(83 days)
The PadPro 2502 Sterile radiotransparent external electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a 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. 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" 2502 Sterile Multifunction Electrodes. This submission claims substantial equivalence to an existing device, the "PadPro" 2001 Electrode (K014209). The primary difference for the 2502 model is that it is sterilized and labeled as such.
The information primarily focuses on comparing the new device to its predicate device to establish substantial equivalence rather than detailing an independent study to prove specific performance against acceptance criteria in the traditional sense of a clinical trial. The "study" here is essentially the comparison to the predicate device and adherence to recognized standards.
Here's an attempt to extract and infer the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from referenced standards or implied from predicate) | Reported Device Performance (for PadPro 2502) |
|---|---|---|
| Functional Equivalence | Indicated for use in external pacing, defibrillation, and monitoring applications as a disposable device for single patient use. Provides a conductive interface for defibrillator/pacemaker. Intended for adult patients. Compatible with defibrillators up to 360 joule maximum. | SAME as predicate device ("PadPro" 2001). Can be used for defibrillation, pacing, cardioversion, and monitoring. Compatible with all makes/models of defibrillators, including Bi-Phasic units. Intended for adult patients, low power (360 joule max) defibrillators. |
| Physical Characteristics | Radiotransparent, non-sterile (for predicate), latex-free, single patient use, self-adhesive, sealed in foil pouch. Size: 12 x 7 cm. | Radiotransparent, sterile, single patient use, latex-free, sealed in pouch designed for ETO sterilization. Size: SAME 12 x 7 cm. |
| Safety Standards | IEC 601-1 (1988), Amendment No. 1 (1991), Amendment No. 2 (1995) - Medical Electrical Equipment - Part 1: General requirements for safety. Sec. 898.12 Performance standard (implied electrical safety/performance). ANSI/AAMI DF-39 (3.3.19) - self-adhesive electrodes for monitoring and defibrillation (implied performance in terms of adhesion, conductivity, current distribution). | SAME standards met as predicate device. Implies that the sterilized device continues to meet these safety and performance standards. |
| Sterility | Not applicable to the predicate device (non-sterile). | Sterile. (This is the primary modification and implicitly, the sterilization process itself would need to be validated to ensure sterility without compromising performance). |
2. Sample Size Used for the Test Set and Data Provenance
The text does not explicitly describe a separate "test set" or a formal clinical study with a specified sample size for the PadPro 2502. The core of the submission is a claim of substantial equivalence to the predicate device, PadPro 2001. The "study" largely consists of demonstrating that the modification (sterilization) does not alter the fundamental safety and effectiveness when compared against established standards.
There is no mention of data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically associated with clinical trials, which are not detailed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. As there's no described independent test set or clinical study with patient data requiring expert review for ground truth, this aspect is not applicable to the summary provided. The "ground truth" for this submission relies on the established performance and safety of the predicate device and the adherence to recognized industry standards.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the submission (substantial equivalence claim based on predicate device and standards, not a new clinical study with expert adjudication).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on device characteristics and regulatory standards, not on human reader performance with or without AI assistance. The device in question is a medical electrode, not an AI-powered diagnostic tool.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The device is an electrode, not an algorithm.
7. The Type of Ground Truth Used
For the PadPro 2502, the "ground truth" is established through:
- Performance of the predicate device (PadPro 2001): Its history of safe and effective use.
- Adherence to recognized industry standards: IEC 601-1 and ANSI/AAMI DF-39. These standards define the expected performance and safety characteristics of such electrodes.
- Sterilization validation (implied): While not explicitly detailed, the process of sterilization itself would have to be validated to ensure it achieves sterility without compromising the device's function or material integrity, thereby implicitly establishing a ground truth for its "sterile" claim.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this device submission. This concept typically applies to machine learning or AI models, which is not relevant for this medical electrode.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this question is not applicable.
§ 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.