NeuroBlate System

K162762 · Monteris Medical, Inc. · GEX · Oct 26, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K162762
• Device Name: NeuroBlate System
• Applicant: Monteris Medical, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 26, 2016
• 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) for neurosurgical procedures, such as tumor or epileptic foci ablation. System inputs include MRI images; processed via M-Vision and M-Vision Pro software for trajectory planning and real-time thermographic analysis. Output consists of visual guidance for probe placement and thermal monitoring. Operated by neurosurgeons in an MRI suite; system includes gas-cooled laser delivery probes (SideFire/FullFire), probe drivers (robotic/advanced), interface platform, and electronics rack. Physician interprets thermographic data to guide thermal therapy; aids in precision tissue ablation. Benefits include minimally invasive access to intracranial targets.

Clinical Evidence

No clinical data. Bench testing from previous submissions remains applicable as no physical or technological changes were made.

Technological Characteristics

MRI-compatible laser surgical system; 1064 nm laser source. Components: gas-cooled laser delivery probes, robotic/advanced probe drivers, interface platform, and control workstation. Connectivity: interfaces with MRI systems. Software: M-Vision and M-Vision Pro for planning and thermographic analysis. Sterilization: not specified (components are MRI-compatible).

Indications for Use

Indicated for ablation, necrosis, or coagulation of soft tissue in neurosurgery using 1064 nm lasers; intended for use in patients requiring interstitial 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 (K120561)
• NeuroBlate™ System (K141983)
• NeuroBlate™ System (K143457)

Submission Summary (Full Text)

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

October 26, 2016

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

Re: K162762

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 29, 2016 Received: September 30, 2016

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. 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 device

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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/ResourcesforYou/Industry/default.htm. 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.

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.

# Jennifer R. Stevenson -A

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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### Section 4: Indications for Use

510(k) Number (if known): K162762

Device Name: Monteris Medical NeuroBlate™ System

#### 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.

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Section 5: 510(k) Summary

# a. 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>Principal Regulatory Affairs Specialist<br>Monteris Medical, Inc<br>TEL: [phone]<br>FAX: [phone]<br>Email: [e-mail] |
| Device Common Name: | Magnetic Resonance Image Guided Laser Thermal<br>Therapy System |
| Device Classification Number: | 21 CFR 878.4810<br>Laser surgical instrument for use in general and plastic<br>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 # | K120561, K141983, K14347 |
| Predicate Device Regulation: | 21 CFR 878.4810<br>Laser surgical instrument for use in general and<br>plastic surgery and in dermatology |
| | 21 CFR 882.4560 |
| | Stereotaxic instrument |
| | Predicate Device Classification &<br>Product Code: |

# b. Date Summary Prepared

29 Sept 2016

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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, sans-serif font, with "MONTERIS" in a larger font size above the word "MEDICAL". Above the company name, there is a semi-circular arrangement of teal-colored circles, resembling a stylized representation of water droplets or molecules.

#### c. 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 K143457, 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 Advanced and Robotic Probe Drivers and interconnections for the Laser Delivery Probes;
- 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, bone screws, fiducial markers, stereotactic manual driver with mandrel and T-handle, and other manual accessory instruments and tools.

#### 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

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Image /page/5/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, blue sans-serif font, with the word "MEDICAL" in a smaller font size directly below it. Above the word "MONTERIS" are several teal-colored circles of varying sizes, arranged in a semi-circular pattern.

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

This submission proposes no physical changes to the NeuroBlate System hardware, software, or accessories. The indications for use within the NeuroBlate Systems' Instructions for Use (IFU) have not been changed, however, the product labeling has been modified and corrected as outcomes from the Class 1 Recall's corrective actions as well as from Monteris' response to FDA 483's observation. This submission also provides a listing of historical non-significant changes which have occurred.

The labeling changes include removing references to the discontinued (recalled) 2.2mm SideFire Probes (SFS) as well as providing clarified (or duplicate) warnings and precautions to more easily verify compliance to 21 CFR 1000 -1050 Radiological Health requirements as well as FDA Laser Notice #50 requirements.

Additionally, there are no manufacturing changes, process changes, materials changes, or technology proposed changes to the NeuroBlate System. The technical modes of action and technical principles remain the same as the predicate devices. Considering the proposed changes are labeling related, the previously provided in-vitro (bench) data remains applicable and no additional bench testing was required.

The application for the Monteris Medical NeuroBlate™ System with the modified labeling is substantially equivalent to the predicate Monteris NeuroBlate™ System (K120561, K141983, K143457) 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 modified labeling is substantially equivalent to the predicate NeuroBlate™ System.

#### f. Summary of Supporting Data

This submission proposes no physical changes, manufacturing changes, process changes, materials changes, technology changes to the NeuroBlate System. Considering the proposed changes are labeling, the previously provided in-vitro (bench) data remains applicable and no additional bench testing was required.

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Image /page/6/Picture/0 description: The image shows the logo for Monteris Medical. The logo consists of the word "MONTERIS" in a bold, blue sans-serif font, with the word "MEDICAL" in a smaller font below it. Above the word "MONTERIS" are two clusters of teal-colored circles, arranged in a symmetrical pattern.

Reviewing the specific individual 21 CFR 1000 - 1050 requirements, demonstrates that the proposed labeling updates comply with these requirements and are substantially equivalent to the predicate devices.