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 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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Monteris Medical NeuroBlate System with Fusion-S Software V3.17. It describes the device, its indications for use, and a comparison to a predicate device. However, it does not contain specific acceptance criteria, performance metrics, or detailed results of a study (like a clinical trial) that proves the device meets those criteria, as typically found in a comprehensive clinical study report.

The document refers to "design verification and design validation" and "performance testing" but only provides a high-level summary rather than concrete data.

Therefore, many of the requested details cannot be extracted from this document, and the response will reflect that.

Here's the information that can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

The document states: "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." And "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."

However, the specific "acceptance criteria" and "reported device performance" are not detailed in this summary. It only states that the performance was "within acceptable limits" and "comparable" to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "test methods" and "metrics" but does not specify the nature or origin of any data used for testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. While the system is intended to be "interpreted by a trained physician," there is no mention of experts establishing a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided and is unlikely to be relevant. The NeuroBlate System is explicitly described as a "neurosurgical tool" and not an AI-driven diagnostic or interpretative system that assists human readers. While it provides "MRI-based trajectory planning assistance" and "near real-time thermographic analysis," these are functionalities of a surgical guidance system, not an AI to improve human reader performance in a diagnostic context. The document also states: "Patient management decisions should not be made solely on the basis of the NeuroBlate System analysis." This further indicates its role as a tool rather than an independent diagnostic AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not detail specific "standalone" performance metrics in the way a diagnostic AI would. The device, the NeuroBlate System, is a surgical tool with software for planning and monitoring. The software component (Fusion-S V3.17) is an integral part of this human-in-the-loop surgical system. Therefore, a "standalone algorithm only" performance study in the context of diagnostic AI is not applicable or described.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided in the document. The document describes "design verification and design validation" but doesn't specify the ground truth for these tests.

8. The sample size for the training set

This information is not provided. The document describes software modifications and validation but does not mention a "training set" in the context of machine learning, suggesting that the software updates are likely traditional software engineering changes rather than a new AI model being trained.

9. How the ground truth for the training set was established

This information is not provided and is likely not applicable given the nature of the software modification described (traditional software updates vs. AI model training).

Summary Table of What Could Be Extracted:

Category	Detail Provided in Document
Acceptance Criteria & Performance	Acceptance Criteria: "Each verification test protocol incorporated clearly defined acceptance criteria." Reported Performance: "All tested metrics were measured to be within acceptable limits and improvements were noted in several metrics." (Specific criteria and metrics are NOT detailed.) The performance was "found to be comparable to that of predicate V3.16 software."
Test Set Sample Size & Provenance	Not provided.
Experts for Ground Truth	Not provided.
Adjudication Method	Not provided.
MRMC Comparative Effectiveness	Not performed/not applicable for this type of surgical guidance system. The device is a "neurosurgical tool" providing "planning and monitoring" and "thermographic analysis" under MRI. Patient management decisions should not be made solely on its analysis.
Standalone Performance	The device is a human-in-the-loop surgical system not a standalone diagnostic algorithm. No standalone performance study (in the context of AI diagnostics) is described.
Type of Ground Truth	Not specified.
Training Set Sample Size	Not provided; likely not applicable as the software update appears to be traditional software engineering rather than AI model training.
Training Set Ground Truth	Not provided; likely not applicable.

Study Proving Device Meets Acceptance Criteria:

The document briefly describes the study as "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."

Design Verification: "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."
Design Validation: "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."
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."

In essence, the study was a set of internal design verification and validation tests following the company's quality system, comparing the V3.17 software to its predicate V3.16 version. The specific details, raw data, or detailed methodologies are not included in this 510(k) summary.

Summary

{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)

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 Medical131 Cheshire Lane, suite 100Minnetonka, MN 55305866-799-7655www.monteris.com
Correspondent ContactInformation:	David H. MuellerSenior Principal Regulatory Affairs SpecialistMonteris Medical,TEL: 763-333-1614Email: DMueller@Monteris.com
Device Common Name:	Magnetic Resonance Image Guided Laser ThermalTherapy System
Device Regulation and Name:	21 CFR 878.4810Laser surgical instrument for use in general andplastic surgery and in dermatology21 CFR 882.4560Stereotaxic instrument
Device Classification &Product Code:	Class II, GEX, ONOClass 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 878.4810Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 882.4560Stereotaxic instrument
Predicate Device Classification &Product Code:	Class II, GEXClass II, HAW

{4}------------------------------------------------

5b. Date Summary Prepared

February 10, 2023

5c. Description of Device

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.

{5}------------------------------------------------

5d. Indications for Use

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 MedicalNeuroBlate System(K193375, K201056)	IntendedAlternative Modified Fusion-SSoftware (V3.17)
Company	Monteris Medical	Identical
Regulation Number	21 CFR 878.4810Laser surgical instrument for use in generaland plastic surgery and in dermatology21 CFR 882.4560Stereotaxic 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 isindicated for use to ablate, necrotize, orcoagulate intracranial soft tissue,including brain structures, throughinterstitial irradiation or thermal therapyin medicine and surgery in the discipline ofneurosurgery with 1064 nm lasers.The Monteris Medical NeuroBlate Systemis intended for planning and monitoringthermal therapies under MRI visualization.It provides MRI-based trajectory planningassistance for the stereotaxic placement ofMRI compatible (conditional) NeuroBlateLaser Delivery Probes. It also providesnear real-time thermographic analysis ofselected MRI images.When interpreted by a trained physician,this System provides information that maybe useful in the determination orassessment of thermal therapy. Patientmanagement decisions should not be madesolely on the basis of the NeuroBlateSystem analysis.	The Monteris Medical NeuroBlateSystem is a neurosurgical tool and isindicated for use to ablate, necrotize,or coagulate intracranial soft tissue,including brain structures (e.g., braintumor, radiation necrosis, andepileptogenic foci as identified by non-invasive and invasive neurodiagnostictesting, including imaging), throughinterstitial irradiation or thermaltherapy in medicine and surgery in thediscipline of neurosurgery with 1064nm lasers.The Monteris Medical NeuroBlateSystem is intended for planning andmonitoring thermal therapies underMRI visualization. It provides MRI-based trajectory planning assistancefor the stereotaxic placement of MRIcompatible (conditional) NeuroBlateLaser Delivery Probes. It also providesnear real-time thermographic analysisof selected MRI images.When interpreted by a trainedphysician, this System providesinformation that may be useful in thedetermination or assessment of thermatherapy. Patient management decisionshould not be made solely on the basisof the NeuroBlate System analysis.
Operating Principle(Technology)	MRI-guided Laser Probe with near-realtime thermographic monitoring of targettissue temperature	Identical
Mode of Action	Laser Interstitial Thermal Therapy(LITT)	Identical
Characteristic	Predicate:Monteris MedicalNeuroBlate System(K193375, K201056)	IntendedAlternative Modified Fusion-SSoftware (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 hardwareSoftware 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 MedicalNeuroBlate System(K193375, K201056)	IntendedAlternative Modified Fusion-SSoftware (V3.17)
3.3mm Probe Size asper Probe BodyLength Range	Size #000Size #00Size #1Size #2Size #3Size #4Size #5	Identical
2.2mm Probe Size asper Probe BodyLength Range	Size #000Size #00Size #1Size #2Size #3Size #4Size #5	Identical
Probe Diameters andLaser OutputDirection	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 andCautions	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.

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.