AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE

K032421 · Ambu, Inc. · MKJ · Feb 27, 2004 · Cardiovascular

Device Facts

• Record ID: K032421
• Device Name: AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE
• Applicant: Ambu, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Feb 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion. The Paediatric Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec. The electrode can be used with mono- and biphasic defibriliators. The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs). Disposable electrode, for single use, only, The electrode is intended for use on defibrillators who's output is maximum 100 Joule. Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.

Device Story

Ambu Pediatric Multi-Function Defibrillation Electrodes are disposable, single-use conductive pads; interface with external defibrillators and transcutaneous pacemakers. Electrodes capture ECG signals for monitoring; deliver electrical energy for defibrillation or pacing therapy. Used in clinical settings by healthcare professionals; specific connector/cable configurations match host device requirements. Benefits include standardized, reliable interface for pediatric emergency cardiac care; facilitates rapid delivery of life-saving therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Disposable, single-use multi-function electrode pads. Designed for pediatric patients <10kg. Compatible with mono- and biphasic defibrillators (max 100J) and transcutaneous pacemakers (max 200mA, 200ms). Interface via specific connectors/cables tailored to host device systems.

Indications for Use

Indicated for pediatric patients weighing less than 10kg (22lbs) requiring defibrillation, pacing, ECG monitoring, or synchronized cardioversion. Compatible with mono- and biphasic defibrillators (max 100J) and transcutaneous pacemakers (max 200mA, 200ms).

Regulatory Classification

Identification

An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.

Submission Summary (Full Text)

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Image /page/0/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. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

FEB 27 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K032421

> Trade Name: Ambu Pediatric Multi-Function Defibrillation Electrodes Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: 74 MKJ, MLN Dated: December 01, 2003 Received: December 02, 2003

Dear Mr. Parikh:

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.

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Page 2 - Mr. Sanjay Parikh

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. 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,

Dara R. Jackner

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):

Device Name:

Ambu Paediatric Multi-function Defibrillation Electrode

Indications For Use:

Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.

The Paediatric Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.

The electrode can be used with mono- and biphasic defibriliators.

The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).

Disposable electrode, for single use, only,

The electrode is intended for use on defibrillators who's output is maximum 100 Joule.

Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.

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)

Duma R. Jones
Division Sign-Off)
Division Cardiovascular Devices

Owlsion . Cardiovascular Devices

510(k) Number K03242

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