NAVIGUS II MR

K012719 · Image-Guided Neurologics, Inc. · HAW · Oct 22, 2001 · Neurology

Device Facts

• Record ID: K012719
• Device Name: NAVIGUS II MR
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Oct 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Device Story

Navigus II MR Trajectory Guide provides stereotactic guidance for neurological procedures; used within MRI environment in conjunction with MR imaging. Device facilitates accurate delivery of instruments/devices (biopsy needles, catheters, electrodes) to target sites 3mm or larger. Operated by neurosurgeons/clinicians during planning and execution of stereotactic procedures. Device acts as mechanical guide for instrument trajectory; benefits patient by enabling precise targeting during minimally invasive neurosurgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stereotaxic instrument; MR-compatible materials; mechanical trajectory guidance system; designed for use within MRI environment; manual operation.

Indications for Use

Indicated for patients undergoing neurological procedures requiring stereotactic guidance for instrument or device placement, including biopsies, catheter, and electrode introduction, for target sites 3mm and larger.

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" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping lines that form a bird-like shape.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 22 2001

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

Re: K012719

Trade/Device Name: Navigus II MR Trajectory Guide Regulation Number: 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: II Product Code: HAW Dated: August 13, 2001 Received: August 14, 2001

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 (21 CFR Part 807); labeling (21 CFR Part 801); 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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Page 2 - Mr. David M. Lee

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with are your your 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 011 594-4659. Additionally, for questions on the promotion and advertising of Compliance al (ass 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,

Susan Walker, MD

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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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Page **_ of _**

510(k) Number (if known):_KO1Q719

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Intended Use: The NAVIGUS II MR Trajectory Guide is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The Trajectory Guide is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode introduction. This device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

(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 Division ological Devices

510(k) Number K012719.

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Over-The-Counter Use . .

(Optional Formal 1-2-90

Prescription Use
(Per 21 CFR 801.109)