(90 days)
The Katecho External Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The KDP-80 electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) card1ac pacemaker and the patients skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum). The Katecho KDP-80 Defilb/Pace Electrodes are designed for, and to be used interchangeably with Physio Control Defibrillation Devices that use Quik Combo Electrodes.
KATECHO KDP-80 Defib/Pace Electrodes
I'm sorry, but without further context or additional documents, I cannot provide a detailed description of the acceptance criteria and the study that proves the device meets them. The provided text is a 510(k) clearance letter from the FDA for the "K-Defib/Pace Adult Electrode, Model KDP-80."
While the letter states that the device is "substantially equivalent" to legally marketed predicate devices, it does not contain the acceptance criteria, study details, or performance results that would allow me to populate the table and answer the specific questions you've asked. The letter confirms clearance based on a determination of substantial equivalence, which is a regulatory pathway, but it doesn't elaborate on the underlying performance data.
To provide the requested information, I would need access to the actual 510(k) submission or supporting performance studies conducted by Katecho, Inc.
Therefore, I cannot fulfill your request at this time.
§ 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.