(238 days)
The DIXI Medical Microdeep Depth Electrodes are intended for temporary (
The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping.
The DIXI Medical Microdeep Depth Electrode is intended for temporary (
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).