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 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 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 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.

As previously described in K171255, K182036, K193375, 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 (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, M-Vision Fusion, and 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 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.

AI/ML Overview

The provided FDA 510(k) summary (K201056) for the NeuroBlate System does not contain a study that proves the device meets specific acceptance criteria in the manner one might expect for a stand-alone AI/software device evaluation.

Instead, this document describes a modification to the device's "Indications for Use" statement. The core argument for safety and effectiveness is based on the device's substantial equivalence to previously cleared predicate devices (K171255, K182036, K193375). The modifications are described as "minor (non-significant)" and intended to "improve clarity and ease of understanding."

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a new study, nor details about sample sizes, expert qualifications, or adjudication methods for a test set, because such a study is not presented in this document.

Here's what can be extracted based on the provided text:

No new study data for AI/software performance is presented in this 510(k) for the modifications. The document explicitly states: "As these modifications to the Indications For Use do not create a new intended use or raise new or different questions of safety or efficacy and incorporates previously provided clinical data(4), additional clinical data are not necessary to demonstrate substantial equivalence." Clinical data from previous submissions (which are incorporated by reference) formed the basis for the original clearances.

Let's address the specific points you asked for, in the context of what is available in this document:

A table of acceptance criteria and the reported device performance: This document does not present such a table because it's a submission for an IFU clarity update, not a new performance study. The performance of the NeuroBlate System was established in prior 510(k) clearances (K171255, K182036, K193375) through "in-vitro (bench) and in-vivo (animal) data." No specific numerical acceptance criteria or performance metrics are reported in this document.
Sample size used for the test set and the data provenance: Not applicable to this specific submission. The data provenance would refer to the previous clearances (K171255, K182036, K193375) which are not detailed here. The submission mentions "Real World Evidence from Monteris' on-going post-market registry" and "scientific clinical literature peer reviewed published data," but these are cited as justification for the clarity of the IFU rather than a new test set for the modifications.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to this specific submission.
Adjudication method for the test set: Not applicable to this specific submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable to this specific submission. The device description of the NeuroBlate System as a "neurosurgical tool" that provides "near real-time thermographic analysis" and "information that may be useful in the determination or assessment of therapy" when "interpreted by a trained physician" indicates physician involvement. However, this document does not present an MRMC study comparing physician performance with and without the device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable to this specific submission. The device is explicitly designed for "interpretation by a trained physician" and patient management decisions "should not be made solely on the basis of the NeuroBlate System analysis."
The type of ground truth used: Not applicable to this specific submission. For the previous clearances, it would likely have involved histopathological confirmation for ablation efficacy in animal models and potentially post-treatment imaging or clinical outcomes for human studies (if any were submitted then).
The sample size for the training set: Not applicable to this specific submission. This document pertains to an IFU update, not a new algorithm development or re-training.
How the ground truth for the training set was established: Not applicable to this specific submission.

In summary: K201056 is a 510(k) submission primarily focused on clarifying the Indications For Use statement of an existing medical device (NeuroBlate System). It does not present new performance data, test sets, or studies comparing the device's performance against acceptance criteria in the context of a new or modified AI/software component, as its justification rests on substantial equivalence to prior FDA clearances. The performance and safety of the device were established in those earlier submissions, which are referenced but not detailed here.

Summary

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August 21, 2020

Monteris Medical David H. Mueller Senior Principal Regulatory Affairs Specialist 14755 27th Avenue North, Suite C Plymouth, Minnesota 55447

Re: K201056

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 Dated: July 20, 2020 Received: July 22, 2020

Dear Mr. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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 (OS) 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 mediation-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,

Xiaolin Zheng, Ph.D. 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

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Indications for Use

510(k) Number (if known) K201056

Device Name NeuroBlate System

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the word "MONTERIS" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" is a series of teal-colored circles arranged in an arc shape. The circles vary in size, with the largest circles in the center and the smallest circles on the edges.

510(k) Summary

a. Device Information:

Category	Comments
Sponsor:	Monteris Medical14755 27th Avenue NorthSuite CPlymouth, MN 55447763-253-4710Fax: 763-746-0084www.monteris.com
Correspondent ContactInformation:	David H. MuellerSenior Principal Regulatory Affairs SpecialistMonteris MedicalTEL: 763-253-2732FAX: 763-746-0084Email: DMueller@Monteris.com
Device Common Name:	Magnetic Resonance Image Guided Laser ThermalTherapy System
Device Classification Number:	21 CFR 878.4810Laser surgical instrument for use in general and plasticsurgery and in dermatology
Device Classification &Product Code:	21 CFR 882.4560Stereotaxic instrumentClass II, GEXClass II, HAW
Device Proprietary Name:	NeuroBlate® System
Predicate Devices	Monteris Medical NeuroBlate® System (K171255,K182036, K193375)
FDA Guidance ReferencePredicate Devices(¹)	K163244, truFreeze SystemK171626, truFreeze System

b. Date Summary Prepared

August 17, 2020

c. Description of Device

1 Food and Drug Administration. The Least Burdensome Provisions: Guidance for Industry and Food and Drug Administration Staff. Draft Guidance. February 5th ed. Washington, D.C., U.S. Department of Health and Human Services. Food and Drug Administration, Center for Devices and Radiological Health, US Printing Office, 2019

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Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical. The logo has the word "MONTERIS" in blue, all-caps, bold letters. Below that is the word "MEDICAL" in smaller, blue, all-caps letters. Above the word "MONTERIS" are 9 teal-colored circles of varying sizes.

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 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, M-Vision Fusion, and 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 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.

Change Description

Considering the Laser Interstitial Therapy (LITT) related Real World Evidence(') from Monteris' on-going post-market registry, the available scientific clinical literature peer reviewed published data, and the corresponding FDA publications, Monteris' minor (non-significant) modifications to the Indications For Use(3) statement duplicate existing information in order to improve clarity and ease of understanding for the NeuroBlate System's (a) "tool" indication and (b) existing intended patient populations. These updates are in alignment with the current intended use. The modified text (underlined) will read:

2 United States Food and Drug Administration. Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices; Guidance for Clinical Investigators, Industry, and FDA Staff. August 31st ed. Washington, D.C .: FDA, 2017.

3 United States Food and Drug Administration, the 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications (510(k)), Guidance for Industry and Food and Drug Administration Staff. Washington, D.C.: FDA, 2014.

http://www.fda.gov/downloads/MedicalDevices/..../UCM284443.pdf

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Image /page/5/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, blue, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several blue-green circles of varying sizes, arranged in an arc.

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 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 1064 nm lasers.

The Monteris Medical NeuroBlate® System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based traiectory 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 therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™™ System analysis.

The clarified and duplicated indications were determined to not create a new intended use or raise different questions of safety and effectiveness, and were also determined to not introduce any new or different technical characteristics which could raise different questions of safety and effectiveness, i.e., the clarified indications are consistent with the existing intended use as well as the existing Indications For Use.

d. Indications For Use

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.

e. Comparison to Predicate Devices

The application for the Monteris Medical NeuroBlate System with the modified labeling is substantially equivalent (and/ or identical) to the predicate Monteris NeuroBlate System (K171255, K182036, K193375) in intended use, Indications For Use, technology, design and physician use.

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Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are several teal-colored circles of varying sizes, arranged in an arc shape.

f. Summary of Supporting Data

Considering the intended labeling clarifications include no physical, material, or software related device design changes, the NeuroBlate System predicates' previously provided in-vitro (bench) and in-vivo (animal) data remains applicable and are incorporated by reference.

As these modifications to the Indications For Use do not create a new intended use or raise new or different questions of safety or efficacy and incorporates previously provided clinical data(4), additional clinical data are not necessary to demonstrate substantial equivalence.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.