(85 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 prompt asks for details about the acceptance criteria and study that proves a device meets those criteria. However, the provided text describes a reprocessed medical device (Webster CS Bi-Directional Diagnostic Electrophysiology (EP) Catheters) and its 510(k) submission to the FDA.
The context of the provided text is a regulatory submission for a reprocessed device, aiming to demonstrate its substantial equivalence to a predicate device. This type of submission focuses on proving that the reprocessed device is as safe and effective as the original, not on proving a novel device's initial performance against specific clinical acceptance criteria in the way an AI algorithm or a de novo device might.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not typically applicable to a 510(k) submission for a reprocessed medical device, as these are more relevant to the validation of diagnostic algorithms or new clinical devices.
Based on the provided text, here’s an analysis aligned with the request, focusing on what is available:
The document describes the regulatory approval process for a reprocessed medical device, not a new AI-powered diagnostic device. As such, the concept of "acceptance criteria" is geared towards demonstrating "substantial equivalence" to a predicate device rather than meeting specific quantifiable performance metrics in a clinical trial setting. Similarly, the "study" proving this largely consists of bench and laboratory testing rather than clinical trials with human subjects for clinical efficacy.
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the "acceptance criteria" are implied by the battery of functional, safety, and validation tests performed to ensure the reprocessed device is equivalent to the original. The "reported device performance" is the successful completion of these tests, confirming that the reprocessed device functions as intended and safely.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance (Successful Completion) |
|---|---|
| Device is biocompatible. | Biocompatibility testing was conducted and presumably passed. |
| Device is adequately cleaned after reprocessing. | Cleaning Validation was conducted and presumably passed, demonstrating effective removal of visible soil and decontamination. |
| Device is adequately sterilized. | Sterilization Validation was conducted and presumably passed. |
| Device meets visual inspection standards. | Visual Inspection was conducted and presumably passed. |
| Device meets dimensional specifications. | Dimensional Verification was conducted and presumably passed. |
| Device has proper electrical continuity and resistance. | Electrical Continuity and Resistance testing was conducted and presumably passed. |
| Device performs as expected in simulated clinical use. | Simulated Use testing was conducted and presumably passed. |
| Device maintains mechanical characteristics. | Mechanical Characteristics testing was conducted and presumably passed. |
| Auto ID Technology functions correctly (if applicable). | Auto ID Verification testing (for models with Auto ID Technology) was conducted and presumably passed. |
| Device meets electrical safety standards. | Electrical Safety Testing (Dielectric and Current Leakage) was conducted and presumably passed. |
| Device packaging maintains integrity and sterility. | Packaging Validation was conducted and presumably passed. |
| Device is equivalent to the predicate device in all aspects related to safety and effectiveness for its intended use. | Innovative Health concludes "that the Reprocessed Webster Coronary Sinus (CS) Bi-directional Diagnostic Electrophysiology (EP) Catheters are as safe and effective as the predicate devices described herein" based on the comprehensive testing performed. The purpose, design, materials, function, and intended use were found identical, with "no changes to the claims, clinical applications, patient population, performance specifications, or method of operation." |
Regarding the other requested information, much of it is not applicable or explicitly stated in this type of regulatory document for a reprocessed device:
2. Sample size used for the test set and the data provenance:
- The document mentions "Bench and laboratory testing was conducted." It does not specify the sample size for each test (e.g., how many reprocessed catheters were tested for electrical continuity).
- Data provenance is not specified beyond being "bench and laboratory testing" conducted by or for Innovative Health, LLC. It is likely internal testing data. The country of origin of the data is implied to be within the US, where Innovative Health operates. The data is prospective for the purpose of this submission (i.e., collecting data on the reprocessed devices to support the 510(k)).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The "ground truth" for a reprocessed device is typically conformance to engineering specifications and performance standards of the original device, as evaluated through technical testing. There is no mention of human experts establishing ground truth in a clinical or diagnostic sense for these engineering and safety tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of diagnostic outputs, typically in studies involving interpretation of medical images or data by multiple readers. The testing performed here involves objective measurements against predefined engineering and safety criteria.
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. An MRMC study is designed to evaluate the performance of diagnostic devices or algorithms (often AI-based) that involve human interpretation. The reprocessed catheter is a physical diagnostic tool for direct physiological measurement, not an interpretative system. The filing states: "The catheter is designed for use in the coronary sinus." and "The Reprocessed Webster CS Bi-directional Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures, i.e. stimulation and recording only." There is no AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable, as there is no algorithm or AI component in this reprocessed catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for this submission is established through engineering specifications, direct measurements, and established safety/performance standards for the original predicate device and for reprocessed medical devices. This includes demonstrating that the reprocessed device meets physical, electrical, and material requirements, and is appropriately cleaned and sterilized.
8. The sample size for the training set:
- This is not applicable, as there is no machine learning/AI model that requires a training set.
9. How the ground truth for the training set was established:
- This is not applicable, as there is no machine learning/AI model.
§ 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).