specific sample size used for performance evaluation related to the device's primary function of pattern recognition for myoelectric control. The non-clinical performance data described relates to engineering verification and validation testing of the hardware and software components.

The data provenance for these engineering tests would typically be internal laboratory testing conducted by Coapt, LLC or a contracted testing facility. No information about country of origin of data or retrospective/prospective nature is provided for these engineering tests.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This information is not applicable and not provided in the document because the performance evaluation relies on engineering tests and conformance to standards, not on clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document, as there was no test set requiring expert adjudication for clinical or performance outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done and is not mentioned in the document. The device is a "Cutaneous Electrode" (Class II, Product Code GXY) that enhances the control of existing prosthetic devices; it's not a diagnostic imaging device where MRMC studies are typically performed. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) Was Done

The document describes "Calibration and Pattern Recognition Test" and "Feature Extraction Test" which would involve the algorithm operating in a standalone manner, processing signals and performing its designated function. However, the exact methodology, metrics, and quantitative results of these algorithm-only tests are not detailed beyond stating they "Passed."

7. The Type of Ground Truth Used

For the engineering tests (e.g., cabling, power, wireless), the ground truth is simply the expected operational output or state of the system (e.g., cable connected correctly, power on, wireless connected). For the "Calibration and Pattern Recognition Test" and "Feature Extraction Test," the ground truth would be the expected or correct pattern recognition output based on the input EMG signals, but the specifics of how this ground truth was defined or evaluated are not elaborated. There is no mention of expert consensus, pathology, or outcomes data as ground truth for these tests.

8. The Sample Size for the Training Set

The document does not mention the sample size for a training set. While the device utilizes "Pattern Recognition technology," the details of its development and training, including the dataset size, are not provided in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document. Given the use of "Pattern Recognition technology," a training set with associated ground truth (e.g., specific muscle movements or intentions linked to EMG patterns) would typically be required, but the document does not elaborate on this aspect of the device's development.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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: (512) 327.9997

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 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 contains the following components.

1. Device Interface Cable (clinician-specified termination type)
1. COMPLETE CONTROLLER main processor
1. COMPLETE CALIBRATE patient interface button
1. COMPLETE CO-AMP consolidated EMG amplifier
1. EMG Interface Cable
1. Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
1. Socket cut-out template for the COMPLETE CALIBRATE button
1. COMPLETE COMMUNICATOR USB dongle
1. 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 CareProduct GmbH	Device Comparison
Trade Name	COMPLETE CONTROLSystem	Axon Bus ProstheticSystem
510(k) Number	To be determined	K123795	Not applicable
ClassificationProduct Code	GXY	GXY	Same
Regulation Number	21 CFR 890.3450	21 CFR 890.3450	Same
Regulation Name	Cutaneous electrode	Cutaneous electrode	Same
Subsequent ProductCode	IQZ (Hand, External LimbComponent, Powered)	IQZ (Hand, External LimbComponent, Powered)	Same
Indications for Use	The COMPLETE CONTROLSystem is to be usedexclusively for externalprosthetic fittings of theupper limbs.	The Axon-Bus ProstheticSystem is to be usedexclusively forexoprosthetic fittings ofthe upper limbs.	Same
Use/Field ofApplication	The COMPLETE CONTROLSystem is suitable forunilateral or bilateralamputations starting withthe transradial/transhumeral amputationlevel or, in case ofdysmelia, for forearm orupper arm fittings.	The Axon-Bus ProstheticSystem is suitable forunilateral or bilateralamputations starting withthe transradial/transhumeral amputationlevel or, in case ofdysmelia, for forearm orupper arm fittings.	Same
Conditions of Use	The COMPLETE CONTROLSystem was developed foreveryday use and mustnot be used for unusual	The Axon-Bus ProstheticSystem was developed foreveryday use and mustnot be used for unusual	Same

Table 5A – Comparison of Characteristics
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Manufacturer	Coapt, LLC	Otto Bock Health CareProduct GmbH	Device Comparison
Trade Name	COMPLETE CONTROLSystemactivities. These activitiesinclude, for example,sports with excessivestrain and/or shocks tothe wrist unit (pushups,downhill, mountainbiking) or extreme sports(free climbing, paragliding,etc.) Furthermore, theCOMPLETE CONTROLSystem should not beused for the operation ofmotor vehicles or motor-driven equipment.	Axon Bus ProstheticSystemactivities. These activitiesinclude, for example,sports with excessivestrain and/or shocks tothe wrist unit (pushups,downhill, mountainbiking) or extreme sports(free climbing, paragliding,etc.) Furthermore, theAxon-Bus ProstheticSystem should not beused for the operation ofmotor vehicles or motor-driven equipment.
Mechanism of Action	The components of theCOMPLETE CONTROLSystem are assembled bya prosthetist according tothe individual needs of theamputee.	The components of theAxon-Bus ProstheticSystem are assembled bya prosthetist according tothe individual needs of theamputee.	Same
Power Requirements	5.3-16.8 VDC115 mA at 7.4 V	Li-Ion BatteryVarious (1150/1500)	Differs
Physical Dimensions
Central Control Unit	COMPLETE CONTROL lerW: 25.9 mm (1.02 in)L: 66.1 mm (2.60 in)H: 13.5 mm (0.53 in)	AxonMaster53 x 28 x 9 mm	Similar
	Complete Co-AmpW: 21.4 mm (0.84 in)L: 47.8 mm (1.88 in)H: 9.6 mm (0.38 in)
Manufacturer	Coapt, LLC	Otto Bock Health CareProduct GmbH	Device Comparison
Trade Name	COMPLETE CONTROLSystem	Axon Bus ProstheticSystem
	Complete CalibrateW: 17.8 mm (0.70 in)L: 27.6 mm (1.09 in)H: 11.7 mm (0.46 in)Depth below socket face:7.6 mm (0.30 in)Protrusion above socketface: 4.0 mm (0.16 in)Socket mounting hole cut-out size: 14 x 24 mm (0.55x 0.94 in)	27 x 18 x 9.5 mm	Similar
	Complete CommunicatorW: 21.8 mm (0.86 in)L: 69.2 mm (2.72 in)including USB end-capH: 16.1 mm (0.63 in)	Not available	Assumed similar
Clinician SoftwareTool	YesCOMPLETE CONTROLRoom Software	YesOttobock Software	Similar
Electrical SafetyTesting Passed	IEC 60601-1IEC 61000-4-3IEC 61000-4-3IEC 61000-4-8IEC 60601-1-2CISPR 11FCC Part 15	IEC 60601-1IEC 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.

Regulation Number and Section

§ 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).