Monteris Medical NeuroBlate System

Monteris Medical,

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

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K171255
Device name
Monteris Medical NeuroBlate System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-04-28
Decision date
2017-07-25
Submission type
Traditional
Technology type
Other(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. The existing NeuroBlate indications for use are in reference to the ablation of soft brain tissue, i.e., brain tissue ablation refers to the ablation of "intracranial soft tissue," including "brain structures."

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.

Device Description

The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy that is currently indicated for the practice of neurosurgery. The NeuroBlate System is typically used for the minimally invasive ablation of neurosurgeon identified target tissue (tumors, epileptic foci) in the brain. 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 AXiiiS stereotaxic mini-frame and 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.

Summary parsed at:2026-06-01 06:00:15 UTC

Predicate devices

2

K171255 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K171255 as a predicate