(189 days)
The Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. In addition, the Webster Duo-Decapolar catheter is designed to facilitate electrogram mapping in the atrial reqion of the heart and the coronary sinus.
The Reprocessed Webster Duo-Decapolar Diagnostic Electrophysiology (EP) Catheter has been designed for electrophysiological mapping of heart. The catheters have a hightorque shaft with a deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording.
The tip deflection is controlled at the proximal end by a tubular handpiece in which a piston slides. When the piston is pushed forward with the thumbknob, the tip is deflected (curved). When the piston is pulled back, the tip straightens. The high-torque shaft allows the plan of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The provided text describes a 510(k) premarket notification for a Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against clinical acceptance criteria with a study designed to evaluate such. As such, the information typically found in a clinical study report regarding acceptance criteria and performance against those criteria (especially for AI/software devices) is not present in this document.
Here's an analysis based on the document:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria and reported device performance in the context of clinical efficacy or diagnostic accuracy. The testing described is primarily for functional and safety testing to demonstrate that the reprocessed device performs comparably to the original device.
The "acceptance criteria" here are implied by the battery of tests performed to ensure the reprocessed device is safe and effective and functions like the new device. These include:
- Biocompatibility: The reprocessed device must be biocompatible.
- Cleaning Validation: The cleaning process must effectively remove contaminants.
- Sterilization Validation: The sterilization process must render the device sterile.
- Functional Testing:
- Visual Inspection: Device appearance must meet specifications.
- Dimensional Verification: Dimensions must be within specified tolerances.
- Electrical Continuity and Resistance: Electrical properties must be within specifications.
- Simulated Use: The device must perform as expected under simulated use conditions.
- Mechanical Characteristics: Mechanical properties (e.g., tip deflection) must be maintained.
- Electrical Safety Testing:
- Dielectric and Current Leakage: Electrical safety must be within acceptable limits.
- Packaging Validation: Packaging must maintain device integrity and sterility.
The document states, "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed Webster Duo-Decapolar Diagnostic EP Catheters." It then lists the above tests, implying that the device "met" the unstated acceptance criteria for each of these tests to conclude that it is "as safe and effective as the predicate devices."
2. Sample size used for the test set and the data provenance:
The document does not detail the sample sizes for the functional and safety tests. Studies for reprocessed medical devices typically involve testing a representative sample size of reprocessed units. No information on data provenance (e.g., country of origin, retrospective/prospective) is provided, as these are lab-based performance tests, not clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The testing described is laboratory-based mechanical, electrical, and material testing, not human-interpretation-based evaluation requiring expert ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not described here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable and no such study was done. This device is a reprocessed electrophysiology catheter, not an AI or software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for the performance claims of this reprocessed device is the established performance specifications and accepted safety and efficacy profiles of the original, new Webster Duo-Decapolar Diagnostic EP Catheter (K101991), and the performance standards for the specific functional and safety tests (e.g., electrical resistance limits, sterilisation assurance levels, biocompatibility standards). The reprocessed device is deemed safe and effective if it meets these engineering and performance standards, thereby being substantially equivalent.
8. The sample size for the training set:
This is not applicable. There is no training set mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).