NeuroBlate System

Monteris Medical,

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

11

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K182036
Device name
NeuroBlate System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-07-30
Decision date
2018-10-15
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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 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.

Intended Use

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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 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.

Device Description

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; 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™ and M-Vision Pro™ FUSION™ 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 Axiiis stereotaxic mini-frame and the Monteris Cranial Bolt and Mini-Bolt fixation components, and The AtamA Stabilization System, as well as, 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). Monteris' existing NeuroBlate System Laser Delivery Probes include the 3.3mm FullFire and SideFire Probes and the 2.2mm FullFire Probe. In order to ensure that the Probe tip maintains an appropriate temperature while the laser is on, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software which regulates the cooling system for the laser probe.

Summary parsed at:2026-06-01 05:57:52 UTC

Predicate devices

11

K182036 references 11 predicate/reference devices

Cited as predicate

3

3 submissions cite K182036 as a predicate