(28 days)
Yes
The device description explicitly states that the system provides muscle contraction signals needed for "pattern recognition algorithms," which are a common component of machine learning systems used in myoelectric control.
No
Explanation: The Alpha Control Liner System is described as an interface solution that detects muscle contractions and converts signals into a digital format for controlling prosthetic devices. It does not directly provide therapy or treatment for a medical condition. Its function is to facilitate the control of a prosthetic, making it an accessory to a prosthetic device rather than a therapeutic device itself.
No
The device is an interface solution for prosthetic fittings, designed to convert muscle contraction signals into a digital format for controlling a prosthetic limb. It is not used for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a liner, module, module cap, lock, and electrodes.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "exoprosthetic fittings of the upper limbs." This clearly indicates a device used externally on the body for prosthetic purposes.
- Device Description: The description details a system that detects muscle contractions and converts them into digital signals for controlling a prosthetic limb. This is a biomechanical and control system, not a diagnostic test performed on samples taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition. The device's function is to facilitate the control of a prosthetic device based on muscle signals.
Therefore, the Alpha Control Liner System falls under the category of a medical device used for prosthetic control, not an In Vitro Diagnostic device.
No
The provided input text does not contain any language indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Alpha Control Liner System is an interface solution designed to provide the Complete Control System Gen2with amputee muscle contraction signals needed for the pattern recognition algorithms. The Alpha Control System integrates electronics into a fabric covered elastomeric prosthetic liner to non-invasively detect muscle contractions and convert the signals into a digital format. The Alpha Control System is a substitute for the EMG Interface Cable currently provided with the Complete Control System Gen2. Patients can achieve control of their devices and benefit from quick donning and doffing of the prosthesis. The Alpha Control System simplifies electrode placement and allows a prosthetist to spend less time fabricating the prosthesis as well as adjusting system settings and configurations.
The Alpha Control System is used in conjunction with the Coapt Complete Control System Gen2 and does not require an additional battery.
The Alpha Control System contains the following components.
- Alpha Control Liner (gel-lined user interface)
- Alpha Control Module (re-packaged Complete CO-AMP consolidated EMG amplifier, Covered under 510(k) number K162891)
- Module Cap (secures the Module inside the Liner)
- Alpha Control Lock (socket suspension and connection to Complete Controller)
- Electrodes (Covered under 510(k) number K190416)
- Fabrication aids for the Lock
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 Alpha Control Liner 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
- Cytotoxicity testing per ISO 10993-5
- Skin irritation testing per ISO 10993-10
- Sensitization testing per ISO 10993-10
The Alpha Control Liner System 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 |
|---|---|
| Liner Thickness | Pass |
| Liner Doffing Force | Pass |
| Donning/Doffing Fatigue | Pass |
| Liner Umbrella Static Loading | Pass |
| Liner Umbrella Fatigue Loading | Pass |
| Lead Impedance Fatigue | Pass |
| Lead Impedance - Corrosion | Pass |
| Lock Body Static Loading | Pass |
| Lock Body Fatigue Loading | Pass |
| Liner High Pot Test | Pass |
| Module High Pot Test | Pass |
| Module Level Test | Pass |
| Coapt System Integration Testing | Pass |
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.
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/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
January 11, 2023
Coapt Blair Lock CEO 303 W. Institute Pl. Suite 200 Chicago, Illinois 60610
Re: K223738
Trade/Device Name: Alpha Control Liner System (ACLS) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: December 14, 2022 Received: December 14, 2022
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tushar Bansal -S
for Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223738
Device Name Alpha Control Liner System (ACLS)
Indications for Use (Describe)
The Alpha Control Liner System is to be used exclusively for exoprosthetic 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
Image /page/3/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.
Special 510(k) Summary Alpha Control Liner System
1. Submitter Information
| Manufacturer: | Coapt, LLC |
|---|---|
| 303 W. Institute Pl. Suite 200 | |
| Chicago, IL 60610 | |
| Contact Person: | Blair Lock |
| CEO | |
| Contact Information: | 844-262-7800 x700 |
| blair.lock@coaptengineering.com | |
| Contract Manufacturer: | WillowWood Global, LLC |
| 15441 Scioto Darby Rd | |
| Mt. Sterling, OH 43143 | |
| Contact Person: | Matthew Wernke, PhD |
| Research and Development Manager | |
| Contact Information: | (740) 869-3377 |
| matt.wernke@willowwood.com | |
| Date Prepared: | December 12, 2022 |
2. Disclaimer
The submitting company requests that they are notified should a Freedom of Information Request is made to obtain a copy of this 510k application so that the company can properly identify any confidential information and redact it prior to public release.
3. Device Identification
| Trade/Proprietary Name: | Alpha Control Liner System (ACLS) |
|---|---|
| Common/Usual Name: | Cutaneous Electrode |
| Classification Name: | Electrode, cutaneous |
| Regulation Number: | 21 CFR §882.1320 |
| Product Code: | GXY, Cutaneous electrode |
| Subsequent Product Code: | Not applicable |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4
Image /page/4/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, while the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in gray.
4. Legally Marketed Predicate Device
| 510(k) Number | Device Name |
|---|---|
| K191083 | Coapt Complete Control System Gen2 |
5. Device Description
The Alpha Control Liner System is an interface solution designed to provide the Complete Control System Gen2with amputee muscle contraction signals needed for the pattern recognition algorithms. The Alpha Control System integrates electronics into a fabric covered elastomeric prosthetic liner to non-invasively detect muscle contractions and convert the signals into a digital format. The Alpha Control System is a substitute for the EMG Interface Cable currently provided with the Complete Control System Gen2. Patients can achieve control of their devices and benefit from quick donning and doffing of the prosthesis. The Alpha Control System simplifies electrode placement and allows a prosthetist to spend less time fabricating the prosthesis as well as adjusting system settings and configurations.
The Alpha Control System is used in conjunction with the Coapt Complete Control System Gen2 and does not require an additional battery.
The Alpha Control System contains the following components.
- Alpha Control Liner (gel-lined user interface) 1.
- Alpha Control Module (re-packaged Complete CO-AMP consolidated EMG amplifier, Covered under 510(k) number K162891)
-
- Module Cap (secures the Module inside the Liner)
-
- Alpha Control Lock (socket suspension and connection to Complete Controller)
-
- Electrodes (Covered under 510(k) number K190416)
-
- Fabrication aids for the Lock
6. Indication for Use Statement
The Alpha Control Liner System is to be used exclusively for exoprosthetic fittings of the upper limbs.
7. Comparison to Predicate Device
The following table compares the Alpha Control Liner System 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.
5
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 letters is the phrase "COMPLETE CONTROL" in gray.
| Manufacturer: | Coapt, LLC | WillowWood Global
LLC | Device
Comparison |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Trade Name: | COMPLETE CONTROL
System Gen2 | Alpha Control Liner
System | |
| 510(k) Number | K191083 | K223738 | Not applicable |
| Classification Product
Code | GXY | GXY | Same |
| Regulation Number | 21 CFR 882.1320 | 21 CFR 882.1320 | 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 Gen2
is to be used exclusively
for exoprosthetic fittings
of the upper limbs. | The Alpha Control Liner
System is to be used
exclusively for
exoprosthetic fittings of
the upper limbs. | Same |
| Use/Field of
Application | The COMPLETE
CONTROL System Gen2
is suitable for unilateral or
bilateral amputations. | The Alpha Control Liner
System is suitable for
unilateral or bilateral
amputations. | 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 Gen2 should not
be used for the operation
of motor vehicles or
motor-driven equipment. | The Alpha Control Liner
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
Alpha Control Liner
System should not be
used for the operation of
motor vehicles or motor-
driven equipment. | 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
Alpha Control Liner
System are assembled by
a prosthetist according to
the individual needs of
the amputee. | 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 |
| Manufacturer: | Coapt, LLC | WillowWood Global
LLC | Device
Comparison |
| Trade Name: | COMPLETE CONTROL
System Gen2 | Alpha Control Liner
System | |
| User-Interface
Materials | Electrodes: 316L Stainless
Steel | Electrodes: 316L
Stainless Steel | Same |
| | Liner: Not applicable | Liner: Tri-block
copolymer gel | Different;
Improvement
for electrode
contact |
| 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 | Similar |
| Biocompatibility
Testing Passed | ISO 10993-1 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Similar;
additional
Bio-
compatibility
testing
performed |
6
Image /page/6/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, and the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in a smaller font.
The design of the Alpha Control Liner System is similar to the predicate currently on the market. The Alpha Control Liner System is a substitute for one of the components of the predicate device and therefore is intended to work in conjunction with the predicate device. Together, they can be used for external prosthetic fittings of the upper limbs and are suitable for unilateral and bilateral 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 Alpha Control Liner System and the listed predicate device are classified as product code: GXY, cutaneous electrodes under 21 CFR 882.1320.
The Alpha Control Liner System contains hardware that is functionally equivalent to the predicate device. Both devices contain electronics that use various algorithms to process surface electromyography signals into a digital signal that can be used by the pattern recognition algorithm to control a prosthetic limb. The Alpha Control Liner System is designed to operate with the predicate device. The Alpha Control Liner System and the predicate 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 system can operate using a power source between 5.0-20.0VDC. The subject Alpha Control Liner System can operate using a slightly narrower voltage range, from 5.3-16.8 VDC. The slightly narrower operating voltage does not raise any concerns of safety or effectiveness, as the
7
Image /page/7/Picture/1 description: The image shows the logo for COAPT Complete Control. The word "COAPT" is in large, bold letters, with "CO" in orange and "APT" in gray. Below the word "COAPT" is the phrase "COMPLETE CONTROL" in smaller, gray letters. The logo is simple and modern, with a focus on the company's name.
subject device has passed electrical safety testing under IEC 60601-1, and in-house performance testing.
Another slight difference between the subject device and the predicate, Complete Control System Gen2 is the increased power consumption. The Complete Control System Gen2 uses less than half of the energy as the subject Alpha Control Liner System. This does not raise any concerns of safety and efficacy as the subject passed all required testing for electrical safety under IEC 60601-1, and inhouse performance testing.
The subject and predicate device differ slightly in their interface materials. The predicate device used an EMG Interface Cable to connect the electrodes to the controller electronics. This cable is routed on the outside of the socket by the prosthetist treating the patient. The subject Alpha Control Liner System suspends the cable pathways into a tri-block copolymer gel, fabric covered liner which is worn by the patient. This is an improvement to allow more consistent contact of the electrodes and skin within an exoprosthesis socket. This improvement is possible because the elastic properties of the elastomer and fabric allow the liner to stretch over the patient's limb and therefore have a constant pressure keeping the electrodes in contact with the skin. Since the Alpha Control Liner is worn by the patient, it must pass the signal to the socket. To best preserve the sEMG signals, the Alpha Control liner includes electronics that convert the sEMG signals to a digital signal before passing to the socket. The functions for signal amplification, filtering, and EMG (electromyography) signal transmission of the Alpha Control Liner System are based on the same design of the predicate device. This does not add or modify any existing risks as the subject device has passed all applicable safety and performance testing.
The predicate, Complete Control System Gen2 is used with passivated 316L stainless steel electrodes (K190416). This is the electrodes (K190416) embedded in the Alpha Control Liner System. The use of the same material for the electrodes for predicate and subject device do not raise any additional questions of safety, as the Alpha Control Liner System has been tested for biocompatibility to ISO 10993-1, 10993-5, and 10993-10. The predicate, Complete Control System Gen2 does not include a liner. The liner material of the Alpha Control Liner System does not raise any additional questions of safety, as the Alpha Control Liner System has been tested for biocompatibility to ISO 10993-1, 10993-5, and 10993-10.
The subject, Alpha Control Liner System is intended to be used with the Complete Control System Gen2. Therefore, the Alpha Control Liner System will use the same software tool, the Complete ControlRoom. The use of the same software tool does not raise any questions of safety and effectiveness as the Alpha Control Liner System has passed validation testing showing compatibility with the Complete Control System Gen2 and Complete ControlRoom software.
Both the subject device, Alpha Control Liner System, and predicate device, Complete Control System Gen2, underwent electrical safety testing for IEC 60601-1. Both devices received passing results. Additionally, the predicate device, Complete Control System Gen2, underwent electromagnetic compatibility testing in accordance with IEC 60601-1-2, CISPR 11, and FCC Part 15. These standards are not applicable to the subject device. Alpha Control Liner System, as it does not contain any wireless capabilities.
The predicate device, Complete Control System Gen2, does not come into contact with the user. Therefore, evaluation to the standard ISO 10993-1 for biocompatibility resulted in no tests being applicable. The subject device, Alpha Control Liner, comes into contact with healthy skin of the user. Therefore, evaluation to the standard ISO 10993-1 for biocompatibility resulted in testing to ISO 10993-5 for cytotoxicity, ISO 10993-10 for skin irritation, and ISO 10993-10 for sensitization. The Alpha Control Liner System received passing results for all three biocompatibility tests.
8
Image /page/8/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "COA" are in orange, while the letters "PT" are in gray. Below the letters is the text "COMPLETE CONTROL" in gray.
The subject device provides muscle contraction signals similar to the EMG Interface Cable of the predicate device. As with the predicate the subject device does not include prosthetic limbs.
8. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the Alpha Control Liner System and in showing substantial equivalence to the predicate device that is subject to this Special 510(k) submission, Coapt LLC and WillowWood Global LLC completed a number of non-clinical performance tests. The Alpha Control Liner System 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 Alpha Control Liner 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
- Cytotoxicity testing per ISO 10993-5 ●
- Skin irritation testing per ISO 10993-10
- . Sensitization testing per ISO 10993-10
The Alpha Control Liner System 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 |
|---|---|
| Liner Thickness | Pass |
| Liner Doffing Force | Pass |
| Donning/Doffing Fatigue | Pass |
| Liner Umbrella Static Loading | Pass |
| Liner Umbrella Fatigue Loading | Pass |
| Lead Impedance Fatigue | Pass |
| Lead Impedance - Corrosion | Pass |
| Lock Body Static Loading | Pass |
| Lock Body Fatigue Loading | Pass |
| Liner High Pot Test | Pass |
| Module High Pot Test | Pass |
| Module Level Test | Pass |
| Coapt System Integration Testing | Pass |
-
- Clinical Performance Data
9
Image /page/9/Picture/1 description: The image shows the logo for COAPT Complete Control. The letters "CO" are in orange, while the letters "APT" are in gray. Below the letters is the phrase "COMPLETE CONTROL" in gray.
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.
10. 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 Alpha Control Liner System 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 Alpha Control liner System has received passing results for safety testing for electrical safety, ingress protection, and mechanical strength; passing results for performance and usability testing for cabling connection, power on and boot, inputs, and outputs; and validation testing with compatible prosthetic devices.
The Alpha Control Liner System, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device.