(30 days)
The PadPro pediatric electrodes are indicated for use in external pacing, defibiliation and monitoring applications as a non-sterne, disposable device for single pediatric use only. The PadPro 2603 electrodes provide ine conductive meetiatic patient's skin. The electrode is intended for use on
The electrodes are multifunction because they can be used for defibrillation, pacing, cardioversion, and monitoring. PadPro electrodes can be used on all makes and models of defibrillator, including all of the Bi-Phasic units. Radio transparent. "One Pad System" enables the pads to stay with the patient as they move through departments. PadPro has an electrode for any clinical need or patient situation. The high tack adhesive gel allows PadPro electrodes to be repositioned multiple times. PadPro can provide onsite conversion of current cables to accept the PadPro electrodes. The polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing. PadPro's adapter system simply plugs into the OEM cable. Standardization of products - One connector can be used throughout the institution, no matter what brand of defibrillation/pacing unit is being used. All PadPro products are Latex free.
The provided documentation is a 510(k) premarket notification for a medical device (PadPro 2603 Pediatric Multifunction Electrodes). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data for a new, innovative device with a complex algorithm.
Therefore, much of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies involving AI algorithms or novel diagnostics, is not applicable to this document. The document's purpose is to establish that the new device is as safe and effective as a previously approved device.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to the predicate device (PadPro 2602 Pediatric Electrode K002280). This isn't a quantitative performance metric in the typical sense but rather a comparison of indications for use, technological characteristics, and safety/effectiveness. The document states that the device "meets the standards referenced above." The referenced standards are International Electrotechnical Commission (IEC) 601-1: Medical Electrical Equipment 601-1 (1988) Part 1: General requirements for safety Amendment No. 1 (1991) Amendment No. 2 (1995 and Sec.898.12 Performance standard; ANSI/AAMI DF-39 (3.3.19) standard, self adhesive electrodes for monitoring and defibrillation.
- Reported Device Performance: The document doesn't provide specific numerical performance metrics for the PadPro 2603. Instead, it asserts its performance is "SAME" or improved (e.g., "Slightly larger than 2602" for size, and features like "polymer adhesive gel allows superior contact for uniform current distribution and more effective defibrillation and pacing").
| Acceptance Criteria (Implicit from 510k) | Reported Device Performance (PadPro 2603) |
|---|---|
| Substantial Equivalence to "PadPro" 2602 Pediatric Defibrillator Electrodes (K002280) | Asserted as substantially equivalent in all respects to legally marketed electrodes for the same purpose. |
| Indications for Use | SAME as predicate (external pacing, defibrillation, monitoring for 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.