(83 days)
ZOLL Superpadz Adult Multi-Function Electrodes will be used for the following clinical applications:
- Defibrillation .
- Cardioversion .
- Noninvasive Pacing .
- Electrocardiograph Monitoring .
In conjunction with these devices: - ZOLL PD™ 1200 Pacemaker/Defibrillator .
- ZOLL PD™ 1400 Pacemaker/Defibrillator .
- ZOLL PD™ 2000 Pacemaker/Defibrillator .
- ZOLL D 900 Defibrillator .
- ZOLL D 1400 Defibrillator .
- ZOLL D 2000 Defibrillator .
- ZOLL 1600 Pacemaker/Defibrillator .
- ZOLL 1700 Pacemaker/Defibrillator .
- ZOLL NTP 1000 Noninvasive Temporary Pacemaker .
- ZOLL M Series .
Superpadz Adult Multi-Function Electrodes
The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "ZOLL Superpadz Adult Multi-Function Electrode." It's a regulatory document confirming substantial equivalence to a legally marketed predicate device, allowing the manufacturer to market their product.
The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. It is a regulatory approval letter, not a scientific study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested information is simply not present in this document.
§ 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.