(75 days)
HeartSee™ software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cclmin/q. Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity.
HeartSee™ is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification. The clinician remains ultimately responsible for the final assessment and diagnosis based on standard practices, clinical judgment and interpretation of PET images or quantitative data.
HeartSee is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map for facilitating the interpretation of PET perfusion images in patients with suspected or known coronary artery disease. HeartSee is intended for use by trained professionals, such as nuclear technicians, nuclear medicine or nuclear cardiology physicians, or cardiologists with appropriate training and certification.
HeartSee contains two fundamental components. First, the software imports cardiac PET images in DICOM format from PET scanners with DICOM output. These images are reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. Second, the software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/gm), Coronary Flow Reserve (CFR) as the stress/rest perfusion ratio and the Coronary Flow Capacity combining CFR and stress perfusion, all on a pixel basis for regional and global values. HeartSee and the predicate K231731 also display stress subendocardial to subepicardial ratio and subendocardial stress to rest ratio on relative activity tomograms, and stress relative topogram maps expressed as a fraction of maximum cc/min/g. called relative stress flow (RSF). Archiving output data is supported for clinical diagnostics, quality control and research.
In addition to these established measurements of perfusion in cc/min/g, CFR and CFC, HeartSee has software for determining left ventricular ejection fraction (EF) by PET-CT using Rb-82 compared to EF.
The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria for the HeartSee™ Cardiac P.E.T. Processing Software.
The document is a 510(k) premarket notification clearance letter from the FDA. It states that:
- This device, HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4, is substantially equivalent to a legally marketed predicate device (Optional Screen Displays For HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 (K231731)).
- The primary changes from the predicate device are a software platform migration to the Windows operating system, minor software application updates, and cybersecurity enhancements.
- The core functionality of determining quantitative myocardial perfusion, Coronary Flow Reserve (CFR), and Coronary Flow Capacity (CFC) map, along with their displays and left ventricular ejection fraction (EF) determination, remains essentially the same as the predicate.
- No new clinical testing was performed in support of this 510(k) Premarket Notification. The substantial equivalence is based on nonclinical testing of the predicate device, combined with system testing and cybersecurity testing of the proposed device, due to the nature of the modifications being primarily platform and minor updates.
Therefore, I cannot provide the requested table, sample sizes, expert details, adjudication methods, MRMC study information, standalone performance, ground truth types, or training set details because this information is not present in the provided FDA 510(k) clearance letter.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.