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 near 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.

The NeuroBlate™ System components consist of:

Families of gas-cooled Laser Delivery 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™ FUSION™ 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, 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).

This submission's proposed change simply replaces the Probe's existing internal metallic (wire) thermocouple with a non-metallic fiber optic. temperature sensor. The optical fiber temperature sensor has the identical function as the existing metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.

Corresponding hardware and software changes are proposed in order to incorporate the new optical fiber component, e.g., (hardware) modified Connector Module, a Signal Conditioner (converts optical fiber signal to electrical temperature signal), and (software) M-Vision Pro Software Package (V3.14), along with associated labeling updates.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Monteris Medical NeuroBlate™ System with the fiber optic temperature sensor.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. Therefore, the level of detail regarding specific acceptance criteria and study results, particularly for standalone performance or comparative effectiveness, is less comprehensive than what might be found in a full clinical study report.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list specific numerical acceptance criteria for device performance in a table format. Instead, it broadly states that:

"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."

And for validation:

"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."

The core purpose of this submission is to demonstrate that the functionality of the new fiber optic temperature sensor (FOTS) is identical to the existing metallic (wire) thermocouple in measuring the probe tip's internal temperature and transmitting the data to the NeuroBlate System and M-Vision Software. The key performance aspect is that the FOTS prevents MRI induced unintentional Probe heating, which was the root cause of a recall (Z-0194-2018).

Given this, the "acceptance criteria" can be inferred as ensuring the new FOTS system performs as reliably and accurately as the previous system, while also actively eliminating the MRI-induced heating issue. Without specific protocols, a table of acceptance criteria and reported device performance cannot be generated with numerical values from this text. The reported device performance is that the new FOTS system successfully prevents the MRI induced unintentional Probe heating by eliminating the coupling of MR energy to the probe umbilical.

Detailed Information on the Study:

A table of acceptance criteria and the reported device performance
- As explained above, explicit numerical acceptance criteria are not provided in this 510(k) summary. The primary criteria would revolve around the accurate and reliable measurement of probe tip internal temperature, and the successful prevention of MRI-induced heating. The reported performance is that the new FOTS system achieves this by addressing the root cause of the previous recall.
Sample size used for the test set and the data provenance
- The document describes "design verification and design validation processes" but does not specify sample sizes for these tests.
- Data provenance: Not explicitly stated, but given it's a medical device for intracranial use, the testing would generally be conducted in controlled laboratory or simulated environments, primarily in the US (where Monteris Medical is based). The study is retrospective in the sense that it's a modification to an existing device in response to a recall, and testing would validate the new design. It is not a clinical study on patients.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The ground truth for device performance in this context would likely be established through engineering measurement standards, calibration against established temperature reference standards, and MRI compatibility testing protocols. These would involve engineers and technical experts in fields like laser physics, MRI compatibility, and materials science, rather than medical experts for ground truth establishment for this specific modification.
Adjudication method for the test set
- Adjudication methods (like 2+1, 3+1) are typically used for interpreting human-derived data like imaging reads. This scenario involves technical performance testing of a physical and software modification. Therefore, an adjudication method in this sense is not applicable and not mentioned.
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, an MRMC comparative effectiveness study was not done. This submission is for a modification to a laser ablation system's internal temperature sensor, not for an AI-assisted diagnostic tool. The device's primary function (laser ablation) and the interpretation of thermographic analysis by physicians remain unchanged.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The core modification is the replacement of a physical temperature sensor (thermocouple with Fiber Optic Temperature Sensor - FOTS) and associated hardware/software changes. The performance of the FOTS itself, in terms of accurate temperature measurement and signal transmission to the system's software, would have been tested in a standalone capacity (i.e., the sensor's accuracy and behavior independent of a human operator, but within the device system) as part of the "Design Verification" process. The document does not provide details on these specific tests or results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the temperature sensor's performance would be based on physical measurement standards. This would involve:
  - Calibration against known temperature references.
  - Evaluation of the sensor's accuracy and precision according to established engineering and metrology standards.
  - Validation that the sensor effectively measures the probe tip's internal temperature and that the system controls cooling appropriately.
  - Crucially, validation that the FOTS does not interact adversely with MRI fields (the root cause of the recall), which would involve specialized MRI compatibility testing.
The sample size for the training set
- This is not applicable. This device is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense. The software modifications are to integrate the new sensor signal, not to train an algorithm using data.
How the ground truth for the training set was established
- This is not applicable as there is no training set mentioned or implied for a machine learning model. The software changes are integration and adaptation for the new sensor's signal.

Summary

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October 15, 2018

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

Re: K182036

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 Dated: July 27, 2018 Received: July 30, 2018

Dear David 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

Matthew C. Krueger -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K182036

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)

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Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a dark blue, sans-serif font, with the word "MONTERIS" in a larger font size than the word "MEDICAL" which is placed directly below it. Above the company name, there is a series of teal-colored circles arranged in an arc shape, with larger circles in the center and smaller circles towards the edges.

510(k) Summary

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 Laser ThermalTherapy System
Device Classification Number:	21 CFR 878.4810Laser surgical instrument for use in general and plasticsurgery 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:

Manufacturer	Monteris Medical
CommercialName	NeuroBlate System
CommonName:	Laser Interstitial Thermal Therapy (LITT)Laser surgical instrument for use in general and plastic surgery and in dermatologyStereotaxic instrument
PremarketNotification #	K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955,K131278, K120561, K081509
Regulation	21 CFR 878.481021 CFR 882.4560
Class/ ProductCode	Class IIGEX, HAW

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Image /page/4/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the company name in a bold, dark blue font, with the word "MONTERIS" stacked above the word "MEDICAL". Above the company name is a series of teal-colored circles arranged in an arc shape. There are 3 larger circles in the center, with smaller circles on either side.

Date Summary Prepared

27 July 2018

Description of Device

As previously described in K170724, K171255, K172881, and K173305, 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 (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™ FUSION™ ● 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, 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).

Monteris' existing NeuroBlate System Laser Delivery Probes ("Probe") include the 3.3mm FullFire and SideFire Probes and the 2.2mm FullFire Probe. In order to ensure that the Probe tip maintains an appropriate temperature while the laser is on, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software

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which regulates the cooling system for the laser probe, e.g., ensures sufficient gas coolant is sent to the Probe tip to maintain an appropriate temperature.

Note: The only function for the Probe's temperature sensor is to measure the Probe tip's internal temperature, i.e., the sensor is not utilized for determining the patient's brain tissue temperature and is not utilized for the software's thermography visualization.

To perform a NeuroBlate procedure, a NeuroBlate Laser Probe is connected to a Portable Connector Module (PCM). The PCM integrates with the Interface Platform(IP). The IP attaches to the MRI system's patient table or the ATAMA board, and provides supporting electronics for the Probe Drivers and interconnections (including the Portable Connector Module) for the Laser Delivery Probes.

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 near real-time thermographic analysis of selected MRI images.

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Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo features a series of teal-colored circles arranged in an arc shape above the company name. The company name, "MONTERIS," is written in a bold, dark blue sans-serif font, with the word "MEDICAL" in a smaller font size directly below it.

Comparison to Predicate Device

In order to ensure that the Probe tip does not over-heat during laser ablation, all Monteris Probes incorporate an internal temperature sensor which measures the probe tip's internal temperature. The sensor transmits the temperature reading to the NeuroBlate System and associated M-Vision Software which regulates the cooling system for the laser probe ensuring sufficient gas coolant is sent to the Probe tip to maintain an appropriate temperature.

This submission's proposed fiber optic temperature sensor (FOTS) has the identical function as the existing (predicate) NeuroBlate Probe's metallic (wire) thermocouple, i.e., to measure the probe tip's internal temperature and to transmit the temperature measurement to the NeuroBlate System and associated M-Vision Software.

These proposed changes are in response to a recall (Z-0194-2018) regarding MRI induced unintentional Probe heating. Replacing the metallic thermocouple with a FOTS prevents the MR energy from coupling to the probe umbilical and thus eliminates the root cause of unintended Probe heating.

In order to incorporate the FOTS component, the current NeuroBlate hardware, software and labeling are also modified.

Hardware: Portable Connector Module (PCM) The proposed PCM modifies the existing PCM to incorporate a new optical fiber connector port (and a pre-attached fiber optic cable). The modified and existing PCM remain Substantially Equivalent.
Hardware: Signal Conditioner

The current NeuroBlate Probe's Thermocouple (TC) provides its temperature signal via electrical current while the modified Probe with FOTS utilizes light signals. The provided FOTS signal is "converted" to a temperature signal at the new Optical Signal Conditioner. The Optical Signal Conditioner and the existing Signal Conditioner (WIKA Transmitter Puck) remain Substantially Equivalent.

Hardware: Associated Fiber Optic Cabling and Accessories ● The current Thermocouple (TC) transmits its electrical temperature signal via electrical cabling and connectors. A fiber optic electrical signal must be transmitted via fiber optic cabling and connectors. These cables and accessories remain Substantially Equivalent.
Software: M-Vision V3.14 Software ● The existing M-Vision V3.13 Software is slightly modified to form V3.14 such that the system reads probe tip temperature via an optic signal conditioner. Several minor

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Image /page/7/Picture/0 description: The image shows the logo for Monteris Medical. The logo features a series of teal circles arranged in an arc shape above the company name. The company name, "MONTERIS," is written in a bold, dark blue font, with the word "MEDICAL" appearing in a smaller font size directly below it.

software updates were also completed to incorporate FOTS. M-Vision V3.13 and V3.14 remain Substantially Equivalent.

Labeling: Fiber Optic Labeling Updates and Additional Labeling Clarifications ● Labeling updates include product label branding (i.e., Optic™), corresponding Probe and system component drawings, photographs and instructions related to FOTS incorporation. Additionally, existing Contraindications, Warnings, Cautions, and Instructions are duplicated within the IFU and clarified for ease of reader understanding.
The 510(k) application for the Monteris Medical NeuroBlate™ System with the fiber optic temperature measurement system demonstrates it to be substantially equivalent to the predicate 510(k) submissions for the Monteris NeuroBlate™ System [K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, K131278, K120561, and K081509 in intended use, technology, design and physician use.

As the modifications presented do not change the intended use, operating principles, or raise any unaddressed safety concerns, it can be concluded the application NeuroBlate™ System with the fiber optic temperature (measurement) sensor is substantially equivalent to the predicate NeuroBlate™ System.

Summary of Supporting Data

The development process for the NeuroBlate™ System Probe with the fiber optic temperature sensor 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 Probe 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.

As the proposed modifications do not change the intended use, operating principles or raise any unaddressed safety concerns, the application for the Monteris Medical NeuroBlate™ System Probe with the fiber optic temperature sensor is substantially equivalent to the predicate Monteris NeuroBlate™ System (K173305, K17288, K171255, K170724, K162762, K143457, K141983, K131955, K131278, K120561, and K081509) 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.