NeuroBlate System

K173305 · Monteris Medical, · GEX · Nov 17, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K173305
• Device Name: NeuroBlate System
• Applicant: Monteris Medical,
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

NeuroBlate System provides MRI-guided laser interstitial thermal therapy (LITT) for intracranial soft tissue ablation. System inputs include MRI images; processed via M-Vision/M-Vision Pro software to provide real-time thermographic analysis and trajectory planning. Components include 1064 nm gas-cooled laser delivery probes (SideFire/FullFire), probe drivers (robotic/advanced), interface platform, and control workstation. Used in neurosurgery; operated by physicians. System assists in stereotaxic probe placement and thermal monitoring. Output allows physicians to visualize thermal therapy progress; aids in clinical decision-making for tumor or epileptic foci ablation. Benefits include minimally invasive precision thermal therapy.

Clinical Evidence

Bench testing only. Design verification and validation protocols were executed to confirm that the M-Vision/M-Vision Pro (V3.13) software met all design inputs and user needs. No clinical trial data was required or presented.

Technological Characteristics

MRI-compatible laser surgical system. Uses 1064 nm laser energy for thermal ablation. Components: gas-cooled laser delivery probes, robotic/advanced probe drivers, interface platform, and control workstation. Software-based trajectory planning and real-time thermographic analysis. Connectivity via system umbilicals and cables to MRI subsystems. Sterilization: components provided sterile or compatible with standard neurosurgical sterilization protocols.

Indications for Use

Indicated for ablation, necrosis, or coagulation of intracranial soft tissue, including brain structures, in neurosurgical procedures using 1064 nm lasers. Intended for use in patients requiring thermal therapy under MRI guidance.

Regulatory Classification

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.

Predicate Devices

• NeuroBlate™ System (K172881)

Submission Summary (Full Text)

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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);

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K173305

Device Name Monteris Medical NeuroBlate™ System

#### Indications for Use (Describe)

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.

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/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.<br>14755 27th Avenue North<br>Suite C<br>Plymouth, MN 55446<br>763-253-4710<br>Fax: [phone]<br>www.monteris.com |
| Correspondent Contact<br>Information: | David H. Mueller<br>Senior Principal Regulatory Affairs Specialist<br>Monteris Medical,<br>TEL: [phone] x2732<br>FAX: [phone]<br>Email: [e-mail] |
| Device Common Name: | Magnetic Resonance Image Guided Laser<br>Thermal Therapy System |
| Device Classification Number: | 21 CFR 878.4810<br>Laser surgical instrument for use in general and<br>plastic surgery and in dermatology<br><br>21 CFR 882.4560<br>Stereotaxic instrument |
| Device Classification &<br>Product Code: | Class II, GEX<br>Class 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 878.4810<br>Laser surgical instrument for use in general<br>and plastic surgery and in dermatology<br><br>21 CFR 882.4560<br>Stereotaxic instrument |
| Predicate Device Classification &<br>Product Code: | Class II, GEX<br>Class II, HAW |

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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

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.

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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.

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.

## 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

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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.