NeuroOne Submits Special 510(k) Application Following Appeal

NeuroOne Medical Technologies has submitted a special 510(k) application for its stereo electroencephalography (sEEG) electrode.

The electrode is currently cleared for use with equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. But NeuroOne wants to extend the clearance for use on patients from less than 24 hours to less than 30 days.

The special submission followed the FDA’s decision that the device is not substantially equivalent to the reference product for the extended use. The agency said the company could submit a special 510(k) application with more information relating to subacute toxicity to support a finding of substantial equivalence.

Special 510(k) applications are usually reviewed within 30 days instead of 90 days for a traditional 510(k) submission.