NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000

K033619 · Image-Guided Neurologics, Inc. · HAW · Mar 2, 2004 · Neurology

Device Facts

• Record ID: K033619
• Device Name: NAVIGUS UNIBODY FIDUCIAL MARKER SYSTEM, MODEL FM-4000
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Mar 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Device Story

Navigus Unibody Fiducial Marker System provides fixed reference points for stereotactic surgery; used in conjunction with CT imaging. Device serves as radiopaque marker to facilitate image-guided surgical navigation. Used in clinical settings by neurosurgeons or qualified medical professionals. System aids in spatial registration of patient anatomy to preoperative CT images; enables precise localization of surgical targets. Benefits include improved accuracy in stereotactic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Radiopaque fiducial marker system; unibody design. Designed for compatibility with CT imaging modalities. Non-active device; no energy source or software components.

Indications for Use

Indicated for patients undergoing stereotactic surgery requiring fixed reference points for 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an eagle-like emblem with three stylized lines representing the bird's body and wings. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 2004

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

Re: K033619

Trade/Device Name: Navigus Unibody Fiducial Marker System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 14, 2004 Received: January 15, 2004

Dear Mr. Lec:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bected. 9 retty pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate (of use stated in the enclosure) (o regar) the enactment date of the Medical Device Amendments, or to conninered process that have been recordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). and Cosmetic Tion (110) that the device, subject to the general controls provisions of the Act. The r ou may, moreloro, mains of the Act include requirements for annual registration, listing of general oonlines provisions 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 If your device is clusion of too as controls. Existing major regulations affecting your device can may be subject to sach additional results , 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 1 lease of advised that 1191 bilseanter over device complies with other requirements of the Act that I DX has made a asid regulations administered by other Federal agencies. You must or any I cactar stutures and registeries, including, but not limited to: registration and listing (21 Comply with an the Act 81equirements, and manufacturing practice requirements as set CI K Furt 6075, adoming (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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Page 2 - Mr. David M. Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms reter nation. The FDA finding of substantial equivalence of your device to a legally promanced 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 If you dosire specific acreoliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

for 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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## Indications for Use

510(k) Number (if known): K033619

Device Name: Navigus Unibody Fiducial Marker System

Indications For Use: The Navigus Unibody Fiducial Marker System is intended to provide fixed reference point(s) in patients requiring stereotactic surgery in conjunction with CT imaging.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Muriami C. Provost

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

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KO33619 510(k) Number_