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 Probes. 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 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.

This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T General Electric Magnetic Resonance Imaging Systems.

AI/ML Overview

The provided document, K131955, describes the Monteris Medical NeuroBlate™ System and its substantial equivalence to a predicate device. This submission specifically addresses the compatibility of the NeuroBlate System with General Electric (GE) MRI systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based only on the provided text:

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

The provided document does not explicitly state acceptance criteria in a quantitative format for specific performance metrics of the device itself. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device, specifically regarding compatibility with additional MRI systems.

The core acceptance criterion is that the modified device (NeuroBlate™ System compatible with GE MRI) is substantially equivalent to the predicate device (NeuroBlate™ System compatible with Siemens and IMRIS MRI) in terms of:

Intended use
Technology
Design
Physician use
Patient contacting materials
Technical modes of action and technical principles
No change in operating principles or unaddressed safety concerns.

The reported device performance is that it meets this substantial equivalence.

Acceptance Criteria Category	Reported Device Performance (Summary)
Substantial Equivalence
Intended Use	Met (Identical)
Technology	Met (Materially the same)
Design	Met (Materially the same)
Physician Use	Met (Identical)
Patient Contacting Materials	Met (Identical in composition, source, and use)
Technical Modes of Action	Met (Materially the same)
Technical Principles	Met (Materially the same)
Operating Principles	Met (No change)
Safety Concerns	Met (No unaddressed safety concerns)
MRI Compatibility
With GE 1.5T MRI systems	Demonstrated (Works as well as with Siemens and IMRIS MRIs)
With GE 3.0T MRI systems	Demonstrated (Works as well as with Siemens and IMRIS MRIs)

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 a bench testing and software testing approach to demonstrate compatibility.

Sample Size for Test Set: The document does not specify a numerical sample size for "test sets" in the context of patient data or specific device units tested. It refers to "bench testing" and "software testing," which typically involve testing under controlled laboratory conditions rather than with human subjects.
Data Provenance: Not applicable in the context of clinical data. The testing described is "bench testing" and "software testing," which are laboratory-based studies to verify device functionality and compatibility. There is no mention of country of origin for such data.
Retrospective or Prospective: Not applicable as the testing described is not a clinical study involving patients.

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. The study described focuses on technical compatibility and substantial equivalence, not on clinical performance assessed by experts. The statement "When interpreted by a trained physician, this System provides information that may be useful..." refers to the intended use of the device, not the validation of its compatibility with GE MRIs.

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

This information is not provided in the document. Adjudication methods are typically relevant for clinical studies where expert consensus is needed to establish ground truth for ambiguous cases, which is not the type of study described here.

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

No such MRMC comparative effectiveness study is mentioned or implied in the provided text. The device is a "Magnetic Resonance Image Guided Laser Thermal Therapy System," not described as an AI-powered diagnostic or assistive tool for human readers in the context of this submission. The submission is focused on MRI compatibility validation.

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

The document mentions "software and bench testing" demonstrating compliance. This implies standalone testing of the software and hardware components (algorithm only for software, device performance for bench testing) to ensure functionality and compatibility. However, it does not detail specific algorithm-only performance metrics or studies in isolation from the overall system and its intended use. The "thermographic analysis" and "trajectory planning assistance" provided by the software are functionalities of the system, which would have been tested in a standalone manner during software testing.

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

For the compatibility study, the "ground truth" would be established by technical specifications, engineering standards, and successful demonstration of the device's functionality and safety when integrated with GE MRI systems. This would involve:

Bench Test Results: Direct measurements and observations of device performance (e.g., laser energy delivery, probe positioning accuracy, temperature monitoring) within the MRI environment.
Software Test Results: Verification that the M Vision™ Software performs its functions (procedure planning, interactive monitoring, thermographic analysis) correctly and integrates properly with the GE MRI interface.
MRI Artifact Assessment: Ensuring the device does not produce unacceptable artifacts in the MRI images.
Safety Standards Compliance: Adherence to relevant safety standards for medical devices and MRI compatibility.

Therefore, the ground truth is based on technical validation against specifications and safety standards rather than expert consensus on clinical cases or pathology outcomes.

8. The sample size for the training set

This information is not provided. Training sets are relevant for machine learning algorithms. While the system's software provides "thermographic analysis" and "trajectory planning assistance," there is no indication that it utilizes a "training set" in the sense of supervised machine learning for its primary function in this submission. The focus is on the device's physical and software compatibility with new MRI machines.

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

Not applicable, as no "training set" in the context of machine learning is mentioned for this submission.

Summary

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K131955

NeuroBlate™ System – GE MRI Compatibility Special Premarket Notification

Section 5: 510(k) Šummary

Category	Comments
Sponsor:	Monteris Medical Corp.16305 36th Ave. North, Suite 200Plymouth, MN 55446763-253-4710Fax: 763-746-0084www.monteris.comJUL 30 2013
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
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

a. Device Information:

Predicate Device Information:

Predicate Device:	NeuroBlate™ System
Predicate Device Manufacturer:	Monteris Medical
Predicate Device Common Name:	Monteris NeuroBlate™ System
Predicate Device Premarket Notification #	K120561
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

b. Date Summary Prepared 25 June 2013

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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.

This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T General Electric Magnetic Resonance Imaging Systems.

d. Indications for Use

e. Comparison to Predicate Device

The application Monteris Medical NeuroBlate™ System (GE, Siemens, and IMRIS MRI compatible) is substantially equivalent to the predicate Monteris NeuroBlate™ System (Siemens, and IMRIS MRI compatible) 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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The application System is compatible with listed GE 1.5 and 3.0T MRI systems, along with the predicate Systems compatibility with listed Siemens and IMRIS 1.5 and 3.0 MRI Systems

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 application NeuroBlate™ System (GE, Siemens, and IMRIS MRI compatible) is substantially equivalent to the predicate NeuroBlate™ System (Siemens, and IMRIS MRI compatible).

f. Summary of Supporting Data

Software and bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling. It demonstrates that the NeuroBlate System works as well with the GE MRI's as it does with the Siemens and IMRIS MRI's.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 30, 2013

Monteris Medical, Incorporated % Mr. Craig Coombs Coombs Medical Device Consulting, Incorporated 1193 Sherman Street, Alameda, California 94501

Re: K131955

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: June 26, 2013 Received: July 01, 2013

Dear Mr. Coombs:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Mr. Coombs

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

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): K131955

Device Name: Monteris Medical NeuroBlate™ System

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 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.

Prescription Use × AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR AND/OR 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)

Page 1 of 1

Neil R Ogden 2013.07.29 09:27:30 -04'00' (Division Sign-off) for MxM Division of Surgical Devices 510(k) Number

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.