HIGHPAK-12

K062331 · Ad Elektronik GmbH · MPD · Jul 10, 2007 · Cardiovascular

Device Facts

• Record ID: K062331
• Device Name: HIGHPAK-12
• Applicant: Ad Elektronik GmbH
• Product Code: MPD · Cardiovascular
• Decision Date: Jul 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5300
• Device Class: Class 2

Indications for Use

The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.

Device Story

HighPak-12 is a rechargeable lithium manganese battery designed as a replacement power source for the LifePak-12 defibrillator. It features a molded plastic case identical in form factor to the predicate NiCd battery, ensuring physical compatibility. The device utilizes lithium manganese cell technology to provide equivalent voltage with increased amp-hour capacity, resulting in extended operational life. It is compatible with existing 'Smart Battery' charging systems used by the LifePak-12. The battery is installed by clinical staff into the defibrillator to provide necessary electrical power for device operation. By offering higher capacity, it benefits the patient and clinician by extending the duration the defibrillator can remain in service without requiring a recharge.

Clinical Evidence

Bench testing only. Testing evaluated electromagnetic compatibility (EMC), charging and discharging performance, and physical fit/operation within the LifePak-12 defibrillator.

Technological Characteristics

Lithium manganese rechargeable battery; molded plastic casing; identical form factor to predicate NiCd battery; compatible with 'Smart Battery' charging systems; Class II device (Auxiliary Power Supply).

Indications for Use

Indicated for use as a power supply for the LifePak-12 defibrillator in clinical settings.

Regulatory Classification

Identification

Low-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body. High-energy DC-defibrillator: A device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.

Predicate Devices

• LifePak-12 Defibrillator (K041459)
• LifePak-12 Defibrillator (K040775)
• LifePak-12 Defibrillator (K010918)
• LifePak-12 Defibrillator (K002445)
• LifePak-12 Defibrillator (K991910)

Submission Summary (Full Text)

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### K062331

## 510(k) Summary

JUL 10 2007

## General Information

| Classification | Class II |
|----------------|-------------------------------------------------------------------------------------------------|
| Trade Name | HighPak® -12 Smart Battery |
| Submitter | AD Elektronik GmbH<br>Sudentenstrasse 7-9<br>35883 Wetzlar<br>Germany<br>Tel: [phone] |
| Contact | Daniel Kraushaar<br>Operations Manager |

## Intended Use

The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.

## Predicate Devices

| K041459<br>Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
|--------------------|--------------------------|-----------|--------------|
| K040775<br>Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K010918<br>Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K002445<br>Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |
| K991910<br>Control | LifePak-12 Defibrillator | Medtronic | Inc./Physio- |

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#### K062331

#### Device Description

The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.

#### Materials

All materials used in the manufacture of the HighPak -12 Battery are suitable for this use and have been used in numerous previously cleared products.

#### Testing

Product testing was conducted to evaluate conformance to product specification. Testing included electromagnetic compatibility (EMC), charging, discharging, proper fit and operation in the LifePak-12 Defibrillator.

### Summary of Substantial Equivalence

The HighPak-12 Battery is equivalent to the predicate LifePak-12 battery. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human figures connected at the arms, representing the department's mission to protect the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 0 2007

AD Elektronik GmbH c/o Mr. Gregory J. Mathison President Regulatory Strategies, Inc. 3924 Cascade Beach Road Lutsen, MN 55612

Re: K062331

Trade/Device Name: HighPak-12 Rechargeable Battery Regulation Number: 21 CFR 870.5300 Regulation Name: Auxiliary Power Supply (ac or dc) for Low-Energy dc-Defibrillator Regulatory Class: Class II (two) Product Code: MPD Dated: July 6, 2007 Received: July 9, 2007

Dear Mr. Mathison:

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 - Gregory J. Mathison

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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely vours.

er R. Vochner

\ 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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# K062331

# Indications for Use

510(k) Number (if known):

This application > Ko6233|

Device Name:

Indications for Use:

HighPak® -12 Rechargeable Battery

The HighPak® -12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.

X Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-9)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

sumner R. Vechner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ko6233 |