(30 days)
The COMPLETE CONTROL System Gen2 is to be used exclusively for external prosthetic fittings of the upper limbs.
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
The acceptance criteria and study proving the device meets these criteria are detailed below. It is important to note that this document is a 510(k) summary for a medical device (COMPLETE CONTROL System Gen2), which aims to demonstrate substantial equivalence to a predicate device, not necessarily to independently prove the device's efficacy through extensive clinical trials as would be required for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | Pass |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Pass |
| Cabling Connection Test | Device functions as intended with relevant cabling. | Pass |
| Power On and Boot Test | Device powers on and boots up correctly. | Pass |
| Bluetooth Connectivity and Profile Test | Bluetooth connection established and maintained; profile functions as specified. | Pass |
| Inputs Test | Device correctly receives and processes all specified inputs. | Pass |
| Outputs Test | Device correctly generates and provides all specified outputs. | Pass |
| Calibration and Pattern Recognition Test | Device calibrates successfully and performs pattern recognition as intended. | Pass |
| File Save Test | Device successfully saves data/settings. | Pass |
| Ingress Protection and Material Strength | Compliance with IEC 60601-1 (for enclosure material) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data or typical sample sizes seen in clinical trials. The performance evaluation primarily focuses on non-clinical bench testing and adherence to international electrical safety and EMC standards. Therefore, an explicit sample size for human subjects or their data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary, as human clinical testing was not required for this submission. The tests performed were on the device itself.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the evaluation primarily involved non-clinical bench testing and adherence to standards, not the establishment of ground truth for diagnostic or prognostic interpretations by clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as above. The testing was objective measurement against predefined technical specifications and international standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not conducted and is not mentioned in this 510(k) summary. The submission focuses on demonstrating substantial equivalence to a predicate device through technical and performance comparisons, not on measuring human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The testing described is primarily standalone in nature, as it evaluates the device's adherence to electrical safety standards, EMC, and its internal functionality (cabling, power, Bluetooth, inputs, outputs, calibration, pattern recognition, file save). The "algorithm only" aspect is embedded within the "Calibration and Pattern Recognition Test," which confirms the device's ability to perform its core function. However, this is integrated into the device's overall performance testing rather than a separate, isolated algorithm-only study as might be conducted for an image analysis AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests was adherence to established international standards (IEC 60601-1 for electrical safety and physical characteristics, IEC 60601-1-2 for EMC) and the device's own internal design specifications and requirements. For the functional tests, the "ground truth" was whether the device performed its intended function as designed (e.g., connected, powered on, saved files).
8. The Sample Size for the Training Set
The document does not provide information about a "training set" sample size. The device uses "pattern recognition technology to non-invasively acquire user-specific muscle signals." For such systems, the "training set" typically refers to individual patient-specific muscle signal data used to train the system for that particular user. This is a personalized calibration process, not a large, general training dataset used for machine learning model development in the traditional sense as this is a medical device, not a diagnostic AI.
9. How the Ground Truth for the Training Set Was Established
As noted above, for myoelectric pattern recognition systems, the "training" involves a user-specific calibration process. The document states, "Patients can achieve control of their devices, eliminate control switching, and benefit from quick and powerful recalibration." This implies that the "ground truth" for each user's calibration is derived from their own movements and muscle signals, allowing the system to learn the unique patterns associated with their intended prosthetic movements. The system does not rely on a pre-established "ground truth" from a large, independent dataset for its core pattern recognition function, but rather on real-time muscle signal acquisition and mapping by the individual user.
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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
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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
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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
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
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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 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
- 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 | Coapt, LLC | Device |
|---|---|---|---|---|---|---|---|
| Trade Name: | COMPLETE CONTROLSystem Gen2 | COMPLETE CONTROLSystem | Trade Name: | COMPLETE CONTROLSystem Gen2 | COMPLETE CONTROLSystem | Comparison | |
| 510(k) Number | K191083 | K162891 | Not applicable | Use/Field ofApplication | for exoprosthetic fittingsof the upper limbs.The COMPLETECONTROL System Gen2is suitable for unilateral orbilateral amputations. | exoprosthetic fittings ofthe upper limbs.The COMPLETECONTROL System issuitable for unilateral orbilateral amputations. | Same |
| Classification Product Code | GXY | GXY | Same | Conditions of Use | The COMPLETECONTROL System Gen2was developed foreveryday use and must notbe used for unusualactivities. These activitiesinclude, for example,sports with excessivestrain and/or shocks to thewrist unit (pushups,downhill, mountainbiking) or extreme sports(free climbing,paragliding, etc.)Furthermore, theCOMPLETE CONTROLSystem should not be usedfor the operation of motorvehicles or motor-drivenequipment. | The COMPLETECONTROL System wasdeveloped for everydayuse and must not be usedfor unusual activities.These activities include,for example, sports withexcessive strain and/orshocks to the wrist unit(pushups, downhill,mountain biking) orextreme sports (freeclimbing, paragliding,etc.) Furthermore, theCOMPLETE CONTROLSystem should not beused for the operation ofmotor vehicles or motor-driven equipment. | Same |
| Regulation Number | 21 CFR 882.1320 | 21 CFR 882.1320 | Same | Mechanism of Action | The components of theCOMPLETE CONTROLSystem Gen2 areassembled by a prosthetistaccording to the individualneeds of the amputee. | The components of theCOMPLETE CONTROLSystem are assembled bya prosthetist according tothe individual needs ofthe amputee. | Same |
| Regulation Name | Cutaneous electrode | Cutaneous electrode | Same | Power Requirements | 5.0-20.0 VDC50 mA at 7.4V | 5.3-16.8 VDC115 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 COMPLETECONTROL System Gen2is to be used exclusively | The COMPLETECONTROL System is tobe used exclusively for | Same | Central Control Unit | Gen2 CompleteController (with DeviceInterface and EMGInterface connected)W: 60.3 mm (2.37 in)L: 52.2 mm (2.05 in)H: 8.0 mm (0.31 in) | Complete ControllerW: 25.9 mm (1.02 in)L: 66.1 mm (2.60 in)H: 13.5 mm (0.53 in) | Similar |
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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.
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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 CONTROLSystem Gen2 | COMPLETE CONTROLSystem | Comparison |
| n/a | Complete Co-AmpW: 21.4 mm (0.84 in)L: 47.8 mm (1.88 in)H: 9.6 mm (0.38 in) | Part ofController | |
| Gen2 Complete CalibrateButtonW: 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 socketface: 3.6 mm (0.14 in)Socket mounting hole cut-out size: 12.7 mm (0.5 in)diameter x 22.7 mm (0.89in) length | 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 holecut-out size: 14 x 24 mm(0.55 x 0.94 in) | Similar | |
| CommunicationComponent | Complete CommunicatorDongleW: 15.8 mm (0.62 in)L: 21.8 mm (0.86 in)H: 6.0 mm (0.24 in) | 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) | Similar |
| Miscellaneous | |||
| Clinician SoftwareTool | YesComplete ControlRoomSoftware | YesComplete ControlRoomSoftware | 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 61000-4-3IEC 61000-4-3IEC 61000-4-8IEC 60601-1-2CISPR 11FCC 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.
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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.
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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.
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 ProfileTest | Pass |
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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 RecognitionTest | 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.
§ 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).