Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Monteris Medical NeuroBlate® System is a surgical tool for brain surgery (e.g., tumor and epilepsy surgery) and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis.
The Monteris Medical NeuroBlate System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures (e.g., brain tumor, radiation necrosis, and epileptogenic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging), through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate Laser Delivery Probes. It also provides near real-time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis.
The Monteris NeuroBlate System is a collection of MRI-compatible laser devices and accessories that create an MRI guided intracranial delivery of precision thermal therapy in the practice of neurosurgery. The NeuroBlate System components consist of: Families of gas-cooled Laser Delivery Probe (Probe) (SideFire & FullFire) to deliver controlled energy to a target zone. Probe Drivers (Advanced Probe Driver, Robotic Probe Driver) which allow the surgeon to precisely position, stabilize and manipulate a probe, endoscope or other device within the target zone. An Interface Platform, which attaches to the MRI system patient table and provides supporting electronics for the Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module). A System Electronics Rack and Components, which includes the laser and necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation. A Control Workstation including the M-Vision™, M-Vision Pro™, M-Vision Fusion™, or Fusion-S™ software, which includes a user interface for procedure planning, interactive monitoring of NeuroBlate procedures, and interfaces to the MRI and hardware subsystems. The NeuroBlate System is utilized with stereotaxic frames and patient stabilization systems, such as: The Monteris Cranial Bolt and Mini-Bolt fixation components, and The AtamA Stabilization System, MRI head coils, and other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.
Summary parsed at:2026-06-01 05:32:06 UTC
