AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE

K032278 · Ambu, Inc. · GXY · Mar 5, 2004 · Neurology

Device Facts

• Record ID: K032278
• Device Name: AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
• Applicant: Ambu, Inc.
• Product Code: GXY · Neurology
• Decision Date: Mar 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Intended Use

The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

Device Story

Single Patient EEG/EP Cup Electrode; used for recording biopotential signals (EEG, nerve potentials) when connected to monitoring/stimulation equipment. Device consists of cup electrodes for single patient use. Operates by detecting electrical signals from patient skin; signals transmitted to external recording/monitoring hardware. Used in clinical settings by healthcare professionals. Output provides diagnostic data for clinical decision-making regarding neurological status. Benefits include reduced risk of cross-contamination due to single-patient use design.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Cutaneous electrode (21 CFR 882.1320); cup-style form factor; single-patient use design; intended for biopotential signal acquisition.

Indications for Use

Indicated for use with recording, monitoring, and stimulation equipment to record biopotential signals, including EEG and nerve potentials. For single patient use only.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 5 2004

Mr. Sanjay Parikh Technical and Regulatory Affairs Manager Ambu, Inc. 611 North Hammonds Ferry Road Linthicum, Maryland 21090-1356

Re: K032278

Trade/Device Name: Single Patient EEG/EP Cup Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Codc: GXY Dated: March 1, 2004 Reccived: March 2, 2004

Dear Mr. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn 310(a) per device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regard the Medical Device Amendments, or to commerce prior to May 20, 1776, the enaoceance with the provisions of the Federal Food, Drug, devices that have been roomsoned in assee approval of a premarket approval application (PMA). alle Cosmetic Act (Act) that to not requesubject to the general controls provisions of the Act. The 1 ou may, therefore, market of the Act include requirements for annual registration, listing of general controls provisions of the recorplabeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it If your device is classimod (600 abs. Existing major regulations affecting your device can may be subject to suen addrenial comlations, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oour acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does no/1 F Icase of advised that I Drivisation over device complies with other requirements of the Act that 117A has made a actornations administered by other Federal agencies. You must of any I coclar statutes and regaranents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as sch CFA Fart 807), idocing (21 OFF Part 820); and if applicable, the clectronic forth in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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## Page 2 - Mr. Sanjay Parikh

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter witi anow you to begin mailioning of substantial equivalence of your device to a legally premaired 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 If you desire specific at novies your [phone]. Also, please note the regulation entitled, Colliaci the Office of Compullier and (SSL notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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

Enclosure

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## Indications for Use

510(k) Number (if known): K032278

Device Name:__ Single Patient EEG/EP Cup Electrode

Indications For Use:

The Single Patient EEG/EP Cup Electrode is intended for use with recording, monitoring and stimulation equipment for the purpose of recording of biopotential signals for example: Electroencephalograph (EEG) and Nerve potentials signals. The electrodes are for single patient use only.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Division Sign Division of General, Restorative. and Neurological Devices

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