According to a June 8, 2018 posting in the Federal Register, the FDA has decided to classify in vivo cured intramedullary fixation rods as class II (special controls) devices through the de novo process.
The devices will be identified as a “prescription implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent that polymerizes the monomer within the balloon creating a hardened rigid structure.”
IlluminOss Medical Initiative
The order was issued in response to a December 2016 de novo classification request from IlluminOss Medical, Inc. for the company’s IlluminOss Photodynamic Bone Stabilization System. “After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls,” FDA writes.
Special Controls
According to a posting in Regulatory Focus, the special controls include, “built-in safety measures to prevent cross-contamination, validation of cleaning and disinfection instructions in the submitted performance data, as well as device insertion and removal demonstrated via performance testing are some the special controls that FDA is calling for to address the potential risks to health, such as balloon leakage or device migration.”
De Novo Process
All medical devices are automatically assigned as class III device, until the FDA decides otherwise through 510(k) clearance or through de novo classification. Device makers typically use the de novo process if they believe there is no legally marketed device upon which to base a determination of substantial equivalence. If granted de novo classification, the device can serve as a predicate for future devices seeking 510(k) clearance.
In a November 1, 2016 press release, the company said its system was developed “with the potential to provide better patient experiences and outcomes than currently used nails and plates.”
The system has been in use in international markets since 2010, “where it has been observed to result in smaller incisions, shorter procedure times, and more rapid post-procedure patient mobility with reduced hospital stays and lower complication rates for patients.”
