(112 days)
The cardiac position emission tomography (PET) analysis tool, HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee is intended for processing of DICOM images, visual analysis and quantification of relative myocardial tracer uptake, and quantification of absolute myocardial blood flow and CFR when applied to diagnostic cardiac PET images in patients with suspected or known coronary artery disease.
The cardiac positron emission tomography (PET) analysis tool HeartSee is a software package intended for use by nuclear medicine and nuclear cardiology physicians and technologists to facilitate image interpretation. Archiving of output data will be supported for clinical diagnostics, quality control, and research.
HeartSee contains two fundamental components. First, the software can import cardiac PET images in DICOM format from any camera manufacturer. These images can be reoriented to cardiac axes to produce standard tomographic and topographic displays of relative uptake. A trained, licensed physician can interpret these processed images as per standard practice.
Second, the CFR software can quantify absolute myocardial blood flow per unit tissue (cc/min/gm) in stress and rest PET cardiac images and quantitatively assess the coronary flow reserve (CFR).
To compute coronary flow reserve (CFR) - the ratio of increased blood flow (stress) to baseline blood flow (rest) – three inputs are required: integrated arterial activity in the early part after bolus injection, average myocardial activity in the late part after bolus injection, and correction factors for partial volume effects of the PET scanner. The first number comes from a region of interest (ROI) drawn in the thoracic aorta or left atrium on images taken soon after radionuclide bolus administration. The second number comes from the topographic maps of myocardial uptake acquired later after radiotracer injection. The third number varies by PET camera and will be initialized in a user preference file.
HeartSee is a software package that uses standard, industrial computing hardware and applications.
This device is HeartSee, a cardiac PET analysis software.
Please note that the provided document is a 510(k) summary, which often provides less granular detail on study designs compared to full study reports or publications. Therefore, some information may not be explicitly available and will be noted as such.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state formal acceptance criteria with numerical thresholds. Instead, it relies on demonstrating substantial equivalence to predicate devices (K090178 and K113754). This typically means the new device performs similarly well or not worse than the predicates.
However, the document mentions specific validation studies for its two main functionalities:
| Acceptance Criteria (Inferred from Substantial Equivalence and Validation) | Reported Device Performance |
|---|---|
| Component 1: Reorient to Cardiac Axes & Tomographic/Topographic Displays | Demonstrated through visual analysis capabilities and the interpretation by a trained, licensed physician as per standard practice. (No specific quantitative metric for "acceptance" is provided, but implies visually acceptable reconstruction). |
| Component 2: Quantification of Absolute Myocardial Blood Flow (MBF) and Coronary Flow Reserve (CFR) | Correlation with Reference Standard: |
- For absolute MBF, the study comparing MBF from 82 patients processed by the new algorithm showed **"excellent agreement (r=0.99, 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.