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The intended use of the Cyberkinetics Neurotechnology Systems, Inc. NeuroPort Microelectrode Array System is for temporary (< 30 days) recording and monitoring of brain electrical activity.

The NeuroPort Array connects to the NeuroPort System (510(k) K042626 and K060523). This combination of devices supports recording and display of local field potentials and extra cellular spikes from the brain. The NeuroPort System is not modified by this 510(k) submission. The NeuroPort Array has 100 electrode contacts on a silicon substrate of 4 mm by 4 mm. The NeuroPort Array is implanted in the cortex of the brain for less than 30 days. The NeuroPort Array passes neural activity of the brain cortex to the NeuroPort System through the Patient Cable. The NeuroPort Array consists of high impedance electrodes. The NeuroPort Array impedance is in the range of 0.1 to 1.0 Meg ohms per electrode. The modification described within this 510(k) submission is summarized as providing a 1.5 mm length NeuroPort Array option in addition to the cleared to market 1,0 mm NeuroPort Array option. Along with the longer NeuroPort Array, the Inserter Wand applied to place the NeuroPort Array is modified to support a variation with the 0.5 mm additional insertion depth.