← Product Code [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX) · K222983 # NeuroBlate Fusion-S Software V3.17 (K222983) _Monteris Medical, · GEX · Mar 15, 2023 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94surgical-devices/GEX/K222983 ## Device Facts - **Applicant:** Monteris Medical, - **Product Code:** [GEX](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEX.md) - **Decision Date:** Mar 15, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4810 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **Attributes:** Therapeutic ## Intended Use 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. ## Device Story NeuroBlate System provides MRI-guided laser interstitial thermal therapy (LITT) for intracranial soft tissue. System components include gas-cooled laser delivery probes (SideFire/FullFire), probe drivers for stereotaxic positioning, interface platform, electronics rack, and control workstation running Fusion-S software. Used in neurosurgery; operated by physicians. Input: MRI images. Processing: software performs trajectory planning and near real-time thermographic analysis of tissue temperature during laser delivery. Output: visual monitoring of thermal therapy. Benefit: minimally invasive precision ablation of brain lesions. Physician interprets output to guide therapy; clinical decisions not based solely on system analysis. ## Clinical Evidence Bench testing only. Design verification and validation protocols confirmed that the modified Fusion-S V3.17 software meets design inputs and user needs. Performance was found to be comparable to the predicate V3.16 software, with improvements noted in several metrics. ## Technological Characteristics MRI-guided laser thermal therapy system using 1064 nm lasers. Components: gas-cooled laser delivery probes (2.2mm/3.3mm), robotic/advanced probe drivers, interface platform, and control workstation. Software: Fusion-S V3.17. Connectivity: interfaces with MRI systems. Sterilization: probes are provided sterile. ## Regulatory Identification (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon. ## Predicate Devices - NeuroBlate System ([K193375](/device/K193375.md)) - NeuroBlate System ([K201056](/device/K201056.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 15, 2023 Monteris Medical David Mueller Senior Principal Regulatory Affairs Specialist 131 Cheshire Lane; Suite 100 Minnetonka, Minnesota 55305 Re: K222983 Trade/Device Name: NeuroBlate System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: GEX, HAW, ONO Dated: February 10, 2023 Received: February 10, 2023 Dear David Mueller: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Digitally signed Adam D by Adam D. Pierce -5 Pierce -S Date: 2023.03.15 17:11:43 -04'00' Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K222983 Device Name Monteris Medical NeuroBlate System, NeuroBlate Fusion-S Software V3.17 #### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) |
☑ Prescription Use (Part 21 CFR 801 Subpart D)
|
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
| |---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED.This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Section 3: 510(k) Summary - K222983 ## 5a. Device Information: | Category | Comments | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Monteris Medical
131 Cheshire Lane, suite 100
Minnetonka, MN 55305
866-799-7655
www.monteris.com | | Correspondent Contact
Information: | David H. Mueller
Senior Principal Regulatory Affairs Specialist
Monteris Medical,
TEL: 763-333-1614
Email: DMueller@Monteris.com | | Device Common Name: | Magnetic Resonance Image Guided Laser Thermal
Therapy System | | Device Regulation and Name: | 21 CFR 878.4810
Laser surgical instrument for use in general and
plastic surgery and in dermatology

21 CFR 882.4560
Stereotaxic instrument | | Device Classification &
Product Code: | Class II, GEX, ONO
Class II, HAW | | Device Proprietary Name: | Monteris Medical NeuroBlate® System | # Predicate Device Information: | Predicate Device: | NeuroBlate System | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate Device Manufacturer: | Monteris Medical | | Predicate Device Common Name: | Monteris NeuroBlate System | | Predicate Device Premarket Notification #: | K193375, K201056 | | Predicate Device Regulation: | 21 CFR 878.4810
Laser surgical instrument for use in general
and plastic surgery and in dermatology

21 CFR 882.4560
Stereotaxic instrument | | Predicate Device Classification &
Product Code: | Class II, GEX
Class II, HAW | {4}------------------------------------------------ #### 5b. Date Summary Prepared February 10, 2023 ### 5c. Description of Device 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. As previously described in K201056. the NeuroBlate System is tvpically used for the minimally invasive ablation of target tissue (tumors, radiation necrosis, epileptic foci) in the brain. The NeuroBlate System components consist of: - Families of gas-cooled Laser Delivery 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-STM 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. There is no change to entire system, with the exception of an additional NeuroBlate Fusion-STM Software Package (V3.17). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one intended change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission. {5}------------------------------------------------ #### 5d. Indications for Use 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. #### 5e. Comparison to Predicate Device There is no change to entire system, with the exception of an additional (alternative) NeuroBlate Fusion-S Software Package (V3.17). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria. there is at least one intended change which modifies an existing risk control measure for a hazardous situation and thus, per FDA 510(k) guidance, requires a new 510(k) submission The substantial equivalency comparisons for the NeuroBlate System's Technical Characteristics are described in Table 1. {6}------------------------------------------------ | Table 1: Substantial Equivalence: NeuroBlate System Comparison Table | | | |----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Characteristic | Predicate:
Monteris Medical
NeuroBlate System
(K193375, K201056) | Intended
Alternative Modified Fusion-S
Software (V3.17) | | Company | Monteris Medical | Identical | | Regulation Number | 21 CFR 878.4810
Laser surgical instrument for use in general
and plastic surgery and in dermatology

21 CFR 882.4560
Stereotaxic instrument | Identical | | FDA Product Code | GEX & HAW | Identical | | Indications for Use | 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, 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 therma
therapy. Patient management decision
should not be made solely on the basis
of the NeuroBlate System analysis. | | Operating Principle
(Technology) | MRI-guided Laser Probe with near-real
time thermographic monitoring of target
tissue temperature | Identical | | Mode of Action | Laser Interstitial Thermal Therapy
(LITT) | Identical | | Characteristic | Predicate:
Monteris Medical
NeuroBlate System
(K193375, K201056) | Intended
Alternative Modified Fusion-S
Software (V3.17) | | Design | 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, including the supporting cables and interconnections. A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation, and A Control Workstation including the M-Vision TM, M-Vision Pro , 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 Monteris Cranial Bolt and Mini-Bolt fixation components, and The AtamA Stabilization System, MRI head coils, as well as, other optional accessories, including: drill bits, bolts, thumbscrews, instrument adaptors, accessory host adaptors, MRI trajectory wands, cranial screws, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools. | Identical NeuroBlate System hardware
Software is changing as described along with the corresponding labelling updates, i.e., utilizing Fusion-S V3.17 Software | | NeuroBlate Software | NeuroBlate M-Vision and Fusion-S Software Version V3.15 and V3.16 | NeuroBlate Fusion-S Software Version V3.17 | | Probe Distal diameter | 2.2mm and 3.3 mm | Identical | | Characteristic | Predicate:
Monteris Medical
NeuroBlate System
(K193375, K201056) | Intended
Alternative Modified Fusion-S
Software (V3.17) | | 3.3mm Probe Size as
per Probe Body
Length Range | Size #000
Size #00
Size #1
Size #2
Size #3
Size #4
Size #5 | Identical | | 2.2mm Probe Size as
per Probe Body
Length Range | Size #000
Size #00
Size #1
Size #2
Size #3
Size #4
Size #5 | Identical | | Probe Diameters and
Laser Output
Direction | 2.2mm NeuroBlate FullFire (DTP) Probes 3.3mm NeuroBlate FullFire (DTP) Probes 3.3mm NeuroBlate SideFire (SFP) Probes | Identical | | Energy Source | Donier Medilase D Laser, or NeuroLase Laser | Identical | | Warnings and
Cautions | Warnings and Cautions included in labeling and IFU content | Warnings and Caution statements updated | # Table 1: Substantial Equivalence: NeuroBlate System Comparison Table {7}------------------------------------------------ K222983 Page 5 of 7 {8}------------------------------------------------ ## 5f. Summary of Supporting Data The updated Fusion-S (V3.17) Software development process followed Monteris' documented Quality System and incorporated a design verification and design validation process. This process included an overarching Design Verification and Design Validation Master Plan. This plan describes the design verification and the design validation of the user needs for the Fusion-S (V3.17) Software when used within the NeuroBlate System. The Design Verification process utilized protocols to detail the associated tests. Each verification test protocol incorporated clearly defined acceptance criteria. The corresponding test reports confirmed (and documented) the design output met the design input for the requirements. The Design Validation process utilized protocols to detail the associated tests. Each validation protocol described the objective, test method and acceptance criteria. The corresponding test reports confirmed (and documented) the modified NeuroBlate System met the user needs and intended use. {9}------------------------------------------------ ### 5g. Discussion of Performance Testing The performance of the V3.17 software was tested utilizing automated and manual test methods and was found to be comparable to that of predicate V3.16 software. All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics. #### 5h. Conclusion Monteris concludes that the application for the Monteris Medical NeuroBlate System with the alternative V3.17 Software is substantially equivalent to the predicate Monteris NeuroBlate System (K193375, K201056) in intended use, technology, design and physician use. --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94surgical-devices/GEX/K222983](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94surgical-devices/GEX/K222983) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com