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VERAFEYE Imaging Catheter: The VERAFEYE Imaging Catheter is intended for intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

VERAFEYE Imaging System: The VERAFEYE Imaging System is intended for cardiac applications. The system transmits ultrasound energy into adult patients creating 2D (B-mode), & 3D images of the heart, cardiac valves, great vessels, and surrounding anatomical structures to evaluate the presence or absence of pathology. The system also provides the ability to indicate scale with respect to anatomical structures, which provides information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. The system utilizes catheters which are intended for intra-cardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult patients is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The VERAFEYE System is intended to be used for live, minimally-invasive guidance of several different intracardiac procedures including, but not limited to, atrial ablation procedures and transseptal punctures. The system will provide image information of cardiovascular anatomic features, spatial relationships of other devices within the heart and great vessels, physiological information of cardiovascular structures and features. In doing so we expect to provide an imaging system capable of improving the safety, expediency, cost-effectiveness and patient tolerance of the aforementioned procedures compared to the same procedures using the existing technologies and methodologies. The system will be comprised of a catheter and an ultrasound imaging system with a console and computer screen. The VERAFEYE Imaging System includes the System Console (SC) for image display and manipulation as well as the Catheter Interface Unit (CIU) which the catheter connects to. The SC will have two monitors to allow for ease of image view and review for both the technician and physician user. The technician user will be able to control the system software via a graphical user interface using multiple methods of input including a mouse and keyboard. Caster wheels on the SC will allow easy movement of the system throughout the cardiac interventional lab which can have a small footprint as well as small obstacles to cross. The catheter will be a 11Fr single use, sterile device, which will be able to perform intracardiac and intraluminal ultrasound imaging of adults. The catheter will be capable of live 2D side viewing imaging, as well as live 3D rendered images. The imaging system will be able to resolve and measure features such as the inferior and superior vena cava, ascending and descending aorta, left and right atria, left and right ventric valve, mitral valve and tricuspid valve. The physician user will have easy steering maneuverability of the catheter via deflection and rotation, facilitating control over the position of the transducer to allow for multiple angles of images.

This appears to be a 510(k) Pre-market Notification document for the VERAFEYE System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence, rather than detailing a study used to prove the device meets specific acceptance criteria in the context of an AI/ML study.

Therefore, the requested information points (1-9) which are typically associated with performance evaluations of AI/ML devices, are not directly addressed in this document. The document focuses on regulatory comparison and safety/effectiveness based on non-clinical data and equivalence to existing devices.

Specifically:

• Acceptance Criteria and Reported Device Performance: This document doesn't provide a table of acceptance criteria for AI performance or reported device performance in that context. It focuses on functional and technological comparisons with predicate devices.
• Sample Size and Data Provenance (Test Set): Not applicable as this is not an AI/ML performance study.
• Number of Experts and Qualifications (Ground Truth): Not applicable.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. The document states, "No clinical testing is included in the submission. Determination of substantial equivalence is based on an assessment of non-clinical data."
• Standalone Performance Study (Algorithm Only): Not applicable.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

The document primarily makes a case for substantial equivalence based on technical characteristics, intended use, and non-clinical performance data, rather than reporting on an AI/ML specific performance study. It lists various safety and performance standards (e.g., UL 60601-1, IEC 60601-2-37, ISO 10993-1) that the device was tested against to demonstrate safety and effectiveness for regulatory clearance.

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