SUBDURAL STRIP ELECTRODE

K021144 · Nicolet Biomedical, Inc. · GYC · Jun 24, 2002 · Neurology

Device Facts

• Record ID: K021144
• Device Name: SUBDURAL STRIP ELECTRODE
• Applicant: Nicolet Biomedical, Inc.
• Product Code: GYC · Neurology
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 882.1310
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

Device Story

Subdural Strip Electrodes are passive, single-patient-use, disposable devices used by licensed medical professionals. They function as an interface between the brain surface/subdural space and external medical equipment. The electrodes capture electrical biopotentials from the brain or deliver stimulation signals. They are used in clinical settings to support neurological monitoring or stimulation procedures. The device does not contain active electronics or software; it serves as a conduit for signal transmission to and from external diagnostic or therapeutic equipment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Passive cortical electrodes; lead wires terminate in safety connectors compliant with 21 CFR Part 898. Provided sterile for single-patient use. No active electronics, software, or energy source.

Indications for Use

Indicated for temporary placement on the brain surface or subdural space for stimulation or recording of electrical activity in patients requiring such monitoring or stimulation.

Regulatory Classification

Identification

A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.

Predicate Devices

• Ad-Tech Medical Instrument Corp. (K970587)
• Ad-Tech Medical Instrument Corp. (K923803)
• Ad-Tech Medical Instrument Corp. (K850342)

Submission Summary (Full Text)

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JUN 2 4 2002

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# Summary of Safety and Effectiveness

| Company Name: | Nicolet Biomedical<br>5225 Verona Road<br>Madison, WI 53711 | |
|----------------------------|-------------------------------------------------------------------------------------------|--|
| Contact:<br>Phone:<br>Fax: | Glen Hermanson, Manager of Standards and Compliance<br>608 441-2065<br>608 441-2007 | |
| Summary Date: | April 3, 2002 | |
| Trade Name: | Subdural Strip Electrodes | |
| Common Name: | Cortical Electrode | |
| Classification Name: | 21 CFR 882.1310; Product Code: GYC | |
| Predicate Device: | 510(k) Number: K970587, K923803, K850342<br>Manufacture: Ad-Tech Medical Instrument Corp. | |

Trade Name:

### 1.0 Description of Device

Subdural Strip Electrodes are used by licensed medical professionals to support stimulation and recording of biopotentials from the surface of the brain or the subdural space above the surface of the brain. The electrodes connect to medical equipment in support of stimulation and recording.

Subdural Electrode

The electrodes are provided to the user sterile. The electrodes are single patient use, disposable devices.

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#### 2.0 Intended Use

The intended use of the Nicolet Subdural Strip Electrodes is the same as the predicate electrodes. The Nicolet Subdural Strip Electrodes can be temporally placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

#### 3.0 Technological

The Subdural Strip Electrodes are made from the same materials as the predicate devices. The electrode lead wires terminate in a safety connector, complying with the FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR Part 898.

These electrodes do not contain active electronics or software. The electrodes connect to the user's medical equipment.

#### 4.0 Conclusions

The intended use and technology of the Nicolet Subdural Strip Electrodes is substantially equivalent to the predicate electrodes. No new questions of safety or effectiveness are raised.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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" arranged around the perimeter. Inside the circle is a stylized symbol composed of three parallel, curved lines that resemble a stylized caduceus without the snake.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 2 4 2002

Nicolet Biomedical, Inc. c/o Mr. Gary Syring Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K021144

Trade/Device Name: Nicolet Biomedical/Subdural Strip Electrode Regulation Number: 882.1310 Regulation Name: Cortical Electrode Regulatory Class: II Product Code: GYC Dated: April 5, 2002 Received: April 9, 2002

Dear Mr. Syring:

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. Gary Syring

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.

Sincerely yours,

Mark A. Mikkelson

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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< 02 | 1 4 510(k) Number (if known): Device Name: Nicolet Subdural Strip Electrodes Indications For Use:

> The Nicolet Subdural Strip Electrodes can be temporarily placed on the surface of the brain or subdural space in support of stimulating the brain or recording the brain's electrical activity.

### (PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K021144
(Optional Format 3-10-98)