(66 days)
PENTARAY® NAV ECO High Density Mapping Catheter:
The PENTARAY® NAV ECO High Density Mapping Catheter is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. The PENTARAY® NAV ECO High Density Mapping Catheter provides location information when used with compatible CARTO®3 EP Navigation Systems. (This catheter is not compatible with CARTO® 3 EP Navigation Systems prior to version 3.x).
DECANAV® Mapping Catheter:
The DECANAV® Catheter is indicated for electrophysiological mapping of cardiac structures i.e., recording and stimulation, including in the coronary sinus. In addition, the catheter is used with compatible CARTO® 3 System to provide catheter tip location information.
Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology and Auto ID:
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.
PENTARAY® NAV eco High Density Mapping Catheter:
The PENTARAY® NAV eco High Density Mapping Catheter is a multi-electrode diagnostic catheter designed to facilitate electrophysiological mapping of all structures in the heart (recording and stimulation). The catheter's distal end is a flower-shaped probe with 5 spines that radiate from the center. Each spine has 4 ring electrodes that are used for stimulation and recording within the heart. The flower is available in a 30mm diameter and several ring spacing configurations to achieve optimal mapping and contact with various cardiac structures.
DECANAV® Mapping Catheter:
The DECANAV® Catheter has been designed to be used with the CARTO® 3 Navigation System (a magnetic field location technology) to facilitate electrophysiological mapping of the heart. The catheter has a high-torque shaft with a deflectable tip section containing an array of platinum/iridium electrodes that can be used for stimulation and recording of cardiac electrical signals.
The DECANAV® Catheter has a single proximal electrode that can be used for unipolar recording signals. The DECANAV® Catheter tip deflection is controlled by a proximal hand piece that features a thumb operated sliding piston and is offered in various curve types. The plane of the curved tip can be rotated during use.
The DECANAV® Catheter interfaces with standard recording equipment and CARTO® 3 EP Navigation System equipment via interface cables with the appropriate connectors.
Webster® CS Catheter with Auto ID:
The Webster® Coronary Sinus Catheter is a steerable, multi-electrode catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart. The device is a 6 FR catheter with a usable length of 115 cm. The catheter has a high-torque shaft with a deflectable tip selection containing an array of platinum electrodes that can be used for stimulation and recording.
Standard features of this catheter include a braided 6 FR deflectable tip section with an array of platinum electrodes that includes a 2 mm tip dome. The braided tip is controlled by a proximal hand piece that features a thumb operated sliding piston, and is offered in a various curve types. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate position of the catheter tip at the desired site.
The catheter is equipped with Electronically Erasable Programmable 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 catheter interfaces with CARTO® EP Navigation Systems equipped with Auto ID Technology via interface cables with the appropriate connectors.
Webster® CS Catheter with EZ Steer Technology:
The Webster® CS Catheters with EZ Steer Bi-directional Technology (D-1263-04-S and D-1263-05-S) are diagnostic. 7F, 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 bi-directional tip provides the user with two 180° opposed single plane curves. Currently, the available curves 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 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 following cables are used to provide a means for interface of the catheters with the appropriate equipment:
- D-1221-21
- D-1221-26
- D-1221-25
Webster® CS Catheter with EZ Steer Technology and Auto ID:
The Webster CS Catheters with EZ Steer Bi-directional Technology (D-1263-06-S and 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 bidirectional deflection and are 115 cm long. These catheters include a braided bi-directional 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-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 Webster CS Catheters with EZ Steer Bi-directional Technology and Auto ID (D-1263-06-S & D-1263-07-S) are equipped with Electronically Erasable Programable Read Only Memory (EEPROM) which is used to store unique catheter identification information. CARTO 3 EP Navigation Systems equipped with Auto ID Technology can access the stored information and automatically recognize the catheter information. The catheters interface with CARTO 3 EP Navigation Systems via an interface cable (D-1286-16) with the appropriate connectors.
Here's a breakdown of the acceptance criteria and study findings based on the provided text.
The provided text describes modifications to existing electrophysiology mapping catheters, primarily concerning a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation.
The submission does not describe an AI/ML-driven device or study. Instead, it focuses on demonstrating the substantial equivalence of modified catheters to their predicate devices, with the main change being the allowed use of direct imaging guidance. Therefore, many of the requested categories related to AI/ML performance, such as test set size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this submission.
Acceptance Criteria and Reported Device Performance
Given the nature of the submission (modifications to existing medical devices to allow for direct imaging guidance during use), the "acceptance criteria" are based on demonstrating that these modifications do not adversely affect the safety and effectiveness of the devices, and that they remain substantially equivalent to their predicates. The primary evidence presented is a clinical study focused on the safety and effectiveness of the updated workflow (zero/low fluoroscopy) rather than the inherent performance of an AI component.
| Acceptance Criteria Category | Reported Device Performance and Study Findings |
|---|---|
| PENTARAY® NAV ECO HD Mapping Catheter | Technological Characteristics: Identical in design and all technological characteristics to the predicate device (K201750). The main difference is a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation. |
| Performance Data: Underwent bench and animal testing, passed all intended criteria. | |
| DECANAV® Mapping Catheter | Technological Characteristics: Identical in design and all technological characteristics to the predicate device (K080425). The main difference is a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation. |
| Performance Data: Underwent bench and animal testing, passed all intended criteria. | |
| Webster® CS Catheter with Auto ID | Technological Characteristics: Identical in design and all technological characteristics to the predicate device (incorporated via Letter to File to K080425). The main difference is a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation. |
| Performance Data: Underwent bench and animal testing, passed all intended criteria. | |
| Webster® CS Catheter with EZ Steer Technology | Technological Characteristics: Identical in design and all technological characteristics to the predicate device (K101345). The main difference is a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation. |
| Performance Data: Underwent bench and animal testing, passed all intended criteria. | |
| Webster® CS Catheter with EZ Steer Technology with Auto ID | Technological Characteristics: Identical in design and all technological characteristics to the predicate device (K101345). The main difference is a change to the instructions for use to allow direct imaging guidance (fluoroscopy or ultrasound) during catheter manipulation. |
| Performance Data: Underwent bench and animal testing, passed all intended criteria. | |
| Clinical Safety & Effectiveness (for new workflow) | A Real-World Evidence study (REAL AF Registry Sub-Study) evaluated the safety and acute effectiveness of Paroxysmal Atrial Fibrillation ablation with a zero/low fluoroscopy workflow. |
| Results: The study demonstrated the safety and effectiveness of the zero/low fluoroscopy workflow. Primary safety and secondary acute effectiveness endpoints were met in the REAL AF Registry population. The safety of the zero/low fluoroscopy workflow was further supported by comparable cumulative incidences of the secondary safety endpoint between the zero/low fluoroscopy group and the conventional fluoroscopy group. |
As this submission is for modifications to existing non-AI/ML devices, the following inquiries are largely not applicable:
- Sample size used for the test set and the data provenance: The document mentions a "Real-World Evidence study (REAL AF Registry Sub-Study)" but does not specify a distinct "test set" in the context of algorithm evaluation. It describes a clinical study population.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The clinical study evaluated procedural outcomes and safety, not an algorithm's performance against expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 applicable, as this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" equivalent would be the clinical outcomes and safety endpoints observed in the "Real-World Evidence study (REAL AF Registry Sub-Study)."
- The sample size for the training set: Not applicable, as this is not an AI/ML algorithm.
- How the ground truth for the training set was established: Not applicable, as this is not an AI/ML algorithm.
§ 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).