NEUROBLATE SYSTEM

K141983 · Monteris Medical Corp. · GEX · Aug 11, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K141983
• Device Name: NEUROBLATE SYSTEM
• Applicant: Monteris Medical Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 11, 2014
• 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 soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides real time thermographic analysis of selected MRI images. When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.

Device Story

NeuroBlate System provides MRI-guided laser interstitial thermal therapy (LITT). Inputs: MRI images (1.5T/3.0T Philips, Siemens, IMRIS, GE). Components: gas-cooled laser delivery probes; probe driver for stereotaxic positioning; system electronics rack; control workstation with M Vision software. Operation: surgeon uses M Vision software for trajectory planning and real-time thermographic monitoring during laser ablation. Output: visual thermographic analysis of MRI images. Used in clinical/neurosurgical settings. Benefits: precision thermal therapy for soft tissue; real-time monitoring allows physician to assess therapy progress. Physician interprets output to guide clinical decision-making.

Clinical Evidence

Bench testing only. Software and bench testing demonstrated that the system performs equivalently with Philips MRI systems as it does with previously cleared Siemens, IMRIS, and GE MRI systems, meeting medical community expectations and labeling requirements.

Technological Characteristics

System includes gas-cooled laser delivery probes, probe driver, electronics rack, and control workstation. Operates with 1064 nm lasers. MRI-compatible (conditional). Connectivity: interfaces with 1.5T and 3.0T MRI systems (Philips, Siemens, IMRIS, GE). Software: M Vision software for planning and thermographic analysis.

Indications for Use

Indicated for neurosurgical patients requiring ablation, necrosis, or coagulation of soft tissue via interstitial laser thermal therapy. Contraindicated for use as the sole basis for patient management decisions.

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 (K120561)
• NeuroBlate™ System (K131278)
• NeuroBlate™ System (K131955)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 11, 2014

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

Re: K141983

Trade/Device Name: Monteris Medical NeuroBlate System Regulation Number: 21 CFR 878.4810, 882.4560 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Stereotaxic instrument Regulatory Class: Class II Product Code: GEX, HAW Dated: July 18, 2014 Received: July 21, 2014

Dear Mr. Coombs:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or 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 (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

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

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## Indications for Use

510(k) Number (if known) K141983

Device Name Monteris Medical NeuroBlate System

## Indications for Use (Describe)

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides real time thermographic analysis of selected MRI images.

When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.

## Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

## Neil R Ogden -S 2014.08.11 10:48:05 -04'00

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Image /page/3/Picture/0 description: The image shows the logo for Monteris Medical. The logo features the word "MONTERIS" in a bold, sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" is a graphic of several green circles arranged in a pattern.

## Section 5: 510(k) Summary

### a. Device Information:

| Category | Comments |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Monteris Medical Corp.<br>16305 36th Ave. North, Suite 200<br>Plymouth, MN 55446<br><br>Brooke Ren, Ph.D.<br>Senior Vice President of Operations<br>Tel: [phone]; Fax: [phone]<br>www.monteris.com |
| Correspondent Contact<br>Information: | Craig Coombs<br>Coombs Medical Device Consulting<br>1193 Sherman Street<br>Alameda, CA 94501<br>Tel: [phone]; Fax: [phone] |
| Device Proprietary Name: | Monteris Medical NeuroBlate™ System |
| 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 |
| Device Classification &<br>Product Code: | 21 CFR 882.4560<br>Stereotaxic instrument<br>Class II, GEX<br>Class II, HAW |

### Predicate Device Information:

| Predicate Device: | NeuroBlate™ System |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device Manufacturer: | Monteris Medical |
| Predicate Device Common Name: | Monteris NeuroBlate™ System |
| Predicate Device Premarket Notification # | K120561, K131278, K131955 |
| Predicate Device Regulation: | 21 CFR 878.4810<br>Laser surgical instrument for use in general<br>and plastic surgery and in dermatology<br>21 CFR 882.4560<br>Stereotaxic instrument |
| Predicate Device Classification &<br>Product Code: | Class II, GEX<br>Class II, HAW |

#### b. Date Summary Prepared 18 July 2014

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## c. Description of Device

The Monteris Medical NeuroBlate™ System is a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal therapy. The NeuroBlate System components consist of:

- . Gas-cooled Laser Delivery Probes (Probes) to deliver controlled energy to a target zone;
- A Probe Driver which allows the surgeon to precisely position, stabilize and . manipulate a laser probe within the target zone;
- . A System Electronics Rack and Components, which includes necessary umbilicals, cables, penetration panels, and small hardware for system mechanical, electrical, and electronic operation; and
- A Control Workstation including the M Vision™ Software, which includes a user . interface for procedure planning, interactive monitoring of NeuroBlate™ procedures, and interfaces to the MRI and hardware subsystems.

This submission clears the use of the NeuroBlate System with specific 1.5 & 3.0T Philips Magnetic Resonance Imaging Systems.

### d. Indications for Use

The Monteris Medical NeuroBlate™ System is indicated for use to ablate, necrotize, or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.

The Monteris Medical NeuroBlate™ System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) NeuroBlate™ Laser Delivery Probes. It also provides real time thermographic analysis of selected MRI images.

When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the NeuroBlate™ System analysis.

#### e. Comparison to Predicate Device

The application Monteris Medical NeuroBlate System, which is compatible with Siemens, IMRIS, GE and Philips MRI's, is substantially equivalent in intended use, technology, design, and physician use to the predicate Monteris NeuroBlate System (K131955), which is compatible with only Siemens, IMRIS, and GE MRI's.

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

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

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The application System is compatible with the listed Philips 1.5 and 3.0T MRI systems, along with the predicate Systems compatibility with listed Siemens, IMRIS and GE 1.5 and 3.0T MRI Systems.

As the modifications presented in the current device do not change the intended use, operating principles, or raise any unaddressed safety concerns, with respect to the predicate device, it can be concluded the application NeuroBlate System (Siemens, IMRIS, GE and Philips MRI compatible) is substantially equivalent to the predicate NeuroBlate System (Siemens, IMRIS, and GE MRI compatible).

### f. Summary of Supporting Data

Software and bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling. It demonstrates that the NeuroBlate System works as well with the Philips MRI's as it does with the Siemens, IMRIS, and GE MRI's.