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The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Ampa One System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use: - Ampa L and M Coils - MT determination and Depression treatment - Ampa Pulse Generator - Provide Electrical power to the coils - Ampa Control Pad - The software interface for operators to control TMS treatment - Axon Cable - Provides connections between the Ampa Pulse Generator and Ampa Control Pad - Ampa Magic Arm - Support system to securely hold the coils in place during treatment - Neuronavigation Cap - Fabric cap worn by patient with integrated markings for determination of cerebral cortex treatment targets The system comes preloaded with a mobile app on the Ampa Control Pad containing the software interface for operation of the system.

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

The Ultimate rTMS for OCD is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Obsessive-Compulsive Disorder (OCD). It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. Area of the brain to be simulated for ODC treatment is the Dorsomedial Prefrontal Cortex.

The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medications in the current episode.

The Ultimate rTMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medical device produces non-invasive, repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex for the treatment of Major Depressive Disorder. It can be used in patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories of research institutions. The Ultimate rTMS principle of operation is based on the discharge of high voltage capacitor through stimulation coil; the pulsed magnetic field generated by the discharge current penetrates through neuromuscular tissues nearby to induce electrical currents in cortical neurons. Area of the brain to be simulated for MDD treatment is Left Dorsolateral Prefrontal Cortex.

For Adults: Horizon 3.0 TMS Therapy Systems are indicated for the treatment of Major Depressive Disorder (MDD) in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). For Adolescents: Horizon 3.0 TMS Therapy Systems are indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).

The Horizon® 3.0 TMS Therapy System is a computerized, electromechanical medical device that produces and delivers non-invasive, magnetic stimulation 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"). The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of - Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode - as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). - as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15--21) The Horizon® 3.0 TMS Therapy System is used for patient treatment by prescription only under the supervision of a licensed physician. It can be used in both inpatient settings, including physicians' offices, clinics, and hospitals. The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and accessories. The Horizon® 3.0 TMS Therapy System is offered in three configurations: - Horizon 3.0 Inspire (Cleared under K241518). - - Horizon 3.0 (Cleared under K232235, K223154, K222171 and K211389), - - Horizon 3.0 with StimGuide Pro (Cleared under K232235). The three tiers of system offer equivalent safety and effectiveness with the main purpose allowing for physician offices, clinics and hospitals to choose a configuration that suits the organizational needs and provide different entry levels to promote the accessibility of TMS Therapy Treatments to health delivery organizations. All three configurations have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation. All configurations are composed from the following main components: - Stimulating Unit & Power Supply - - User Interface - Applicating Coil for Motor Threshold - - -Applicating Coil for Treatment Delivery - -System and Applicating Coil Cart and Holding Arm The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

The Ampa One System is intended for treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.

The Ampa One System is a computerized, electromechanical device that produces and delivers non-invasive, magnetic fields to induce electrical currents in brain tissues to target specific regions of the cerebral cortex. The system contains two different coils for targeting different regions of the brain. The L Coil is designed to target the left dorsolateral prefrontal cortex (DLPFC). The M Coil is designed to target the bilateral prefrontal cortex (DMPFC). Both coils are used within the Ampa One System to treat Major Depressive Disorder (MDD) in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. Transcranial magnetic stimulation (TMS) is a non-invasive technique for stimulating brain and neural tissue. The principle of magnetic stimulation is implicit in Faraday's law. The pulses of current are generated with a circuit containing a capacitor connected to the stimulating coil. With the capacitor charged to a certain level, the conducting state will cause the discharging of the capacitor through the coil. A magnetic field is generated proportional to this current. The rapid change in the magnetic field induces a current in conducting materials e.g. the body tissue. If the current induced in the human body is of sufficient amplitude and duration, it will excite neurons. The Ampa One System is an integrated system composed of the following hardware and software components with associated functions to enable its intended use: - . Ampa L and M Coils - MT determination and Depression treatment - . Bridge Box & cables - Allows connection to the pulse generator and control treatment protocols from the pulse generator and Ampa tablet with software - Ampa tablet with software - The software interface for operators to control TMS treatment - . Ampa Magic Arm - Support system to securely hold the coils in place during treatment - Neuronavigation Cap Fabric cap worn by patient with integrated markings for determination of . cerebral cortex treatment targets The system is intended to be used with the MagVenture MagPro R30 Pulse Generator (K230014) and cannot be used without a compatible pulse generator. The system comes with a tablet preloaded with a mobile app containing the software interface for operation of the system.

Horizon® 3.0 TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).

The Horizon® 3.0 TMS 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"). The Horizon® 3.0 TMS Therapy System is a non-invasive tool for the stimulation of cortical neurons for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The Horizon® 3.0 TMS Therapy 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 physicians' offices, clinics, and hospitals. The Horizon® 3.0 TMS Therapy System configurations are an integrated system consisting of a combination of hardware, software, and configurations: - Horizon 3.0 Inspire (Subject of this submission). - Horizon 3.0 (Previously cleared under K232235, K223154, K222171 and K211389). - Horizon 3.0 with StimGuide Pro (Cleared under K232235). All three configurations, including the subject Horizon 3.0 Inspire configuration, have identical intended use/indications for use, common specifications, equivalent performance and equivalent composition. All three devices share equivalent technological characteristics and principles of operation. All configurations are composed from the following main components: - Stimulating Unit & Power Supply - User Interface - Applicating Coil for Motor Threshold - Applicating Coil for Treatment Delivery - System and Applicating Coil Cart and Holding Arm The Horizon 3.0 with StimGuide Pro specifically includes a stereotactic infrared tracking system for aiding coil positioning.

The BrainsWay Deep TMS™ 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 BrainsWay Deep TMS™ System enables direct non-invasive activation of deep brain structures. 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 to the brain's neuronal pathways, localized axonal depolarizations are produced, thus activating neurons in the targeted brain structure. The BrainsWay Deep TMS™ System is composed of the following main components: 1. Cart a) TMS Neurostimulator b) Cooling System c) Positioning Device 2. Helmet a) Aiming Apparatus (i.e., ruler/grid) b) Electromagnetic Coil (H Coil) c) Cap

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

The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS). The Apollo TMS Therapy System is comprised of the following principal components: - User Interface - Main Unit (with or without housing) - Stimulation Coil - Coil Positioning System The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administrates treatment protocols and the patient´s individual stimulation dose determined by the patient´s individual motor threshold. Stimulation is applied via the stimulation coil which is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of a coil positioning system. The observed and documented increase in cortical excitability after high frequency (10Hz) rTMS has been shown to persist beyond the duration of the train of stimulation.

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

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.