(135 days)
The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL E Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The device is light weight and easy to carry for transport.
The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to re-assess the patient in the event a no shock advised determination is returned.
Defibrillator Function: 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 emergecy response team.
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 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 ventricualr fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
Intended Use - Semiautomatic Operation (AED): 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.
Intended Use - CPR Monitoring: 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 compression depth of 1.5 to 2 inches (3.8 to 5.0 cm) for adult patients. The CPR monitoring function is not intended for use on patients under 8 years of age.
External Pacemaker (Pacer Version Only) Intended Use - Pacemaker: This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation. The purposes of pacing include: Resuscitation from standstill or bradycardia of any etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia, Pediatric Pacing.
Monitor Intended-Use Multi-parameter Monitoring: This product may be used for monitoring various patient vital signs, including: electrocardiogram (ECG), Pulse Oximetry (SpO2), End Tidal CO2, 12-Lead ECG, and Non-Invasive Blood Pressure (NIBP). 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. 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. 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.
The ZOLL E Series with Real CPR Help™ provides 'real-time' user CPR assistance when used in conjunction with ZOLL CPR-D-padz™ Multi-function Electrodes. CPR feedback is provided via ZOLL's unique sensor assembly that relays user compression data to the ZOLL E Series. The ZOLL E Series with Real CPR Help™ provides a metronome to encourage rescuers to perform CPR at the AHA/ECR recommended rate of 100 compressions per minute (CPM). The ZOLL E Series additionally provides chest compression performance feedback to the user through displayed symbols, text messages and voice prompts.
The ZOLL E Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing and multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, end tidal CO2, 12-Lead ECG monitoring, non-invasive blood pressure measurement, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL E Series is intended for use by qualified medical personnel who are trained and authorized to respond to medical emergencies, to facilitate the ability to monitor and assess the physiological characteristics of the indicated patients in a critical care environment. The device is light weight and easy to carry for transport.
The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing a patient's ECG signal via the Advisory feature on the device The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable and will prompt the end-user to provide therapy in the event of a shock advised determination. The user will be prompted to re-assess the patient in the event a no shock advised determination is returned.
The ZOLL E Series with Real CPR Help™ is a device that provides real-time CPR assistance and monitoring functions. The primary focus of the performance testing for this device, as described in the provided text, is on ensuring substantial equivalence to a predicate device, particularly concerning the new "Real CPR Help™" feature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific numerical performance metrics for the ZOLL E Series with Real CPR Help™. Instead, the performance testing focuses on demonstrating substantial equivalence to existing predicate devices and compliance with functional requirements and safety standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| CPR Compression Performance Feedback | The acquired depth and rate signals are used to provide CPR compression performance feedback to the user through displayed symbols, text messages, and voice prompts. This feedback is deemed equivalent to other ZOLL defibrillators with user CPR feedback. |
| Functional Requirements | Extensive performance testing ensures that the ZOLL E Series with Real CPR Help™ performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. |
| Safety Testing | Safety testing assures the device complies with applicable sections of recognized industry and safety standards. |
| Software Modifications Impact | Functional testing of the device's features and functions was conducted to ensure that the modifications to the software (for Real CPR Help™) did not degrade or impact other product features, functions or performance specifications. |
| Substantial Equivalence (Overall Conclusion) | Performance and safety testing of the ZOLL E Series with Real CPR Help™ demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety, and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be functional and safety testing rather than a clinical trial with a patient test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for a test set. The validation seems to be based on functional and safety testing to demonstrate equivalence and compliance with standards rather than expert-adjudicated ground truth data.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. As no expert ground truth establishment is mentioned, an adjudication method would not be applicable in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's own performance and its substantial equivalence to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document does not explicitly describe a "standalone" or "algorithm only" performance study in the context of typical AI/ML medical device evaluations. The "Real CPR Help™" function is an integrated feature of the ZOLL E Series device, and its performance is assessed as part of the overall device functionality and equivalence. The CPR feedback mechanism relies on a sensor and algorithm, but its performance is discussed in terms of its output (displayed symbols, text, voice prompts) being equivalent to other ZOLL defibrillators with CPR feedback, implying an integrated system test.
7. Type of Ground Truth Used
The "ground truth" for the performance testing appears to be:
- Predicate Device Performance: The functional requirements and performance specifications of the previously marketed ZOLL Defibrillators equipped with CPR Feedback.
- Industry and Safety Standards: Applicable sections of recognized industry and safety standards to which the device must comply.
- Internal Functional Requirements: The device's own design specifications for features and functions.
There is no mention of pathology, outcomes data, or expert consensus on clinical cases as the ground truth.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This device is described as an upgrade to an existing product line (ZOLL E Series Defibrillator) with the addition of the "Real CPR Help™" feature, rather than a new AI/ML algorithm developed from scratch requiring a distinct training dataset. The "Real CPR Help™" acquired signals are used to provide feedback, implying a rule-based or engineered system rather than a machine learning model requiring a large training dataset as commonly understood today.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, the method for establishing its ground truth is not applicable and therefore, not specified.
§ 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.