|Company:||Precision Biometrics, Inc.|
|Subject:||Device/Lacks Premarket Approval Application/Adulterated/Misbranded|
|Issuer:||Center for Devices and Radiological Health|
|Issued:||Nov. 28, 2007||Closed:||
Department of Health and Human Services
Public Health Service
Center for Devices and
NOV 28 2007
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
Precision Biometrics, Inc.
981-A Industrial Road
San Carlos, California 94070
Dear Mr. Marcarian:
We are writing to you because your firm is marketing the MyoVision 8000 Static Surface EMG System (M8) and the Dynamic Surface EMG System (D4) in the United States for new intended uses that go beyond your marketing clearance from the Food and Drug Administration (FDA). The MyoVision 8000 Static Surface EMG System (M8) and the Dynamic Surface EMG System (D4) are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are intended for use in the cure, mitigation, treatment, prevention, or diagnosis of a disease or medical condition, or because they are intended to affect the structure or any function of the body, 21 U.S.C. 321(h).
The Act generally requires manufacturers of medical devices to obtain marketing approval or clearance for their products from FDA before they may offer them for sale. This helps protect the public health by ensuring that new medical devices are shown to be both safe and effective or substantially equivalent to other devices already legally marketed in this country.
A review of our records reveals that a premarket notification, K882062, was submitted for a device identified as Biostar™ (later changed to MyoVision) by a firm identified as Targus Concepts (later changed to Precision Biometrics, Inc.), Redwood City, California. By letter addressed to you dated June 17, 1988, FDA issued a substantial equivalence determination, permitting the Biostar™ to be marketed as a biofeedback device. A biofeedback device as classified in Title 21, Code of Federal Regulations , section 882.5050 states that, "A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters."
The Food and Drug Administration sent you a letter dated August 30, 2004, asking, among other things, for the identification of the premarket notification for the devices identified as the MyoVision 8000 Static Surface Electromyography (SEMG) System and the Dynamic Surface electromyography (EMG) module. Your response, dated January 26, 2005, stated that these devices were allowed to be marketed under premarket notification number K882062.
On October 31, 2007, FDA's Center for Devices and Radiological Health (CDRH), Office of Compliance (OC), reviewed your internet web site, www.myovision.com. The following statements were made for the Static sEMG System (M8) and the Dynamic sEMG System (D4):
"How do we look for vertebral subluxations with MyoVision?"
"Computerized SEMG Scanning provides qualitative and quantitative data to assist the Doctor of Chiropractic in evaluating which areas/levels of the nervous system are being adversely affected by Vertebral Subluxations."
Your 510(k) submission did not support diagnostic indications for your product such as "evaluating which areas/levels of the nervous system are being adversely affected by Vertebral Subluxations." According to our records, your firm has not obtained marketing clearance or approval from FDA for this new intended use for your Static sEMG System (M8) and the Dynamic sEMG System (D4). The use of language on your web site which states or implies that the Static sEMG System (M8) and the Dynamic sEMG System (D4) may be used for diagnostic purposes such as to evaluate "which areas/levels of the nervous system are being adversely affected by Vertebral Subluxations" indicates a major modification in the intended use of these devices and requires a new premarket submission. [21 CFR 807.81(a)(3)(ii)].
Because you did not receive premarket clearance or approval from FDA to market your Static sEMG System (M8) and the Dynamic sEMG System (D4) for use in "evaluating which areas/levels of the nervous system are being adversely affected by Vertebral Subluxations," marketing them for this new intended use is a violation of the law. Specifically, the devices are adulterated under section 501(f)(1)(B) of the Act [21 U.S.C. 351(f)(1)(B)] because you do not have an approved Premarket Approval Application (PMA) to demonstrate that they are safe and effective for the new intended use. 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 them into commercial distribution for the new intended use, as required by section 510(k) of the Act [21 U.S.C. 360(k)], and 21 CFR 807.81(a)(3)(ii). For a device requiring premarket approval, the notification required by section 510(k) of the Act is deemed satisfied when a PMA is pending before the agency. [21 C.F.R. 807.81(b)]
FDA requests that Precision Biometrics, Inc. immediately cease marketing the Static sEMG System (M8) and the Dynamic sEMG System (D4) for use in "evaluating which areas/levels of the nervous system are being adversely affected by Vertebral Subluxations" as described above. Please submit a written response within fifteen (15) working days from the date you receive this letter describing your intent to comply with this request. Please direct your response to Mr. William C. MacFarland at the Food and Drug Administration, 2094 Gaither Road (HFZ-343), Rockville, Maryland 20850, facsimile at (240)276-0325.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that you comply with each applicable requirement of the Act and FDA implementing regulation
Timothy A. Ulatowski
Office of Compliance
Center for Devices and