NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX

K992304 · Image-Guided Neurologics, Inc. · HAW · Aug 27, 1999 · Neurology

Device Facts

• Record ID: K992304
• Device Name: NAVIGUS TRAJECTORY GUIDE, MODEL TG-XXXX
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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/CT environment and in conjunction with MR/CT 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. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Device Story

Trajectory Guide provides stereotactic guidance for neurological procedures; used in MRI/CT environments; facilitates accurate delivery of instruments/devices (biopsies, catheters, electrodes) to target sites ≥3mm. Device functions as mechanical guide for surgical instrumentation; assists surgeons in navigating target sites during planning and operation. Benefits include improved precision in stereotactic delivery of surgical tools to intracranial targets.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical stereotactic guidance device; designed for use within MRI/CT imaging environments; compatible with standard stereotactic surgical instrumentation for biopsies, catheter, and electrode placement.

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 within MRI/CT environments.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 27 1999

Mr. Michael J. Renner Vice President, Operations Image-Guided Neurologics, Inc. 2290 W. Eau Gallie Boulevard Melbourne, Florida 32935

K992304 Re: Trade Name: Navigus Traiectory Guide Regulatory Class: II Product Code: HAW Dated: July 7, 1999 Received: July 8, 1999

Dear Mr. Renner:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Michael J. Renner

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Mark N Melkerson

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

Enclosure

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510(K) NUMBER (IF, KNOWN): 99230 4 DEVICE NAME: NAN JUNS TRASECTORy by INDICATIONS FOR USE:

The 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/CT environment and in conjunction with MR/CT 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. The device will provide accurate delivery of devices or instruments to target sites 3mm and larger.

Mark M Mellemson

Division Sign-O (Division Sign-Om)
Division of General Restorative Devices 510(k) Number

(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

K992304