NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES

K023949 · Image-Guided Neurologics, Inc. · HAW · Feb 25, 2003 · Neurology

Device Facts

• Record ID: K023949
• Device Name: NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 25, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.

Device Story

Navigus II Trajectory Guide with Verification Reticules provides stereotactic guidance for neurological instrument placement; used in conjunction with Image Guided Workstation Systems; utilizes preoperative MR and/or CT imaging data; facilitates biopsies, catheter placement, and electrode introduction; single-use, ETO sterilized device; operated by neurosurgeons in clinical/OR settings; provides physical trajectory alignment for surgical tools; enhances precision of instrument insertion; improves procedural accuracy and patient outcomes.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stereotaxic instrument; single-use; ETO sterilized; compatible with Image Guided Workstation Systems; utilizes preoperative MR/CT imaging for trajectory planning; mechanical guidance for surgical instruments.

Indications for Use

Indicated for patients undergoing neurological procedures requiring stereotactic guidance for instrument placement, including biopsies, catheter placement, and electrode introduction, using preoperative MR and/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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2003

Image-Guided Neurologics, Inc. David M. Lee Director, Regulatory Affairs 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935

Re: K023949

Trade/Device Name: Navigus II Trajectory Guide with Verification Reticules Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: November 22, 2002 Received: November 27, 2002

Dear Mr. Lee:

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 such 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

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Page 2 - Mr. David M. Lee

(21 CFR Part 807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

for Mark A. Milkenon

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| 510(k) NUMBER (IF KNOWN) : | K023949 |
|----------------------------|---------|
| DEVICE NAME: | |
| INDICATIONS FOR USE: | |

Intended Use: The Navigus II Trajectory Guide with Verification Reticules is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures performed in conjunction with the use of an Image Guided Workstation System using preoperative MR and/or CT imaging. These procedures include biopsies, catheter placement and electrode introduction. The device is ETO sterilized and for one time use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter-Use (Optional Format 1-2-9

Mark N. Mellersen

(Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_

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