MICROTARGETING ELECTRODE

K991522 · FHC, Inc. · GZL · Aug 4, 2000 · Neurology

Device Facts

• Record ID: K991522
• Device Name: MICROTARGETING ELECTRODE
• Applicant: FHC, Inc.
• Product Code: GZL · Neurology
• Decision Date: Aug 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.

Device Story

Device consists of electrodes and protective shielded tube; used for intra-operative single-unit neuronal activity recording during functional neurosurgery. Input: neuronal electrical signals from brain tissue. Output: raw electrical signals for clinician monitoring. Operated by neurosurgeons in OR setting. Output allows real-time identification of neuronal activity to assist in surgical targeting and decision-making during functional neurosurgical procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Depth electrode system comprising electrodes and protective shielded tube. Includes sterilizable case. Designed for intra-operative single-unit recording. Passive sensing device.

Indications for Use

Indicated for intra-operative recording of single unit neuronal activity in the brain during functional neurosurgery.

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

• uEEG ProSystem 5000 Depth Electrode (K991077)
• Pali-Trode (K981015)
• Radionics SME (K961858)

Submission Summary (Full Text)

{0}------------------------------------------------

Main Street, Bowdoinham, ME 04008 US
Phone: [phone] • Fax: [phone]
Email: *[e-mail]* • Website: www.fh-co.com

#### AUG 4 2000

K991522
f.1d2

# 510(k) SUMMARY of SAFETY and EFFECTIVENESS

#### A. General Information

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

FHC, Inc

207-666-8190

Frederick Haer

July 12, 2000

Not yet applied for

9 Main Street Bowdoinham, ME 04008

- 3. Telephone:
4. Contact Person:

5. Date Prepared:

6. Registration Number:

#### B. Device

- 1. Name:
- 2. Trade Name:
- 3. Common Name:

Classification Name: 4.

- 5. Product Code:
- 6. Class:
- 7 Regulation Number:

microTargeting™ Electrodes

microTargeting™ Electrodes

Depth Electrode

Depth Electrode

84 GZL

- II
Not yet applied for

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

# C. Identification of Legally Marketed Devices

| 1. Name: | uEEG ProSystem<br>5000 Depth Electrode | Pali-Trode | Radionics SME |
|-------------------|----------------------------------------|---------------|----------------|
| 2. K Number: | K991077 | K981015 | K961858 |
| 3. Date Cleared: | June 9, 1999 | June 16, 1998 | August 7, 1996 |

#### D. Description of the Device

The microTargeting™ Electrodes (K991522) are for intra-operative single-unit recording during functional neurosurgery.

# microTargeting™ Electrodes Components

- Electrodes
- Protective Tube (Shielded) .

# microTargeting™ Electrodes Accessories

- . Sterilizable Case (E5-75)
### E. Intended Use Statement

The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.

# F. Technological Characteristics Summary

The microTargeting™ Electrodes are substantially equivalent to the Microrecording Systems Consultants µEEG ProSystem (K991077) Depth Electrode, Preferred Instruments Pali-Trode (K981015) and the Radionics SME (K961858).

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™ Electrodes.

p.24/2

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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.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2000 AUG

Mr. Frederick Haer President/CEO FHC, Inc. 9 Main Street Bowdoinham, Maine 04008

Re: K991522/S2

Trade Name: microTargeting™ Electrodes Regulatory Class: II Product Code: GZL Dated: July 17, 2000 Received: July 18, 2000

Dear Mr. Hare:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have leviewed your bocuon 310(x) hear substantially equivalent (for the indications for use above and we have determined the covices 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 enactment date of the Medical Dories Thisean Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, Controls provisions of the rict metals ready and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (600 above) and additional controls. Existing major regulations (Fremarks) it hay over device of Federal Regulations, Title 21, Parts 800 to 895. allecting your device can or reamination assumes compliance with the current Good A substantially equivalent acceminates 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 inspections, the Food and Drag Hamilies result in regulatory action. In addition, FDA may publish Comply with the GHT regarater a your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have Itsponse to your premarket nearces of cor devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 nonitication. The I Drivinant of veation for your device and thus, permits your device to proceed to the market.

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### Page 2 - Mr. Frederick Haer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in witro diagnostic devices), please contact the Office of Compliance at additionally 607.10 for in Hug angliestions on the promotion and advertising of your device, (2017 594 4639. picase contact the Orifice or Somphanes (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsibility of the number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

uma R. lochner.

Celia M. Witten, Ph.D., M.D. 8 Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

K991522 510(k) Number (if known):

Device Name: microTargeting™ Electrode

Indications For Use:

The microTargeting™ Electrodes are intended for use in intra-operative recording of single unit neuronal activity in the brain.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

ume R. Vochmes.

(Division Sign-Off) (Division Sign-On) Restors: Devices Division of General Restores Division of General Reston 22

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