(351 days)
This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping. In addition, the preformed shape of the Halo XP catheter's tip section is designed particularly for the tricuspid annulus.
The Cordis Webster deflectable 720 electrode catheter has been designed for electrophysiological mapping of the tricuspid annulus. The catheter has a high-torque shaft with a halo-shaped tip section containing ten pairs of platinum electrodes that can easily be seen under fluoroscopy. The tip section also contains a radiopaque marker in the center of the electrode array. The tip section of the catheter has a halo-shaped preformed loop which can be positioned around the atrial aspect of the tricuspid annulus.
A piston in the handpiece is attached to an internal puller which changes the radius of curvature. When the piston is pushed forward, the radius of curvature of the preformed loop is reduced: when the thumbknob is pulled back, the radius of curvature is increased until the tip section returns to the preformed shape. The high-torque shaft allows the plane of the loop to be maneuvered in order to facilitate accurate positioning.
The Cordis Webster deflectable T20 electrode catheter facilitates simultaneously local electrograms spanning the tricuspid annulus, from midseptal to anterior to lateral to posterolateral. Recordings of the entire annulus can be obtained without repositioning the catheter tip.
The provided 510(k) summary for the T20 Diagnostic Deflectable Tip Catheter does not contain information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/ML or imaging device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. The "acceptance criteria" here are implicitly linked to showing that the new device performs "as well as" the predicate device and that any differences are not statistically significant in a way that would affect safety and effectiveness.
Here's an attempt to structure the information based on the provided text, while noting the absence of details typically found in AI/ML performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate performance) | Reported Device Performance (T20 Catheter) |
|---|---|---|
| Electrical Performance | Comparable to predicate device across relevant electrical characteristics. | No statistically significant differences in outcome compared to predicate. |
| Mechanical Performance | Comparable to predicate device across relevant mechanical characteristics (e.g., deflection, torqueability). | No statistically significant differences in outcome compared to predicate. |
| Biocompatibility | Comparable to predicate device. | Not explicitly detailed in performance data section, but generally implied for such devices. |
| Material/Design Integrity | Catheter maintains integrity and functionality during intended use. | No statistically significant differences in outcome compared to predicate. |
| Safety and Effectiveness | Device is as safe and effective as the predicate device. | Concluded to be substantially equivalent to the predicate device, implying comparable safety and effectiveness. |
Note: The submission states that tests were performed according to FDA's "Electrode Recording Catheter Preliminary Guidance." This guidance would outline the specific tests and expected results (acceptance criteria) for such devices, but the specific numerical criteria and detailed results are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "nonclinical performance testing" which typically involves a set number of devices tested under laboratory conditions.
- Data Provenance: Non-clinical (bench testing/laboratory testing). No patient data is mentioned as this is a non-clinical submission for substantial equivalence.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. This was non-clinical testing; "ground truth" in the context of clinical endpoints or diagnostic accuracy is not relevant here. The "truth" is based on the physical and electrical measurements of the device compared to the predicate.
- Qualifications of Experts: Not applicable. Testing was likely performed by engineers/technicians in a laboratory setting.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No human interpretation of results requiring adjudication is described. Measurements would be objective and compared against pre-defined engineering specifications or predicate performance.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done? No. This type of study is typically for evaluating diagnostic accuracy with human readers, often relevant for AI/ML devices. This submission pertains to an electrophysiological catheter for mapping, not a diagnostic imaging or AI system that interprets data for human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done? Not applicable in the context of an AI/ML algorithm. The performance testing was on the device's physical and electrical characteristics as manufactured.
7. Type of Ground Truth Used
- Type of Ground Truth: "Ground truth" here refers to established engineering specifications and the measured performance of the predicate device. The performance of the T20 catheter was compared directly to these objective benchmarks and the predicate's performance.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Established: Not applicable. No training set for an AI/ML 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).