HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A

K992977 · Hewlett-Packard Co. · MKJ · Dec 1, 1999 · Cardiovascular

Device Facts

• Record ID: K992977
• Device Name: HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A
• Applicant: Hewlett-Packard Co.
• Product Code: MKJ · Cardiovascular
• Decision Date: Dec 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.) The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.

Device Story

Non-sterile, disposable multifunction pediatric electrodes; provide conductive interface between pediatric patient skin and external defibrillator/transcutaneous cardiac pacemaker. Used for pacing, defibrillation, cardioversion, and monitoring. Designed for use with Hewlett Packard Codemaster Defibrillators. Applied by clinicians in clinical settings to patients requiring cardiac intervention. Facilitates energy delivery and signal acquisition for cardiac rhythm management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Non-sterile, disposable pediatric electrodes. Conductive interface for defibrillation, pacing, and monitoring. Compatible with low-power defibrillators (max 360 Joules).

Indications for Use

Indicated for pediatric patients requiring external pacing, defibrillation, cardioversion, or ECG monitoring. Designed for use with Hewlett Packard Codemaster Defibrillators with maximum output of 360 Joules.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 1 1999

Mr. Warren Walters Hewlett-Packard Company c/o Katecho, Inc. 2500 Bell Avenue Des Moines, IA 50321

Re : K992977 Hewlett Packard M3503A and M3504A Multifunction Pediatric Defib Electrodes Requlatory Class: III (three) Product Code: 74 MLN Dated: September 1, 1999 Received: September 3, 1999

Dear Mr. Walters:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Warren Walters

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

joann H. Wentroheser fes,

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 14, Page 1 of 1

## Indications for use Statement

510k Number: x992977

"Howlett Packard M3503A & M3504A Multifunction Pediatric Defib Electrodes" Device Name:

Indications For Use:

The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)

The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

foan A. Wechter
(ision Sign-Off)

vision of Cardiovascular, Respiratory, . Neurological Devices

> 10(k) Number K442977

**Prescription Use**

OR Over-The Counter Use

(Per 21 CFR 801.109)

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