09/09/96 NEURODYNE MEDICAL CORPORATION – Biofeedback units
Product labeling for the MEDAC System/3R states, “MEDAC System 3R–is a new configuration for rehabilitation & pain management applications where more than 2 EMGs are needed. All of the stress assessment software features of the standard MEDAC along with 4 channels of surface, PPG (heart rate, pulse height, etc.), 2 channels skin temperature/respiration, and skin conductance level are supported.”
The above-quoted product labeling is also used with the MEDAC System/3, Neuromuscular System/3, Biofeedback System/3, and Rehabilitation System/3. The inclusion of this product labeling with these devices implies that they can also be used in conjunction with the stress assessment software and in pain management applications.
Neither of the 510(k)’s submitted by Davicon, Inc. appears to include this intended use. The reference to the stress assessment software and the use of these devices for pain management is a major change in the intended use of these devices which would require a new premarket notification.
Product labeling for the MEDAC System/3 states, “[a]dditional software provided with the MEDAC System/3 consists of the Brief Physiological Stress Profile, and integrated versions of two third party programs, the Stress Audit and the Headache Checklist.”
Since no premarket notification was provided to cover the new intended uses of the devices specified above, and the devices were not found to be substantially equivalent to a predicate device, the devices are also adulterated within the meaning of Section 501(f)(1)(B) of the Act, in that they are Class III devices under Section 513(f) and do not have an approved application for premarket approval in effect pursuant to Section 515(a), or an approved application for an investigational device exemption under Section 520(g).
The devices specified above are further misbranded within the meaning of Section 502(o) of the Act, in that the devices were not included in a list required by Section 510(j) of the Act.