(45 days)
ZOLL First Responder Padz Adult Defibrillation Electrodes will be used for the following clinical applications:
- Defibrillation
- Electrocardiograph Monitoring
In conjuction 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 1700 Facemanen sive Temporary Pacemaker
- ZOLL M Series
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Bio-Detek Incorporated for their ZOLL First Responder Padz Adult Defibrillation Electrodes. This document primarily focuses on the regulatory approval process and the determination of substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information such as:
- Table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth used
- Sample size for training set
- Method for establishing ground truth for training set
This document is a regulatory approval letter, not a technical report or study summary.
§ 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.