NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

K011971 · Image-Guided Neurologics, Inc. · HAW · Aug 3, 2001 · Neurology

Device Facts

• Record ID: K011971
• Device Name: NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 3, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The Navigus Trajectory Guide Biopsy Kit is intended to provide stereotactic guidance for the placement of a brain biopsy needle in conjunction with the use of a Frameless Image Guided Workstation system and/or CT imaging. The device is for single time use.

Device Story

Navigus Trajectory Guide Biopsy Kit provides stereotactic guidance for brain biopsy needle placement; used with Frameless Image Guided Workstation and/or CT imaging. Device is single-use; intended for neurosurgical procedures. Facilitates accurate needle trajectory to target site; assists surgeon in biopsy needle positioning. Benefits include improved precision in image-guided neurosurgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use stereotactic guidance kit for brain biopsy. Designed for integration with Frameless Image Guided Workstation and CT imaging systems. Mechanical guidance assembly.

Indications for Use

Indicated for stereotactic guidance during brain biopsy needle placement in patients requiring image-guided neurosurgical procedures using Frameless Image Guided Workstation 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 3 2001

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

Re: K011971

Trade/Device Name: Navigus Trajectory Guide Biopsy Kit Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: June 21, 2001 Received: June 25, 2001

Dear Mr. Lee:

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 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). 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 provision, 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 requirements, 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. David M. Lee

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 nothleation. THCT D71 midning of saction 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 11 you desire specific dayse for your actic devices), please contact the Office of Compliance at additionally 607.10 for in viao alagliestions on the promotion and advertising of your device, [phone]. Radhionally, 2011 - 12:4639. Also, please note the regulation prease connect the ories ceference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small miorination on your responsibilities and more [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

R. Mark N. Wilkerson

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) : 1 ( c) // 9/ |

DEVICE NAME:

INDICATIONS FOR USE:

Intended Use: The Navigus Trajectory Guide Biopsy Kit is intended ntended Use: The Navigus Trajector Starement of a brain biopsy
to provide stereotactic guidance for the placement of a brain biopsy Cuided to provide stereotactic guidante 10- a Frameless Image Guided
needle in conjunction with the use of a MB and/or CT imaging needle in confunction with the about will and/or CT imaging. Workstation Bystem in a goten in a got 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 1-2-96)

Koll 971

for Mark N. Mulhessen
Division Sign Off

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

510(k) Number_

23