(40 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 Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-04 & D-1263-05) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-04) and DF (D-1263-05). 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 Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06 & D-1263-07) 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 bidirectional deflection and are 115 cm long. These catheters include a braided bidirectional deflectable tip section. The braided bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves include FJ (D-1263-06) and DF (D-1263-07). 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 Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06 & D-1263-07) 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.
The catheters interface with Carto EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.
The provided text describes a 510(k) summary for the "Webster CS Catheter with EZ Steer Technology" and "Webster CS Catheter with EZ Steer Technology and Auto ID." This is a medical device, and the information focuses on its substantial equivalence to a predicate device, its description, and its indications for use.
Crucially, the provided document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically expected for an AI/ML medical device.
Here's why and what can be extracted:
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Device Type: This is a diagnostic electrophysiology mapping catheter, a hardware device. The "EZ Steer Technology" and "Auto ID" suggest mechanical and electronic features, not an AI/ML algorithm that requires performance metrics like sensitivity, specificity, or AUC against a ground truth.
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Performance Data Section: The document explicitly states under "5.4 Performance Data": "The Webster CS Catheters have passed bench testing to validate the mechanical and electrical integrity of the catheters and the performance of the catheters with the ancillary equipment." This confirms the focus is on physical and electrical device function, not an AI model's diagnostic accuracy.
Therefore, many of the requested categories (sample size, data provenance, number of experts, adjudication, MRMC, standalone performance, training set details) are not applicable or not provided in this type of 510(k) summary for a non-AI/ML hardware device.
However, I can extract what is implied about "acceptance criteria" and "study" from the context of a 510(k) for such a device:
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for a Hardware Catheter) | Reported Device Performance |
|---|---|
| Mechanical Integrity: Ability to deflect, steer, and maintain structural soundness. | Passed bench testing to validate mechanical integrity. |
| Electrical Integrity: Proper functioning of electrodes for mapping and stimulation. | Passed bench testing to validate electrical integrity. |
| Performance with Ancillary Equipment: Compatibility and proper function when connected to other systems (e.g., Carto EP Navigation Systems). | Passed bench testing to validate performance with ancillary equipment. |
| Bi-directional Deflection: Achieve two 180° opposed single-plane curves. | Catheters provide two 180° opposed single-plane curves (FJ and DF models). |
| Electrode Spacing and Number: Meet specified design (2mm tip electrode, 10 total electrodes, 2-8-2mm spacing). | Catheters incorporate 2mm tip electrode, 10 total electrodes, 2-8-2mm electrode spacing. |
| Catheter Length: Meet specified design (115 cm). | Catheters are 115 cm long. |
| Auto ID Functionality (for Auto ID models): Ability to store and be recognized by Carto EP Navigation Systems. | EEPROM stores unique catheter identification; Carto EP Navigation Systems can access. |
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Sample size used for the test set and the data provenance: Not applicable/not provided for this type of hardware bench testing. The "test set" would be the manufactured catheters and components subjected to engineering tests. Data provenance would be internal Biosense Webster engineering labs.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical/electrical testing is established by engineering specifications and measurements, not clinical expert consensus.
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Adjudication method for the test set: Not applicable. Engineering tests rely on pass/fail criteria against specifications.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for a hardware catheter. This type of study is relevant for AI/ML diagnostic tools where human readers interpret data.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This device is a physical catheter, not an algorithm.
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The type of ground truth used: Engineering specifications, physical measurements, electrical measurements, and functional checks against design requirements.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set."
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a hardware medical device and its clearance based on substantial equivalence, relying on standard engineering bench testing to ensure mechanical and electrical integrity and performance with ancillary equipment. It is not an AI/ML device, and thus the specific questions related to AI/ML performance metrics are not addressed or relevant in this context.
§ 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).