NeuroBlate System

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 3, 2026 Monteris Medical Amber Daly Senior Quality Manager 131 Cheshire Ln., Suite 100 Minnetonka, Minnesota 55305 Re: K262315 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: ONO Dated: July 8, 2026 Received: July 8, 2026 Dear Amber Daly: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262315 - Amber Daly Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the {2} K262315 - Amber Daly Page 3 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-devices/device-advice-comprehensive-regulatory-assistance/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, # JAIME RABEN -S for Julia Slocomb, PhD Acting 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 {3} # Indications for Use Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. K262315 Please provide the device trade name(s). NeuroBlate System Please provide your Indications for Use below. 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 (for example, brain tumor, radiation necrosis, and epileptogenic foci as identified by noninvasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 1064 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older. Please select the types of uses (select one or both, as applicable). ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) Please select the age group(s) for which the device(s) is to be used. ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) ? ? {4} MONTERIS MEDICAL # 510(k) Summary: K262315 a. Device Information: | Category | Comments | | --- | --- | | Sponsor / Submitter: | Monteris Medical 131 Cheshire Lane, suite 100 Minnetonka, MN 55305 866-799-7655 www.monteris.com | | Correspondent Contact Information: | Amber Daly Senior Quality Manager Monteris Medical TEL: 763-647-8799 Email: adaly@monteris.com | | Device Common Name: | Magnetic Resonance Image Guided Laser Thermal Therapy System | | Device Classification Regulation & Name: | 21 CFR 878.4810 • Laser surgical instrument for use in general and plastic surgery and in dermatology | | Device Classification & Product Code: | Class II, ONO | | Device Proprietary Name: | NeuroBlate® System | Predicate Device Information: | Manufacturer | Monteris Medical | REFERENCE PREDICATE: CLS | | --- | --- | --- | | Commercial Name | NeuroBlate System | TRANBERG®|Thermoguide Therapy System | | Common Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology; Stereotaxic instrument | Laser surgical instrument for use in general and plastic surgery and in dermatology | | Premarket Notification # | K260976, K240877 | K214125 | | Regulation | 21 CFR 878.4810 21 CFR 882.4560 | 21CFR878.4810 | | Class/ Product Code | Class II; ONO, GEX, HAW | Class II; ONO, | # b. Date Summary Prepared 07Jul2026 # c. Description of Device 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. 1 {5} MONTERIS MEDICAL 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 Robotic Probe Driver 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™, M-Vision Pro™, M-Vision Fusion™, 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 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. ### d. Indications for Use/ 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 (for example, brain tumor, radiation necrosis, and epileptogenic foci as identified by noninvasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 1064 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older. ### e. Comparison to Predicate Device The application for the Monteris Medical NeuroBlate System with the modified labeling is substantially equivalent to the predicate Monteris NeuroBlate System (K260976, K240877) and the other described predicates in intended use, technology, design and physician use. Reference Table 1. This submission proposes no (zero) physical changes to the NeuroBlate System hardware, software, accessories, operating principles or functionality. The proposed indication clarifications present no (zero) physical or technological changes to the predicate device. The only change proposed in this submission is the indication clarification as described in the NeuroBlate Instructions for Use (IFU), e.g., there are no changes to the NeuroBlate System's software, hardware, materials, laser probes, sterilization, packaging, technology or maximal performance, fundamental technology, technical modes of action and technical principles, or the composition, source, and use of patient contacting materials. 2 {6} MONTERIS MEDICAL Additionally, there are no material, or technology proposed changes to the NeuroBlate System. The technical modes of action and technical principles remain the same as the predicate NeuroBlate devices. Considering the proposed changes are labeling related, the previously provided in-vitro (bench) data remains applicable and no additional bench testing was required. The fundamental functionality and technical characteristics of the proposed modified device is identical to the existing NeuroBlate System (K260976, K240877), as well as being substantially equivalent to the other described reference device. Thus, the proposed modified device is as safe as the described predicate devices. ### f. Summary of Supporting Data This submission proposes no physical changes, materials changes, or technology changes to the NeuroBlate System. Considering the proposed changes are labeling, the previously provided in-vitro (bench), in-vivo (animal) data remains applicable and no additional testing was required. Multiple FDA Guidance documents were utilized to ensure substantial equivalency, e.g.: - United States Food and Drug Administration. Deciding When to Submit a 510(k) for a Change to an Existing Device. Washington, D.C.: FDA, 2017. - United States Food and Drug Administration, Guidance for Industry and Food and Drug Administration Staff, General/Specific Intended Use. Washington, D.C.: FDA, 1998 - United States Food and Drug Administration. Premarket Assessment of Pediatric Medical Devices Guidance, Guidance for Industry and Food and Drug Administration Staff. March 24th edition. Washington, D.C. 2014 The proposed modifications to the NeuroBlate System's Indications For Use (IFU) are to provide clarification for the existing terminology utilized within the existing indications as the device is currently utilized. The proposed changes are not intended to provide specific indications for use which are different than the current language. ### g. Risk Analysis Summary Monteris Medical's Quality Systems utilize various Risk Assessment and Risk Mitigation methodologies. As there are no physical changes, materials changes, or technology changes to the NeuroBlate System, and that the technical modes of action and technical principles remain the same as the predicate devices, and that the proposed changes are labeling related, the previously provided (K260976, K240877) Risk Assessment and Risk Mitigation documentation remains applicable. 3 {7} MONTERIS MEDICAL Table 1: Substantial Equivalency Indications For Use Comparison | UNDER REVIEW: Proposed modified NeuroBlate System | PREDICATE: Monteris NeuroBlate System K240877 | REFERENCE PREDICATE: Visualase V2™ MRI Guided Laser Ablation K250307 | | --- | --- | --- | | • Note: Underlined text indicates modified text when compared to K240877 Indications for Use | • Note: Underlined text used as reference for comparison to proposed clarified | • Note: Underlined text used as reference for comparison to proposed clarified | | PRIMARY FDA ProCode: ONO | PRIMARY FDA ProCode ONO | PRIMARY FDA ProCode ONO | | SUBSEQUENT FDA ProCode: None | SUBSEQUENT FDA ProCode: GEX, HAW | SUBSEQUENT FDA ProCode: None | | 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 (for example, brain tumor, radiation necrosis, and epileptogenic foci as identified by noninvasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 1064 nm lasers. | 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 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 noninvasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. | | Not Included | 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 | Not included | | The intended patients are adults and pediatric patients from the age of 2 years and older. | 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 intended patients are adults and pediatric patients from the age of 2 years and older. | 4