The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation. The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not use the unit's AED function on patients under 8 years of age.

Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions: Unconsciousness, Absence of breathing, and Absence of pulse. This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate. The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient. They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol. Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. Note: This device must not be connected to internal pacemaker electrodes. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradvcardia might be expected, Suppression of tachycardia.

This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), Carboxyhemoglobin (SpCO), Methemoglobin (SpMet), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles. SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions. EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients. 12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias. NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

Device Description

The ZOLL E Series® Defibrillator, reviewed and cleared by FDA under premarket notification K111594, is designed for all emergent care situations and provides multiparameter monitoring of patients in critical care and transport. The ZOLL E Series combines defibrillation, CPR feedback, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry (SpO2), end tidal CO2 (EtCO2), 12-Lead ECG monitoring, noninvasive blood pressure measurement and data printing and recording in a single instrument.

The previously cleared Shock Conversion Estimator (SCE), initially reviewed and cleared by the agency under K072923, utilizes Shock Predictive (SPI) as a parameter in the shock advisory algorithm. Shock Predictive Index number is also called "Amplitude Spectral Area (AmSA) value" of the ECG Waveform, developed by the Weil Institute of Critical Care Medicine. In the previously cleared version of the E-Series, when the E Series device is configured to enable the Shock Conversion Estimator (SCE) function, the software compares the calculated Shock Predictive Index (AmSA) against a userconfigurable threshold during shock advisory rhythm analysis. If the rhythm is shockable and the computed index is greater-than or equal-to the pre-configured threshold, the shock advisory algorithm will then issue a "Shock Advised" prompt to the user. If the Shock Predictive Index (AmSA) is less-than the threshold, the shock advisory algorithm will then issue a "Continue CPR" prompt to the user.

With the current application, we are proposing a software revision that will enable the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. After the trained rescuer has confirmed the ECG rhythm by manually analyzing the characteristics of the ECG waveform, the rescuer may utilize the displayed Shock Predictive Index (AmSA) value to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (SCE), reviewed and cleared by the agency under K072923.

AI/ML Overview

This document describes a 510(k) premarket notification for a software revision to the ZOLL E Series Defibrillator, specifically enabling the display of the Shock Predictive Index (AmSA) in manual mode. The submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness. Therefore, many of the requested categories (like extensive clinical studies with specific sample sizes, ground truth adjudication, or MRMC studies) are explicitly stated as "Not Applicable" or implicitly not performed as the primary evidence relies on non-clinical software verification and validation, alongside literature support for the underlying AmSA concept.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Primary Goal: Demonstrating Substantial Equivalence	Confirmed as substantially equivalent to the predicate device (ZOLL E Series, K111594).
Functional Equivalence: Display of Shock Predictive Index (AmSA) in Manual Mode	The software revision enables the E Series device to display the calculated Shock Predictive Index (AmSA) when used in manual mode with CPR defibrillation electrodes. This allows the rescuer to manually perform the function previously executed by the Rhythm Analysis Function Shock Conversion Estimator (K072923).
Safety and Efficacy: Device performance and adherence to standards	Safety and efficacy were shown through software verification and system level validation. Performance testing ensures the device performs as well as predicate devices and meets all functional requirements and performance specifications. Safety testing assures compliance with applicable sections of recognized industry and safety standards.
Clinical Evidence (Novel Claims):	N/A - Clinical evidence was not necessary to show substantial equivalence for this software revision. The modification allows manual interpretation of an existing parameter (AmSA) that was already part of a cleared automated function.
Literature Support for AmSA:	The use of AmSA in estimating defibrillation success is supported by five cited literature references (Povoas et al. 2002, Pernat et al. 2001, Young et al. 2004, Ristagno et al. 2008, Li et al. 2008). These papers provide scientific backing for the underlying principle of AmSA as a predictor of defibrillation success, which is the basis for its display to the user.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly mentioned for specific clinical data in this submission. The "test set" primarily refers to software verification and system-level validation, rather than a traditional patient-based clinical study.
Data Provenance: Not applicable for a separate test set as the primary evidence relies on non-clinical software testing and validation. The literature cited for AmSA would have their own data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as the submission focuses on software verification and system-level validation for a software update, rather than a clinical study requiring expert-established ground truth on patient data for the new specific functionality (displaying AmSA). The underlying concept of AmSA and its use as a predictor of defibrillation success would have been established and validated in the scientific literature cited.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The validation method for this software update is described as "software verification and system level validation," which typically involves engineering and quality assurance processes against predefined requirements, rather than clinical adjudication on patient cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. Clinical evidence was explicitly stated as "N/A - Clinical evidence was not necessary to show substantial equivalence." The device provides information (AmSA) to the human operator, who then makes a decision; the study does not compare human performance with vs. without this specific display.

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

The original Shock Conversion Estimator (SCE), cleared under K072923, was an "algorithm only" function that issued a "Shock Advised" or "Continue CPR" prompt. The current software revision allows the human operator to manually perform the function by interpreting the displayed AmSA value. Therefore, a standalone (algorithm only) performance study of this new manual interpretation functionality was not conducted, as the intent is human-in-the-loop.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the new functionality (displaying AmSA for manual interpretation), a clinical "ground truth" involving patient outcomes was not specifically established or documented in this submission. The ground truth for the concept of AmSA as a predictor of defibrillation success is derived from the scientific literature cited, which would have based findings on various methods including clinical outcomes. For the software itself, the "ground truth" during verification and validation would be adherence to software requirements and specifications.

8. The sample size for the training set

Not applicable. This submission is for a software revision to display an already calculated parameter; it does not describe a new algorithm requiring a training set in the machine learning sense. The AmSA calculation itself was presumably developed and validated in prior efforts as referenced by existing predicate devices and literature.

9. How the ground truth for the training set was established

Not applicable, as there was no new training set for a new algorithm described in this submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus symbol is composed of three human profiles facing to the right, with the snakes forming the lower part of the symbol.

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

January 16, 2015

Zoll Medical Corporation Tanmay B. Shukla Regulatory Affairs Specialist 269 Mill Road Chelmsford, MA 01824-4105

Re: K133239

Trade/Device Name: E Series Automated External Defibrillator Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: December 12, 2014 Received: December 15, 2014

Dear Tanmay B. Shukla,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Melissa A. Torres -S

For 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

510(k) Number (if known): K133239

Device Name: E Series

Intended Use:

Defibrillator Function

The E Series products must be prescribed for use by a physician or medical advisor of an emergency response team. Do not use the unit's AED function on patients under 8 years of age.

Intended Use - Manual Operation

Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:

· Unconsciousness
· Absence of breathing, and
· Absence of pulse.

This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically siqnificant heart beats.

In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate.

The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Intended Use - Semiautomatic Operation (AED)

They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.

Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

Intended Use - CPR Monitoring

The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Use - Pacemaker

This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.

Note: This device must not be connected to internal pacemaker electrodes.

The purposes of pacing include:

• Resuscitation from standstill or bradycardia of any etiology

Noninvasive pacing has been used for resuscitation from cardiac standstill, reflex vagal standstill, drug induced standstill (due to procainamide, quinidine, digitalis, b-blockers, verapamil, etc.) and unexpected circulatory arrest (due to anesthesia, surgery, angiography, and other therapeutic or diagnostic procedures). It has also been used for temporary acceleration of bradycardia in Stokes-Adams disease and sick-sinus syndrome. It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.

• As a standby when standstill or bradvcardia might be expected

Noninvasive pacing may be useful as a standby when cardiac arrest or symptomatic bradycardia might be expected due to acute myocardial infarction, drug toxicity, anesthesia or surgery. It is also useful as a temporary treatment in patients awaiting pacemaker implants or the introduction of transvenous therapy. In standby pacing applications, noninvasive pacing may provide an alternative to transvenous therapy that avoids the risks of displacement, infection, hemorrhage, embolization, perforation, phlebitis and mechanical or electrical stimulation of ventricular tachycardia or fibrillation associated with endocardial pacing.

· Suppression of tachycardia

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 33lbs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

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Monitor - Intended Use Multi-parameter Monitoring

ECG monitoring is performed by connecting the patient to the 3 or 5 lead patient cable, MFE Pads, or through the paddles.

SpO2 monitoring is indicated for detecting arterial oxygen saturation of blood and pulse rate for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

SpCO monitoring is indicated for detecting carbon monoxide concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

SpMet monitoring is indicated for detecting oxidized hemoglobin concentration in arterial blood for adult, pediatric and neonatal patients who are well or poorly perfusing, during both no motion and patient motion conditions.

EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients.

12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias.

NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

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Image /page/5/Picture/0 description: The image shows the word "ZOLL" in a sans-serif font. The letters are a light blue color. A registered trademark symbol is located to the right of the second "L".

ZOLL Medical Corporation Worldwide Headquarters 269 Mill Road Chelmsford, MA 01824 U.S.A.

978-421-9655 978-421-0025 Main Fax

510(k) Summary:

Applicant's Name and Address:	ZOLL Medical Corporation269 Mill RoadChelmsford, MA 01824
Application Correspondent:	Tanmay Shukla978-421-9171
Date Summary Prepared:	April 22, 2014
Classification:	Class III
Device Name	ZOLL E Series
Product Code	Automated External Defibrillators(MKJ)Cardiopulmonary Resuscitation Aid(LIX)Low-Energy - Defibrillators (LDD)Cardiac Monitors - includingCardiotachometer and Rate Alarms(DRT)External Transcutaneous CardiacNon-Invasive Pacemaker (DRO)Noninvasive Blood PressureMeasurement System (DXN)Blood Pressure Computer (DSK)Carbon Dioxide Gas Analyzer (CCK)Oximeter (DQA)
Predicate Devices	ZOLL E Series (K111594)

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Description:

Intended Use:

Intended Use — Manual Operation

Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:

Unconsciousness
Absence of breathing, and
Absence of pulse.

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Intended Use - Semiautomatic Operation (AED)

Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.

Intended Use — CPR Monitoring

The CPR monitoring function is not intended for use on patients under 8 years of age.

Intended Use — Pacemaker

• Resuscitation from standstill or bradycardia of any etiology

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It is safer, more reliable, and more rapidly applied in an emergency than endocardial or other temporary electrodes.

• As a standby when standstill or bradvcardia might be expected

• Suppression of tachycardia

Increased heart rates in response to external pacing often suppress ventricular ectopic activity and may prevent tachycardia.

Pediatric Pacing

Pacing can be performed on pediatric patients weighing 331bs / 15kg or less using special ZOLL pediatric MFE Pads. Prolonged pacing (in excess of 30 minutes), particularly in neonates, could cause burns. Periodic inspection of the underlying skin is recommended.

Monitor – Intended Use Multi-parameter Monitoring

ECG monitoring is performed by connecting the patient to the unit via the 3 or 5 lead patient cable, MFE Pads, or through the paddles.

EtCO2 monitoring is indicated for the continuous measurement of end tidal carbon dioxide (EtCO2) and respiration rate for adult, pediatric and neonatal patients.

12 Lead ECG analysis is indicated for the diagnosis and treatment of adult and pediatric patients with acute myocardial infarction or other cardiac arrhythmias.

NIBP monitoring is indicated for the measurement of arterial blood pressure for resting adult, pediatric, and neonatal patients.

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Substantial Equivalence - Non-Clinical Evidence:

When enabled, E Series device can display the calculated Shock Predictive Index (AmSA) in the manual mode enabling the operator to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (K072923) except that the following steps, which would otherwise be performed by the machine, would now be performed manually by the operator:

. Determining whether the rhythm is shockable or non-shockable.
If shockable, comparing the displayed Shock Predictive Index (AmSA) with the selected Shock Predictive Index (AmSA) threshold (decided by the Medical Director per local protocol) and making an appropriate treatment decision.

Safety, efficacy and substantial equivalence was shown through software verification and system level validation.

Substantial Equivalence - Clinical Evidence:

N/A - Clinical evidence was not necessary to show substantial equivalence

Comparison of Technological Characteristics

The ZOLL E Series utilizes the same features and functions as the indicated predicate device: ZOLL E Series (K111594). Through a software revision, the Shock Predictive Index (AmSA) that was calculated and utilized in the Rhythm Analysis Function Shock Conversion Estimator (K072923) can now be displayed on the E Series device screen when used in manual mode. The rescuer may utilize the Shock Predictive Index (AmSA) to perform the same function as the Rhythm Analysis Function Shock Conversion Estimator (K072923) in a manual mode.

Performance Testing:

Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL E Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. The use of the AmSA value in estimating the likelihood of defibrillation success is supported by the following literature that is cited in the submission:

1. Povoas H, Weil MH, Tang W, Bisera J, Klouche K, Barbatis A. Predicting the success of defibrillation by electrocardiographic analysis. Resuscitation 2002: 53:77-82.
1. Pernat AM, Weil MH, Tang W, Pernat A, Bisera J. Optimizing timing of ventricular defibrillation. Crit Care Med 2001; 29:2360-5.
1. Young C, Bisera J, Gehman S, Snyder D, Tang W, Weil MH. Amplitude spectrum area: measuring the probability of successful defibrillation as applied to human data. Crit Care Med 2004; 32:S356-8.
1. Ristagno G. Gullo A. Berlot G. Lucangelo U. Geheb E. Bisera J. Prediction of successful defibrillation in human victims of out-of-hospital cardiac arrest: a retrospective electrocardiographic analysis. Anaesth Intensive Care 2008; 36:46-50.

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1. Li Y, Ristagno G, Bisera J, Tang W, Deng Q, Weil MH. Electrocardiogram waveforms for monitoring effectiveness of chest compression during cardiopulmonary resuscitation. Crit Care Med 2008; 36:211-5.
  Safety testing assures that the device complies with applicable sections of recognized industry and safety standards.

Conclusion

The information provided in this 510(k) demonstrates that the ZOLL E Series' features and functions are substantially equivalent to those of the indicated commercially distributed devices with regard to performance, safety and effectiveness.

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.