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The Visualase V2 ™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: - a diode laser (energy source) - a coolant pump to circulate saline through the laser application - Visualase workstation which interfaces with MRI scanner's host computer - Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; one monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections

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 intended patients are adults and pediatric from the age of 2 years and older.

The Monteris NeuroBlate System is a collection of MRI-compatible laser devices and accessories that create an MRI guided 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 Advanced and Robotic Probe Drivers and interconnections for the Laser Delivery Probes; - A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation. - A Control Workstation including the M-Vision™ and M-Vision Pro™ 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 and MRI receive-only head coil, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, bone screws, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.

The TRANBERG®|Thermoguide Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in neurosurgery, for a wavelength of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the TRANBERG®|Thermoguide therapy system can process images using proton resonancefrequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. The TRANBERG®|Thermoguide Therapy System is compatible with the following 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. When interpreted by a trained physician, this device 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 analysis using the TRANBERG®|Thermoguide Therapy System.

The TRANBERG®|Thermoguide Therapy System is indicated for use in an MRI suite to perform soft tissue ablations under MRI guidance, it consists of three parts: - 1) TRANBERG®|Mobile Laser Unit, cleared by K142216. - 2) TRANBERG®|Laser applicator and introducer, cleared by K201466. - 3) TRANBERG®|Thermoguide Workstation, article no. 1100-01, new in this submission. The TRANBERG® Mobile Laser Unit includes a laser generator that operates at the wavelength of 1064nm, a continuous wave. The generated laser light is locally applied by means of a single use applicator kit (TRANBERG®)Laser applicator and introducer, cleared by K201466) through a minimally invasive surgical or percutaneous procedure. The energy from the laser generator is transmitted to tissue through the TRANBERG® Laser applicator and absorbed by the tissue surrounding the laser applicator, resulting in increased tissue temperature that necrotizes or coagulates soft tissue. The TRANBERG® Laser applicator is a 12m long optical fiber that allows the laser generator to be placed in the MRI control room. A workstation with software (TRANBERG®)Thermoguide Workstation) is used to extract temperature maps from magnetic resonance (MR) images and to calculate the thermal dose in treated tissue. Algorithms used in the system to calculate temperature maps and thermal dose in tissue are well established and described in scientific literature. The TRANBERG® Mobile Laser Unit has safety systems to prevent the use of a malfunctioning unit, including self-testing at startup and continuous monitoring of software and components that are critical for the unit and laser emission to function optimally. All laser safety requirements are met according to IEC 60601-2-22:2019. The TRANBERG® Laser applicator utilizes an RFID tag which limits the maximum power and time (per applicator type) that can be used. It also ensures that an expired fiber, a reused fiber, or a fiber programmed for a different use cannot be used as a treatment fiber. The TRANBERG®|Thermoguide Workstation has an interface for control of the TRANBERG®|Mobile Laser Unit output through the computer interface port of the laser control). It controls power and time settings on the laser unit, and it can start and stop the laser control and safety as per medical laser equipment requirements are managed by the TRANBERG®|Mobile Laser Unit. Mandatory conditions must be satisfied to enable the laser unit and run a treatment. When one of more of these conditions are not met, the laser will not allow emitting laser radiation until all conditions are fulfilled: - Real time images from the scanner are received at least every 5s. If Thermoguide Workstation detects update rates longer than 5s the laser emission is automatically interrupted. - Laser unit enabled and the connection is verified, any loss of communication within 1.5s between the Laser unit and Thermoquide workstation or data incoherency automatically stops the laser emission. - The use of the RFID tag is a mandatory condition to run a treatment and limits the maximum power and time (per applicator type). - Laser Applicator type confirmed and received by TRANBERG®Thermoguide Workstation, the information is read on the RFID tag belonging to the fiber. - Minimum 1 ROI (monitoring or guard) has been set. - Baseline temperature (e.g., core body temperature) is set and confirmed - B0 drift compensation: Reference baseline ROI is set and confirmed - Placement of the High temperature guard ROI. - Test dose successful and confirmed Safety guard functionality: TRANBERG®Thermoguide Workstation can be used to prescribe limits for the temperature at certain points (ROIs) in the image which can, in turn, be used to deactivate the laser if the limits are reached.

The Visualase MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic 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 800nm through 1064mm lasers.

The Visualase MRI-Guided Laser Ablation System comprises hardware and software components used in combination with three MR-compatible (conditional), sterile, single-use, saline-cooled laser applicators with proprietary diffusing tips that deliver controlled energy to the tissue of interest. The system consists of: a diode laser (energy source) a coolant pump to circulate saline through the laser application Visualase workstation which interfaces with MRI scanner's host computer Visualase software which provides the system's ability to visualize and monitor relative changes in tissue temperature during ablation procedures, set temperature limits and control the laser output; two monitors to display all system imaging and laser ablation via a graphical user interface and peripherals for interconnections Remote Presence software provides a non-clinical utility application for use by Medtronic only and is not accessible by the user