(89 days)
The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.
When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)
The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Hewlett Packard M3503A and M3504A Multifunction Pediatric Defib Electrodes" and mentions the indications for use, but it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
§ 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.