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510(k) Data Aggregation
(41 days)
The Biosense Webster PENTARAY™ NAV eco High-Density Mapping Catheter is indicated for multiple electrode 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).
The Biosense Webster PENTARAY® Nav eco 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.
This document is a 510(k) summary for a medical device ([K201750](https://510k.innolitics.com/search/K201750): Pentaray Nav eco High-Density Mapping Catheter), which is submitted to the FDA for market clearance. It asserts that the device is substantially equivalent to a predicate device ([K123837](https://510k.innolitics.com/search/K123837)).
Therefore, the information you've requested regarding acceptance criteria and performance studies that would prove the device meets acceptance criteria in the context of an AI/machine learning device is not present in this document. This typically involves performance metrics like sensitivity, specificity, AUC, etc., derived from studies comparing algorithm output to ground truth.
This 510(k) specifically states:
- "The subject catheter is identical in design to the current catheter."
- "The intended use of the predicate device as a diagnostic catheter designed to facilitate mapping of structures within the heart remains the same in the subject device."
- "The purpose of this 510(k) submission is to add clarification to the precautions. There are no other changes between the subject device and the predicate device approved per K123837."
- "The PENTARAY™ NAV eco High-Density Mapping Catheter underwent bench and animal testing. The catheter passed all intended criteria in accordance with appropriate test criteria and standards."
This is a design modification submission (adding clarification to precautions) for an already cleared device, not a new device with novel AI algorithms requiring extensive clinical performance validation for its AI components with human-in-the-loop studies. The "Performance Data" section solely refers to bench and animal testing, which are standard for physical medical devices to ensure safety and functionality, not AI algorithm performance.
Therefore, I cannot provide the requested information from this document in the context of an AI/ML device. The document does not describe the kind of performance studies (e.g., MRMC, standalone algorithm performance) or the robust ground truth establishment methods typically associated with AI/ML device validation.
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(82 days)
The Biosense Webster PENTARAY® NAV eco High-Density Mapping Catheter is indicated for multiple electrode 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.)
The PENTARAY® High-Density Mapping Catheter family is a 7 Fr, multi-electrode electrophysiological mapping catheter designed for diagnostic electrogram mapping and pacing in all chambers (atria and ventricles) of the heart. Six proposed PENTARAY® NAV eco High-Density Mapping Catheters (D-1282-07-S to D-1282-12-S) will be similar to six predicate PENTARAY® NAV High-Density Mapping Catheters (D-1282-01-S to D-1282-06-S), modified only to implement an "eco" Handle. The modification to implement this "eco" Handle involves removing the Printed Circuit Board (PCB) that is associated with the Magnetic Location Sensor from the Handle Extension and connecting this catheter to an existing "eco" Interface Cable and a short, reusable cable component that now contains this PCB. This cable containing the PCB (known as the Dongle) is associated with the CARTO® 3 Electrophysiology (EP) Navigation System. This "eco" Handle is the only modification of the predicate catheters to create the six proposed Biosense Webster PENTARAY NAV eco Catheter models.
The working tip of the six proposed PENTARAY NAV eco Catheters is identical to the predicate catheters. The proposed catheters will continue to have five flexible spines, each with four ring electrodes for a total of 20 electrodes. There will continue to be three different electrode spacing configurations (4-4-4, 2-6-2, or 1-8-1 mm) and two different curves (F or D) in order to accommodate different clinical situations. The tip of the shaft of both the predicate and proposed catheters house a Magnetic Location Sensor that provides magnetic location information when used with the CARTO® 3 EP Navigation System. In addition to the 20 spine electrodes, two additional Ring Electrodes are located near the tip of the shaft for a total of 22 ring electrodes that provide location information via ACL technology when used with the CARTO 3 EP Navigation System. The shafts of the proposed and predicate catheters are the same as are the distal ends of the Handle. All the modifications are in the proximal portion of the Handle where the changes described in the previous paragraph were effected.
This document describes a 510(k) premarket notification for the PENTARAY® NAV eco High-Density Mapping Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the PENTARAY® NAV High-Density Mapping Catheter.
The key information regarding the acceptance criteria and the study performed is as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | Passed all intended criteria in accordance with appropriate standards and test criteria. |
| ECG Signal Quality (Animal Test) | Confirmed that the proposed device had no change in the quality of the ECG signals compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of a specific numerical count for a "test set" in the context of a clinical study. The device's performance was evaluated through bench testing and a single animal test.
- Data Provenance: The bench testing and animal testing were conducted internally by the manufacturer (Biosense Webster, Inc.). No information on country of origin for any external data, or whether it was retrospective or prospective, is provided as no human clinical trials were performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No clinical test set requiring expert ground truth establishment was conducted. The evaluation relied on engineering bench tests and an animal study.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring human expert adjudication was conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not performed. The submission explicitly states, "No clinical testing was deemed necessary." The device is a hardware mapping catheter, not an AI diagnostic tool that would typically be evaluated with MRMC studies.
6. Standalone (Algorithm Only) Performance Study
Not applicable. The PENTARAY® NAV eco is a medical device (catheter), not a standalone algorithm. Its performance is evaluated as an integrated system with the CARTO® 3 EP Navigation System.
7. Type of Ground Truth Used
- For Bench Testing: Engineering specifications and established industry standards for catheter performance served as the ground truth.
- For Animal Test (ECG signal quality): The quality of ECG signals obtained using the predicate device likely served as the comparative "ground truth" to ensure no degradation with the modified device.
8. Sample Size for the Training Set
Not applicable. This device is a hardware catheter, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there was no training set for an AI algorithm.
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