(123 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 catheter based 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 V6.0with the VISITAG SURPOINT™ Module are identical to those described for the predicate device.
This FDA 510(k) summary (K180238) for the CARTO 3 EP Navigation System Version 6.0 and Accessories with the VISITAG SURPOINT™ Module focuses on demonstrating substantial equivalence to a predicate device (K170600), rather than establishing new acceptance criteria or proving performance of the fundamental technology. Therefore, much of the requested information regarding specific acceptance criteria, detailed study results, sample sizes for test/training sets, and expert involvement is not explicitly provided in this document.
However, based on the information available, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the performance data in general terms, stating that "All testing passed in accordance with appropriate test criteria and standards." It does not provide specific quantitative acceptance criteria or detailed performance metrics. The focus is on demonstrating that modifications did not negatively affect existing features.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| New and modified features verified (functional testing) | All testing passed in accordance with appropriate test criteria and standards. |
| Existing features not negatively affected (regression testing) | All testing passed in accordance with appropriate test criteria and standards, and the modified device did not raise new questions of safety or effectiveness. |
| Magnetic location sensor accuracy (stated to be identical to predicate) | (Implied to be same as predicate due to "identical magnetic location sensor accuracy" statement, but no specific values provided) |
2. Sample Size Used for the Test Set and Data Provenance:
The document states, "The CARTO® 3 EP Navigation System, Version 6.0 with the VISITAG SURPOINT™ Module underwent extensive bench testing..." This indicates the testing was conducted on the device itself (likely multiple units or configurations) rather than on patient data. No sample size for a "test set" in terms of patient data or data provenance (country of origin, retrospective/prospective) is provided, as the study appears to be bench-based and not a clinical study involving patient data with ground truth.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided as the testing described is bench testing, not a clinical study involving expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not provided as the testing described is bench testing, not a clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned. The document focuses on device modifications and bench testing, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
The document describes "extensive bench testing" to verify new and modified features. While this is likely focused on the algorithm's performance within the system, it's not explicitly labeled as an "algorithm-only standalone performance study" in the context of comparative clinical evaluations. The device itself is a "Programmable Diagnostic Computer," so its functionality is inherently algorithmic.
7. Type of Ground Truth Used:
For the bench testing, the "ground truth" would likely be derived from:
- Engineering specifications and design documents: To verify that the new features function as intended.
- Reference measurements/simulations: For aspects like magnetic location sensor accuracy, comparing device output to known physical parameters.
- Predicate device behavior: For regression testing, verifying that existing features still perform identically or within expected tolerances compared to the predicate.
No "expert consensus, pathology, or outcomes data" ground truth is relevant or mentioned for this type of testing.
8. Sample Size for the Training Set:
This information is not provided. The document describes enhancements to an existing system, implying refinement of existing algorithms rather than the development of entirely new ones requiring large-scale training sets for machine learning. If machine learning was used in the development of the "VISITAG SURPOINT™ Module" or "HD Coloring" feature, the details of its training are not disclosed in this summary.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as there is no mention of a dedicated training set or machine learning model development in detail.
In summary, this 510(k) pertains to modifications of an existing device and relies on bench testing to demonstrate substantial equivalence, rather than new clinical effectiveness studies with explicit acceptance criteria, patient data, and expert interpretation.
§ 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).