(140 days)
The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only. The catheter is designed for use in the coronary sinus.
The Reprocessed Webster Coronary Sinus (CS) Diagnostic Electrophysiology (EP) Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 7FR catheter with a usable length of 115cm. The catheter has a high-torque shaft with a bi-directional deflectable tip section containing an array of platinum electrodes that can be used for stimulation and recording. Standard features of this catheter include a braided bi-directional deflectable tip section with an array of platinum electrodes that includes a 2mm tip dome. Additionally, two asymmetric curve types are available providing two 180º opposed, single plane curves. The curve types include DF and FJ. A Rocker Lever is used to deflect the tip. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the way typically seen for AI/ML-driven medical devices.
Instead, this document is an FDA 510(k) clearance letter for a reprocessed medical device: Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter. The letter and accompanying 510(k) summary pertain to demonstrating substantial equivalence to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a novel device.
Here's why the requested information cannot be fully extracted and what the document does provide:
- No AI/ML Component: The device described is a physical catheter used for electrophysiological mapping. There is no mention of any artificial intelligence or machine learning component, therefore, questions regarding effect size of AI assistance, standalone algorithm performance, training sets, or expert adjudication for AI output are not applicable.
- Emphasis on Substantial Equivalence: The entire document focuses on proving the reprocessed device is as safe and effective as the original, legally marketed predicate device. This is done through comparisons of technological characteristics, indications for use, and functional/safety testing, rather than setting specific performance metrics for a novel technology.
- "Acceptance Criteria" are not performance metrics for a novel device: The "acceptance criteria" for this reprocessed device would be demonstrating that its performance (e.g., electrical continuity, mechanical characteristics, biocompatibility, sterility) is equivalent to the original device after reprocessing, and that the reprocessing itself is safe and effective. The document lists the types of tests conducted, but not specific numeric thresholds they had to meet for the reprocessed device to be considered "accepted."
However, I can provide a summary based on the information available, interpreting "acceptance criteria" in the context of a reprocessed device's substantial equivalence demonstration.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a reprocessed device, the "acceptance criteria" are intrinsically tied to demonstrating equivalence to the predicate device and ensuring the reprocessing does not compromise safety or efficacy. Specific quantitative performance thresholds are not provided in this summary, but the types of tests performed serve as the basis for "acceptance."
| Acceptance Criteria Category (Implied by Testing) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Biocompatibility | Demonstrated to meet safety standards after reprocessing. |
| Cleaning Validation | Demonstrated that the cleaning process effectively removes visible soil and decontaminates the device. |
| Sterilization Validation | Demonstrated that the sterilization process achieves the required sterility assurance level (SAL). |
| Functional Testing: | |
| Visual Inspection | Satisfied visual quality standards. |
| Dimensional Verification | Maintained original device dimensions. |
| Electrical Continuity and Resistance | Maintained electrical properties equivalent to the original device. |
| Simulated Use | Performed as expected in simulated use scenarios. |
| Mechanical Characteristics | Maintained mechanical properties (e.g., steerability, deflection) equivalent to the original device. |
| Auto ID Verification (for Auto ID models) | Functioned correctly with CARTO EP Navigation Systems. |
| Electrical Safety Testing: | |
| Dielectric and Current Leakage | Met electrical safety standards. |
| Packaging Validation | Demonstrated appropriate packaging integrity and protection for the device. |
| Reprocessing Cycle Limit | Device is reprocessed no more than three (3) times, with the device marked and tracked to prevent further reprocessing after reaching the limit. |
| Reprocessing Restriction | Reprocessing performed only by Innovative Health; devices previously reprocessed by other reprocessors are excluded. |
| Substantial Equivalence (Overall) | Concludes that the reprocessed devices are substantially equivalent to the predicate devices in terms of purpose, design, materials, function, and intended use. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test (e.g., how many catheters were subjected to sterilization validation or mechanical testing). It notes that "Bench and laboratory testing was conducted." The provenance is internal laboratory testing by Innovative Health, LLC. (prospective testing of reprocessed devices).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a reprocessed physical device, "ground truth" is established by engineering and laboratory measurements against original device specifications and industry standards, not by expert interpretation of data like in an AI/ML context.
4. Adjudication method for the test set
This question is not applicable for a physical device's engineering and performance testing. Results would be compared directly to established specifications or predicate device performance.
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
Not applicable. This device does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used
The "ground truth" for evaluating the reprocessed catheter is based on:
- Original design specifications of the predicate device.
- Industry standards for medical device safety and performance (e.g., biocompatibility, sterility).
- Comparative performance data against new, original devices.
- The effectiveness of the reprocessing methods themselves (cleaning, sterilization).
8. The sample size for the training set
Not applicable. This device does not involve AI/ML and therefore does not have a training set.
9. How the ground truth for the training set was established
Not applicable. As above, 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).