SUBDERMAL WIRE ELECTRODE, MODEL SWE

K062880 · Ives Eeg Solutions, Inc. · GXZ · Dec 22, 2006 · Neurology

Device Facts

• Record ID: K062880
• Device Name: SUBDERMAL WIRE ELECTRODE, MODEL SWE
• Applicant: Ives Eeg Solutions, Inc.
• Product Code: GXZ · Neurology
• Decision Date: Dec 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.

Device Story

Subdermal Wire Electrode (SWE) is a disposable, single-use needle electrode designed for temporary EEG signal acquisition. Used in hospital ICU settings by clinicians to monitor comatose patients. Device functions similarly to traditional subdermal needle electrodes, providing electrical contact for EEG recording equipment. Benefits include ease of use for temporary monitoring in critical care environments.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use subdermal wire electrode. Functions as a needle electrode for EEG signal acquisition. Class II device (21 CFR 882.1350).

Indications for Use

Indicated for temporary EEG recording in comatose patients aged 6 years and older in hospital Intensive Care Units (ICU).

Regulatory Classification

Identification

A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ives EEG Solutions, Inc. % Mr. John R. Ives President 6325 Rideau Valley Drive Manotick, Ontario K4M 1B3

DEC 2 2 2 2006

Re: K062880

Trade/Device Name: Subdermal Wire Electrode (SWE) Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: September 25, 2006 Received: September 26, 2006

Dear Mr. Ives:

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. John R. Ives

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), 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/industry/support/index.html.

Sincerely yours.

Barbara Powell
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 4. Indications for Use

510(k) Number:

KOLOZECO

Device Name:

Subdermal Wire Electrode (SWE)

The subdermal wire electrode (SWE) is intended for Indications for Use: temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU).

The SWE is a disposable, single use device.

The SWE is intended for use in a similar manner to that of a subdermal needle electrode.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Calvase Brienus

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

510(k) Number_KO(k) Number_KO(

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