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ZapStim Controller Application is intended for use with the Neurosoft TMS system and is indicated for use in delivering the FDA cleared treatment protocol for treatment of Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode.

ZapStim Controller Application is a software application that is indicated to be used by clinicians for the treatment of Major Depressive Disorder. The software resides on a computer system and functions by controlling a third party TMS system (Neurosoft Cloud TMS system, K173441). ZapStim Controller Application software is to be used in place of the Neurosoft TMS User interface for setting certain aspects of the treatment administered by the TMS system. The third party TMS system will physically deliver the therapy to the patient. The ZapStim Controller Application is compatible with the Neurosoft TMS System, K173441, and it is intended to be used in tandem with the Neurosoft TMS System to provide treatment. The software includes a user interface that allows the user to control limited aspects of the treatment administered by the TMS system. The system is currently intended to deliver the FDA cleared treatment protocol for MDD as stated in the indications for use. The ZapStim software is compatible and is to be used in tandem with the specific Neurosoft TMS System components listed below: - Main unit of the magnetic stimulator . - Cooling unit - Extra power supply unit ● - Cooled figure-of-eight coil AFEC-02-100-C ● - USB A to B cable . The ZapStim Controller Application consists of the following main components: - . ZapStim Application (ZapStim.exe) - . Simulator Driver (stimneurosoft.exe) Both components are utilized when using the device. The ZapStim Controller Application is to be distributed predownloaded onto a commercial off the shelf PC. The ZapStim Controller Application is to be accessed on the PC is to be connected via USB to the Neurosoft TMS System. The ZapStim Controller Application can be used to select the treatment protocol to be administered, which at this time will only be the FDA cleared treatment protocol for MDD in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in their current episode. The user cannot edit the treatment protocol using the ZapStim Controller Application. The user can also start, pause, and end the administration of treatment using the ZapStim Controller Application. The ZapStim Controller Application relays the treatment protocol information to the Neurosoft TMS System, which then administers the magnetic stimulation.