Inspections, Compliance, Enforcement, and Criminal Investigations
Neuro Kinetics, Inc. 30-Sep-08
Department of Health and Human Services
Public Health Service
VIA FEDERAL EXPRESS
September 30, 2008
J. Howison Schroeder
President & CEO
Neuro Kinetics, Inc.
128 Gamma Drive
Pittsburgh, PA 15238-2920
Dear Mr. Schroeder:
Based on an inspection of your firm located in Pittsburgh, Pennsylvania on August 15, 16, 21, 2007, and October 10, 2007, and a telephone conversation on August 21, 2008, the Food and Drug Administration (FDA) has learned that your firm is marketing Neuro-Otological Test Center products intended for use in vestibular analysis, such as the Rotary/Barany Chair Assembly, I-Portal Video Nystagmograph, Opto-Kinetic Projection System, Pursuit Tracker Laser Diode Stimulus, and VEST 6.0 Operating Software in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
Under section 201(h) of the Act, Neuro-Otological Test Center products intended for use in vestibular analysis, such as the Rotary/Barany Chair Assembly, I-Portal Video Nystagmograph, Opto-Kinetic Projection System, Pursuit Tracker Laser Diode Stimulus, and VEST 6.0 Operating Software are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body, 21 U.S.C. 321(h). The Act requires that manufacturers of devices that are not exempt obtain marketing approval or clearance for their products from the FDA before they may offer them for sale. This helps protect the public health by ensuring that new devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country for which approval is not required.
The Office of Device Evaluation (ODE) has reviewed your marketing brochure and has determined that a significant change has been made to the Rotary/Barany Chair Assembly cleared under K781268 (Computerized Rotary Vestibular Chair) that requires submission of a new 510(k). Specifically, the control mechanism has been changed from little to no software control over chair movement to significant and extensive software control of chair movement. This change represents a major redesign of the product and raises new questions of safety and effectiveness, because the ability of the extensive software control to safely or effectively operate the chair is unknown.
Failure to obtain marketing approval or clearance before you began offering your product for sale is a violation of the law. Specifically, the Rotary/Barany Chair Assembly, I-Portal Video Nystagmograph, Opto-Kinetic Projection System, Pursuit Tracker Laser Diode Stimulus, and VEST 6.0 Operating Software are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(l)(B), because you do 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). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k). 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 you need to submit in order to obtain approval or clearance for your devices are described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
You 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 Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please let this office know in writing what steps you have taken to correct the problem within fifteen (15) working days from the date you received this letter. We also ask that you explain how you plan to prevent this from happening again. If you need more time, let us know why and when you expect to complete your correction.
Your response should be sent to: Thomas D. Gardine, RM901 HFR-CE100 U.S. Custom House, Philadelphia, Pennsylvania, 19106-2973. If you have any questions about the content of this letter please contact: Richard C. Cherry, Compliance Officer, at (215) 717-3075 (phone) or (215) 597-8212 (fax).
Finally, you should understand that there are many FDA requirements pertaining to the manufacture and marketing of devices. This letter pertains only to the issue of premarket review for your device and does not necessarily address other obligations you have under the law.
Thomas D. Gardine