FHC MICROTARGETING DRIVE SYSTEM

K011992 · FHC, Inc. · HAW · Aug 14, 2001 · Neurology

Device Facts

• Record ID: K011992
• Device Name: FHC MICROTARGETING DRIVE SYSTEM
• Applicant: FHC, Inc.
• Product Code: HAW · Neurology
• Decision Date: Aug 14, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.

Device Story

Stereotactic microdrive system; facilitates precise positioning of microelectrodes, stimulation electrodes, lesion electrodes, and biopsy probes within brain and nervous system. Adaptable to major stereotactic systems; allows addition of position display or power assist and position display capabilities. Used by neurosurgeons in clinical settings. Provides mechanical guidance for surgical instruments; enhances accuracy of neurosurgical targeting. Benefits patient by enabling precise delivery of electrodes or probes during neurosurgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Stereotactic instrument; mechanical microdrive system; adaptable to commercial stereotactic frames; optional power assist and position display modules.

Indications for Use

Indicated for neurosurgical procedures requiring accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous 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.

Predicate Devices

• FHC, Inc microTargeting® Drive System (K003776)

Submission Summary (Full Text)

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# KO11992

## AUG 1 4 2001

### 510(k) SUMMARY of SAFETY and EFFECTIVENESS

FHC, Inc.

9 Main Street

207-666-8190

Frederick Haer

June 6, 2001

1226598

Bowdoinham, ME 04008

#### A. General Information

- 1. Submitter's Name:
2. Address:

3. Telephone Number:

4. Contact Person:

5. Date Prepared:

6. Registration Number:

- B. Device
- 1. Name:

2. Trade Name:

- 3. Common Name:
4. Classification Name:

5. Product Code:

6. Class:

7. Regulation Number:

microTargeting® Drive System microTargeting® Drive System Stereotactic microdrive system Stereotactic Instrument HAW ll

11

882.4560

{1}------------------------------------------------

#### C. Identification of Legally Marketed Devices

| Name | K Number | Date Cleared |
|------------------------------------------|----------|---------------|
| 1. FHC, Inc microTargeting® Drive System | K003776 | Feb. 23, 2001 |

#### D. Description of Device

The microTargeting® Drive System with permits the accurate positioning of microelectrodes, stimulation electrodes, lesion electrodes, biopsy probes and other instruments in the brain and nervous system and is adaptable to all major stereotactic systems. The current microTargeting® Drive System allows the user to add position display capability or add power assist and position display capabilities.

#### E. Intended Use Statement

The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulation electrodes, or other instruments in the brain or nervous system.

#### F. Technological Characteristics Summary

The FHC microTargeting® Drive System is substantially equivalent to the previously marketed FHC microTargeting® Drive System (K003776).

Differences that exist between these devices, relating to technical specifications, physical appearance, and design do not affect the relative safety and effectiveness of the microTargeting® Drive System.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

AUG 1 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frederick Haer President and Chief Executive Officer FHC, Inc. 9 Main Street Bowdoinham, Maine 04008

Re: K011992

Trade/Device Name: microTargeting® Drive System Regulation Number: 882.4560 Regulatory Class: II Product Code: HAW Dated: July 25, 2001 Received: July 26, 2001

Dear Mr. Haer:

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 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 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. Frederick Haer

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 If you desire specific daires diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. Tracklessf Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Sincerely yours,

Ro. Mark A. Mellikson

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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510(k) Number (if known): Kc) / 992

Device Name: microTargeting® Drive System

Indications For Use: The FHC microTargeting® Drive System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate ncaroourg.our provelectrodes, stimulating electrodes, or other pooltioning in the brain or nervous system.

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Melkener

General, Restorative and Neurological Devices

K 011992 510(k) Number _

(Optional Format 3-10-98)