MONTERIS MEDICAL UFO

K090240 · Monteris Medical, · HAW · Aug 6, 2009 · Neurology

Device Facts

• Record ID: K090240
• Device Name: MONTERIS MEDICAL UFO
• Applicant: Monteris Medical,
• Product Code: HAW · Neurology
• Decision Date: Aug 6, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

Device Story

Monteris Medical UFO™ is a frameless stereotaxic instrument guide for neurosurgical procedures. Device consists of three telescoping legs attached to a center ball joint; legs secure to patient skull via titanium bone screws. User adjusts leg height and ball joint axis to establish specific trajectory for surgical tools (laser probes, biopsy needles, electrodes, catheters). Center ball adapters accommodate various tool diameters to ensure alignment. Used in clinical settings by neurosurgeons; facilitates precise instrument placement during procedures planned with MR/CT imaging. MRI-compatible materials; single-use; ethylene oxide sterilized. Provides stable fixation and guidance, potentially improving accuracy and safety of minimally invasive neurosurgical interventions.

Clinical Evidence

Bench testing only. Biocompatibility analysis confirms compliance with ISO 10993. Bench testing demonstrates compliance with product specifications and medical community expectations.

Technological Characteristics

Frameless stereotaxic instrument guide. Materials: MRI-compatible titanium bone screws and other MRI-compatible components. Design: Three telescoping legs with center ball joint and interchangeable adapters for tool alignment. Sterilization: Ethylene oxide. Single-use.

Indications for Use

Indicated for patients undergoing neurological procedures requiring stereotactic guidance, including laser coagulation, biopsies, catheter placement, and electrode procedures, performed in conjunction with preoperative or perioperative MR or CT imaging.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

• Navigus Trajectory Guide (K992304)
• Navigus II Trajectory Guide (K012366)

Submission Summary (Full Text)

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# Section 5: 510(k) Summary

AUG 0 6 2009

| 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: | Frameless Stereotaxic Instrument Guide |
| Device Classification &<br>Product Code: | Class II,<br>HAW |
| Device Classification Name &<br>Citation | Stereotaxic Instrument<br>21 CFR 882.4560 |
| Device Proprietary Name: | Monteris Medical UFO™ |

# Predicate Device Information:

ERIS

| Predicate Devices: | Navigus Trajectory Guide |
|----------------------------------------|------------------------------------------|
| Predicate Device Manufacturers: | Image Guided Neurologics |
| K# | 992304 |
| Predicate Device Common Name: | Frameless Stereotaxic Instrument Guide t |
| Predicate Device Classification Name & | Stereotaxic Instrument |
| Citation: | 21 CFR 882.4560 |
| Predicate Device Classification & | Class II, |
| Product Code: | HAW |

| Predicate Devices: | Navigus II Trajectory Guide |
|----------------------------------------|------------------------------------------|
| Predicate Device Manufacturers: | Image Guided Neurologics |
| K# | 012366 |
| Predicate Device Common Name: | Frameless Stereotaxic Instrument Guide t |
| Predicate Device Classification Name & | Stereotaxic Instrument |
| Citation: | 21 CFR 882.4560 |
| Predicate Device Classification & | Class II, |
| Product Code: | HAW |

.

# b. Date Summary Prepared

30 January 2009

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### c. Description of Device

The Monteris Medical UFO™ (Universal Frameless platform for neur() surgical applications) is designed to facilitate stereotactic targeting and positioning of various neurosurgical devices through a burr hole in the patient's skull. These devices could include laser probes, biopsy needles, electrodes and catheters.

The UFO is comprised of three telescoping legs connected to a center ball joint. Each of the legs can be attached to the patient's skull with two MR1-compatible titanium bone screws. By adjusting the height of each leg, and the axis of the rotatable center ball, various trajectories can be obtained for the guide that runs through the center ball. UFO is MRI compatible

Multiple center ball adapters are available to interface with the center ball guide tube. These adapters reduce the guide tube diamcter down to an inner diameter that is compatible with the outer diameter of the tools that the user may want to place through the UFQ. The adapter for a specific tool ensures the tool remains lined up along the intended axis of the UFO.

Several accessories are provided with the UFO to improve its utility during the preparation for stereotactic neurological procedures. They are all made of MRI compatible materials only.

All devices are single use only and ethylene oxide sterilized.

#### d. Intended Use

The Monteris Medical UFO™ is intended to provide stereotactic guidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

#### e. Comparison to Predicate Device

The Monteris Medical UFO™ is substantially equivalent in intended use, technology, design, materials, and physician use to the Navigus Trajectory Guides (K992304 & K012366).

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

#### f. Summary of Supporting Data

Biocompatibility analysis demonstrates that the UFO is in compliance with ISO 10993.

Bench testing has demonstrated that the device is in compliance with the product specification, the expectations of the medical community and the product labeling.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an eagle with its wings spread.

#### Public Health Service

AUG 0 62009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Monteris Medical, Inc. c/o Craig Coombs President Coombs Medical Device Consultant, Inc. 1193 Sherman St. Alameda, CA 94501

Re: K090240

Trade/Device Name: Monteris Medical UFO Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: July 6, 2009 Received: July 8, 2009

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.

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 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,

Ru. li. M., 46 for

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/16 description: The image shows a logo for Monteris Medical. The logo consists of a stylized graphic element on the left, resembling a signature or abstract design. To the right of the graphic is the word "MONTERIS" in capital letters, with the word "MEDICAL" in smaller capital letters underneath it.

## Section 4: Indications for Use Statement

# 510(k) Number (if known): K09D240

Monteris Medical UFO™ Device Name:

Indications For Use:

The Monteris Medical UFO™ is intended to provide stereotactic quidance, placement and fixation for the operation of instruments or devices during the planning and operation of neurological procedures performed in conjunction with preoperative and(or) perioperative MR or CT imaging. These procedures include laser coagulation, biopsies, catheter placement and electrode procedures.

Prescription Use × 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)

Page 1 of

Prescription Use.
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

k090240

510(k) Number.