The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue, including brain structures, through internal 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 intracranial delivery of precision thermal therapy in the practice of neurosurgery.

As previously described in K172881, 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 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™ 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 M-Vision/ M-Vision Pro Software Package (V3.13). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one proposed 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 text describes the Monteris Medical NeuroBlate™ System (K173305), which is a modification of a previously cleared device (K172881). The submission is for an updated M-Vision/M-Vision Pro Software Package (V3.13). The document primarily focuses on demonstrating substantial equivalence to the predicate device due to a software update that modifies an existing risk control measure.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions that "Each verification test protocol incorporated clearly defined acceptance criteria" and "Each validation protocol described the objective, test method and acceptance criteria." However, it does not provide the specific acceptance criteria or the reported performance data for these tests. It only states that the tests "confirmed (and documented) the design output met the design input for the requirements" and that the "modified NeuroBlate™ System met the user needs and intended use."

To fill the table below, I must infer the general nature of the criteria based on the device and its intended use, as specific details are not provided. The device performs planning and real-time thermographic analysis for thermal therapy. Therefore, acceptance criteria would likely relate to the accuracy, precision, and reliability of these functions.

Metric (Inferred)	Acceptance Criteria (Not explicitly stated, inferred)	Reported Device Performance (Not explicitly stated, inferred)
Design Verification:
Accuracy of trajectory planning assistance	Trajectory planning assistance provided by the M-Vision/M-Vision Pro software should meet predefined accuracy specifications to ensure precise placement of probes.	The design verification process utilized protocols and corresponding test reports confirmed that the design output met the design input for the requirements, implying that the trajectory planning assistance performs as specified.
Accuracy of real-time thermographic analysis	Real-time thermographic analysis provided by the M-Vision/M-Vision Pro software should accurately reflect thermal changes in tissue within specified tolerances.	The design verification process confirmed that the design output met the design input for the requirements, meaning the thermographic analysis functions within its specified accuracy.
Software functionality and reliability	All functions of the M-Vision/M-Vision Pro V3.13 software should perform as intended without errors or crashes, adhering to documented specifications.	The design verification process confirmed that the design output met the design input for the requirements, implying that the software is functional and reliable as per its specifications.
Risk control measure effectiveness (modified)	The modified risk control measure in V3.13 software should effectively mitigate the identified hazardous situation to an acceptable level, as per risk assessment.	The submission for K173305 was specifically triggered because the updated software modifies an existing risk control measure for a hazardous situation. The design verification and validation process documented the meeting of these requirements, implying the modified risk control measure is effective.
Design Validation (User Needs & Intended Use):
System performance in intended use	The NeuroBlate™ System with V3.13 software should effectively ablate, necrotize, or coagulate intracranial soft tissue when used by a trained physician, and information provided should be useful for thermal therapy assessment.	The design validation process utilized protocols and corresponding test reports confirmed that the modified NeuroBlate™ System met the user needs and intended use. This implies the system functions as intended and provides useful information for patient management when interpreted by a trained physician, although specific outcomes are not quantified.
MRI compatibility and visualization	The system's MRI compatibility and ability to provide MRI-based trajectory planning and real-time thermographic analysis should perform reliably in an MRI environment.	The design validation process confirmed the system met user needs and intended use, which would encompass the proper functioning of MRI compatibility and visualization features.

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

The document does not specify the sample size for the test set used in the design verification or design validation. It only mentions that "The Design Verification process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the design output met the design input for the requirements." Similarly, for validation, "The Design Validation process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the modified NeuroBlate™ System met the user needs and intended use."

The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any test sets. The indications for use state "When interpreted by a trained physician," implying that qualified medical professionals are involved in the use and interpretation of the system, but this doesn't directly address the establishment of ground truth for testing purposes.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The submission is for a software update to an existing device, focusing on maintaining substantial equivalence rather than a new clinical effectiveness claim through an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The document describes software (M-Vision/M-Vision Pro) that provides "trajectory planning assistance" and "real-time thermographic analysis." It explicitly states, "Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis," indicating that a human (trained physician) is always intended to be in the loop.

Therefore, it is highly likely that standalone algorithm-only performance was evaluated as part of the design verification (e.g., measuring the inherent accuracy of planning algorithms or thermographic calculations), but not as a replacement for human-in-the-loop performance in the clinical application. The document indicates that the software provides "information that may be useful" and requires interpretation by a trained physician.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for either verification or validation. Given the nature of a laser thermal therapy system, potential ground truths could include:

Physical measurements/phantoms: For accuracy of laser delivery and thermal profile generation during verification.
Pathology/histology: To confirm ablation zones in preclinical or bench testing.
Expert consensus/clinical outcomes: To evaluate the system's utility and accuracy in real or simulated clinical scenarios during validation, although this is inferred.

The document states the purpose of the software update was for a "risk control measure for a hazardous situation," suggesting that the ground truth for evaluating this might involve risk analyses, simulated failure modes, and verification of corrective actions.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This is because the submission concerns a software update (V3.13) for an existing system, and the description focuses on verification and validation of changes rather than the development of a new AI/ML model that typically involves distinct training sets.

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

As no training set is discussed or implied for a new AI/ML model, the establishment of ground truth for a training set is not applicable in this context. The V3.13 software is likely a deterministic software update rather than an adaptive AI system requiring a 'training set' in the machine learning sense.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

November 17, 2017

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

Re: K173305

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: October 17, 2017 Received: October 18, 2017

Dear Mr. 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. 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 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);

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

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).

Sincerely, Michael J. Hoffmann -S

Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K173305

Device Name Monteris Medical NeuroBlate™ System

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}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, dark blue font, with the word "MEDICAL" in a smaller font directly underneath. Above the word "MONTERIS" is a series of teal-colored circles arranged in an arc shape, with larger circles in the center and smaller circles on the sides.

Section 1: 510(k) Summary

5a. Device Information:

Category	Comments
Sponsor:	Monteris Medical Corp.14755 27th Avenue NorthSuite CPlymouth, MN 55446763-253-4710Fax: 763-746-0084www.monteris.com
Correspondent ContactInformation:	David H. MuellerSenior Principal 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 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 #:	K172881
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}------------------------------------------------

K173305 - Page 2 of 4

Image /page/4/Picture/1 description: The image shows the logo for Monteris Medical, followed by the text "5b. Date Summary Prepared" and the date "30 October 2017". The Monteris Medical logo consists of the word "MONTERIS" in bold, uppercase letters, with the word "MEDICAL" in smaller letters underneath. Above the word "MONTERIS" are several small, teal-colored circles arranged in a pattern.

5c. Description of Device

As previously described in K172881, 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 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™ 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).

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

Image /page/5/Picture/1 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in large, bold, dark blue letters, with the word "MEDICAL" in smaller, lighter blue letters underneath. Above the word "MONTERIS" are seven light blue circles arranged in an arc. The circles are of equal size and are evenly spaced.

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 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 M-Vision/ M-Vision Pro Software Package (V3.13). While the modified software package includes several modifications which do not meet the FDA's "significant change" submission criteria, there is at least one proposed 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 application for the Monteris Medical NeuroBlate™ System with the M-Vision/ M-Vision Pro is substantially equivalent to the predicate Monteris NeuroBlate™ System (K172881) 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 M-Vision Pro (V3.13) Software is substantially equivalent to the predicate NeuroBlate™ System.

5f. Summary of Supporting Data

The updated M-Vision/ M-Vision Pro (V3.13) 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 M-Vision Pro (V3.13) Software when used within the NeuroBlate System.

The Design Verification process utilized protocols to detail the associated tests. The corresponding test reports which confirmed (and documented) the design output met the design

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for Monteris Medical. The logo features a series of teal-colored circles arranged in an arc above the company name. The company name, "MONTERIS," is written in a bold, sans-serif font, with the word "MEDICAL" appearing in a smaller font size directly below it.

input for the requirements. Each verification test protocol incorporated clearly defined acceptance criteria.

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

Thus, the application for the Monteris Medical NeuroBlate™ System with the M-Vision Pro (V3.13) is substantially equivalent to the predicate Monteris NeuroBlate™ System (K172881) 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.