(237 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 device 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 proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.
Use of the E Series units 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 fibrilation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heats. 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 Rwave 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).
Use of the E Series unit in CPRReadyCharge Mode is designed for use by qualified medical personnel who have been trained in ACLS (Advanced Cardiac Life Support). The purpose of the CPRReadyCharge algorithm is to anticipate the need to deliver a therapy shock. CPRReadyCharge Mode uses an advisory algorithm that is designed to perform in the presence of CPR artifact. However, the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG. The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of anv therapy. See Table A-4 in Appendix A for a summary ofthe performance. E Series products with CPRReadyCharge Mode 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 E Series units in CPRReadyCharge Mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. E Series units in CPRReadyCharge Mode, when used in conjunction with CPR-D padz, prompt the emergency care personnel to perform CPR, and perform rhythm analysis during CPR compressions. If an underlying shockable rhythm is detected during CPR, the E Series unit in CPRReadyCharge Mode prepares the defibrillator to deliver a shock at the end of the CPR interval.
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 Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where is apparent lack of circulation. Specifications for the ECG rhythm analysis function are provided at the end of this section.
The CPR monitoring function provides visual and audio feedback designed to encourage resouers 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.
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 ofany etiology, As a standby when standstill or bradycardia might be expected, Suppression of tachycardia.
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 device is light weight and easy to carry for transport.
The proposed enhancement to the ZOLL E Series® CPRReadyCharge, is intended to provide personnel trained in its use, with reduced interruption to CPR during victim treatment. The ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy.
The E Series products contain a DC defibrillator capableof 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-qelled, MFE Pads for defibrillation.
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry. Non-invasive Transcutaneous Pacing (NTP) is an established and proven technique. The output current of the pacemaker is continuously variable from 0 to 140 mA. The rate is continuously variable from 30 to 180 pulses per minute (ppm). The pacing output pulse is delivered to the heart by specially designed ZOLL MFE Pads placed on the back and the precordium.
The E Series products will defibrillate, cardiovert and monitor ECG using either defibrillation paddles or ZOLL Multi-Function Electrode (MFE) Pads. The pacer version of the E Series paces using ZOLL MFE Pads.
Here's an analysis of the acceptance criteria and study information for the ZOLL E Series® with CPRReadyCharge, based on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device. This type of document primarily focuses on demonstrating substantial equivalence to a predicate device and typically does not contain the detailed performance study reports, ground truth establishment methodologies, or expert qualifications that would be present in a comprehensive clinical study report. Therefore, much of the requested information (like sample sizes, expert qualifications, adjudication methods, and detailed ground truth establishment for the training set) is not explicitly stated in this 510(k) summary. I will highlight what is available and note what is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it states that the "ECG Rhythm Advisory Algorithm will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy" and refers to "Table A-4 in Appendix A for a summary of the performance." However, "Table A-4 in Appendix A" is not included in the provided text.
Therefore, I cannot provide a table with specific acceptance criteria and reported device performance directly from the given document.
The summary does make the following general performance claims:
- CPRReadyCharge Mode: "detect shockable rhythms with high accuracy."
- CPRReadyCharge Mode vs. Advisory/AED: "the accuracy of the CPRReadyCharge algorithm in the presence of CPR artifact is lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG." (This implies a comparison but doesn't give specific numbers.)
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in the provided text. The document refers to "Table A-4 in Appendix A for a summary of the performance," which would likely contain this information, but the appendix is missing.
- Data Provenance: Not explicitly stated (e.g., country of origin). The document does not specify whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not explicitly stated.
- Qualifications of Experts: Not explicitly stated.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly stated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study measuring human readers' improvement with AI assistance is not mentioned. The document describes the "CPRReadyCharge Mode" as an advisory algorithm intended to "anticipate the need to deliver a therapy shock" and reduces "interruption to CPR." It also states, "The advisory result should always be confirmed through visual inspection of the ECG rhythm by the operator before the delivery of any therapy." This indicates a human-in-the-loop design where the AI provides an advisory function for a human operator, but a formal MRMC study comparing human performance with and without this specific AI assistance is not described in the provided text.
- Effect Size of Human Improvement: Not applicable, as an MRMC study is not described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- Standalone Study: The document implies a standalone performance evaluation of the "ECG Rhythm Advisory Algorithm" within the CPRReadyCharge Mode. It states the algorithm "will perform ECG rhythm analysis during manual CPR chest compressions and detect shockable rhythms with high accuracy" and refers to "accuracy of the CPRReadyCharge algorithm" as being "lower than the accuracy observed in the Advisory or Semiautomatic (AED) algorithm used with artifact-free ECG." This suggests the algorithm's performance was evaluated independently to determine its accuracy in detecting shockable rhythms. However, detailed metrics (sensitivity, specificity, PPV, NPV) are not provided in the main text but are likely in the referenced "Table A-4."
7. The Type of Ground Truth Used for the Test Set
- Type of Ground Truth: The document implicitly refers to the ground truth as the "underlying shockable rhythm" detected during CPR compressions. This implies that the ground truth would be based on expertly determined ECG rhythm classifications. It does not mention pathology or outcomes data as the ground truth for the rhythm analysis itself, but for the broader indication of use in cardiac arrest, clinical outcomes are obviously the ultimate goal.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not explicitly stated in the provided text. 510(k) summaries often do not detail training data.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not explicitly stated in the provided text. Given it's an ECG rhythm analysis algorithm, it's highly probable the ground truth for the training set would also be established by expert ECG interpretation.
Summary of Missing Information:
Many specific quantitative details regarding the device's performance study, especially concerning sample sizes, expert involvement, and detailed ground truth methodologies, are not present in this 510(k) summary. These details would typically be found in an attached appendix or a full study report, which is not provided. The summary focuses on demonstrating equivalence and making high-level performance claims.
§ 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.