(273 days)
Defibrillator Function:
Indications for Use - Manual Operation: Use of the ZOLL REVIVER in the manual mode 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 is to be used only by qualified medical personnel for the purposes of converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
Indications for Use - Advisory Function: The advisory function should only be used to confirm ventricular fibrillation and ventricular tachycardia (greater than 150 beats per minute) in patients meeting the following clinical criteria: Unconsciousness, Absence of breathing, Absence of pulse.
Indications for Use - Semiautomatic Operation (if equipped): The ZOLL REVIVER is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the operator of the device controls the delivery of the shock to the patient. It is 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 in a medically-approved patient care protocol. The ZOLL REVIVER must be prescribed for use by a physician or medical advisor of an emergency response team. Use of the ZOLL REVIVER in the semiautomatic mode 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.
Pacemaker Function (if equipped):
Indications for Use - Pacemaker: This product may be used for cardiac pacing in conscious patients for up to a few hours duration as an alternative to endocardial stimulation. The purposes of pacing include: 1 Resuscitation from standstill or bradycardia of any etiology; 2 As a standby when standstill or bradycardia might be expected; 3 Suppression of tachycardia.
The ZOLL REVIVER contains a standard DC defibrillator capable of delivering up to 360 joules of energy. In manual mode, it may also be used for synchronized cardioversion by using the R-wave of the patient's ECG as a timing reference.
The provided text is a 510(k) premarket notification response letter from the FDA to Zoll Medical Corporation regarding their "Zoll Reviver" device. This document primarily focuses on the regulatory approval and indications for use of the device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study that proves the device meets them, as it is not present in the provided text.
The document states:
- The device is a Zoll Reviver.
- It is a defibrillator with manual, advisory, and semi-automatic functions, and optionally a pacemaker function.
- The FDA has found it substantially equivalent to predicate devices.
- It is classified as Class III.
However, details like performance data, test sets, ground truth establishment, or multi-reader studies are not included in this regulatory approval letter.
§ 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.