AMBU DISPOSABLE ECG ELECTRODE

K041734 · Ambu, Inc. · DRX · Sep 22, 2004 · Cardiovascular

Device Facts

• Record ID: K041734
• Device Name: AMBU DISPOSABLE ECG ELECTRODE
• Applicant: Ambu, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Sep 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.

Device Story

Ambu Disposable ECG Electrode is a single-use device designed for standard electrocardiographic (ECG) monitoring. The electrode serves as a conductive interface between the patient's skin and an ECG monitoring system, facilitating the acquisition of cardiac electrical signals. It is intended for use in clinical settings by healthcare professionals. The device is applied to the patient's skin to capture signals, which are then transmitted to an ECG monitor for display and analysis by clinicians to support diagnostic or monitoring decisions. The disposable nature of the electrode helps mitigate the risk of cross-contamination between patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable ECG electrode; conductive interface for signal acquisition; single-patient use; class II device (21 CFR 870.2360).

Indications for Use

Indicated for use in all standard ECG applications for patients requiring electrocardiographic monitoring. For single patient use only.

Regulatory Classification

Identification

An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2004

Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 611 North Hammonds Ferry Road Linthicum, MD 21090-1356

Re: K041734

Trade Name: Ambu Disposable ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: June 22, 2004 Received: June 25, 2004

Dear Mr. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterings ally marketed predicate devices marketed in interstate 101 use stated in the encrosaly to togally to the Medical Device Amendments, or to connineres provision to May 20, 1978, the excordance with the provisions of the Federal Food. Drug. devices mat have boon results in a were approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls proficions of aactice, 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 If your device is elassified (600 about of ols. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our acements concerning your device in the Federal Register.

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Page 2 -- Mr. Sanjay Parikh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease oc advised that I Dris brissantes vour device complies with other requirements of the Act that I DA has made a decemments ons administered by other Federal agencies. You must or any I cacial stututios and regeranents, including, but not limited to: registration and listing (21 Comply with an the fict brequirements)01); good manufacturing practice requirements as set CFR Part 6077, adoning (21 CFR Part 820); and if applicable, the electronic forth in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation of to begin marketing your device as described in your Section 510(k) This letter will anow yourse ough finding of substantial equivalence of your device to a legally premarket notication: "The Prix mailing sification 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 as no and [phone]. Also, please note the regulation entitled, eonador the Ories of Come to premarket notification" (21CFR Part 807.97) you may obtain. IMisoranding of reference to prescent to promotibilities under the Act may be obtained from the Other general miormation on Journational 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,

B. Simmerman for

Dr. D. Z. Isserman, MD

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K04/734

Device Name: Ambu Disposable ECG Electrode

Indications For Use:

Ambu General Purpose Disposable ECG Electrodes are intended for use in all Standard ECG Applications. Electrodes are made for single patient use only.

Prescription Use (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)

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510(k) Number k041734