To provide power for the specific Automated External Defibrillators (AEDs) for which the original battery packs were designed and manufactured, in back-up and portable use.

Device Description

The Green4Life Batteries are non-rechargeable battery packs utilized as the primary power source or as a standby or backup power source for Automated External Defibrillators (AEDs). These devices provide a means of supplying electrical power through the chemical reaction of lithium cells. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current required by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and discharge method. The goal of these battery packs is to provide a sufficient power source for AEDs for as long as possible under a specified range of environmental conditions.

The Green4Life Batteries are re-celled battery packs of those identified below in Predicate Devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device Model (Green4Life Battery)	Acceptance Criteria: Open Circuit Minimum Voltage @ 20°C	Reported Device Performance (Implied)	Acceptance Criteria: Loaded Circuit Minimum Voltage @ 20°C	Reported Device Performance (Implied)
Cardiac Science 9141 (Vnom=6V)	6.0V	Met	5.5V (L=8 ohms)	Met
Cardiac Science 9141 (Vnom=12V)	12.0V	Met	11.0V (L=15 ohms)	Met
Cardiac Science 9146	12.0V	Met	11.0V (L=15 ohms)	Met
Philips BT1	18.0V	Met	16.6V (L=23 ohms)	Met
Philips M5070 (FRX/Onsite)	9.0V	Met	8.2V (L=11 ohms)	Met
Philips M3863 (FR2)	12.0V	Met	11.0V (L=15 ohms)	Met
Philips 989803150161 (FR3)	12.0V	Met	11.0V (L=15 ohms)	Met
Defibtech DCF-200 (Vnom=3V)	3.0V	Met	2.7V (L=4 ohms)	Met
Defibtech DCF-200 (Vnom=15V)	15.0V	Met	13.8V (L=20 ohms)	Met
Physio Control Lifepak 500	12.0V	Met	11.0V (L=15 ohms)	Met

Additional Acceptance Criteria:

Ease of Installation: Battery pack must easily install into the AED and firmly lock into place as with the original battery pack.
AED Self-Test Result: Upon installation, the AEDs undergo an operational self-test of the installed battery, and the final battery pack acceptance testing requires a reported "pass" by the corresponding AED.

Reported Device Performance: The document states, "The Green4Life Battery packs are re-celled packs manufactured as cleared devices... Performance testing within the specific AED was conducted to verify that the replacement battery pack tested within limits and that reset of battery pack information when operated within the designated AED, for those packs equipped with memory devices, was acceptable." It also states, "Final battery pack acceptance testing requires a reported 'pass' by the corresponding AED." This implies that all stated acceptance criteria were met.

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

Sample Size: The document does not explicitly state a specific numerical sample size for the "Performance Testing" or "Manufacturing Tests," but it implies testing each battery pack. It mentions "typical sampling plans for similar devices" for incoming inspection of lithium cells, and "100% testing" for assembled packs. For the final acceptance test, "the battery packs will be installed into their corresponding AED for a final acceptance test." This suggests that a representative number of each re-celled battery model were tested.
Data Provenance: The testing was conducted by AED Battery Exchange, LLC. The data provenance is internal to the manufacturer, intended to demonstrate equivalence to predicate devices. It is a form of prospective testing for the manufactured re-celled batteries. The company is based in Wauconda, IL, USA.

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

This information is not applicable to this type of device and study. The "ground truth" for battery performance is objective and measurable (voltage, resistance, successful AED operation), not based on expert interpretation like in image analysis or clinical diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations (e.g., medical image reads) where disagreements between experts need resolution. For objective measurements like battery performance, the results are definitive.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance. This submission pertains to a re-celled battery pack.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, in essence, standalone testing was done for the battery's performance. The core tests (open circuit voltage, loaded circuit voltage) are performed directly on the battery packs without human intervention beyond setting up the test equipment and recording results. The "final acceptance test" involves the AED's internal self-test, which is an automated algorithm checking the battery's functionality. This is the "algorithm only" aspect of performance evaluation for this type of device.

7. The Type of Ground Truth Used

The ground truth is based on objective, measurable electrical parameters (voltage under open and loaded conditions) and functional validation (the AED's internal self-test reporting "pass"). This is a form of empirical validation against defined performance specifications.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/machine learning device that requires a "training set" in the conventional sense. The "training" for the manufacturing process is adherence to established specifications and procedures for re-celling and testing.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as point 8. The "ground truth" for the manufacturing process is the successful replication of original battery performance, which is verified by the performance tests described in the acceptance criteria.

Summary

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510(k) Summary Section 5

This 510(k) is being submitted in accordance with the requirements of CFR 807.92.

Administrative Information 5.1

Submitted by: AED Battery Exchange, LLC 1000 Brown Street, Suite #310 Wauconda, IL 60084 USA

Contact Person: Phone:	Keith Hochhalter
Fax:	847-487-9375
Email:	847-487-9376keith@aedbatteryexchange.com

Original Date Prepared: -January 27, 2012 Additional Information Provided: April 4, 2012

5.2 Device Name and Classification:

Common/Generic	Name: Box, Battery
Trade/Proprietary	Name: Green4Life Battery
Classification Name:	Box, Battery, Non-RechargeableRegulatory Class III, Product Code MKJ

5.3 Device Description:

The Green4Life Batteries are re-celled battery packs of those identified below in Predicate Devices.

5.4 Indications for Use:

To power AEDs for which the OEM battery pack was intended. Only qualified service personnel should evaluate, test, or install AED battery packs.

NOV 1 2012

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Predicated Devices: ર્સ્ડ

Company	Device	510(k) #	Date Cleared
Cardiac Science	Replacement Battery 9141	K031987	7/30/2003
		K040438	7/1/2004
Cardiac Science	Replacement Battery 9146	K031987	7/30/2003
		K040438	7/1/2004
Philips	Replacement Battery ForeRunner BTI	K955628	9/10/1996
Philips	Replacement Battery HeartStart	K020715	11/8/2002
Philips	Replacement Battery HeartStart FRX, Onsite/HomeAED (M5070)	K040904	9/16/2004
		K050004	2/25/2005
Philips	Replacement Battery HeartStart FR2 (M3863)	K013425	1/14/2002
		K051632	10/5/2005
Philips	Replacement Battery HeartStart FR3 (989803150161)	K111693	10/28/2011
Defibtech	Replacement Battery DCF-200	K033896	6/16/2004
		K081259	6/15/2009
Physio Control	Replacement Battery Lifepak 500	K955854	11/4/1996

5.6 Substantial Equivalence:

The Green4Life Battery packs are re-celled battery packs of those identified above in Predicate Devices. Existing enclosures are opened, lithium cells are replaced with identical or superior cells, reclosed, reset if memory equipped, and tested. Therefore, the pack is typically the exact original equipment. Only the lithium cells are replaced within the original battery packs unless other components including the power rectifiers, thermal fuses, or current limit fuses are found faulty or damaged during cell removal. In these cases, components will be replaced with identical part number components.

5.7 Testing:

5.7.1 Performance Testing

The Green4Life Battery packs are re-celled packs manufactured as cleared devices. Cells are replaced with identical cells to those used by the OEM or equivalent in specifications over the full temperature range of AED operation. Each AED has an internal test of the battery to verify that it is capable of providing the necessary power to the AED. This self test is a good indicator that the replacement battery back is acceptable. Performance testing within the specific AED was conducted to verify that the replacement battery pack tested within limits and that reset of battery pack information when operated within the designated AED, for those packs equipped with memory devices, was acceptable.

5.7.2 Manufacturing Tests

Incoming inspection of lithium cells will include visual examination and internal resistance measurements on typical sampling plans for similar devices. Approved cells will be assembled into packs where they go through a 100% testing as follows, including an open circuit test, loaded test, and installed test.

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OriginalManufacturer	ModelNumber	Open CircuitMinimumVoltage @20degrees C	Loaded Circuit MinimumVoltage @20 degrees C:L=load resistance,Vnom=nominal voltageoutput,Vmin=minimummeasured voltage output
CardiacScience	9141	For Vnom=6V,Vmin=6.0VFor Vnom=12V,Vmin=12.0V	For Vnom=6V, L=8 ohms,Vmin=5.5VFor Vnom=12V, L=15 ohms,Vmin=11.0V
CardiacScience	9146	Vmin=12.0V	L=15 ohms, Vmin=11.0V
Philips	BT1	Vmin=18.0V	L=23 ohms, Vmin=16.6V
Philips	M5070(FRX/Onsite)	Vmin=9.0V	L=11 ohms, Vmin=8.2V
Philips	M3863 (FR2)	Vmin=12.0V	L=15 ohms, Vmin=11.0V
Philips	989803150161(FR3)	Vmin=12.0V	L=15 ohms, Vmin=11.0V
Defibtech	DCF-200	For Vnom=3V,Vmin=3.0VFor Vnom=15V,Vmin=15.0V	For Vnom=3V,L=4 ohms,Vmin=2.7VFor Vnom=15V,L=20 ohms,Vmin=13.8V
Physic Control	Lifepak 500	Vmin=12.0V	L=15 ohms, Vmin=11.0V

In addition to the above open circuit and load DC voltage tests, the battery packs will be installed into their corresponding AED for a final acceptance test. The battery pack must easily install into the AED and firmly lock into place as with the original battery pack. Upon installation the AEDs undergo an operational self test of the installed battery. Final battery pack acceptance testing requires a reported "pass" by the corresponding AED.

5.8 Conclusion:

AED Battery Exchange has demonstrated through evaluation and testing of the Green4Life Battery packs, that their re-celled battery packs are equivalent with respect to indications for use, technological characteristics, materials, form, fit, and function to the replacement battery packs commercially available for specific AEDs outlined in this submission. This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided as section 15 of this submission.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. The text is in all caps and is oriented to follow the curve of the circle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NOV 1 202

AED Battery Exchange, LLC c/o Mr. Keith Hochhalter 1000 Brown Street, Suite #310 Wauconda, IL 60084

Re: K120350

Trade Name: Green4Life Battery with models M5070-ABE, M3863-ABE, BT1-ABE, 500-ABE, DCF-200-ABE, 9141-ABE and 9146-ABE (7 models total) Regulation Number: 21 CFR 870.5310 Regulation Name: Automated external defibrillator Regulatory Class: Class III (three) Product Code: MKJ Dated: Undated Received: October 19, 2012

Dear Mr. Hochhalter:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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Page 2 - Mr. Keith Hochhalter

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resourcesfor.You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

K120350 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name:_Green4Life Batteries with the following models:

M5070-ABE, M3863-ABE, BT1-ABE, 500-ABE, DCF-200-ABE, 9141-ABE and 9146-ABE (7 models total).

Indications for Use:

To provide power for the specific Automated External Defibrillators (AEDs) for which the original battery packs were designed and manufactured, in back-up and portable use.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K120350

Page 1 of 1

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
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.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.