(106 days)
The PadPro Radiotranslucent (minor shadowing) external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patent use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patient's skin. The electrode is intended for use on adult patients. When a patient requires defibrillation, cardioversion or external pacing, these electrodes 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 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 or model of defibrillation/pacing unit is being used. All PadPro products are Latex free.
The provided text describes a 510(k) premarket notification for the "PadPro" 2516 Multifunction Electrodes. This submission aims to demonstrate substantial equivalence to an already legally marketed device, the Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737), rather than proving the device meets acceptance criteria through a clinical study.
Therefore, many of the requested details about acceptance criteria, clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable in this context. The focus of a 510(k) is to show that the new device is as safe and effective as a predicate device, often through bench testing, design comparison, and adherence to recognized standards.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" for a 510(k) submission are primarily centered on demonstrating substantial equivalence to a predicate device and adherence to relevant industry standards, rather than specific performance metrics from a de novo clinical trial. The "reported device performance" is framed in terms of meeting these standards and being functionally similar to the predicate.
| Acceptance Criteria (Standards and Equivalence) | Reported Device Performance ("PadPro" Electrodes) |
|---|---|
| Indications for Use: Disposable electrodes for automatic and manual external defibrillators for monitoring, pacing, cardioversion, and defibrillation. | SAME as predicate device (Katecho KDP-60 K-Defib/Pace Adult Electrode). |
| Where Used: Hospitals and Paramedic situations. | SAME as predicate device. |
| Basic Features: Radiotranslucent, non-sterile, latex-free, single patient use, self-adhesive, in sealed foil pouch. | Radiotranslucent "minor shadowing" non-sterile, latex free, single patient use, self adhesive, in sealed foil pouch. (Nearly identical, difference noted as "minor shadowing" vs. "radiotranslucent") |
| Standard Met 1: 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). | SAME as predicate device. |
| Standard Met 2: Sec. 898.12 Performance standard (implied for predicate, likely referring to general performance requirements). | SAME as predicate device. |
| Standard Met 3: ANSI/AAMI DF-39 (3.3.19) standard, self-adhesive electrodes for monitoring and defibrillation. | SAME as predicate device. |
| Overall Conclusion: Substantially equivalent to other legally marketed electrodes for this purpose. | In all respects, the PadPro System Defibrillator Electrodes are substantially equivalent. The device meets the standards referenced above. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of this 510(k) submission. The document focuses on demonstrating substantial equivalence through design and feature comparison, and adherence to performance standards, rather than a clinical "test set" from a prospective study. The data provenance is primarily the product specifications and testing results from the manufacturer to demonstrate compliance with standards and equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth in this context is established by the recognized industry standards (IEC, ANSI/AAMI) and the performance characteristics of the predicate device. Expert consensus for a "test set" as in a diagnostic study is not mentioned or required for this type of submission.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a "test set" requiring adjudication in the sense of a clinical trial or diagnostic accuracy study.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC comparative effectiveness study is not mentioned or implied. The submission is for a medical device (defibrillator electrodes) and not a diagnostic AI system where reader performance with and without AI assistance would be evaluated.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a passive component (electrodes), not an algorithm or AI system. Its function is to provide an interface for human-operated defibrillators/pacemakers.
7. The Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established Industry Standards: IEC 601-1 and ANSI/AAMI DF-39. The device's compliance with these standards serves as a benchmark for its safety and basic performance.
- Predicate Device Characteristics: The features, indications for use, and performance claims of the legally marketed Katecho KDP-60 K-Defib/Pace Adult Electrode (K981737). Substantial equivalence to this device is the primary "ground truth" for regulatory clearance.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set mentioned or implied, the establishment of its ground truth is irrelevant to this submission.
§ 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.