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510(k) Data Aggregation
(178 days)
The Nexstim Navigated Brain Stimulation (NBS) 6 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 Nexstim NBS 6 System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat depressive episodes without inducing seizure in adult patients with Major Depressive Disorder (MDD) who have failed antidepressant medication, as well as to provide adjunct treatment to adult patients suffering from Obsessive Compulsive Disorder (OCD).
The Nexstim NBS 6 System is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.
The Nexstim NBS 6 System consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBS 6 System is provided by the software.
The Nexstim NBS 6 System combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target areas for treatment of MDD and adjunct treatment of OCD.
The software used in the Nexstim NBS 6 System is essentially the same software used in the Reference device Nexstim NBT System 2 cleared by FDA in 510(k) submissions K171902 and K182700 except for a new workflow-oriented graphical user interface (GUI) designed for improved ease of use. This GUI is new to the Nexstim NBS 6 System, and allows the user to select which functionality the software will present, including:
• Access to the same functions as in NBT System 2 for:
N/A
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(234 days)
NBS 6 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.
For Adolescents: NBS 6 is indicated as an adjunct for the treatment of MDD in adolescent patients (age 15-21).
The Nexstim NBS 6 System is a non-invasive, repetitive transcranial magnetic stimulation (rTMS) system that delivers repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat depressive episodes without inducing seizure in adult patients with Major Depressive Disorder (MDD) who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode, and as an adjunct for the treatment of MDD in adolescent patients, 15 to 21 years of age.
The Nexstim NBS 6 System is used for patient treatment by prescription only and must be operated by a trained medical professional. It can be used in both inpatient and outpatient settings including physician's offices and clinics, psychiatric hospitals, and general medical/surgical hospitals with psychiatric units.
The Nexstim NBS 6 System consists of a group of devices designed to localize the stimulation site in the brain and deliver rTMS stimulation using controlling and interpretive software. Operational control of the Nexstim NBS 6 System is provided by the software.
The Nexstim NBS 6 System combines magnetic resonance imaging-based (MRI-based), three dimensional (3D) localization of cortical motor areas of the brain with non-invasive TMS and simultaneous electromyography (EMG) measurement to locate areas of the brain that are capable of evoking muscle responses when stimulated, and to locate the target areas for treatment of MDD.
The software used in the Nexstim NBS 6 System is essentially the same software used in the reference device Nexstim NBT System 2 cleared by FDA in 510(k) submissions K171902 and K182700 except for a new workflow-oriented graphical user interface (GUI) designed for improved ease of use. This GUI is new to the Nexstim NBS 6 System, and allows the user to select which functionality the software will present, including:
• Access to the same functions as in NBT System 2 for:
N/A
Ask a specific question about this device
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