EXTENDED LIFE BATTERY

K120350 · Aed Battery Exchange, LLC · MKJ · Nov 1, 2012 · Cardiovascular

Device Facts

• Record ID: K120350
• Device Name: EXTENDED LIFE BATTERY
• Applicant: Aed Battery Exchange, LLC
• Product Code: MKJ · Cardiovascular
• Decision Date: Nov 1, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5310
• Device Class: Class 3

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.

Device Story

Green4Life Batteries are re-celled, non-rechargeable lithium battery packs designed as primary or standby power sources for specific AED models. The manufacturing process involves opening original OEM battery enclosures, replacing internal lithium cells with identical or superior components, and reclosing the pack. If memory-equipped, the pack is reset. The device is used in clinical or field settings where AEDs are deployed; installation and testing are performed by qualified service personnel. The device provides electrical power via chemical reaction. Healthcare providers verify battery functionality through the AED's internal self-test, which reports a 'pass' status upon installation. This ensures the AED remains operational for emergency use, providing a reliable power source for life-saving defibrillation.

Clinical Evidence

No clinical data. Bench testing only. Performance verified through open circuit voltage tests, loaded circuit voltage tests, and final installation acceptance tests within the corresponding AEDs. Each battery must pass the host AED's internal operational self-test to be considered acceptable.

Technological Characteristics

Non-rechargeable lithium battery packs. Components include lithium cells, power rectifiers, thermal fuses, and current limit fuses. Form factor matches original OEM battery enclosures. Connectivity is physical/mechanical (direct installation into AED). Testing includes visual inspection, internal resistance measurement, open circuit voltage, and loaded circuit voltage testing.

Indications for Use

Indicated for use as a power source for specific Automated External Defibrillators (AEDs) in back-up and portable applications. Intended for installation and testing by qualified service personnel only.

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

• Replacement Battery 9141 (K031987, K040438)
• Replacement Battery 9146 (K031987, K040438)
• Replacement Battery ForeRunner BTI (K955628)
• Replacement Battery HeartStart (K020715)
• Replacement Battery HeartStart FRX, Onsite/HomeAED (M5070) (K040904, K050004)
• Replacement Battery HeartStart FR2 (M3863) (K013425, K051632)
• Replacement Battery HeartStart FR3 (989803150161) (K111693)
• Replacement Battery DCF-200 (K033896, K081259)
• Replacement Battery Lifepak 500 (K955854)

Submission Summary (Full Text)

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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: | 847-487-9376<br>[e-mail] |

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<br>Regulatory Class III, Product Code MKJ |

#### 5.3 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.

# 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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| Original<br>Manufacturer | Model<br>Number | Open Circuit<br>Minimum<br>Voltage @20<br>degrees C | Loaded Circuit Minimum<br>Voltage @20 degrees C:<br>L=load resistance,<br>Vnom=nominal voltage<br>output,<br>Vmin=minimum<br>measured voltage output |
|--------------------------|-----------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cardiac<br>Science | 9141 | For Vnom=6V,<br>Vmin=6.0V<br><br>For Vnom=12V,<br>Vmin=12.0V | For Vnom=6V, L=8 ohms,<br>Vmin=5.5V<br><br>For Vnom=12V, L=15 ohms,<br>Vmin=11.0V |
| Cardiac<br>Science | 9146 | Vmin=12.0V | L=15 ohms, Vmin=11.0V |
| Philips | BT1 | Vmin=18.0V | L=23 ohms, Vmin=16.6V |
| Philips | M5070<br>(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<br>(FR3) | Vmin=12.0V | L=15 ohms, Vmin=11.0V |
| Defibtech | DCF-200 | For Vnom=3V,<br>Vmin=3.0V<br><br>For Vnom=15V,<br>Vmin=15.0V | For Vnom=3V,L=4 ohms,<br>Vmin=2.7V<br><br>For Vnom=15V,L=20 ohms,<br>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 [phone] or [phone] 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,

fs

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

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