(164 days)
The intended use of the CARTO™ RMT EP Navigation System v8 is catheter-based atrial and ventricular mapping.
The CARTO RMT System v8 allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps, cardiac electrical propagation maps, cardiac electrical potential maps, impedance maps, and cardiac chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
The CARTO R.MT System v8 is intended to support EP procedures in the presence of the high metallic environment presented by the NIOBE 1 (PM3.0) and Niobe 2 (PM3.1 and PM3.2) Stereotaxis Magnetic Navigation Systems (MNS) in magnetic environments of up to 0.08 Tesla.
Although the CARTO™ RMT system requires the use of a magnetic steerable catheter, i.e. the NAVISTAR RMT, when used in conjunction with the Stereotaxis Niobe MNS, it also enables the use of the standard NAVISTAR and QWIKSTAR catheters when the Stereotaxis magnets are stowed away or when used in a conventional EP lab, maintaining full CARTOTM XP capabilities.
CARTO RMT System v8 includes the CARTOMERGE™ capability to import, register and merge CT or MRI structural images with CARTO maps physiological information and real time catheter navigation.
The CARTO™ RMT EP Navigation System v8 is designed to acquire, analyze, and display electro-anatomical maps of the human heart. The maps are reconstructed using the combination of information gathered from the integration of intracardiac electrograms with their respective endocardial locations. Maps may be displayed as electrical activation maps, electrical propagation maps, electrical maps, impedance maps and chamber geometry maps. The acquired patient signals, including body surface ECG and intracardiac electrograms may also be displayed in real time on the display screen.
In the conventional procedure both the patient and the physician are exposed to X-Ray radiation during the course of the procedure. The CARTO™ RMT System v8 enables cardiac mapping using CARTO™ RMT compatible catheters utilizing the magnetic navigation capabilities of the Stereotaxis Niobe Systems. In this way the system seamlessly combines the benefits of cardiac 3D mapping with remote catheter navigation and may further reduce the hospital staff exposure to dangerous ionizing radiation.
The CARTO" RMT EP Navigation System v8 includes the CARTOMERGE module. The CARTOMERGE module provides for the import, visualization and processing of preacquired cardiac images. These images are then registered and superimposed to the CARTO RMT EP maps. CARTOMERGE supports import of Computed Tomography (CT) and Magnetic Resonance (MRI) images in DICOM format.
The provided text describes the CARTO™ RMT EP Navigation System v8, an electrophysiological mapping system. It details the device's intended use and general description, but it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for the test set.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document mainly focuses on:
- 510(k) Summary: Manufacturer, contact, proprietary device name, classification, and predicate devices.
- Intended Use: Acquiring real-time catheter-based cardiac electrophysiological maps for patients eligible for conventional studies. It also notes its use in conjunction with Stereotaxis Niobe Systems to potentially reduce X-ray exposure, and the CARTOMERGE module for importing and processing imaging data (CT/MRI).
- General Device Description: How it acquires, analyzes, and displays electro-anatomical maps (activation, propagation, electrical, impedance, geometry maps) using intracardiac electrograms and endocardial locations.
- FDA Correspondence: Official notification of clearance and substantial equivalence to predicate devices, along with regulatory obligations.
The statement "The non-clinical bench tests and the location accuracy tests performed under the Niobe environment show that the device is as safe and as effective as the previously marketed devices to which it is being compared and does not raise any new questions of safety or effectiveness" is the closest it comes to mentioning testing, but it does not provide any specifics on methodologies, results, or acceptance criteria. It explicitly states "non-clinical bench tests" and "location accuracy tests" but provides no further details on these studies.
§ 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).