PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)

K060189 · Ives Eeg Solutions, Inc. · GXZ · May 30, 2006 · Neurology

Device Facts

• Record ID: K060189
• Device Name: PEDIATRIC SUBDERMAL WIRE ELECTRODE (PSWE)
• Applicant: Ives Eeg Solutions, Inc.
• Product Code: GXZ · Neurology
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1350
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU). The pSWE is a disposable, single use device. The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.

Device Story

Pediatric Subdermal Wire Electrode (pSWE) is a disposable, single-use needle electrode; used for temporary EEG signal acquisition in comatose pediatric patients (6-21 years) within hospital ICUs. Device functions as a conductive interface between patient scalp and external EEG monitoring equipment; operates similarly to traditional subdermal needle electrodes. Physician or trained clinician inserts electrode subdermally to capture electrical brain activity; signals transmitted to standard EEG recording system for clinical interpretation. Facilitates continuous neurological monitoring in critical care settings; aids in assessment of brain function in comatose patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use subdermal wire electrode. Form factor: needle electrode. Function: EEG signal recording. Class II device (21 CFR 882.1350).

Indications for Use

Indicated for temporary EEG recording in comatose pediatric patients aged 6 to 21 years in hospital Intensive Care Units.

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

Public Health Service

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MAY 3 0 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K060189

Trade/Device Name: Pediatric Subdermal Wire Electrode (pSWE) Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: April 10, 2006 Received: April 17, 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. 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

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## Page 2 - Mr. John Ives

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 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" (21CFR 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/dsma/dsmamain.html

Sincerely yours,

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: Device Name:

K060189 Pediatric Subdermal Wire Electrode (pSWE)

Indications for Use: The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).

The pSWE is a disposable, single use device.

The pSWE 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)

Hulur Remunho

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

**510(k) Number** K060189