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.

AI/ML Overview

The provided text focuses on the 510(k) summary for the HighPak-12 Smart Battery, a rechargeable lithium battery intended for use in the LifePak-12 defibrillator. It primarily discusses the device's description, materials, and testing in the context of establishing substantial equivalence to predicate devices. However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific performance metrics requested.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states "Product testing was conducted to evaluate conformance to product specification." However, it does not provide a specific table of acceptance criteria with numerical targets or the detailed reported device performance against such targets.

It mentions the following testing categories:

Electromagnetic Compatibility (EMC)
Charging
Discharging
Proper fit and operation in the LifePak-12 Defibrillator

The statement "The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life" suggests a performance improvement in terms of amp-hours, but no specific acceptance criterion or quantitative measurement for "longer life" is given.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for testing (e.g., number of batteries tested).
It also does not mention data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to a battery performance test. Ground truth established by experts is typically relevant for diagnostic or image interpretation devices.

4. Adjudication Method for the Test Set:

This information is not applicable to a battery performance test, as there would be no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable to a battery performance test. MRMC studies are used to evaluate human reader performance, often with AI assistance, for diagnostic tasks.

6. Standalone Performance Study (Algorithm Only):

This information is not applicable to a battery, which is a hardware component and not an algorithm. The testing described (EMC, charging, discharging, fit/operation) evaluates the physical device's performance.

7. Type of Ground Truth Used:

For the testing mentioned (EMC, charging, discharging, proper fit and operation), the "ground truth" would be the engineering specifications and functional requirements of the battery and the LifePak-12 defibrillator. For instance, for "charging," the ground truth would be that the battery charges successfully and within expected parameters according to its design and the defibrillator's charging mechanism. For "fit and operation," the ground truth would be seamless physical integration and successful power delivery to the defibrillator.

8. Sample Size for the Training Set:

This information is not applicable. Battery performance testing does not typically involve a "training set" in the context of machine learning or AI algorithms. The testing is for verifying hardware performance.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

In summary, the provided K062331 document for the HighPak-12 Smart Battery outlines its intended use, design similarity to predicate devices, and general categories of testing performed (EMC, charging, discharging, fit/operation). However, it does not detail specific acceptance criteria with numerical values, sample sizes for testing, or information relevant to AI/algorithm performance studies, as these are not relevant for the type of device being described.

Summary

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Page 1 of 2

K062331

510(k) Summary

JUL 10 2007

General Information

Classification	Class II
Trade Name	HighPak® -12 Smart Battery
Submitter	AD Elektronik GmbHSudentenstrasse 7-935883 WetzlarGermanyTel: (49) 06641-9258-0
Contact	Daniel KraushaarOperations Manager

Intended Use

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

Predicate Devices

K041459Control	LifePak-12 Defibrillator	Medtronic	Inc./Physio-
K040775Control	LifePak-12 Defibrillator	Medtronic	Inc./Physio-
K010918Control	LifePak-12 Defibrillator	Medtronic	Inc./Physio-
K002445Control	LifePak-12 Defibrillator	Medtronic	Inc./Physio-
K991910Control	LifePak-12 Defibrillator	Medtronic	Inc./Physio-

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K062331

Device Description

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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)

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 |

Regulation Number and Section

§ 870.5300 DC-defibrillator (including paddles).

(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is 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.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is 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.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.