Inspections, Compliance, Enforcement, and Criminal Investigations

Coapt LLC 1/8/16

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863 

 

January 8, 2016
 
WARNING LETTER
 
CHI-2-16
 
 
VIA UPS NEXT DAY
Mr. Blair A. Lock
Chief Executive Officer
Coapt, LLC
222 W. Ontario Street, Unit # 220
Chicago, Illinois 60654
 
Re: Coapt Complete Control System
Refer to CMS # 448309
 
Dear Mr. Lock:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the Coapt Complete Control Pattern Recognition System (Coapt Complete Control System) in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act). Under section 201(h) of the Act, 21 U.S.C. 321(h), this product is a device because it is intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body. 
 
FDA has reviewed your firm’s website (www.coaptengineering.com) and determined that the Coapt Complete Control System is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g), for the device as described and marketed.  The Coapt Complete Control System is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because your firm did not notify the Agency of your firm’s intent to introduce the device into interstate commerce, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
 
Specifically, a review of your firm’s FDA registration and listing has revealed that the Coapt Complete Control System is listed under 21 C.F.R. 890.1175 (Electrode Cable). Devices listed under 21 C.F.R. 890.1175 are exempt from premarket notification unless they exceed the limitations on exemption at 21 C.F.R. 890.9. Generic devices of this type are “composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.” However, according to your firm’s website, the Coapt Complete Control System introduces different fundamental scientific technology, such as:
  • “Complete Controller: This unit houses a powerful microcontroller – similar to what is found in your smartphone – that receives the signals from the COMPLETE CO-AMP and recognizes your signal patterns. Your signal patterns are then used to command the prosthesis: putting you in control.”
  • “Complete Co-Amp: This impossibly-small unit reads up to eight electrode pairs and conditions the signals for the COMPLETE CONTROLLER.”
  • “The Complete Calibrate: This button, which is mounted onto the prosthetic socket, can be pressed at any time to recalibrate control. Whether at home or on-the-go, you are always empowered to get the most from your prosthesis.”
  • “The Complete Communicator: This USB device plugs into the practitioner’s computer and allows wireless connection to our COMPLETE CONTROLROOM™ software for robust setup and practice tools.”
  • “The Complete Controlroom: Coapt has studied industry practitioners to develop a software interface that makes sense. This simple but powerful user interface allows practitioners to quickly adjust settings on their users' new COMPLETE CONTROL hardware and provide a learning environment for all.” 
Because the Coapt Complete Control System operates using a different fundamental scientific technology than a legally marketed device classified under 21 C.F.R. 890.1175,it exceeds the limitations described in 21 C.F.R. 890.9(b) and is not exempt from premarket notification. 
 
The Agency believes that the Coapt Complete Control System is more appropriately classified as a Cutaneous Electrode under 21 C.F.R. 882.1320, product code GXY, because the Coapt Complete Control System shares similar intended uses and technologies as devices classified under that regulation and product code. Cutaneous Electrodes are Class II devices and typically require 510(k) premarket notification.
 
For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency.  21 C.F.R. 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at
 
 
The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
 
Our office requests that Coapt, LLC immediately cease activities that result in the misbranding or adulteration of the Coapt Complete Control System, such as the commercial distribution of the device for the uses discussed above.
 
Your firm should take prompt action to correct the violations addressed in this letter.  Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and civil money penalties.  Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. 
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrections and/or corrective actions (which must address systemic problems) your firm has taken.  If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities.  If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
 
Your response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 448309) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224 or via email at carrie.plucinski@fda.hhs.gov.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
 
Sincerely,
/S/
William R. Weissinger
District Director

Page Last Updated: 06/14/2017
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