NAVIGUS NEXDRIVE, MODEL MI-3000

K043091 · Image-Guided Neurologics, Inc. · HAW · Feb 7, 2005 · Neurology

Device Facts

• Record ID: K043091
• Device Name: NAVIGUS NEXDRIVE, MODEL MI-3000
• Applicant: Image-Guided Neurologics, Inc.
• Product Code: HAW · Neurology
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

Device Story

NeXdrive Disposable Microdrive is a mechanical positioning device used in neurosurgical procedures. It functions as an accessory to the FHC microTargeting® Drive System and Navigus™ Trajectory Guides. The device provides precise, controlled advancement of electrodes or other instruments into the brain or nervous system. Operated by neurosurgeons in a clinical/OR setting, it facilitates accurate placement of diagnostic or therapeutic probes. The device is disposable, intended to simplify the workflow of stereotaxic instrument positioning during neurosurgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical stereotaxic instrument; disposable microdrive assembly; designed for integration with FHC microTargeting® Drive System and Navigus™ Trajectory Guides; manual or power-assisted operation via system accessories.

Indications for Use

Indicated for precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system in conjunction with Navigus™ Trajectory Guides and FHC microTargeting® Drive System.

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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle.

Public Health Service

FEB - 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K043091

Trade/Device Name: NeXdrive Disposable Microdrive Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: January 13, 2005 Received: January 14, 2005

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 (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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) 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). 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/industry/support/index.html.

Sincerely yours.

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): KO43091

Device Name: NeXdrive Disposable Microdrive

Indications For Use: The NeXdrive Disposable Micro-drive for use the with FHC microTargeting® Drive System Display and Power Assist Accessories is intended to be used in conjunction with the Navigus™ family of Trajectory Guides for the precise positioning of microelectrodes, stimulating electrodes, implantable electrodes, or other instruments in the brain or nervous system.

Prescription Use X

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)

Mark H. Miller
Division Sign-Off

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