(76 days)
The JUMP START is intended to be used to treat patients in cardiopulmonary arrest. It is intended for use in either in-hospital or out-of-hospital arrests.
It is intended for use by personnel who are authorized by a physician/medical director, and who have the following training and skills:
- American Heart Association Heartsaver course, American Red Cross CPR / AED course, or equivalent
- Training in the use of the MRL JUMP START
It should only be used on patients who are unconscious, pulseless, and not breathing spontaneously. The biphasic waveform employed by the JUMP START has not been clinically tested on pediatric patients The device has not been evaluated for cardioversion of atrial fibrillation or direct (internal) cardiac defibrillation. It should not be used on pediatric patients less than 8 years old.
Not Found
This document is a 510(k) clearance letter from the FDA for the "Jump Start" Automated External Defibrillator (AED). It states that the device is substantially equivalent to a legally marketed predicate device.
Unfortunately, this document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Here's why:
- 510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a predicate device, not necessarily on presenting a comprehensive study with detailed acceptance criteria and performance data for the specific device being cleared.
- Lack of Specific Study Details: The letter refers to a "premarket notification" but does not include the actual study design, results, or statistical analysis.
Therefore, I cannot extract the requested information from this document. The document only provides the basic details of the clearance process, such as the device name, regulation number, product code, and the date of clearance. It also includes the intended use statement.
§ 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.