(292 days)
The 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 region of the heart and the coronary sinus.
The Biosense Webster. Duo-Decapolar Catheter, manufacturing part number D-1171-35. is designed for electrophysiological mapping of cardiac structures. The catheter has a high-torque 7 Fr shaft with a tip section containing 10 pairs of platinum-iridium electrodes that can easily be seen under fluoroscopy. The 10 pairs of electrodes are arranged in two sets of five with a spacing of 60 mm between the sets. The electrode spacing within each set is 2-8-2 mm. The D-1171-35 catheter facilitates simultaneous local electrograms due to the greater number of electrodes and its deflection capabilities. All of the electrodes may be used for recording and stimulation purposes.
Tip deflection is controlled at the proximal end by a tubular hand piece in which a piston slides. The piston in the handpiece is attached to an internal puller wire which changes the radius of the curvature. When the piston is pushed forward with the thumbknob, the radius of the curvature is reduced; when the thumbknob is pulled back, the radius of the curvature is increased until the tip section straightens. 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 catheter has a bifurcated Pigtail Connector Subassembly at the proximal end of the hand piece that houses a pair of 10-pin circular connectors. This connector provides a means for the catheter to connect to an interface cable and allow interface of the catheter with standard recording equipment.
The provided text describes a medical device, the Webster Duo-Decapolar Catheter, and its performance data in the context of a 510(k) premarket notification. However, it does not include a table of acceptance criteria or a detailed study proving the device meets those criteria, nor does it contain information about AI integration, human readers, or an MRMC study.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a table format. The text generally indicates that the device "passed all testing in accordance with appropriate test criteria and standards."
- Reported Device Performance: The device "underwent extensive bench (mechanical, electrical and simulated use) testing." It was also "assessed to be safe and effective for use in the coronary sinus based on an animal study performed with the similarly designed Webster CS Catheter with EZ Steer Technology." Specific numerical performance metrics or detailed results are not provided.
2. Sample sized used for the test set and the data provenance:
- Test Set (Animal Study): Not explicitly stated, but it refers to "an animal study." The provenance is also not specified (e.g., country of origin, retrospective or prospective).
- Test Set (Bench Testing): Not applicable for sample size in the traditional sense, as it refers to mechanical, electrical, and simulated use testing of the device itself rather than 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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
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:
- An MRMC study, AI assistance, or human reader improvement data are not mentioned in the provided text. The device is an electrophysiology mapping catheter, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a physical medical instrument, not an algorithm.
7. The type of ground truth used:
- For the animal study, the ground truth would likely be established through direct observation and measurements during the animal procedures, with efficacy and safety assessments based on physiological responses and potentially post-mortem analysis. However, the exact methodology is not detailed.
- For bench testing, the ground truth would be based on engineering specifications and established test standards for mechanical and electrical properties.
8. The sample size for the training set:
- A "training set" in the context of algorithm development is not applicable to this device. The development process involved "extensive bench (mechanical, electrical and simulated use) testing" which served to refine and validate the device's design.
9. How the ground truth for the training set was established:
- As above, a "training set" for an algorithm is not applicable. The device's design was likely validated against engineering specifications and performance expectations derived from predicate devices and clinical understanding of electrophysiology catheters.
§ 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).