PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20

K040479 · Welch Allyn, Inc. · MKJ · Sep 14, 2004 · Cardiovascular

Device Facts

• Record ID: K040479
• Device Name: PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
• Applicant: Welch Allyn, Inc.
• Product Code: MKJ · Cardiovascular
• Decision Date: Sep 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3
• Attributes: Therapeutic, Pediatric

Intended Use

The Pediatric Energy Reducer product is intended to be used to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either in-hospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 10™ was formerly marketed as the MRL JumpStart and AED 20™ was formerly marketed as the MRL LifeQuest AEDefibrillator. The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight. It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.

Device Story

Pediatric Energy Reducer is a passive, reusable accessory for Welch Allyn AEDs. Device consists of a resistive voltage divider circuit in a protective plastic housing. Inserted between AED and standard non-attenuating defibrillation electrodes; attenuates delivered energy by factor of four for pediatric use. Operates passively; does not affect AED wave shape or arrhythmia detection algorithms. Used by clinicians or responders in in-hospital or out-of-hospital settings. Facilitates use of standard electrodes, reducing inventory complexity and cost. Benefits patient by enabling safe pediatric defibrillation therapy using existing adult-sized AED equipment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technological comparison to the predicate device.

Technological Characteristics

Passive resistive voltage divider circuit encapsulated in a protective plastic housing. Connectors provided for AED and electrode interface. Attenuates energy by a factor of four. Reusable accessory. No software or active electronic components.

Indications for Use

Indicated for infants and children up to approx. 8 years of age or 25 kg (55 lbs) in cardiopulmonary arrest (unconscious, pulseless, apneic). Used in in-hospital or out-of-hospital settings. Contraindicated for patients exceeding these weight/age thresholds or those not in cardiac arrest.

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.

Predicate Devices

• Medtronic Physio-Control Infant/Child Reduced Energy Electrodes (K022732)

Submission Summary (Full Text)

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SEP 1 4 2004

0404/79

## Attachment XVI Premarket Notification [510(k)] Summary As Required By 21 CFR 807.92

| Submitted By: | Welch Allyn, Inc.<br>4341 State Street Road<br>P.O. Box 220<br>Skaneateles Falls, New York 13153-0220<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Christopher A. Klaczyk, Sr. Regulatory Engineer |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name: | Pediatric Energy Reducer for AED 10TM<br>Pediatric Energy Reducer for AED 20TM |
| Proprietary Name: | Same as Trade Name |
| Common Name: | Defibrillator, Automatic, External |
| Product Code: | 74MKJ |
| Classification: | All products are Class III per 21 CFR 870.5310,<br>Defibrillator, Automatic, External |
| Predicate Device: | Medtronic Physio-Control Infant/Child Reduced Energy<br>Electrodes (K022732)<br>Class III<br>Common Names: Defibrillator, Automatic, External (MKJ) and<br>Electrode, Electrocardiograph, Multi-Function (MLN) |
| Description: | The reusable Pediatric Energy Reducer products are small,<br>lightweight, passive accessory devices for use with Welch Allyn<br>automatic external defibrillators (AED). The Pediatric Energy<br>Reducer product is inserted between the AED and suitable size<br>non-attenuating defibrillation electrodes. The Pediatric Energy<br>Reducer product attenuates the energy from the defibrillator by<br>a factor of four, making the energy delivered to the electrodes<br>suitable for use on pediatric patients. The Pediatric Energy<br>Reducer product only affects the amplitude of the delivered<br>waveform; the wave shape and arrhythmia detection algorithms<br>are not affected by device use. The device consists of a<br>resistive voltage divider circuit encapsulated in a protective<br>plastic housing. Suitable connectors are provided to engage<br>the Pediatric Energy Reducer to the AED and the electrodes to<br>the Pediatric Energy Reducer. |

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K040479

The Pediatric Energy Reducer product is intended to be used Intended Use: to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either inhospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 10™ was formerly marketed as the MRL JumpStart and AED 20™ was formerly marketed as the MRL LifeQuest AEDefibrillator.

> The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight.

> It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.

Comparison: The Pediatric Energy Reducer product used in conjunction with non-attenuating defibrillation electrodes provides functionality equal to that of the predicate product. The two products use the same technology to provide the attenuation function. The only difference between the subject device and the predicate is that, where the predicate device incorporates the resistive attenuation circuit as part of the disposable electrode assembly, Welch Allyn provides the attenuator as a separate accessory. This facilitates the use of less costly nonattenuating electrodes for all patients, eliminating the potential to confuse attenuating electrodes with non-attenuating electrodes as well as the need to assure sufficient stock of the two styles of electrodes.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 1 4 2004

Welch Allyn, Inc. c/o Mr. Christopher Klaczyk. Senior Regulatory Engineer 4341 State Street Road P.O. Box 220 Skaneateles Falls, NY 13153-0220

K040479 Re:

Ro40477
Trade name: Pediatric Energy Reducer, Models AED-10 and AED-20 Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: July 22, 2004 Received: July 23, 2004

Dear Mr. Klaczyk:

We have reviewed your Section 510(k) premarket notification of intent to market the devices we have reviewed your Section 910(x) premained 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 encrosure) to regars annual date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the exactions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA).)
and Cosmetic Act (Act) that do not require approval of a premarket approval one of the Ast and Cosment Act (Act) that do not require approvis controls provisions of the Act. The You may, therefore, market the devices, saloject to the ments for annual registration, listing of the general controls provisions of the fielding, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controlls) or class III (PMA), it If your device is classifica (sec above) me existing major regulations affecting your device can
may be subject to such additional controls. Existing major 1990 - 1 a 1 litt may be subject to such additional controllor Life 21, Parts 800 to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addi be found in the Ood of Peachar Engerning your device in the Federal Register.

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Page 2 - Mr. Christopher Klaczyk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a buobeine complies with other requirements of the Act
that FDA has made a determination that your device complies with other matt that FDA has made a decidination that your correst by other Federal agencies. You must or any Federal statutes and regulations administered of registration and listing (21)
comply with all the Act's requirements, including, but not limited to: registration and comply with an the Act s requirements, mercess anufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and If applicable, the electronic as a construction forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decisions vour device as described in your Section 510(k) This letter will anow you to begin maneting your as revealence of your device to a legally premarket nothlication. The FDA midning of battained of the revice 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 advice for your as 110 % 4648. Also, please note the regulation entitled, contact the Office of Compuners at (301) 25 - 100 - 100 - 100 may obtain " MISofallung by reference to promantee nowler the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990s C28 AA other general Information on your response in its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Bhimmer
R. D. Zuchlewski, M.D.

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

Page 1 of 1

510(k) Number (if known): K040479

Pediatric Energy Reducer Device Name:

Indications For Use:

The Pediatric Energy Reducer product is intended to be used to treat patients in The Pediative Energy Reducer production in the interior who are unconscious,
cardiopulmonary arrest. It should only be used on patients who in either in cardlopulifionaly arrest. "It should only be audy. It is intended for use in either inwithout a pulse and not breathing opential in Energy Reducer is to be used only nospital or out-of-nospital arrests: "The Poulune =1009)
in conjunction with Automatic External Defibrillator (AED) and disposable electrode in conjunction with Automatio External Donamal (artherly marketed by Medical Research products marketed by Welch Allyn, or as formerly marketed as the MRL JumpStart
Laboratories (MRL). The AED 10™ was formerly hif Orea AED of AFDefiniliater Laboratores (MRL): The AED To - the MDL LifeQuest AEDefibrillator.

The Pediatric Energy Reducer product is intended to be used to treat infrants and The Pediative Energy Neducer product is interrass of age or 25 lbs) weight; therapy should children up to approxermine the child's exact age or weight.

It is intended to be used with normal (non-attenuating) adult electrodes on patients It is intended to be used will normal (normal (normal shorther (in the anterior / posterior who are sumclently large for the clocal out to be appear on smaller patients.

(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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on Sign-Oli)
on of Cardiovascular Devices

510(k) Number K040179

Prescription Use _ × (Part 21 CFR 801 Subpart D) or

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

(Optional Format 3-10-98)