(124 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 with AFM, software V7.3, is a catheter-based atrial and ventricular mapping system designed to acquire and analyze navigation catheters location and intracardiac ECG signals 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 specialized mapping catheters and reference devices. The CARTO® 3 System uses two distinct types of location technology - magnetic sensor technology and Advanced Catheter Location (ACL) technology.
The CARTO® 3 System with AFM consists of the following hardware components:
- Patient Interface Unit (PIU)
- Workstation with Graphic User Interface (GUI)
- Wide-Screen monitors, keyboard, and mouse
- Intracardiac In Port
- Intracardiac Out Port
- Power Supply
- Patches Connection Box and Cables (PU)
- Pedals
- Location Pad (LP)
- Signal Processing Unit (SPU)
All hardware components of the CARTO® 3 system with AFM are identical to those described for the predicate device.
The provided text describes a 510(k) premarket notification for the CARTO® 3 EP Navigation System with Advanced Focus Mapping (AFM). While the document outlines performance testing, it does not provide detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the format requested.
The document discusses:
- Bench Testing:
- Proof of Design – "CARTO® 3 System AFM algorithms were verified to meet specifications." "All testing performed met the acceptance criteria."
- Functional verification – "All system features were found to perform according to specifications and met the tests acceptance criteria."
- Unit Test – "performed to verify isolated software components that were modified."
- Animal Testing: "conducted to evaluate the CARTO® 3 System with AFM functionality under simulated clinical workflow and conditions." "All test protocol steps were successfully completed and expected results were achieved."
However, the specific quantitative acceptance criteria (e.g., "accuracy must be > 95%") and the detailed results against these criteria are not disclosed in this regulatory summary. Similarly, the study design elements like sample size, data provenance, expert qualifications, or detailed ground truth establishment methods for these specific validation tests are not provided. The document focuses on demonstrating substantial equivalence to a predicate device based on identical intended use, fundamental scientific technology, hardware platform, and core mapping technology, with software modifications undergoing verification and validation.
Therefore, based on the provided text, I cannot fill out the requested table or answer most of the detailed questions regarding acceptance criteria and study specifics. The document confirms that testing was done and acceptance criteria were met, but it does not describe those criteria or the exact study details.
Limitations based on the provided text:
- Acceptance Criteria Table: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are provided in the text. It only states that "All testing performed met the acceptance criteria" and "All system features were found to perform according to specifications and met the tests acceptance criteria."
- Sample Size and Data Provenance: Not specified for the bench or animal testing. The animal testing implies prospective data collection in a controlled setting.
- Number/Qualifications of Experts: Not mentioned.
- Adjudication Method: Not mentioned.
- MRMC Comparative Effectiveness Study: Not mentioned. The focus is on a "human-in-the-loop" system, but a comparative effectiveness study with/without AI assistance is not described.
- Standalone Performance: Not explicitly detailed as a separate study. Performance is likely intertwined with the system's overall function during bench and animal testing.
- Type of Ground Truth: For the bench testing, ground truth would be the known, expected outputs based on specifications. For animal testing, it would be the direct physiological measurements and observations during the procedures. No mention of expert consensus, pathology, or outcomes data for validation.
- Training Set Sample Size/Ground Truth Establishment: No information about a training set for machine learning models is provided. The new features appear to be software-driven calculations and displays (CLM, PDM, Ripple Frequency, PASO™ Module Improvement) rather than AI models requiring extensive training data and ground truth labeling in the traditional sense of deep learning. The testing described is verification and validation of these new features and regression testing for existing ones.
§ 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).