(179 days)
Not Found
Yes
The device description explicitly mentions "Pattern Recognition technology" which is a common application of machine learning for classifying signals, in this case, muscle signals (EMG). The "CALIBRATE" module also suggests a training process, which is typical for ML-based pattern recognition systems.
No
The device is described as an advanced control solution for external prosthetic fittings of upper limbs, designed to enhance the functionality of a powered myoelectric prosthesis. It is not directly therapeutic but rather a component that improves the function of a prosthetic device.
No
The device is described as an advanced control solution for prosthetic fittings, enhancing the functionality of a powered myoelectric prosthesis by acquiring and translating muscle signals for intuitive control. Its purpose is to control a prosthetic device, not to diagnose a medical condition.
No
The device description explicitly lists multiple hardware components, including a main processor, amplifier, interface cables, and a USB dongle, in addition to the software.
Based on the provided information, the COMPLETE CONTROL System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "exclusively for external prosthetic fittings of the upper limbs." This clearly indicates a device used externally on the body for a prosthetic function, not for testing biological samples in vitro.
- Device Description: The description details a system that acquires and processes muscle signals (EMG) to control a prosthetic limb. This is a biomechanical control system, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances or markers in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The COMPLETE CONTROL System is a medical device, specifically a component of an external prosthetic system, but it does not fit the definition of an In Vitro Diagnostic device.
No
The letter does not 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
The COMPLETE CONTROL System is to be used exclusively for external prosthetic fittings of the upper limbs.
Product codes (comma separated list FDA assigned to the subject device)
GXY, IOZ
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.
- Device Interface Cable (clinician-specified termination type)
- COMPLETE CONTROLLER main processor
- COMPLETE CALIBRATE patient interface button
- COMPLETE CO-AMP consolidated EMG amplifier
- EMG Interface Cable
- Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
- Socket cut-out template for the COMPLETE CALIBRATE button
- COMPLETE COMMUNICATOR USB dongle
- COMPLETE CONTROLROOM software installation USB dongle
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
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:
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:
- 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
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.
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/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
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 |
4
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.
-
- Device Interface Cable (clinician-specified termination type)
-
- COMPLETE CONTROLLER main processor
-
- COMPLETE CALIBRATE patient interface button
-
- COMPLETE CO-AMP consolidated EMG amplifier
-
- EMG Interface Cable
-
- Fabrication aids for the COMPLETE CONTROLLER, COMPLETE CO-AMP, and COMPLETE CALIBRATE
-
- Socket cut-out template for the COMPLETE CALIBRATE button
-
- COMPLETE COMMUNICATOR USB dongle
-
- COMPLETE CONTROLROOM software installation USB dongle
5
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
Product GmbH | Device Comparison |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Trade Name | COMPLETE CONTROL
System | Axon Bus Prosthetic
System | |
| 510(k) Number | To be determined | K123795 | Not applicable |
| Classification
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
Code | IQZ (Hand, External Limb
Component, Powered) | IQZ (Hand, External Limb
Component, Powered) | Same |
| Indications for Use | The COMPLETE CONTROL
System is to be used
exclusively for external
prosthetic fittings of the
upper limbs. | The Axon-Bus Prosthetic
System is to be used
exclusively for
exoprosthetic fittings of
the upper limbs. | Same |
| Use/Field of
Application | The COMPLETE CONTROL
System is suitable for
unilateral or bilateral
amputations starting with
the transradial/
transhumeral amputation
level or, in case of
dysmelia, for forearm or
upper arm fittings. | The Axon-Bus Prosthetic
System is suitable for
unilateral or bilateral
amputations starting with
the transradial/
transhumeral amputation
level or, in case of
dysmelia, for forearm or
upper arm fittings. | Same |
| Conditions of Use | The COMPLETE CONTROL
System was developed for
everyday use and must
not be used for unusual | The Axon-Bus Prosthetic
System was developed for
everyday use and must
not be used for unusual | Same |
| Table 5A – Comparison of Characteristics | |
|---|---|
| ------------------------------------------ | -- |
6
| Manufacturer | Coapt, LLC | Otto Bock Health Care
Product GmbH | Device Comparison |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| Trade Name | COMPLETE CONTROL
System
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. | Axon Bus Prosthetic
System
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
Axon-Bus Prosthetic
System should not be
used for the operation of
motor vehicles or motor-
driven equipment. | |
| Mechanism of Action | The components of the
COMPLETE CONTROL
System are assembled by
a prosthetist according to
the individual needs of the
amputee. | The components of the
Axon-Bus Prosthetic
System are assembled by
a prosthetist according to
the individual needs of the
amputee. | Same |
| Power Requirements | 5.3-16.8 VDC
115 mA at 7.4 V | Li-Ion Battery
Various (1150/1500) | Differs |
| Physical Dimensions | | | |
| Central Control Unit | COMPLETE CONTROL ler
W: 25.9 mm (1.02 in)
L: 66.1 mm (2.60 in)
H: 13.5 mm (0.53 in) | AxonMaster
53 x 28 x 9 mm | Similar |
| | Complete Co-Amp
W: 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 Care
Product GmbH | Device Comparison |
| Trade Name | COMPLETE CONTROL
System | Axon Bus Prosthetic
System | |
| | 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) | 27 x 18 x 9.5 mm | Similar |
| | 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) | Not available | Assumed similar |
| Clinician Software
Tool | Yes
COMPLETE CONTROL
Room Software | Yes
Ottobock 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 60601-1-2 | Similar |
7
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
8
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.