AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)

{0} PMA P190013: FDA Summary of Safety and Effectiveness Data # SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) ## I. GENERAL INFORMATION Device Generic Name: Automated External Defibrillator Device Trade Name: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) Device Procode: MKJ, NSA Applicant's Name and Address: AED Battery Exchange, LLC 1000 Brown Street, Suite 206 Wauconda, Illinois 60084 Date(s) of Panel Recommendation: None Premarket Approval Application (PMA) Number: P190013 Date of FDA Notice of Approval: February 2, 2021 AED Battery Exchange, LLC remanufactured (or "re-celled") batteries have been on the market in the US since 2012, when FDA issued clearance through the 510(k) Premarket Notification process (K120350, "Extended Life Battery"). Compatible AEDs at the time of K120350 clearance included the Cardiac Science Powerheart AED G3 and the Philips FRx, Onsite/Home, and FR3. P190013 has been submitted in response to the Final Order issued January 29, 2015, in the Federal Register Volume 80 Number 19, Docket No. FDA-2013-N-0234 and republished February 3, 2015, in the Federal Register Volume 80 Number 22, Docket No. FDA-2013-N-0234. This Order required premarket approval of marketed pre-amendment Class III Automated External Defibrillator (AEDs) and Accessories (e.g., batteries, electrode pads). Products affected by this Order are the AED Battery Exchange 9146-ABE and 5070-ABE. Please note that the AED Battery Exchange G5-ABE and FR3-ABE were not pre-amendment Class III AED accessories and are requesting marketing approval for the first time in P190013. A combination of relevant literature and in-vitro bench testing has been reviewed to demonstrate a reasonable assurance of safety and effectiveness for the AED Battery Exchange, models 9146-ABE, G5-ABE, 5070-ABE, and FR3-ABE. ## II. INDICATIONS FOR USE The automated external defibrillator (AED) battery supplies power to an AED as required during self maintenance, automated diagnoses, and defibrillation. The 9146-ABE is indicated for use with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E. The G5-ABE is indicated for use with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C. The 5070-ABE is indicated for use with the Philips HeartStart OnSite/Home, models M5066A, M5068A, and the FRx, model {1} 861304. The FR3-ABE is indicated for use with the Philips HeartStart FR3, models 861388 and 861389. ## III. CONTRAINDICATIONS Automated external defibrillators should not be used when a patient is conscious or breathing normally. ## IV. WARNINGS AND PRECAUTIONS The warnings and precautions can be found in the AED Battery Exchange labeling. ## V. DEVICE DESCRIPTION The 9146-ABE, G5-ABE, 5070-ABE, and FR3-ABE are primary batteries (non-rechargeable) that provide power to AEDs during self maintenance, automated diagnoses and defibrillation. Table 1 lists the four (4) battery models and their compatible AEDs. Table 1: AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, and FR3-ABE) | | Compatible AEDs | Description | | --- | --- | --- | | 9146-ABE | Cardiac Science™ Powerheart® G3 models 9390A, 9390E, 9300A, 9300E (P160033) | Lithium-Sulfur Dioxide (Li-SO2), 12 V, 7.5 A h | | G5-ABE | G5-ABE: Cardiac Science™ Powerheart® G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C (P160033) | Lithium-Sulfur Dioxide (Li-SO2), 12 V, 7.5 A h | | 5070-ABE | Philips™ HeartStart™ Onsite/Home models M5066A, M5068A (P160029); FRx model 861304 (P160028) | Lithium Manganese Dioxide (LMnO2), 9 V, 4.2 A h | PMA P190013: FDA Summary of Safety and Effectiveness Data Page 2 {2} | | Compatible AEDs | Description | | --- | --- | --- | | FR3-ABE | Philips™ HeartStart™ FR3 models 861388 and 861389 (P180028) | Lithium Manganese Dioxide (LMnO2), 9 V, 4.2 A h | AED batteries must be installed in a compatible AED before they can be used. When installed, compatible AEDs are intended for use by personnel trained in their operation (Cardiac Science Powerheart® G3 models 9390A, 9390E, 9300A, 9300E; Cardiac Science™ Powerheart® G5 models G5A-80A, G5A-80C, G5S-80A, G5S-80C); users who have received training basic life support/AED or as part of a physician-authorized emergency medical response training program (Philips™ HeartStart™ FRx model 861304); users who have received training in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized training program (Philips™ HeartStart™ FR3 models 861388 and 861389); and lay-persons (Philips™ HeartStart™ Onsite/Home models M5066A, M5068A) to treat victims of sudden cardiac arrest. ## VI. ALTERNATIVE PRACTICES AND PROCEDURES Defibrillation is the only currently available treatment for termination of ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT). Public access defibrillation is designed to provide potentially lifesaving treatment prior to the arrival of emergency personnel. ## VII. MARKETING HISTORY The 9146-ABE and 5070-ABE have been commercially available in the US since 2012, cleared under K120350. The G5-ABE and FR3-ABE have not been marketed in the United States or any foreign country. ## VIII. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH Below is a list of the potential adverse effects (e.g., complications) associated with the use of the device and AEDs in general, listed in decreasing order of seriousness: - Failure to identify shockable arrhythmia; - Failure to deliver a defibrillation shock in the presence of VF or pulseless VT, which may result in death or permanent injury; - Inappropriate energy which could cause failed defibrillation or post-shock dysfunction; - Myocardial damage; PMA P190013: FDA Summary of Safety and Effectiveness Data {3} - Fire hazard in the presence of high oxygen concentration or flammable anesthetic agents; - Electromagnetic interference (EMI) from the defibrillator impacting other devices especially during charge and energy transfers; - Incorrectly shocking a pulse sustaining rhythm and inducing VF or cardiac arrest; - Bystander shock from patient contact during defibrillation shock; - Interaction with pacemakers; - Skin burns around the electrode placement area; - Allergic dermatitis due to sensitivity to materials used in electrode construction; and - Minor skin rash. ## IX. SUMMARY OF NONCLINICAL STUDIES ### Bench Testing Through risk assessment conducted as part of a risk management process in alignment with the FDA-recognized voluntary consensus standard ISO 14971:2019, relevant hazards and estimated risks associated with the specific manufacturing procedure for remanufacturing the batteries were identified, in consideration of the performance of the original equipment manufacturer (OEM) batteries. Risk control measures were then identified and verified through non-clinical bench performance testing, which included selective application of relevant clauses from FDA-recognized voluntary consensus standards and other consensus standards. Table 2 summarizes design verification and design validation activities conducted to demonstrate a reasonable assurance of safety and effectiveness for the AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE). Table 1: Bench Testing | Test Title | Acceptance Criteria | Results | | --- | --- | --- | | Medical electrical equipment - Part 2-4: Particular requirements for basic safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010/(R)2015) | Acceptance criteria as specified by Subclause 201.101.2 – Requirements for INFREQUENT USE, MANUAL DEFIBRILLATORS and Subclause 201.1.2.2 – Requirements for MANUAL DEFIBRILLATORS | Acceptable | | Drop Test | Conducted in accordance with IEC 60601-1:2012 and in consideration of ANSI/AAMI ES60601-1:2005 + A1:2012, Subclause 15.3.4. Tests | Acceptable | PMA P190013: FDA Summary of Safety and Effectiveness Data {4} | Test Title | Acceptance Criteria | Results | | --- | --- | --- | | | conducted within OEM AED and as a stand-alone battery. | | | Shock Cycle Count Verification | Minimum shock cycle count verified using specifications of OEM batteries. | Pass | | Operation Time Verification | Minimum operation time verified using specifications of OEM batteries. | Pass | | Storage Temperature Verification | Storage temperature verified using specifications of OEM batteries. | Pass | | Charge State Recognition | Charge state recognition verified for conformity with IEC 60601-2-4:2010/(R)2015, Subclause 201.15.4.3.101 using OEM AED. | Pass | | Label Integrity Verification | Conducted in accordance with IEC 60601-1:2012 and in consideration of ANSI/AAMI ES60601-1:2005 + A1:2012 | Pass | | Software Verification | Conducted in accordance with FDA guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.” | Acceptable | | Enclosure Protection (IEC 60529) | Ingress Protection (IP) ratings evaluated using specifications of OEM batteries. | Pass | | EMC Verification by Component Analysis | N/A | Acceptable | | Shelf Life Verification by Component Analysis | N/A | Acceptable | PMA P190013: FDA Summary of Safety and Effectiveness Data {5} | Test Title | Acceptance Criteria | Results | | --- | --- | --- | | Thermal Extreme (UN38.3) | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | | Vibration (UN38.3) | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | | Shock Safety (UN38.3) | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | | External Short Circuit Safety (UN38.3) | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | | Altitude Safety (UN38.3) | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | | Label Integrity Verification | Conducted in accordance with IEC 60601-1:2012. | Pass | | Software Verification | Conducted in accordance with FDA guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” issued May 2005. | Pass | PMA P190013: FDA Summary of Safety and Effectiveness Data Page 6 {6} | Test Title | Acceptance Criteria | Results | | --- | --- | --- | | Packaging (UN38.3 tested), 49 CFR compliant for US ground transportation | Conducted in accordance with “Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria,” Section 38.3. | Pass | ## X. SUMMARY OF PRIMARY CLINICAL STUDIES The final order, Effective Date of Requirement for Premarket Approval for Automated External Defibrillator Systems, published on January 29, 2015 and republished on February 3, 2015, states that clinical study information can be leveraged for AEDs from both published studies and clinical data previously submitted to FDA under the 510(k) Premarket Notification process. AED Battery Exchange, LLC did not submit clinical data in support of a reasonable assurance of safety and effectiveness. Data supportive of a reasonable assurance of safety and effectiveness is available in the compatible AED Summaries of Safety and Effectiveness Data: P160028: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160028B.pdf P160029: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160029B.pdf P160033: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160033B.pdf ## XI. PANEL MEETING RECOMMENDATION AND FDA'S POST-PANEL ACTION In accordance with the provisions of section 515(c)(3) of the act as amended by the Safe Medical Devices Act of 1990, this PMA was not referred to the Circulatory Systems Devices Panel, an FDA advisory committee, for review and recommendation because the information in the PMA substantially duplicates information previously reviewed by this panel on January 25, 2011 as part of the 515(i) process. The majority of the panel recommended that AEDs be regulated as Class III PMAs to have better oversight of device manufacturing and post-market performance. ## XII. CONCLUSIONS DRAWN FROM PRECLINICAL AND CLINICAL STUDIES ### A. Effectiveness Conclusions Benefits of use of the batteries with their specific AEDs outweigh the risks with which it is associated. This is verified through the longevity of the commercialization of the products, through the literature on clinical safety and effectiveness, and through the post-market data, including tracking and trending of complaints and vigilance. PMA P190013: FDA Summary of Safety and Effectiveness Data {7} B. Safety Conclusions The nonclinical testing and data collected on the battery models 9146-ABE, 5070-ABE, G5-ABE, and FR3-ABE in use with their respective AEDs did not identify or result in any unacceptable safety concerns associated with use of the AED Battery Exchange Models 9146-ABE, 5070-ABE, G5-ABE, and FR3-ABE. C. Benefit-Risk Determination The benefit of early defibrillation therapy is the survival of patients in sudden cardiac arrest (SCA). The time from collapse to defibrillation is critical in patient survival. For every minute that passes between collapse and defibrillation, survival rates from ventricular fibrillation (VF) SCA decrease by 7% - 10%. The magnitude of this benefit is either life or death. Patients are likely to put a high value on this treatment because it has the potential to save their lives. Patients are therefore willing to accept the risks of this treatment to achieve the benefit. If the treatment provides timely successful defibrillation, the patient will (or may) survive a life-threatening cardiac arrest situation and will be able to seek further treatment. 1. Patient Perspectives: This submission did not include specific information on patient perspectives for this device. In conclusion, given the available information above, the data support that for the AED Battery Exchange 9146-ABE (when used with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E); the AED Battery Exchange G5-ABE (when used with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C); the AED Battery Exchange 5070-ABE (when used with the Philips HeartStart OnSite/Home, models M5066A, M5068A, and the FRx, model 861304); and the AED Battery Exchange FR3-ABE (when used with the Philips HeartStart FR3, models 861388 and 861389), the probable benefits outweigh the probable risks. D. Overall Conclusions The data in this application support the reasonable assurance of safety and effectiveness of the AED Battery Exchange 9146-ABE (when used with the Cardiac Science Powerheart G3, models 9390A, 9390E, 9300A, and 9300E); the AED Battery Exchange G5-ABE (when used with the Cardiac Science Powerheart G5, models G5A-80A, G5A-80C, G5S-80A, and G5S-80C); the AED Battery Exchange 5070-ABE (when used with the Philips HeartStart OnSite/Home, models M5066A, M5068A, and the FRx, model 861304); and the AED Battery Exchange FR3-ABE (when used with the Philips HeartStart FR3, models 861388 and 861389), respectively, when used in accordance with the indications for use. PMA P190013: FDA Summary of Safety and Effectiveness Data Page 8 {8} PMA P190013: FDA Summary of Safety and Effectiveness Data Page 9 XIII. **CDRH DECISION** CDRH issued an approval order on February 2, 2021. XIV. **APPROVAL SPECIFICATIONS** Directions for use: See device labeling. Hazards to Health from Use of the Device: See Indications, Contraindications, Warnings, Precautions, and Adverse Events in the device labeling. Post-approval Requirements and Restrictions: See approval order.