(206 days)
Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.
The Paediatic Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.
The electrode can be used with mono- and biphasic defibriliators.
The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).
Disposable electrode, for single use, only,
The electrode is intended for use on defibrillators who's output is maximum 100 Joule.
Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.
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This document is a 510(k) clearance letter from the FDA for a medical device: "Ambu Pediatric Multi-Function Defibrillation Electrodes." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.
The "Indications for Use" section (page 2) describes what the electrodes are designed for (defibrillation, pacing, monitoring ECG, synchronized cardioversion) and specific patient/device parameters (pediatric patients
§ 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.