K Number

Device Name

EXTENDED LIFE BATTERY

Manufacturer

AED BATTERY EXCHANGE, LLC

Date Cleared

2012-11-01

(269 days)

Product Code

MKJ

Regulation Number

870.5310

Intended Use

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K031987, K955628, K020715, K040904, K013425, K111693, K033896, K955854

Reference Devices

K031987, K955628, K020715, K040904, K013425, K111693, K033896, K955854

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus solely on the electrical and physical characteristics of battery packs for AEDs. There is no mention of AI or ML in the intended use, device description, or performance testing.

Therapeutic

No.
The device is a non-rechargeable battery pack for Automated External Defibrillators (AEDs) and is intended to provide power to the AED, not to directly provide therapy.

Diagnostic

This device is a battery pack for Automated External Defibrillators (AEDs). Its intended use is solely to provide power to AEDs, not to diagnose medical conditions or analyze data from the body.

SaMD (Software as a Medical Device)

The device description explicitly states it is a "non-rechargeable battery pack" and describes its function as supplying electrical power through a "chemical reaction of lithium cells," which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use is to power Automated External Defibrillators (AEDs). This is a therapeutic and life-support function, not a diagnostic one.
Device Description: The device is a battery pack that provides electrical power. It does not interact with biological samples or perform any diagnostic tests.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or prognosis of a disease or condition

The device's function is purely to provide power to another medical device (the AED). While the AED itself is a medical device, the battery pack is an accessory that enables its operation.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

MKJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Only qualified service personnel should evaluate, test, or install AED battery packs.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.
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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K031987, K955628, K020715, K040904, K013425, K111693, K033896, K955854

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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:	847-487-9376
keith@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-Rechargeable
Regulatory 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

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.

| Original
Manufacturer | Model
Number | Open Circuit
Minimum
Voltage @20
degrees C | Loaded Circuit Minimum
Voltage @20 degrees C:
L=load resistance,
Vnom=nominal voltage
output,
Vmin=minimum
measured voltage output |
|--------------------------|-----------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiac
Science | 9141 | For Vnom=6V,
Vmin=6.0V

For Vnom=12V,
Vmin=12.0V | For Vnom=6V, L=8 ohms,
Vmin=5.5V

For Vnom=15V,
Vmin=15.0V | For Vnom=3V,L=4 ohms,
Vmin=2.7V

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.

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.

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

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

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