(156 days)
The Webster CS 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 Coronary Sinus Deflectable Mapping Catheters (D-1263-01-S & D-1263-02-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-5-2 mm or 2-8-2 mm electrode spacing, have uni-directional deflection with an MZ curve, and are 115 cm long. The catheters include a handle with a thumb knob, which allows deflection of the distal end of the catheter. The handle also has a 10-pin connector for interfacing to a recording system though a standard catheter cable. The braided, bendable/conformable shaft allows torque and contact force to be transmitted from the handle to the distal end. The distal tip is unbraided and soft. These two predicate models are identical except that the electrode spacing is 2-5-2 mm for D-1263-01-S and 2-8-2 mm for D-1263-02-S.
The Webster CS Catheters with EZ Steer Technology (D-1263-04-S & D-1263-05-S) are diagnostic, 7Fr. deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the Webster CS Catheters with EZ Steer Technology include FJ (D-1263-04-S) and DF (D-1263-05-S). These catheters include a handle with a Rocker Lever, which is used to deflect the tip. The hightorque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The Webster CS Catheters with EZ Steer Technology (D-1263-06-S & D-1263-07-S) are diagnostic, 7Fr, deflectable, mapping electrophysiology (EP) catheters with the ability to map electrical activity within the Coronary Sinus through distal Platinum/Iridium electrodes located along the catheter's pre-shaped tip. The catheters incorporate a 2 mm tip electrode, 10 total electrodes, 2-8-2 mm electrode spacing, have bi-directional deflection and are 115 cm long. These catheters include a braided bi-directional deflectable tip section. The braided bidirectional tip provides the user with two 180° opposed single plane curves. Currently, the available curves for the modified Webster CS Catheters include FJ (D-1263-06-S) and DF (D-1263-07-S). These catheters include a handle with a Rocker Lever which 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 catheters are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. Carto EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Biosense Webster Coronary Sinus Deflectable Mapping Catheters:
Acceptance Criteria and Device Performance:
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on demonstrating substantial equivalence to a previously cleared predicate device (K050877).
The "Summary of Testing" section states: "The Webster CS Catheters have been subjected to performance testing to validate the integrity of the catheters and the performance of the catheters with the ancillary equipment." However, it does not provide the results of this testing in a quantifiable manner or against pre-defined acceptance criteria related to accuracy, sensitivity, specificity, or other performance characteristics typically measured in a clinical study for AI/diagnostic devices.
Therefore, a table of acceptance criteria and reported device performance cannot be generated from the provided document as it does not contain this specific information.
Missing Information/Not Applicable Based on Provided Text:
The following information cannot be extracted from the provided 510(k) summary because it primarily focuses on substantial equivalence for a medical device (catheter), not on the performance of a diagnostic AI algorithm. Many of the questions are more relevant to AI/ML device submissions.
- Sample sized used for the test set and the data provenance: Not described in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not described in the document.
- Adjudication method for the test set: Not described in the document.
- 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 described in the document. This is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not described in the document. This is not an AI device.
- The type of ground truth used: Not explicitly described in the context of a clinical study or diagnostic performance. The ground truth for this type of device would typically be observed physiological responses during electrophysiological procedures rather than a diagnostic label.
- The sample size for the training set: Not applicable as this is not an AI/ML device, and no training set is mentioned.
- How the ground truth for the training set was established: Not applicable as this is not an AI/ML device.
Key Takeaway from the Document:
The 510(k) submission for the Biosense Webster Coronary Sinus Catheters (new models and models with EZ Steer and Auto ID) demonstrates their safety and effectiveness by asserting substantial equivalence to an existing, legally marketed predicate device (K050877). The document indicates "performance testing" was conducted to validate integrity and performance with ancillary equipment, but the details, specific criteria, and results of these tests are not included for public review in this summary. The FDA's clearance (K090898) confirms their agreement on substantial equivalence based on the submitted data.
§ 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).