(142 days)
HeartSee K171303 Software for cardiac positron emission tomography (PET) is indicated 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 in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images by quantification of their severity.
HeartSee K171303 is intended for use by trained professionals, such as 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 K171303 is a software tool for cardiac positron emission tomography (PET) for determining regional and global absolute rest and stress myocardial perfusion in cc/min/q, 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 ot known coronary artery disease. HeartSee K171303 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 K171303 software quantifies absolute rest and stress myocardial perfusion per unit tissue (cc/min/g), 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. Archiving output data is supported for clinical diagnostics, quality control and research.
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Acceptance Criteria and Device Performance Study
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating that K171303 performs "identically" to the predicate device (K143664) for certain metrics and "better" for others.
| Acceptance Criteria / Performance Metric | Predicate Device (K143664) Performance | Device (K171303) Performance | Result (K171303 vs. K143664) |
|---|---|---|---|
| Quantitative Measurements: | |||
| Rest Perfusion (cc/min/g) | N/A (implicit) | Values within two decimal places of K143664 | Identical |
| Stress Perfusion (cc/min/g) | N/A (implicit) | Values within two decimal places of K143664 | Identical |
| Coronary Flow Reserve (CFR) | N/A (implicit) | Values within two decimal places of K143664 | Identical |
| Mean values and standard deviations for Rest Perfusion, Stress Perfusion, and CFR | N/A (implicit) | Identical to K143664 | Identical |
| Correlation between K171303 and K143664 for Rest-Stress perfusion and CFR | N/A (implicit) | R = 1.0, P |
§ 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.