BRAINET KIT

K043009 · Jordan Neuroscience, Inc. · GXY · Jan 12, 2005 · Neurology

Device Facts

• Record ID: K043009
• Device Name: BRAINET KIT
• Applicant: Jordan Neuroscience, Inc.
• Product Code: GXY · Neurology
• Decision Date: Jan 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.

Device Story

BraiNet Kit consists of BraiNet template and BrainDisc cutaneous electrodes; used by medical professionals/paraprofessionals to simplify EEG electrode placement on scalp. BraiNet template made of elastic/Velcro; BrainDisc electrodes made of polycarbonate with silver/silver-chloride center and copper lead wire. Device facilitates connection of electrodes to medical equipment for brain electrophysiology recording. Single patient use, disposable. BraiNet provided non-sterile; subdermal needle electrodes provided sterile. No automated processing or software involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

BraiNet template: commercial grade elastic and Velcro. BrainDisc electrode: medium grade polycarbonate, silver/silver-chloride center, insulated copper lead wire. Single patient use, disposable. Non-sterile (except subdermal needles). No software or electronic components.

Indications for Use

Indicated for use by medical professionals and paraprofessionals to support EEG electrode placement on the scalp for electrophysiology recording.

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, Infa-Cap (K780045)
• AMBU Disposable Cup Electrode

Submission Summary (Full Text)

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# JAN 1 2 2005

K043009

## 510(k) Summary of 510(k) Information

# Summary of 510(k) Information

| Company Name: | Jordan NeuroScience, Inc.<br>399 E. Highland Ave., Suite 316<br>San Bernardino CA 92404 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact: | Anne Perry |
| Phone: | 909 881-2694 |
| Fax: | 909 882-2891 |
| Summary Date: | October 22, 2004 |
| Trade Names: | BraiNet Kit (BraiNet® and BrainDisc™) |
| Common Name: | Electrode Cap & Subdermal EEG Needle electrodes and Cutaneous EEG electrodes |
| Classification Name: | 21 CFR 882.1320; Product Code: GXY |
| Predicate Device: | 510(k) Number: K780045 |

Manufacture: Electro-Cap International Trade Name: Electro-Cap, Infa-Cap

#### 1.0 Description of Device

The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording.

The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.

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#### 2.0 Intended Use

The intended use of the BraiNet® is the same as the predicate Eletro-Cap, Infa-Cap. The BraiNet® template is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The intended use of the BrainDisc™ cutaneous electrode is the same as the predicate AMBU Disposable Cup Electrode. The BrainDisc™ is placed on the scalp to support electroencephalograph (EEG) recording.

#### 3.0 Technological

The BraiNet® is made from commercial grade elastic and Velcro materials common to the garment industry.

The BrainDisc™ is made from medium grade polycarbonate with silver/silverchloride center with attached insulated copper lead wire.

#### 4.0 Conclusions

The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

JAN 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Anne Perry CFO Jordan NeuroScience, Inc. 399 E. Highland Avenue, Suite 316 San Bernardino, California 92404

Re: K043009

Trade/Device Name: BraiNet® Kit Regulation Number: 21 CFR 882.1320, 21 CFR 882.1350 Regulation Name: Cutaneous electrode; Needle electrode Regulatory Class: II Product Code: GXY and GXZ Dated: October 22, 2004 Received: November 1, 2004

Dear Ms. Perry:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have roviewed your be determined the device is substantially equivalent to legally marketed relevelocate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of preated at Device Amendments or to devices that have been reclassified in accordance with the the Moureal Do Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions or the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the of the act, of were regarly ents. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before (1.0., annintened) and rares in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 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

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## Page 2 - Ms. Anne Perry

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.

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 the labeling regulation, 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). You may obtain other general information on your responsibilities under the Act 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.dsmaldsmamain.html.

Sincerely yours,

Miriam C. Provost

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

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# Attachment A

### Indications for Use Form

Page 1 of 1

KO43009 510(k) Number (if known): 3004622056 (Specification Developer)

Device Name: BraiNet® Kit

Indications For Use:

The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.

iriam C. Provost

Division of General, Restorative. and Neurological Devices

**510(k) Number** K043009

Over-The-Counter Use Prescription Use _ X OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional format 1-2-96)