MICROTARGETING GUIDELINE 4000

K071364 · FHC, Inc. · GZL · Jul 25, 2007 · Neurology

Device Facts

• Record ID: K071364
• Device Name: MICROTARGETING GUIDELINE 4000
• Applicant: FHC, Inc.
• Product Code: GZL · Neurology
• Decision Date: Jul 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The microTargeting® Guideline 4000 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.

Device Story

The microTargeting® Guideline 4000 is an intraoperative neurophysiological recording and stimulation system. It accepts inputs from microelectrodes to perform electrophysiological recording and stimulation of brain motor and sensory neurons. The device features up to ten expandable recording channels, continuous display of active channels, and five analysis windows. It supports simultaneous bilateral procedures and is compatible with most stereotactic systems. The system includes an isolated stimulator for micro- and macrostimulation, adjustable filters for noise reduction, and integrated electrode impedance checking. It provides high-fidelity audio monitoring and includes a handheld remote controller and a portable printer. Data can be monitored remotely over the internet. Used in the operating room by neurosurgeons, neurologists, or clinical neurophysiologists, the system assists in the accurate positioning of depth electrodes during functional neurosurgery. The output allows clinicians to visualize and analyze neural activity, facilitating precise electrode placement and potentially improving surgical outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Intraoperative neurophysiological recording and stimulation system. Features up to 10 recording channels, isolated stimulator for micro/macrostimulation, and adjustable filters. Includes handheld remote, integrated impedance checking, and remote internet monitoring capability. Portable design with integrated printer. Operates as a depth electrode system (21 CFR 882.1330).

Indications for Use

Indicated for use by neurosurgeons, neurologists, or clinical neurophysiologists to assist in functional neurosurgical procedures by recording from and stimulating brain motor and sensory neurons to aid in the accurate placement of depth electrodes.

Regulatory Classification

Identification

A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.

Predicate Devices

• Axon Instruments, Inc. Guideline System 3000 (K970943)
• Alpha Omega Neurotrek Physiological Navigation System (K993622)

Submission Summary (Full Text)

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K071364 FHC

Microelectrodes and Instrumentation for
Neuroscience
Research and Clinical microTargeting
®

JUL 2 5 2007

FHC Corporate & Manufacturing
1201 Mein Street
Bowain, AME 04287-7302 USA
Tel: [phone]
US & CAN 800-326-2906
「個人. 207-600-8292
E-mail thon@ih-co nom
www.th.co.com:

## 510(k) SUMMARY

- A. FHC, Inc., 1201 Main Street, Bowdoin, Maine 04287 Submitter: Tel: [phone]; Fax: [phone]
- B. Contact Person: Lee D. Margolin, MS, PhD.
- Date of Summary Preparation: March 7, 2007 C.
- D. Trade Name: microTargeting® Guideline System 4000

Common Name: Intraoperative neurophysiological recording and E. stimulating device

Classification Name: Depth electrode (21 CFR 882.1330, Product Code ட் GZL)

## G. Substantially Equivalent To:

1. Axon Instruments, Inc. Guideline System 3000 (K970943; decision date: Aug. 18, 1997)

2. Alpha Omega Neurotrek Physiological Navigation System (K993622; decision date: Jan. 24, 2000)

## H. Description:

The microTargeting® Guideline 4000 is designed for intraoperative electrophysiological microelectrode recording, stimulation, data collection, analysis and storage.

The microTargeting® Guideline 4000 has the following advantages and features:

- Expandable recording channels to a maximum of ten .
- All active channels continuously displayed .
- Up to five analysis windows ●
- Support for simultaneous bilateral procedures .
- Support for most common stereotactic systems .
- Rugged, transportable design .
- Continually adjustable filters minimize noise pick-up .
- Isolated stimulator capable of micro- and macrostimulation
- Handheld remote controller

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- Integrated electrode impedance checking ●
- High fidelity audio monitoring .
- Portable, full photolithography inkjet printer .
- t Remote data monitoring capabilities over internet

Intended Use:The microTargeting® Guideline 4000 is intended to be used l. by a neurosurgeon, neurologist or clinical neurophysiologist to accurately position depth electrodes during functional neurosurgical procedures.

Technological Characteristics: The technological characteristics of the J. microTargeting® Guideline System 4000 are the same as those in the predicate devices. There is no new technology, materials or method of manufacture introduced. Specifications in every category are either the same, very similar, or improved.

Substantial Equivalence statement: The microTargeting® Guideline K. 4000 is substantially equivalent to the predicate devices in design, construction, materials, intended use and performance characteristics. Non-clinical review of the device shows the device meets similar performance specifications as the predicate devices. No new issues of safety or effectiveness are introduced in the use of this device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is oriented towards the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2007

FHC, Inc. % Intertek Testing Services 2307 East Aurora Road Unit B7 Twinsburg, Ohio 44087 ATTN: Daniel W. Lehtonen or Jay Y. Kogoma

Re: K071364

Trade/Device Name: microTargeting Guideline 4000 Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL Dated: July 18, 2007 Received: July 19, 2007

Dear Mr. Lehtonen or Mr. Kogoma:

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

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Page 2 -- Mr. Daniel W. Lehtonen or Mr. Jay Y. Kogoma

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,
Mark A. Millenson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): __

Device Name:_microTargeting® Guideline 4000

Indications For Use:

The microTargeting® Guideline 4000 system is intended to assist in functional neurosurgical procedures where recording from and stimulation of brain motor and sensory neurons will aid in the placement of depth electrodes.

X____AND/OR Over-The-Counter Use ________ Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

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

**510(k) Number** K071369

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