K Number

Device Name

COMPLETE CONTROL System Gen2

Manufacturer

Coapt, LLC

Date Cleared

2019-05-24

(30 days)

Product Code

GXY CUT IQZ

Regulation Number

882.1320

Intended Use

The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

Device Description

The COMPLETE CONTROL System Gen2 is an advanced control solution designed to provide the functionality of a powered myoelectric prosthesis for upper extremity amputees. The COMPLETE CONTROL System Gen2 employs pattern recognition technology to non-invasively acquire user-specific muscle signals for the control of industry-standard upper extremity prostheses. Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration. The COMPLETE CONTROL System Gen2 simplifies electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations. The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery. The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. The system has been validated for a specific set of prosthetic elbow, wrist and hand components which are listed in the user manual. The COMPLETE CONTROL System Gen2 contains the following components: - COMPLETE CONTROLLER main processor - Device Interface Cable (clinician-specified termination type) - EMG Interface Cable (clinician-specified termination type) - COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER) - Fabrication aid for the COMPLETE CONTROLLER - Socket cut-out template for the COMPLETE CALIBRATE Button - COMPELTE CONTROLROOM Application - COMPLETE COMMUNICATOR Dongle

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K162891

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The device description explicitly mentions "pattern recognition technology" used to acquire and control the prosthesis based on muscle signals. While not explicitly stating "AI" or "ML," pattern recognition in this context strongly implies the use of algorithms that learn and adapt to user-specific muscle patterns, which is a core application of machine learning. The mention of "quick and powerful recalibration" further supports this, suggesting an adaptive system.

Therapeutic

No.
The device is a control solution for prosthetic fittings, not a therapeutic device itself.

Diagnostic

The device is an advanced control solution for powered myoelectric prostheses, designed to acquire muscle signals for controlling upper extremity prostheses. It assists with prosthetic fitting and control, not with diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device description explicitly lists multiple hardware components, including a main processor, cables, a button, and a dongle, in addition to the software application.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is explicitly stated as being for "external prosthetic fittings of the upper limbs." This is a mechanical and electrical control system for a prosthetic device, not a diagnostic test performed on biological samples.
Device Description: The description details a system that acquires muscle signals (EMG) to control a prosthetic limb. It does not mention analyzing biological samples like blood, urine, or tissue.
Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
Performance Studies: The performance studies focus on electrical safety, EMC, and functional testing of the device's components and control capabilities. They do not involve clinical studies related to diagnosing a disease or condition.

In summary, the COMPLETE CONTROL System Gen2 is a medical device used for controlling a prosthetic limb, which falls under a different regulatory category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Overview

Intended Use / Indications for Use

The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

Product codes

GXY, IQZ

Device Description

The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery.

The COMPLETE CONTROL System Gen2 is an embedded system that is used in conjunction with an upper-limb prosthetic device. The system has been validated for a specific set of prosthetic elbow, wrist and hand components which are listed in the user manual.

The COMPLETE CONTROL System Gen2 contains the following components:

COMPLETE CONTROLLER main processor
Device Interface Cable (clinician-specified termination type)
EMG Interface Cable (clinician-specified termination type)
COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER)
Fabrication aid for the COMPLETE CONTROLLER
Socket cut-out template for the COMPLETE CALIBRATE Button
COMPELTE CONTROLROOM Application
COMPLETE COMMUNICATOR Dongle

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper limbs (for external prosthetic fittings)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Non-Clinical Performance Data

Coapt. LLC completed a number of non-clinical performance tests. The COMPLETE CONTROL System Gen2 meets all the 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 Gen2 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 Compatibility (EMC) testing per IEC 60601-1-2

The COMPLETE CONTROL System Gen2 was also 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	Pass
Power On and Boot Test	Pass
Bluetooth Connectivity and Profile Test	Pass
Inputs Test	Pass
Outputs Test	Pass
Calibration and Pattern Recognition Test	Pass
File Save Test	Pass

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K162891

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 24, 2019

Coapt, LLC Blair Lock Chief Executive Officer 222 W. Ontario Street, Suite #300 Chicago, Illinois 60654

Re: K191083

Trade/Device Name: COMPLETE CONTROL System Gen2 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY, IQZ Dated: April 11, 2019 Received: April 24, 2019

Dear Blair Lock:

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Carlos Peña, PhD, MS Director OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K191083

Device Name COMPLETE CONTROL System Gen2

Indications for Use (Describe)

The COMPLETE CONTROL System Gen2 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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Image /page/3/Picture/1 description: The image shows the logo for COAPT. The letters "CO" are in orange, and the letters "APT" are in gray. Below the letters is the text "COMPLETE CONTROL" in gray.

Special 510(k) Summary COMPLETE CONTROL System Gen2

1. Submitter Information

Manufacturer:	Coapt, LLC
	222 W. Ontario St., Suite 300
	Chicago, IL 60654
Contact Person:	Blair Lock, MScE, Peng
	Chief Executive Officer
Contact Information:	(844)262-7800 x700
	Blair.lock@coaptengineering.com
Date Prepared:	May 23rd, 2019

2. Device Identification

Trade/Proprietary Name:	COMPLETE CONTROL System Gen2
Common/Usual Name:	Cutaneous Electrode
Classification Name:	Electrode, cutaneous
Regulation Number:	21 CFR §882.1320
Product Code:	GXY, Cutaneous electrode
Subsequent Product Code:	IQZ, Hand, External Limb Component, Powered
Device Class:	Class II
Classification Panel:	Neurology

3. Legally Marketed Predicate Device

510(k) Number	Device Name
K162891	Coapt Complete Control System

4. Device Description

Image /page/4/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, and the letters "PT" are in gray. There is an orange dot between the "A" and the "P". Below the letters, the words "COMPLETE CONTROL" are written in gray.

electrode placement and allows a prosthetist to spend less time adjusting system settings and configurations.

The COMPLETE CONTROL System Gen2 is designed to work seamlessly with most major manufacturers' devices as an easy plug-and-play add-on and does not require an additional battery.

The COMPLETE CONTROL System Gen2 contains the following components:

COMPLETE CONTROLLER main processor
o Device Interface Cable (clinician-specified termination type)
EMG Interface Cable (clinician-specified termination type) ●
COMPLETE CALIBRATE Button (part of COMPLETE CONTROLLER) ●
Fabrication aid for the COMPLETE CONTROLLER ●
Socket cut-out template for the COMPLETE CALIBRATE Button ●
0 COMPELTE CONTROLROOM Application
COMPLETE COMMUNICATOR Dongle 0

5. Indication for Use Statement

The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.

6. Comparison to Predicate Device

The following table compares the COMPLETE CONTROL System Gen2 to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials used, 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 efficacy based on the similarities to the predicate device.

Manufacturer:	Coapt, LLC	Coapt, LLC	Device Comparison	Manufacturer:	Coapt, LLC
Trade Name:	COMPLETE CONTROL
System Gen2	COMPLETE CONTROL
System		Trade Name:	COMPLETE CONTROL
System Gen2	COMPLETE CONTROL
System	Comparison
510(k) Number	K191083	K162891	Not applicable	Use/Field of
Application	for exoprosthetic fittings
of the upper limbs.
The COMPLETE
CONTROL System Gen2
is suitable for unilateral or
bilateral amputations.	exoprosthetic fittings of
the upper limbs.
The COMPLETE
CONTROL System is
suitable for unilateral or
bilateral amputations.	Same
Classification Product Code	GXY	GXY	Same	Conditions of Use	The COMPLETE
CONTROL System Gen2
was developed for
everyday use and must not
be used for unusual
activities. These activities
include, for example,
sports with excessive
strain and/or shocks to the
wrist unit (pushups,
downhill, mountain
biking) or extreme sports
(free climbing,
paragliding, etc.)
Furthermore, the
COMPLETE CONTROL
System should not be used
for the operation of motor
vehicles or motor-driven
equipment.	The COMPLETE
CONTROL System was
developed for everyday
use and must not be used
for unusual activities.
These activities include,
for example, sports with
excessive strain and/or
shocks to the wrist unit
(pushups, downhill,
mountain biking) or
extreme sports (free
climbing, paragliding,
etc.) Furthermore, the
COMPLETE CONTROL
System should not be
used for the operation of
motor vehicles or motor-
driven equipment.	Same
Regulation Number	21 CFR 882.1320	21 CFR 882.1320	Same	Mechanism of Action	The components of the
COMPLETE CONTROL
System Gen2 are
assembled by a prosthetist
according to the individual
needs of the amputee.	The components of the
COMPLETE CONTROL
System are assembled by
a prosthetist according to
the individual needs of
the amputee.	Same
Regulation Name	Cutaneous electrode	Cutaneous electrode	Same	Power Requirements	5.0-20.0 VDC
50 mA at 7.4V	5.3-16.8 VDC
115 mA at 7.4 V	Similar
Subsequent Product Code	IQZ (Hand, External Limb Component, Powered)	IQZ (Hand, External Limb Component, Powered)	Same	Physical Dimensions
Indications for Use	The COMPLETE
CONTROL System Gen2
is to be used exclusively	The COMPLETE
CONTROL System is to
be used exclusively for	Same	Central Control Unit	Gen2 Complete
Controller (with Device
Interface and EMG
Interface connected)
W: 60.3 mm (2.37 in)
L: 52.2 mm (2.05 in)
H: 8.0 mm (0.31 in)	Complete Controller
W: 25.9 mm (1.02 in)
L: 66.1 mm (2.60 in)
H: 13.5 mm (0.53 in)	Similar

Image /page/5/Picture/1 description: The image shows the logo for COAPT. The letters "CO" are in orange, while the letters "APT" are in gray. Below the logo, the words "COMPLETE CONTROL" are written in gray.

Image /page/6/Picture/1 description: The image shows the logo for COAPT Complete Control. The word "COAPT" is in large letters, with the "C" and "O" in orange and the "A", "P", and "T" in gray. There is an orange dot in the middle of the "A". Below the word "COAPT" is the phrase "COMPLETE CONTROL" in smaller, gray letters.

Manufacturer:	Coapt, LLC	Coapt, LLC	Device
Trade Name:	COMPLETE CONTROL
System Gen2	COMPLETE CONTROL
System	Comparison
	n/a	Complete Co-Amp
W: 21.4 mm (0.84 in)
L: 47.8 mm (1.88 in)
H: 9.6 mm (0.38 in)	Part of
Controller
	Gen2 Complete Calibrate
Button
W: 16.9 mm (0.67 in)
L: 26.9 mm (1.06 in)
H: 9.6 mm (0.38 in)
Depth below socket face:
3.9 mm (0.15 in)
Protrusion above socket
face: 3.6 mm (0.14 in)
Socket mounting hole cut-
out size: 12.7 mm (0.5 in)
diameter x 22.7 mm (0.89
in) length	Complete Calibrate
W: 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 socket
face: 4.0 mm (0.16 in)
Socket mounting hole
cut-out size: 14 x 24 mm
(0.55 x 0.94 in)	Similar
Communication
Component	Complete Communicator
Dongle
W: 15.8 mm (0.62 in)
L: 21.8 mm (0.86 in)
H: 6.0 mm (0.24 in)	Complete Communicator
W: 21.8 mm (0.86 in)
L: 69.2 mm (2.72 in)
including USB end-cap
H: 16.1 mm (0.63 in)	Similar
Miscellaneous
Clinician Software
Tool	Yes
Complete ControlRoom
Software	Yes
Complete ControlRoom
Software	Similar
Electrical Safety
Testing Passed	IEC 60601-1
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
IEC 60601-1-2
CISPR 11
FCC Part 15	IEC 60601-1
IEC 61000-4-3
IEC 61000-4-3
IEC 61000-4-8
IEC 60601-1-2
CISPR 11
FCC Part 15	Same
Housing Material	Polyurethane	Polyjet	Similar

The design of the COMPLETE CONTROL System Gen2 is similar to the predicate and many other offerings on the market. The COMPLETE CONTROL System Gen2, like the predicate device, can be used for external prosthetic fittings of the upper limbs.

Image /page/7/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, while the letters "PT" are in gray. Below the letters is the phrase "COMPLETE CONTROL" in gray.

The COMPLETE CONTROL System Gen2 and the listed predicate device, are classified as product code: GXY, cutaneous electrodes under 21 CFR 882.1320, with subsequent product code IQZ for hand, external limb component, powered.

The COMPLETE CONTROL System Gen2 and its predicate are solely for exoprosthetic use. The field of use/application is the same for the subject and predicate device. They are both used for the control of myoelectric exoprostheses and are suitable for unilateral amputations. The subject and predicate device also share the same conditions for use and must only be used for normal daily activities, as listed in the labeling.

The COMPLETE CONTROLLER contains hardware that is functionally equivalent to the predicate device. Both devices contain electronics that use various algorithms to drive a prosthetic limb. As with the predicate, the COMPLETE CONTROL System Gen2 is designed to operate with a wide range of prosthetic devices. The COMPLETE CONTROL System Gen2 and the predicate COMPLETE CONTROL System are the same in that they are not provided with a power source. They are both rated to functioning at similar voltages. The predicate COMPLETE CONTROL System can operate using a power source between 5.3-16.8 VDC. The subject, COMPLETE CONTROL System Gen2 can operate using a slightly expanded voltage range, from 5.0-20.0VDC, the slightly expanded operating voltage does not raise any concerns of safety or effectiveness, as the subject device has passed electrical safety testing under IEC 60601, and in-house performance testing. Another slight difference between the subject device and the predicate, COMPLETE CONTROL System is the decreased power consumption. The COMPLETE CONTROL System Gen2 uses less than half of the energy as the predicate COMPLETE CONTROL System. This was an optimization of the COMPELTE CONTROL System Gen2 and does not raise any concerns of safety and efficacy as the subject passed all required testing for electrical safety.

The subject and predicate device are also similar in size because they must be able to fit inside of an exoprosthesis socket. The subject device has a slightly smaller footprint than the predicate COMPLETE CONTROL System. This is an optimization to allow the system to have a better fit into an exoprosthesis socket. The slight difference in size between the subject device and predicate does not add or modify any existing risks or raise any concerns of safety and efficacy.

The COMPLETE CO-AMP of the predicate device is not present in the COMPLETE CONTROL System Gen2. Rather, the functions for signal amplification, filtering, and EMG (electromyography) signal transmission are incorporated within the COMPLETE CONTROLLER of the COMPLETE CONTROL System Gen2. The purpose of this change is to decrease the number of parts and optimize space usage within a myoelectric prosthetic. This difference between the subject device and the predicate does not add or modify any existing risks as the subject device has passed all applicable safety and performance testing.

The enclosure material in the predicate COMPLETE CONTROL System (unmodified device) is comprised of Polyjet, whereas the subject COMPLETE CONTROL System Gen2 is comprised of cast Polyurethane plastic. Polyjet is a reliable material as noted in the predicate device and is very applicable for implants. Nonetheless, Cast Polyurethane was chosen for the COMPLETE CONTROL System Gen2 because of its combination of low production cost and high quality finish. The flexibility of the silicone mold also makes designing for undercuts or draft unnecessary. The change in material does not raise any concerns of safety or efficacy, as the COMPLETE CONTROL System Gen2 has passed the same IEC 60601-1 testing for ingress protection and material strength as the predicate, COMPLETE CONTROL System. Also, the change in enclosure material does not affect the biocompatibility of the device since the enclosure is placed within another manufacturer's prosthesis and does not come into contact with the patient.

Image /page/8/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, and the letters "PT" are in gray. Below the letters is the phrase "COMPLETE CONTROL" in a smaller font.

The subject device provides similar advanced electronic control and algorithms that control the different limb prosthetics. As with the predicate, COMPLETE CONROL System, the subject device does not include prosthetic limbs.

The COMPLETE CONTROL System Gen2 electronic components are similar to the predicate device and many other offerings on the market. Both devices manage EMG inputs and control signals to drive a prosthetic limb. The use of the same algorithm in the Gen1 and Gen2 versions of the COMPELTE CONTROL System does not raise any concerns of safety or effectiveness.

One of the core software differences between the predicate COMPLETE CONTROL System and the COMPLETE CONTROL System Gen2 is the addition of a mobile app for the user. The mobile app allows the user to easily recalibrate the prosthesis without the requirement of a computer. The COMPLETE CONTROLROOM software that accompanies the COMPLETE CONTROL System Gen2 is designed to be the same as the COMPLETE CONTROLROOM application provided for the predicate device, it is just optimized to now be provided in a mobile application format, in addition to the pc application format.

The COMPLETE CONTROL System Gen2 is similar regarding physical characteristics and design to the COMPLETE CONTROL System (unmodified device). The COMPLETE CONTROL System Gen2 shares the same indications for use, device operation, overall technical and functional capabilities, and therefore is substantially equivalent to the predicate COMPLETE CONTROL System.

7. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the COMPLETE CONTROL System Gen2 and in showing substantial equivalence to the predicate device that is subject to this Special 510(k) submission. Coapt. LLC completed a number of non-clinical performance tests. The COMPLETE CONTROL System Gen2 meets all the requirements for overall design and electrical safety results, confirming that the design output meets the design inputs and specifications for the device.

Electrical safety testing per IEC 60601-1 .
. Electromagnetic Compatibility (EMC) testing per IEC 60601-1-2

Test Name	Result
Cabling Connection Test	Pass
Power On and Boot Test	Pass
Bluetooth Connectivity and Profile
Test	Pass

Image /page/9/Picture/1 description: The image shows the logo for COAPT. The letters "COA" are in orange, and the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in gray.

Inputs Test	Pass
Outputs Test	Pass
Calibration and Pattern Recognition
Test	Pass
File Save Test	Pass

8. Clinical Performance Data

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

9. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device when the 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 different questions regarding its safety and effectiveness as compared to the predicate device(s).

The technological characteristics between the COMPLETE CONTROL System Gen2 and predicate are remarkably similar and therefore substantially equivalent. The slight differences between devices do not raise new questions of safety and effectiveness as compared to the predicate as the COMPLETE CONTROL System Gen2 has received passing results for safety testing for electrical safety, electromagnetic compatibility, ingress protection, and mechanical strength: passing results for performance testing for cabling connection, power on and boot, bluetooth connectivity and profile, inputs, outputs, calibration and pattern recognition, and file save; and validation testing with compatible prosthetic devices.

The COMPLETE CONTROL system Gen2, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.