HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A

K991871 · Hewlett-Packard Co. · MKJ · Aug 5, 1999 · Cardiovascular

Device Facts

• Record ID: K991871
• Device Name: HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A
• Applicant: Hewlett-Packard Co.
• Product Code: MKJ · Cardiovascular
• Decision Date: Aug 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable defibrillator and/or the external M3501A & M3502A electrodes provide the conductive interface between and the electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose classified as low power (360 Joule maximum.)

Device Story

Multifunction adult defibrillation electrodes (M3501A/M3502A) serve as conductive interface between patient and defibrillator/monitor. Used for external pacing, defibrillation, and cardioversion. Applied to patient skin; connected to instrument. Facilitates delivery of electrical therapy (up to 360 Joules) and signal monitoring. Used in clinical settings by healthcare professionals. Benefits include enabling life-saving cardiac rhythm management and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

Indications for Use

Indicated for adult patients requiring external pacing, defibrillation, or cardioversion. Intended for use with defibrillators classified as low power (360 Joule maximum). Single patient use only.

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

AUG - 5 1999

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

K991871
Multifunction Adult Defib. Electrodes Model Numbers M3501A/M3502A
Multifunction Adult (three) Re: Murcilanov Class: III (three) Product Code: 73 MLN May 28, 1999 Dated: Received: June 1, 1999

Dear Mr. Walters:

We have reviewed your Section 510 (k) notification of intent to market We have reviewed your Section July have determined the device is the device referenced above and we nave decoraner as a
substantially equivalent (for the indications for use stated in substantially equivalent (for the indicate devices marketed in
enclosure) to legally marketed predicate devices date enclosure) to legally marketed programs and comment date of the interstate commerce prior to May 20, 1970, cho been reclassified
Medical Device Amendments, or to devices that have been Food, Drug, and Medical Device Amendments, Of Co Geviews Food, Drug, and in accordance with the provisions of the rederal room and of the productions of the country of the device, subject to
controls and the provisions of the Act. The general cont Cosmetic Act (Act). You may, the Act. The general controls the general controls provisions of the Act. Inc. general registration,
provisions of the Act include requirements for annual registration, and provisions of the Act include requirements research and listing of devices, good manufacts.
prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special If your device is classified (see above) incoles subject to such Controls) or class III (Permarket Applovar); ic maj as
additional controls. Existing major regulations affecting your device additional controls. Existing mayor regardisons, Title 21, Parts 800
can be found in the Code of Federal Regulant ion assumes compliance can be found in the Code of rederal nation assumes compliance
to 895. A substantially equivalent determination assumes as set to 895. A substantially equivaries actoring Practice requirements, as set
with the Current Good Manufacturing USS for Medical Devices: with the Current Good Manufaccaring read for Medical Devices:
forth in the Quality System Regulation (QS) for Medical periodic forth in the Quality System Regulation (go) bod that, through periodic QS
General regulation (21 cERR Part Administration (FDA) will verify success General regulation (2) CPR Parc ozo) and chao, estato, (FDA) will verify such inspections, the Food and Dray Aumin Bor regulation may result in assumptions. Failure to compul with the culture announcements
regulatory action. In addition, FDA may publish first announcements regulatory action. In addiction concerning your device in the rederal noglession does not affect any
response to your premarket notification submission does of the Act response to your premarket incrirections 531 through 542 of the Act
obligation you might have under sections Control provision obligation you might have under Sections 351 chirage of the movisions,
for devices under the Electronic Product Radiation Control provisions,
for devices under the Electronic or other Federal laws or regulations.

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Page 2 - Mr. Warren R. Walters

This letter will allow you to begin marketing your device as described.
The FM BAND worserker potification. The FDA finding of substantial This letter will allow you to begin market.ng your acvase .
in your 510 (k) premarket notification. The FDA finding of substantial in your 510(k) premarket notification. The first your your your be er in a classification for your device and thus, permits your comments.
results in a classification for your device and thus, permits your results your results your results y results in a crabbilly.
device to proceed to the market.

If you desire specific advice for your device on our labeling If you desire specific advice for your device on on for in vitro regulation (21 CFR Part 801 and additionally 1631 of Compliance at
diagnostic devices), please contact the Office of Compliance at diagnostic devices), please contact the office of on the promotion and (201) 594-468. Additionaly, for questions on the promosours at
(201) 594-468. Additionaly, for questions of Compliation entitled, at enti advertising of your device, please concacion entitled,
[phone]. Also, please note the regulation (21 CFR [phone]. Also, please note the regulacion cultures and .
"Misbranding by reference to premarket notification" (21 CFR 807.97) . "Misbranding by reference to premarket notification (as may may
Other general information on your responsibilities under the act may Other general information on your responsibilities and its
be obtained from the Division of Small Manufacturers Assistance at its internet be obtained from the Division of Small Malluraced Cromann Collection
toll-free number (800) 638–2041 or (301) 443–6597, or at its internet
s (1) (1) (1) (1) (1) (1) = 5de =6x toll-free number [phone] Of (803)
address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Cullerton

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Vision of Cardiovaoorological Devices - Respiratory, Device Evaluation Center for Devices and Radiological Health

で

Enclosure

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## Indications for use Statement

not assigned 510k Number:

"Hewlett Packard M3501A & M3502A Multifunction Defib Electrodes" Device Name:

Indications For Use:

The Hewlett Packard External electrodes are indicated for use in external Pacing, Defibrillation and The Howlet Packard External electrodes are interess sigle patient use, only. The M3501A & Monitoring applications as a non-sterne, disposable defibrillator and/or the external M3502A electrodes provide the conductive interrace between and the electrode is intended for use on adult patients.

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

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OR Over-The Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use > (Per 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)