MONTERIS MEDICAL AUTOLITT LASER PROBE

K081509 · Monteris Medical, · GEX · May 1, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K081509
• Device Name: MONTERIS MEDICAL AUTOLITT LASER PROBE
• Applicant: Monteris Medical,
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monteris Medical AutoLITT System is indicated for use to 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 AutoLITT 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) AutoLITT Laser Delivery Probe. 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 AutoLITT analysis.

Device Story

System comprises laser probe, probe driver, and VizApp software. Used in neurosurgery for interstitial laser thermal therapy. Inputs: MRI images. Operation: Physician uses software for MRI-based trajectory planning to guide stereotaxic placement of laser probe; system performs real-time thermographic analysis of MRI images during therapy. Output: Visualized trajectory planning and thermographic data. Physician interprets output to assess thermal therapy progress. Benefits: Enables precise, MRI-guided soft tissue coagulation/necrosis. Not for sole use in patient management decisions.

Clinical Evidence

No clinical data. Evidence consists of biocompatibility testing per ISO 10993, bench testing for product labeling compliance, and animal testing demonstrating successful brain tissue coagulation under MRI guidance.

Technological Characteristics

System includes laser delivery probe, probe driver, and VizApp software. Uses 1064 nm laser energy. MRI-compatible (conditional). Software provides trajectory planning and real-time thermographic analysis. Biocompatibility per ISO 10993.

Indications for Use

Indicated for neurosurgical patients requiring soft tissue necrosis or coagulation via 1064 nm interstitial laser thermal therapy. Intended for use by trained physicians for MRI-guided trajectory planning and real-time thermographic monitoring.

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

• Visualase Thermal Therapy System (K071328)
• GreenLight HPS Series Surgical Laser System & Accessories (K062719)
• NaviVision (K062086)

Submission Summary (Full Text)

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

MONTERIS
MEDICAL

1081509

AutoLITT™ System Combined Premarket Notification (K0815(19)

# Section 5: 510(k) Summary

| a. Device Information: | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Category | Comments |
| Sponsor: | Monteris Medical, Inc.<br>100 – 78 Innovation Drive<br>Winnipeg, Manitoba<br>CANADA R3T 6C2<br>Tel: [phone]<br>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]<br>Fax: [phone] |
| Device Common Name: | Magnetic Resonance Image Guided Laser<br>Thermal Therapy System |
| Device Classification &<br>Code: | Class II<br>GEX |
| Device Classification<br>Name: | 21CFR878.4810<br>Laser surgical instrument for use in general<br>and plastic surgery and in dermatology |
| Device Proprietary<br>Name: | Monteris Medical AutoLITT™ System |

### Predicate Device Information:

| Predicate Devices: | Visualase Thermal<br>Therapy System | GreenLight HPS Series<br>Surgical Laser System<br>& Accessories | NaviVision |
|-----------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------|------------------------|
| Predicate Device<br>Manufacturers: | BioTex | LaserScope | BrainLab |
| Predicate Device<br>Common Name: | Magnetic Resonance<br>Image Guided Laser<br>Thermal Therapy<br>System | Laser Probe & Laser | Stereotaxic instrument |
| Premarket<br>Notification # | K071328 | K062719 | K062086 |
| Predicate Device<br>Classification: | 21CFR 878.4810 | 21CFR 878.4810 | 21 CFR 882.4560 |
| Predicate Device<br>Classification &<br>Code: | Class II, GEX | Class II, GEX | Class II, HAW |

b. Date Summary Preparcd

28 April 2009

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

#### c. Description of Device

The Monteris AutoLITT™ System is a combination of three major components: Monteris AutoLITT™ Laser Probe

Monteris AutoLITT™ Probe Driver Monteris AutoLITT™ VizApp Software

#### d. Intended Use

The Monteris Medical AutoLITT System is indicated for use to 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 AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRIbased trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) AutoLITT Laser Delivery Probe. 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 AutoLITT analysis.

#### e. Comparison to Predicate Device

The Monteris Medical AutoLITT™ System is substantially equivalent to the above described predicate devices in intended use, technology, design and physician use.

#### f. Summary of Supporting Data

Biocompatibility data demonstrates that the Laser Probe is in compliance with ISO 10993.

Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling.

Animal testing demonstrated that the System, can be used to coagulate brain tissue under MRI guidance.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

MAY - 1 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K081509

Trade/Device Name: Monteris Mcdical AutoLITT™ System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: March 6, 2009

•

Dear Mr. Coombs:

Received: March 9, 2009

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 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as sct 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.

{3}------------------------------------------------

Page 2 - Mr. Craig Coombs

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act from the · Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milken

Mark N. Melkerson Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known):

Device Name: Monteris Medical AutoLITT™ System

Indications For Use:

The Monteris Medical AutoLITT System is indicated for use to 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 AutoLITT 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) AutoLITT Laser Delivery Probe. 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 AutoLITT analysis.

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

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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

| 510(k) Number | K081509 |
|---------------|---------|
|---------------|---------|

Page 1 of 1