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 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.

This submission adds a line of Diffusing Tip Laser Delivery Probes (DTP) to the existing line of Side-Firing Laser Delivery Probes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, using the specified format. The document focuses on showing substantial equivalence of a new diffusing tip probe to an existing side-firing probe, rather than detailing a rigorous clinical trial with specific performance metrics against an acceptance threshold.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Threshold/Standard)	Reported Device Performance
Safety and Effectiveness	Device is in compliance with the medical community's expectations and product labeling.	Bench testing demonstrated that the System (including the Diffusing-Tip Probe) is in compliance with the medical community's expectations and the product labeling. It "demonstrates that NeuroBlate system works as well with the Diffusing-Tip Probe as it does with the Side-Firing Probe." Additionally, animal testing was performed. The application "does not change the intended use, operating principles, or raise any unaddressed safety concerns" compared to the predicate device.
Performance - Ablation	Not explicitly stated as a numerical criterion; implied performance is that the Diffusing-Tip Laser Delivery Probes (DTP) create ablation lesions.	The application system with the Diffusing-Tip Laser Delivery Probe can create larger ablation lesion volumes during laser firing than the predicate Side-Firing Probe.
Substantial Equivalence	Device is substantially equivalent to the predicate device in intended use, technology, design, and physician use, and does not raise any new questions of safety or effectiveness.	The application Monteris Medical NeuroBlate™ System with the Side-Firing and Diffusing Tip Laser Delivery Probes is substantially equivalent to the predicate Monteris NeuroBlate™ System with only the Side-Firing Laser Delivery Probes in intended use, technology, design and physician use. The Indications for Use and fundamental technology are unchanged. All patient contacting materials are identical. Technical modes of action and principles are materially the same. Modifications do not change intended use, operating principles, or raise unaddressed safety concerns.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of human data or a sample size for such a set. The studies mentioned are primarily "bench and animal testing."

Test Set Sample Size: Not specified for human data; applied to "bench and animal testing."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The data appears to be from internal company testing (bench and animal studies).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The study relies on bench and animal testing, not a ground truth established by human experts for a specific test set of cases. The device's information is to be "interpreted by a trained physician," but this refers to its clinical use, not the validation study itself.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication method as the study design does not involve human readers evaluating a test set of cases that would require adjudication.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (laser delivery probes), not an AI-assisted diagnostic tool for human readers.

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

This is not directly applicable in the context of this device. The NeuroBlate System, while having software for planning and monitoring, is a physical medical device (laser delivery probe) used by a physician. Its performance is intrinsically tied to human-in-the-loop operation. The "standalone" performance here refers to the physical and functional performance of the device itself (e.g., ablation capabilities confirmed through bench and animal testing), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's performance (specifically, its ability to ablate, necrotize, or coagulate soft tissue and its compliance with expectations) was established through:

Bench Testing: Laboratory evaluations of the device's physical and functional properties.
Animal Testing: In-vivo studies on animals to assess the device's effects on tissue.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a medical device (hardware and associated software for control), not an AI algorithm that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI algorithm mentioned in this document.

Summary

{0}------------------------------------------------

长131278

NeuroBlate™ System – Add Diffusing Tip Laser Delivery Probe Special Premarket Notification

Section 5: 510(k) Summary

JUL 1 1 2013

Category	Comments
Sponsor:	Monteris Medical Corp.16305 36th Ave. North, Suite 200Plymouth, MN 55446763-253-4710Fax: 763-746-0084www.monteris.com
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 dermatology
	21 CFR 882.4560Stereotaxic instrument
Predicate Device Classification &Product Code:	Class II, GEXClass II, HAW

b. Date Summary Prepared

1 May 2013

{1}------------------------------------------------

c. Descrintion 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 adds a line of Diffusing Tip Laser Delivery Probes (DTP) to the existing line of Side-Firing Laser Delivery Probes.

d. Indications for Use

e. Comparison to Predicate Device

The application Monteris Medical NeuroBlate™ System with the Side-Firing and Diffusing Tip Laser Delivery Probes is substantially equivalent to the predicate Monteris NeuroBlate™ System with only the Side-Firing Laser Delivery Probes in intended use. technology, design and physician use.

The Indications for Use for the modified NeuroBlate System are unchanged from the predicate NeuroBlate System. The fundamental technology is also unchanged.

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

{2}------------------------------------------------

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

The application System with the Diffusing-Tip Laser Delivery Probe can create larger ablation lesion volumes during laser firing than the predicate Side-Firing Probe. The Side-Firing Probe remains useful for fine-tuning the edges of an ablation target or for focal energy delivery if probe position within the target warrants such use.

Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling. It demonstrates that NeuroBlate system works as well with the Diffusing-Tip Probe as it does with the Side-Firing Probe.

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 with the added Diffusing Tip Laser Delivery Probe is substantially equivalent to the predicate NeuroBlate™ System.

f. Summary of Supporting Data

Bench and animal testing has demonstrated that the System in general, and the DTP in particular, are in compliance with the medical community's expectations and the product labeling.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

July 11, 2013

Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

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

Re: K131278

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: May 03, 2013 Received: May 06, 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 10 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

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

Page 2 - Mr. Craig Coombs

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/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

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

Section 4: Indications for Use

510(k) Number (if known): K131278

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 × (Part 21 CFR 801 Subpart D) AND/OR

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 2013.07.09 15:15:23 -04'00'

(Division Sign-off) for MxM Division of Surgical Devices 510(k) Number K131278

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.