The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue 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 Probe. It also provides 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 unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy. The NeuroBlate System components consist of:

A gas-cooled Laser Delivery Probe (Probe) to deliver controlled energy to a target . zone:
. A Probe Driver which allows the surgeon to precisely position, stabilize and manipulate a laser probe within the target zone;
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™ Software, which includes a user ● interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.

AI/ML Overview

This document describes a 510(k) premarket notification for the Monteris Medical NeuroBlate™ System. The submission aims to demonstrate substantial equivalence to a predicate device, the Monteris AutoLITT® System, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Here's a breakdown of the requested information based on the provided text:

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

The provided text does not include explicit acceptance criteria with quantitative performance metrics for the device's clinical efficacy or safety, as would be expected for a study demonstrating clinical performance against predefined thresholds. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing and compatibility assessments.

Therefore, a table of acceptance criteria and reported device performance directly related to clinical outcomes cannot be constructed from this document.

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

The document primarily describes bench testing for aspects like electromagnetic compatibility, MRI compatibility, and probe placement accuracy. There is no mention of a "test set" in the context of patient data for clinical performance evaluation. The data provenance and sample size for such a clinical test set are therefore not applicable here.

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)

Since there is no patient-based test set described for clinical performance, there is no information provided on experts establishing ground truth for such a set.

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

Given the lack of a patient-based test set for clinical performance, no adjudication method is mentioned or applicable.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The NeuroBlate™ System is a medical device for laser thermal therapy, not an AI-assisted diagnostic tool that would typically involve a multi-reader study of diagnostic interpretation.

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

This question is not directly applicable. The NeuroBlate™ System is a physical device used by a physician. While it includes "M Vision™ Software" for planning and monitoring, the document doesn't describe a "standalone algorithm only" performance study in the context of AI or diagnostic interpretation. Its "standalone" function is as a laser thermal therapy system with integrated monitoring.

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

For the bench testing described, the "ground truth" would be engineering specifications and established physical principles (e.g., actual probe placement, measured electromagnetic interference, temperature changes during RF heating, ASTM standards for MR compatibility). There is no mention of ground truth related to clinical outcomes, pathology, or expert consensus in the context of clinical efficacy for the device.

8. The sample size for the training set

Since this is a 510(k) submission focused on substantial equivalence through bench testing, there is no mention of a "training set" for an algorithm in the machine learning sense. The device is not presented as a machine learning system that requires a training set of data.

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

As there is no mention of a training set, the method for establishing its ground truth is not applicable.

In summary:

The provided document, a 510(k) summary, demonstrates the substantial equivalence of the NeuroBlate™ System to a predicate device primarily through bench testing and adherence to engineering and regulatory standards (e.g., IEC, ASTM). It does not present a clinical study with detailed acceptance criteria, performance metrics, and patient data analysis as typically seen for novel clinical efficacy claims or AI/diagnostic device approvals. The focus is on verifying the device's functionality, safety (e.g., MRI compatibility, EMC), and that modifications from the predicate do not alter its intended use or raise new safety concerns.

Summary

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K12056/

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NeuroBlate™ System Traditional Premarket Notification

Section 5: 510(k) Summary

1 2013 APR

a. Device Information:
Category	Comments
Sponsor:	Monteris Medical, Inc.100 - 78 Innovation DriveWinnipeg, ManitobaCANADA R3T 6C2Tel: 204-272-2220Fax: 204-272-2219www.monteris.com
Correspondent ContactInformation:	John SchellhornPresident & C.E.O.Monteris Medical Corp.16305 36th Ave. North, Suite 200Plymouth, MN 55446763-253-4712 office617-230-1252 mobilejschellhorn@monteris.com
Device Common Name:	Magnetic Resonance Image Guided LaserThermal Therapy System
Device Classification Number:	21 CFR 878.4810Laser surgical instrument for use in general andplastic surgery and in dermatology
	21 CFR 882.4560Stereotaxic instrument
Device Classification &Product Code:	Class II, GEXClass II, HAW
Device Proprietary Name:	Monteris Medical NeuroBlateTM System

Predicate Device Information:

Predicate Device:	AutoLITT® System
Predicate Device Manufacturer:	Monteris Medical
Predicate Device Common Name:	Monteris AutoLITT® System
Predicate Device Premarket Notification #	K081509
Predicate Device Regulation:	21 CFR 878.4810Laser surgical instrument for use ingeneral and plastic surgery and indermatology21 CFR 882.4560Stereotaxic instrument
Predicate Device Classification &Product Code:	Class II, GEXClass II, HAW

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b. Date Summary Prepared . 28 March 2013

c. Description of Device

A gas-cooled Laser Delivery Probe (Probe) to deliver controlled energy to a target . zone:
. A Probe Driver which allows the surgeon to precisely position, stabilize and manipulate a laser probe within the target zone;
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™ Software, which includes a user ● interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.

d. Indications for Use

e. Comparison to Predicate Device

The Monteris Medical NeuroBlate™ System is substantially equivalent to the predicate Monteris AutoLITT® device in intended use, technology, design and physician use.

All patient contacting materials are identical in composition, source, and use with respect to the predicate device.

The technical modes of action and technical principles are materially the same the predicate devices.

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Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.

As the modifications presented in the current device do not change the intended use, operating principles, or raise any unaddressed safety concerns, with respect to the predicate device, it can be concluded the NeuroBlate™ System is substantially equivalent to the AutoLITT® System.

f. Summary of Supporting Data

Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.

In particular the following testing was conducted to demonstrate electromagnetic and MRI compatibility:

. EMC/EMI testing in accordance with IEC 60601-1-2.
Verification of probe placement accuracy within MR environment. .
Testing for RF Induced heating during MR Imaging. ●
MR compatibility for 1.5T and 3T per ASTM standards.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Letter dated: April 1, 2013

Monteris Medical, Incorporated % Mr. John Schellhorn Chief Executive Officer 16305 36th Ave. North, Suite 200 Plymouth, MN 55446

Re: K120561

Trade/Device Name: Monteris Medical 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: February 22, 2012 Received: February 24, 2012

Dear Mr. Schellhorn:

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. 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.

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 – Mr. John Schellhorn

forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N.Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use

510(k) Number (if known): K120561

Monteris Medical NeuroBlate™ System Device Name:

Indications for Use:

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogdens 2013.03.29 08:48:43 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K120561

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Section 4, Page 1

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.