(168 days)
Defibrillation: Use of the R Series products in the manual and semiautomatic modes for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by: Unconsciousness, Absence of breathing, 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 heartbeats. In manual mode, the unit can also be used for synchronized cardioversion to atrial fibrillation (AF) or ventricular tachycardia (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 in patients meeting the three conditions indicating lack of circulation (previously listed).
External Pacemaker (Pacer Version Only): This product may be used for temporary external, demand or non-demand pacing, as an alternative to endocardial stimulation. External cardiac pacing is indicated for conscious or unconscious patients in asystole, profound bradycardia or any other conditions determined by a clinician to require external pacing.
ECG Monitoring: The device is indicated for monitoring a patient's electrocardiogram (ECG), via the 3 or 5 lead patient cable, MFE Pads, or through the paddles, for the detection of salient cardiac rhythms and dysrhythmias and calculating heart rate.
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.
SpO2 Option (if equipped): The SpO2 Option with Masimo Set Technology is indicated for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for adult, pediatric and neonatal patients, during both no motion and patient motion conditions, and for patients who are well or poorly perfusing in the hospital or pre-hospital environments.
The ZOLL R Series External Defibrillator is indicated for the defibrillation, Noninvasive Transcutaneous Pacing, multi-parameter monitoring of patient vital signs, including: ECG Monitoring, Pulse Oximetry, CPR performance and data printing and recording for resting patients in critical care and transport. The ZOLL R 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 design facilitates table top use while still providing a light weight and easy to carry device for transport. The device is capable of providing Basic Life-Saving (BLS) personnel the option of analyzing an adult or pediatric 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. Therapy is provided by using defibrillation electrode products specifically designed for use with the R Series. When used in conjunction with ZOLL Ready padz One-step CPR or Ready padz One-step Complete Electrodes, the R SERIES provides CPR compression performance feedback using displayed symbols, text messages and voice prompts.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the ZOLL R Series Defibrillator:
The provided document is a 510(k) summary for the ZOLL R Series Defibrillator, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device with extensive new performance studies. Therefore, much of the requested information regarding detailed performance studies for new acceptance criteria is not explicitly stated in this type of submission. The document relies heavily on the fact that existing, cleared algorithms and technologies are being re-used.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in the way a new device's performance study might. Instead, it states that the device reuses existing algorithms and technologies from predicate devices (ZOLL E Series and ZOLL AED Pro Defibrillator).
The primary acceptance criteria are implicitly met by demonstrating that the ECG Analysis Algorithms for shock/no-shock advisory and CPR Aid feature are "identical" or "similar" to those in the predicate devices which have already been cleared by the FDA.
Table 1: Implicit Acceptance Criteria and Reported Device Performance
| Feature/Function | Implicit Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (as stated in document) |
|---|---|---|
| ECG Analysis Algorithm (Advisory feature) | Must determine if acquired heart rhythm is shockable or non-shockable with accuracy comparable to predicate ZOLL AED Pro Defibrillator. | Utilizes "identical ECG Analysis Algorithms" to the predicate ZOLL AED Pro Defibrillator (K041892). |
| CPR Performance Feedback | Must provide performance feedback for compression depth and rate comparable to predicate ZOLL AED Pro. | Provides performance feedback for compression depth and rate "similar to the ZOLL AED Pro." |
| Multi-parameter Monitoring (ECG & Pulse Oximetry) | Technologies for ECG Monitoring and Pulse Oximetry must be similar to predicate ZOLL E Series. | Uses technology "very similar to that of the ZOLL E Series" (K042007). |
| Overall Functional Requirements & Performance Specifications | Device must meet all functional requirements and performance specifications. | "Extensive performance and software testing ensures that the ZOLL R Series Defibrillator meets all of its functional requirements and performance specifications." (No specific numerical data provided here). |
| Safety | Device must comply with applicable sections of recognized industry and safety standards. | "Safety testing assures the device complies with applicable sections of recognized industry and safety standards." |
Study Details
The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than presenting a full, detailed clinical study report for a novel algorithm. For this reason, many of the requested details about specific performance studies (like sample sizes, expert qualifications, etc.) are not explicitly stated for the ZOLL R Series itself, but rather inferred from the predicate devices.
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Sample size used for the test set and the data provenance:
- Not explicitly stated for the ZOLL R Series device. The document states that the ECG analysis algorithms are "identical" to the predicate ZOLL AED Pro. The CPR Aid feature is "similar." The performance of these predicate devices would have been evaluated with test sets, but those details are not provided in this summary for the R Series.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not explicitly stated for the ZOLL R Series device. This information would typically be available in the detailed reports for the original predicate devices' algorithm validation, which are not included here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not explicitly stated for the ZOLL R Series device. Again, this detail would pertain to the validation of the algorithms in the predicate devices.
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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:
- Not applicable/Not stated for this submission. The device includes an "Advisory function" where the algorithm determines shockable/non-shockable rhythms and prompts the user. This is a form of AI assistance, but the submission doesn't describe a comparative effectiveness study in an MRMC format comparing human performance with and without this specific device's assistance. The focus is on the algorithm's performance equivalence to the predicate.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Implicitly yes, for the algorithm itself. The statement "The Advisory Algorithm will determine if the acquired heart rhythm is shockable or non-shockable" indicates a standalone assessment of the algorithm's performance, which is then presented to a human. However, the specific details of that standalone study (like sensitivity/specificity metrics) are not provided, only the assertion that the algorithm is "identical" to a previously cleared one.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for the ZOLL R Series device. For ECG rhythm analysis, ground truth is typically established by expert cardiologists reviewing the ECG waveforms. This would have been done for the predicate device.
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The sample size for the training set:
- Not explicitly stated for the ZOLL R Series device. As the algorithms are "identical" or "similar" to predicate devices, the training was done for those prior iterations, and the specifics are not in this document.
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How the ground truth for the training set was established:
- Not explicitly stated for the ZOLL R Series device. Similar to test set ground truth, for ECG algorithms, this would involve expert cardiologist review and labeling of ECG data.
§ 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.