BRAINET

K021986 · Nicolet Biomedical, Inc. · GXY · Aug 23, 2002 · Neurology

Device Facts

• Record ID: K021986
• Device Name: BRAINET
• Applicant: Nicolet Biomedical, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

Device Story

BraiNet is a single-patient-use, disposable electrode cap used by licensed medical professionals to facilitate the placement of EEG electrodes on the scalp. The device consists of elastic and Velcro garment-grade materials designed to hold electrodes in position for connection to medical equipment for stimulation and recording. It is provided non-sterile. By standardizing electrode positioning, the device assists clinicians in performing EEG procedures, ensuring consistent electrode contact for diagnostic or monitoring purposes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from elastic and Velcro commercial garment-grade materials. Form factor is an electrode cap. Single-patient use, disposable. Non-sterile.

Indications for Use

Indicated for use by licensed medical professionals to support the placement of EEG electrodes on the scalp for stimulation and recording purposes.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Electro-Cap (K780045)

Reference Devices

• Electro-Cap
• Infa-Cap

Submission Summary (Full Text)

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K021986

Image /page/0/Picture/1 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. Underneath the word "Nicolet" is a horizontal line. Below the line, the word "BIOMEDICAL" is written in a smaller, sans-serif font, with a space between each letter.

## AUG 2 3 2002

### 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: | June 17, 2002 | |
| Trade Name: | BraiNet | |
| Common Name: | Electrode Cap | |
| Classification Name: | 21 CFR 882.1320; Product Code: GXY | |
| Predicate Device: | 510(k) Number: K780045<br>Manufacture: Electro-Cap International | |

Trade Name:

#### 1.0 Description of Device

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording.

Electro-Cap, Infa-Cap

The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices.

#### 2.0 Intended Use

The intended use of the Nicolet BraiNet is the same as the predicate Electro-Cap. The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

File: BraiNet 510(k)

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Ko2/986

#### 3.0 Technological

The BraiNet is made from elastic and Velcro commercial garment grade materials.

#### 4.0 Conclusions

The intended use and technology of the Nicolet BraiNet is substantially equivalent to the predicate device. No new questions of safety or effectiveness are raised.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 2 3 2002

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

Re: K021986

Trade/Device Name: BraiNet Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 17, 2002 Received: June 18, 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. Iisting 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" (21 CFR 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,

Mark N. Millerson

Colin M. Wittes, Ph.D., M.D.

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):

Device Name: Nicolet BraiNet

Indications For Use:

The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

R. Mark N. Melleusen

(Div. on Sign-Cff) Division of General, Restorative and Neckological Devices

510(k) Number _

19