(146 days)
The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no special contraindications
The CARTO® 3 EP Navigation System, Version 6.0 is a catheterbased atrial and ventricular mapping system designed to acquire and analyze data points, and use this information to display 3D anatomical and electroanatomical maps of the human heart. The location information needed to create the cardiac maps and the local electrograms are acquired using a specialized mapping catheters and reference devices. The system allows electrograms and cardiac maps display based on the received intracardiac signals from the catheters. The CARTO® 3 System V6.0 uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System V6.0 consists of the following components:
- . Patient Interface Unit (PIU)
- Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port ●
- Intracardiac Out Port
- Power Supply ●
- Patches Connection Box and Cables ●
- Pedals
- Location Pad ●
All hardware components of the CARTO® 3 System V6.0 are identical to those described for the predicate CARTO® 3 System V4.2.
This document is a 510(k) Summary for the CARTO® 3 EP Navigation System, Version 6.0 and Accessories. It focuses on demonstrating substantial equivalence to a predicate device (CARTO® 3 EP Navigation System Version 4.2) rather than presenting a study demonstrating acceptance criteria met for a novel device performance.
Therefore, much of the requested information (acceptance criteria, specific study design details like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for a training set) is not explicitly provided in this document in the format typically seen for a new device's performance evaluation.
However, based on the provided text, we can infer some information relevant to the performance evaluation that was conducted to support the updated device's safety and effectiveness.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of explicit acceptance criteria with corresponding performance metrics. Instead, it states that the device "passed all tests in accordance with appropriate test criteria and standards." The performance data section describes the type of testing conducted.
Implied Acceptance Criteria (based on predicate equivalence and enhancements):
- Safety and Effectiveness: No new questions of safety or effectiveness are raised compared to the predicate device.
- Functionality of New Features: The new and modified features (ConfiDENSE Module annotations, CARTO VIZIGO™ Software, TOSHIBA X-ray system compatibility, CARTOSEG updates, GUI modifications) perform as intended.
- Preservation of Existing Functionality: Existing features are not negatively affected by modifications. This implies that the performance of core features (like magnetic location mapping technology and sensor accuracy) is maintained at the level of the predicate device (Version 4.2).
Reported Device Performance:
- "The CARTO® 3 EP Navigation System, Version 6.0 passed all tests in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness."
- Specifically noted is that the device "Have identical magnetic location sensor accuracy" as the predicate.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document mentions "extensive bench and pre-clinical testing under simulated clinical conditions." This suggests that a test set was used, but the size is not quantified.
- Data Provenance: "simulated clinical conditions." This implies a retrospective or de-identified prospective approach if clinical data was used in simulation, or purely simulated data for bench testing. The country of origin for the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not explicitly stated. The evaluation was primarily engineering and functional testing rather than a clinical study requiring expert ground truth in the traditional sense. The "acceptance criteria and standards" would likely refer to engineering specifications and regulatory standards.
4. Adjudication method for the test set
Not explicitly stated. Given the nature of bench and pre-clinical testing, it's unlikely a formal clinical adjudication method (like 2+1 or 3+1) was used. Testing would involve verifying output against known inputs or engineering specifications.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a navigation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images. The enhancements are primarily software features and compatibility updates.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, the described "extensive bench and pre-clinical testing" would represent a form of standalone performance evaluation for the system's functionalities, particularly the new modules and integrability, without direct human-in-the-loop performance being a primary assessment as a "diagnostic" device. For instance, the "magnetic location sensor accuracy" being identical to the predicate would be a standalone technical measurement.
7. The type of ground truth used
- Type of Ground Truth: For the "bench and pre-clinical testing," the ground truth would be based on:
- Engineering specifications: For quantitative measurements like magnetic location sensor accuracy.
- Predicate device's established performance: For verifying that existing features were not negatively impacted.
- Expected functionality: For new features, verifying they operate as designed (e.g., specific annotations are produced, software integrates correctly).
8. The sample size for the training set
Not applicable in the context of this 510(k) summary. This document describes an update to an existing medical device, primarily involving software enhancements and hardware compatibility, not a de novo AI/ML algorithm development that would typically require a training set in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above (no training set mentioned for an AI/ML algorithm in this context).
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).