Section 882.5855 - Brain stimulation programming planning software(a)Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)Classification. Class II (special controls). The special controls for this device are: (1) Software verification, validation, and hazard analysis must be performed.(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.(3) Labeling must include: (i) The implanted brain stimulators for which the device is compatible.(ii) Instructions for use.(iii) Instructions and explanations of all user-interface components.(iv) A warning regarding use of the data with respect to not replacing clinical judgment.