(69 days)
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for defibrillation, ECG monitoring and noninvasive pacing of pediatric patients less than 8 year of age or weighing less than 55 Ibs (25 kg).
The ZOLL pedirpadz™ Reduced Energy Electrode is intended for use only with ZOLL M Series and ZOLL E Series Biphasic AED Defibrillator products. The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are intended to be used by personnel who have been trained on the device operation and in basic life support or other physician authorized emergency medical response system.
The ZOLL M Series AED and ZOLL E Series AED Defibrillator products are indicated for use on victims of cardiac arrest where there is apparent lack of circulation as indicated by:
- . Unconsciousness
- Absence of breathing .
- Absence of pulse. .
The disposable ZOLL pedrpadz™ Reduced Energy Electrode is specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population.
The ZOLL M Series and ZOLL E Series Defibrillator products are portable, batterypowered devices indicated for the defibrillation (manual and AED), 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 and data printing and recording for resting patients in critical care and transport.
When analyzing a patient's heart-rhythm using the incorporated interpretive algorithm, the device analyzes an adult or pediatric patient's ECG signal and, if a shockable rhythm is detected, recommends delivery of a defibrillation shock via voice and visual prompts.
The ZOLL pedi·padz™ Reduced Energy Electrode is designed for use with ZOLL M Series and ZOLL E Series AED Defibrillator products on pediatric patients. The primary purpose of this device is to reduce the energy delivered by the defibrillator to levels appropriate for children less than 8 years old or weighing less than 55 lbs (25 kg).
Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly list quantitative acceptance criteria in a table format with reported device performance. Instead, it describes functional requirements and performance specifications. The implicit acceptance criterion is that the device must maintain performance characteristics, features, and functions that are "very similar" to predicate devices and meet "all functional requirements and performance specifications with regard to safety and effectiveness."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Requirements & Performance Specifications (Safety & Effectiveness) met | "Extensive testing of the ZOLL pedrpadz™ Reduced Energy Electrode with the ZOLL M Series and ZOLL E Series AED ensures that these products meet all functional requirements and performance specifications with regard to safety and effectiveness." |
| Substantial Equivalence to Predicate Devices (Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with Cardiac Science PowerHeart® AED) | "The ZOLL pedirpadz™ Reduced Energy Electrode in conjunction with ZOLL E Series or ZOLL M Series AED products maintain performance characteristics, features and functions that are very similar to those of the Cardiac Science Model 9730 Pediatric Attenuated Defibrillation Electrodes (K022929) with the Cardiac Science PowerHeart® Automated External Defibrillator, Model 9200/9210." |
| "Based on the results of the usability testing, the ZOLL pedirpadz™ Reduced Energy Electrode has demonstrated that its features and functions are substantially equivalent to those of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness." | |
| Energy Reduction for Pediatric Use | "specifically designed for use with ZOLL M Series and ZOLL E Series AED products on children less than 8 years of age or weighing less than 55 lbs (25 kg), to reduce the energy delivered by the device to levels within the range that has been identified as acceptable for the indicated patient population." (This is a design feature, confirmed by "extensive testing"). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "extensive testing" and "usability testing" but does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the number of experts or their qualifications used to establish ground truth for any test set.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers' improvement with AI assistance. The device in question is an electrode, not an AI diagnostic tool that assists human interpretation.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone (algorithm only) performance study in the context of an interpretive algorithm. It refers to the electrode's function in conjunction with the AED's interpretive algorithm for detecting shockable rhythms, but the electrode itself is a passive component reducing energy, not an algorithm. The AED's interpretive algorithm (which analyzes ECG signals) is mentioned, but its standalone performance or the study of it is not detailed.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any testing. Given the nature of the device (an electrode for defibrillation), the "ground truth" would likely relate to electrical performance (e.g., energy attenuation, impedance) and clinical outcomes (e.g., successful defibrillation with appropriate energy levels in an animal model or simulated environment) rather than expert consensus on image interpretation or pathology.
8. Sample Size for the Training Set:
The document does not refer to a training set or its sample size. This device is a hardware component (electrode), not a machine learning algorithm that requires a training set in the conventional sense. The "interpretive algorithm" mentioned for the AED would have a training set, but details are not provided.
9. How Ground Truth for the Training Set Was Established:
As there is no mention of a training set for the electrode and limited information on the AED's internal algorithm, the document does not describe how ground truth for any training set was established.
§ 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.