RECORDING AND STIMULATING ELECTRODE

K012850 · Radionics, A Division of Tyco Healthcare Group LP · GZL · Nov 19, 2001 · Neurology

Device Facts

• Record ID: K012850
• Device Name: RECORDING AND STIMULATING ELECTRODE
• Applicant: Radionics, A Division of Tyco Healthcare Group LP
• Product Code: GZL · Neurology
• Decision Date: Nov 19, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1330
• Device Class: Class 2

Intended Use

To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.

Device Story

Passive probe; stereotactically guided to target brain regions. Functions as recording electrode to capture electrical activity or stimulating electrode to evoke responses. Used during functional neurosurgical procedures; operated by neurosurgeons. Provides real-time electrophysiological data to assist in brain mapping; facilitates identification of functional brain areas; aids surgical decision-making; minimizes risk of damage to critical neural structures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive probe; stereotactic guidance; depth electrode configuration. Materials and sterilization methods are consistent with standard neurosurgical electrode requirements. No active electronic components or software algorithms.

Indications for Use

Indicated for patients undergoing functional neurosurgical procedures requiring brain mapping via electrical recording or stimulation.

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

• Radionics Microelectrode Kit (K991399)
• Microrecording Systems Consultants, LLC, Microelectroencephalography Professional System 5000 for Surgical Neurophysiological Recording (K991077)

Submission Summary (Full Text)

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K 012850

# Section 5: 510(k) Summary

# Recording and Stimulating Electrode 510(k) Summary

This summary of the 510(k) salety and clicctiveness information is submitted in accordance with the requirements of the Sale Medical Devices Act of 1990 and 21 CFR §807.92.

### Submitter of Premarket Notification:

Kevin J. O'Connell Sr. Regulatory Associato Radionics, a Division of Tyco Healthcare Group, LP 22 Torry Avenue Burlington, MA 01803 Telephone: [phone] Fax: [phone]

#### Performance Standards:

No applicable porformance standards have been issued under section 514 of the Food, Drug & Cosmotic Act.

#### Device Name:

| Proprietary Name: | Recording and Stimulating Electrode |
|----------------------|--------------------------------------------------|
| Common/Usual Name: | Recording Electrode and/or Stimulating Electrode |
| Classification Name: | Depth Electrode |

#### Predicate Device(s):

Radionies Microelectrode Kit, 510(k) number K991399, dated Scplomber 21, 1999.

Microrecording Systems Consultants, LLC, Microelectrocncephalography Professional System 5000 for Surgical Neurophysiological Recording, 510(k) number K991077, dated June 9, 1999.

#### Intended Use:

To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.

#### Device Description:

The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2001

Mr. Kevin J. O'Connell Senior Regulatory Associate Radionics, a Division of Tyco Healthcare Group, LP 22 Terry Avenue Burlington, Massachusetts 01803

Re: K012850

Trade/Device Name: Recording and Stimulating Electrode Regulation Number: 882.1330, 882.1310 Regulation Name: Depth electrode, Cortical electrode Regulatory Class: II Product Code: GZL, GYC Dated: August 23, 2001 Received: August 24, 2001

Dear Mr. O'Connell:

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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Kevin J. O'Connell

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Susan Walker, MD

Image /page/2/Picture/5 description: The image shows a black and white drawing of a cursive letter. The letter appears to be a 'P' or a similar looping character. The lines are thick and slightly uneven, suggesting it may have been drawn by hand. The overall impression is simple and abstract.

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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# NOV 1 9 2001

# ODE Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Recording and Stimulating Electrode Device Name:

Indications for Use:

To record clectrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.

# (I'LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE II: NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Pcr 21 CFR § 801.109)

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Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Susan Walk~

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

510(k) Number K012850