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NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (age 15-21).

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components: - Mobile Console - System Software - Treatment Chair - Head Support System - MT Cap - . D-Tect MT Accessory - TrakStar Data Management

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console - System Software - Treatment Chair - Ferromagnetic Treatment Coil - Head Support System or Headrest - SenStar® Connect Treatment Link & SenStar® Treatment Link - Treatment Pack (for use with the SenStar® Connect Treatment Link) - MDD MT Cap and OCD MT Cap - TrakStar™ Patient Data Management System - D-Tect™ MT Accessory - NeuroSITE

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console - System Software - Treatment Chair - Ferromagnetic Treatment Coil - Head Support System - SenStar® Connect Treatment Link & SenStar® Treatment Link - Treatment Pack (for use with the SenStar® Connect Treatment Link) - MT Cap - TrakStar™ Patient Data Management System - D-Tect™ MT Accessory - Beam F3 Treatment Pack - OCD MT Cap

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console - System Software - Treatment Chair - Ferromagnetic Treatment Coil - Head Support System - SenStar® Connect Treatment Link & SenStar® Treatment Link - Treatment Pack (for use with the SenStar® Connect Treatment Link) - MT Cap - TrakStar™ Patient Data Management System - D-Tect™ MT Accessory - Beam F3 Treatment Pack There are two proposed changes to the NeuroStar Advanced Therapy System that are the subject of this 510(k). The first proposed change introduces the capability to use wireless communication to transfer data between the NeuroStar System software and the TrakStar Patient Data Management System, as an alternative to using an ethernet cable to facilitate this transfer. The second proposed change allows for the alternative use of the Beam F3 treatment location method (herein: "Beam F3 method"), in addition to the current method that utilizes a location 5 cm away from the motor threshold within the dorsolateral prefrontal cortex (DLPFC) reqion of the brain. The Beam F3 method requires measuring different skull dimensions and uses these values to calculate the F3 treatment location, which is also located within the DLPFC. This 510(k) introduces software embedded into the NeuroStar System that performs these calculations as well as single-use measuring accessories. Once the F3 treatment location is determined, the treatment parameters and protocols remain the same as those used in the currently marketed NeuroStar Advanced Therapy System.

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive maqnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console . - System Software . - . Treatment Chair - Ferromagnetic Treatment Coil - . Head Support System - SenStar® Connect Treatment Link & SenStar® Treatment Link ● - . MT Cap - TrakStar™ Patient Data Management System ● - D-Tect™ MT Accessory ● The proposed change to the NeuroStar Advanced Therapy System that is the subject of this 510(k) is the addition of the NeuroStar D-Tect™ MT Accessory, which is a non-sterile, multi-use device that provides an optional method to aid in the Motor Threshold (MT) hunt process. This device is used to provide indication and amplitude of hand movement during this process. The D-Tect™ MT Accessory includes a user display interface and a human hand interface with builtin sensors for measuring thumb and finger movements. The device is a standalone accessory that does not communicate or interact with the NeuroStar Advanced Therapy System, except for receiving pulse signals in order to sync data collection. Use of the device is optional, and provides an alternative, quantitative method to determine the MT compared to the standard of care, which includes a qualitative, visual assessment. The D-Tect™ MT Accessory is only used during the Motor Threshold (MT) determination process, which is only performed the first time a patient is seen by the doctor and is performed prior to the first treatment session.

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region. The NeuroStar System consists of a combination of hardware, disposable, and consumable supplies, which are required for the operation of the system. The basic configuration includes the following components: - Mobile Console - System Software - Treatment Chair - Head Support System - TrakStar PC - TrakStar Software

The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The NeuroStar Advanced Therapy System, for adjunctive treatment of OCD, is a computerized, electromechanical medical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The system consists of: 1. Mobile console 2. System software with GUI 3. Treatment chair 4. Head support system 5. Coil positioning system 6. Same Coil for both MT and treatment 7. Coil fixture 8. Data management system.

The NeuroStar Advanced Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Maqnetic Stimulation (TMS). NeuroStar Advanced Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals. NeuroStar Advanced Therapy uses a well-understood property of physics regarding the law of electromagnetic induction, which states that a time-varying or moving magnetic field will induce an electric current in an adjacent conductive substance with the electric current traveling in a direction perpendicular to the motion of the magnetic field. NeuroStar Advanced Therapy uses a generated magnetic field as a vector for delivering an electrical current to a tarqet conductor of interest, which in therapeutic application, is the brain. By using this method of delivering electrical current to the brain the electrical current produced in the brain can be delivered in an anatomically focused manner at discrete cortical areas of interest and can avoid areas of the brain that are not relevant for its therapeutic actions. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console for housing the electronics and includes a software . controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil. - Ferromagnetic Coil for delivering treatment. . - . Head Support System for positioning the treatment coil and includes a laser-guided alignment system - . Optional MT Cap for - Multi-use consumable SenStar Treatment Link for contact sensing of the ● treatment coil with the patient's head and maqnetic field quality control. - TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software

NeuroStar Advanced Therapy is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The NeuroStar Advanced Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS). NeuroStar Advanced Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. NeuroStar Advanced Therapy is used for patient treatment by prescription only under the supervision of a licensed physician and can be used in both inpatient and outpatient settings including physician's offices, clinics, and hospitals. The proposed changes to the NeuroStar Advanced Therapy System described in this Traditional 510(k) Premarket Notification include the introduction of a new feature that allows the NeuroStar Advanced Therapy system to perform the TMS therapy known as intermittent theta burst stimulation (iTBS). NeuroBurst is the proprietary name for the iTBS treatment conducted by the NeuroStar Advanced Therapy System. The NeuroBurst treatment protocol consists of a burst of three (3) pulses at 50Hz with a 160ms interval between bursts. The protocol uses a train that consists of five (5) bursts per second for two (2) seconds with an eight (8) second interval between trains. A treatment session lasts for 20 trains or 3.3 minutes. The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components: - Mobile Console for housing the electronics and includes a software controlled graphical user interface, display monitor, display arm, and gantry that supports the treatment coil. - Ferromagnetic Coil for delivering treatment. - Head Support System for positioning the treatment coil and includes a laser-guided alignment system. - Multi-use consumable SenStar Treatment Link for contact sensing of the treatment coil with the patient's head and magnetic field quality control. - TrakStar Patient Data Management System for recording patient data and includes a stand-alone computer and data management software.

The NeuroStar TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The NeuroStar TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation using brief duration (185 usec nominal) rapidly alternating, or pulsed, magnetic fields to induce electrical currents directed at spatially discrete regions of the cerebral cortex. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation or TMS. NeuroStar TMS Therapy is a non-invasive tool for the stimulation of cortical neurons for the treatment of adult patients with Major Depressive Disorder (MDD) who have failed to receive satisfactory improvement from prior antidepressant medication as described under Intended Use. The NeuroStar System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient and outpatient settings including physician's offices and clinics, and hospitals. The NeuroStar TMS Therapy System is an integrated system consisting of a combination of hardware, software, accessories and consumable supplies. It includes a Mobile Console which houses the electronics, includes a software controlled graphical user interface, and gantry that supports the Treatment Coil. The ferromagnetic Treatment Coil delivers NeuroStar TMS Therapy®. The Head Support System provides accurate positioning of the Treatment Coil using a laser-guided alignment system. The SenStar Connect is a non-sterile, multi-use consumable which is applied to the Treatment Coil, provides contact sensing to monitor contact of the treatment coil with the patient's head throughout a treatment session, quality control by monitoring the magnetic field level prior to patient treatment and provides surface field cancellation to reduce stimulation of the scalp. The TMS TrakStar™ practice data management system consists of a standalone computer and data management software that facilitates recording and retrieval of patient and treatment information and communication of data among multiple NeuroStar TMS Systems.