Bioresearch 3/31/98 TMJ diagnosois software
Your firm failed to obtain a new 510(k) or pre-market approval after making significant changes to the BioPAK System. Analysis software, i.e., “The Interpreter,” was added to the system to aid in the diagnosis of temporomandibular joint disorders. In addition, your firm is promoting an indication for use (“implants”) that is not covered under your existing 51O(k)’s.
The SonoPAK device received 510(k) clearance on May 15, 1991 (K905657/A). A copy of the 51O(k) letter is enclosed. This letter informed Bio-Research that “…a new 51O(k) is necessary if you intend to make any change to the labeling, promotional material, or indication statement for the SonoPAK/QS, SonoPAK.” The letter also states that a new 510(k) is necessary for “…any change to your device’s system requirements specification including software and firmware.”