The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, 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 collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K170724 and K171255, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.

The NeuroBlate™ System components consist of:

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 Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
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™ and M-Vision Pro™ 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, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools).

Thus, there is no change to entire system, with the exception of an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a modification to the Monteris Medical NeuroBlate™ System. The primary modification involves "an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals which incorporate a modified Thermocouple assembly manufacturing process and several umbilical related Strain Relief component updates."

Crucially, the document states that this submission involves no change to the indications for use, intended use, operating principles, or core technology of the NeuroBlate™ system. It asserts substantial equivalence to previous versions (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) based on design verification and validation of the modified umbilical components, not a study of the overall clinical performance of the device or its AI components (such as thermographic analysis).

Therefore, this document does not contain information about a study that measures device performance against acceptance criteria in the way typically expected for an AI/CADe device's clinical efficacy or standalone performance. The "acceptance criteria" discussed are related to engineering and design verification/validation of a modified component, not clinical outcomes or diagnostic accuracy.

Given this context, I cannot directly provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the format you specified, as those types of studies (MRMC, standalone performance, expert ground truth for a test set) are not described for this specific submission. This is a component modification submission, not a new device or a new AI feature submission that would typically require such clinical performance studies.

However, I can extract the information that is present regarding the validation process for the modified umbilical:

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

The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" for the design verification process, and "Each validation protocol described the objective, test method and acceptance criteria" for the design validation process concerning the modified Laser Probe Umbilicals. However, the specific acceptance criteria and the reported numeric performance results for these criteria are NOT provided in this document. It generally states that these processes confirmed the design output met design input requirements and that the modified system met user needs and intended use.

2. Sample sized 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 testing described is design verification and validation of a medical device component (umbilicals), not a clinical study with patient data provenance.

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. Ground truth as typically understood for clinical performance studies (e.g., expert consensus) is not mentioned because this submission focuses on component-level engineering validation.

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 involving human interpretation or uncertain diagnoses, which are not detailed 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

An MRMC study was not described in this document. This submission is for a modification to a component of an existing system, not a new AI-assisted diagnostic or therapeutic tool requiring such a comparative effectiveness study. The "real-time thermographic analysis" mentioned in the device's indications for use is part of the existing system, and this submission does not detail new studies on its performance or the effect size of AI assistance.

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

A standalone performance study of an algorithm was not described in this document for this submission.

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

This information is not provided in the document. The validation pertains to component functionality rather than clinical ground truth for diagnostic accuracy.

8. The sample size for the training set

This information is not provided in the document. This submission describes component modification and validation, not the development or training of an AI algorithm with a training set.

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

This information is not provided in the document. No training set is mentioned as this device modification does not involve an AI model requiring a new training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there is a circular seal with a symbolic design. To the right of the seal, there is a rectangular block with the letters "FDA" in bold, followed by the words "U.S. FOOD & DRUG" in bold and "ADMINISTRATION" in a smaller font size below it. The logo is in black and white.

February 2, 2018

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

Re: K172881

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: September 20, 2017 Received: September 21, 2017

Dear David Mueller:

This letter corrects our substantially equivalent letter of October 20, 2017.

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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

50-2041 or 501-770-7100).

Sincerely,

Jennifer R. Stevenson -S3

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Monteris Medical, which is a medical device company. The logo consists of the word "MONTERIS" in large, bold letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" are several small circles. Below the logo is the text "Section 4: Indications for Use".

510(k) Number (if known): K172881

Device Name: Monteris Medical NeuroBlate™ System

Indications for Use:

× Prescription Use (Part 21 CFR 801 Subpart D) C)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart

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

Evaluation (ODE)

Concurrence of CDRH, Office of Device

Page 1 of __ 1

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Section 1: 510(k) Summary

Category	Comments
Sponsor:	Monteris Medical Corp.14755 27th Avenue NorthSuite CPlymouth, MN 55446763-253-4710Fax: 763-746-0084www.monteris.com
Correspondent ContactInformation:	David H. MuellerPrincipal Regulatory Affairs SpecialistMonteris Medical,TEL: 763-253-4710 x2732FAX: 763-746-0084Email: DMueller@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 dermatology21 CFR 882.4560Stereotaxic instrument
Device Classification &Product Code:	Class II, GEXClass II, HAW
Device Proprietary Name:	Monteris Medical NeuroBlateTM System

5a. 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 #	K081509, K120561, K131278, K131955,
	K141983, K143457, K162762, K170724,
	K171255
Predicate Device Regulation:	21 CFR 878.4810
	Laser surgical instrument for use in general
	and plastic surgery and in dermatology

	21 CFR 882.4560
	Stereotaxic instrument
Predicate Device Classification &	Class II, GEX
Product Code:	Class II, HAW

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5b. Date Summary Prepared

20 September 2017

5c. Description of Device

The Monteris NeuroBlate™ System is a collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K170724 and K171255, the NeuroBlate™ System is typically used for the minimally invasive ablation of target tissue (tumors, epileptic foci) in the brain.

The NeuroBlate™ System components consist of:

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 Advanced, and Robotic, Probe Drivers and interconnections for the Laser Delivery Probes (e.g., Connector Module);
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™ and M-Vision Pro™ 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, fiducial markers, bone screws, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools).

Thus, there is no change to entire system, with the exception of an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals.

5d. Indications for Use

There is no change to the indications for use, i.e., they remain:

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through interstitial

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

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.

5e. Comparison to Predicate Device

There is no change to entire system, with the exception of an additional (alternative) NeuroBlate System modified Laser Probe Umbilicals which incorporate a modified Thermocouple assembly manufacturing process and several umbilical related Strain Relief component updates.

The application for the Monteris Medical NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals is substantially equivalent to the predicate Monteris NeuroBlate™ System (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) in intended use, technology, design and physician use.

As the modifications presented in the current device do not change the intended use, operating principles, or raise any unaddressed safety concerns, it can be concluded the application NeuroBlate™ System with the alternative modified Laser Probe Umbilicals is substantially equivalent to the predicate NeuroBlate™ System.

5f. Summary of Supporting Data

The development process for the NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals 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 modified Laser Probe Umbilicals when used within the NeuroBlate System.

The Design Verification process utilized protocols to detail the associated tests which confirmed the design output met the design input for the requirements. Each verification test protocol incorporated clearly defined acceptance criteria.

The Design Validation process utilized protocols to detail the associated tests which confirmed the modified NeuroBlate™ System met the user needs and intended use. Each validation protocol described the objective, test method and acceptance criteria.

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Thus, as the modifications presented in the current device do not change the intended use, operating principles or raise any unaddressed safety concerns, the application for the Monteris Medical NeuroBlate™ System with the (alternative) modified Laser Probe Umbilicals NeuroBlate™ System is substantially equivalent to the predicate Monteris NeuroBlate™ System (K081509, K120561, K131278, K131955, K141983, K143457, K162762, K170724 and K171255) 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.