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510(k) Data Aggregation
K Number
K180019Device Name
CAAS Workstation
Manufacturer
Pie Medical Imaging BV
Date Cleared
2018-05-03
(121 days)
Product Code
IZI, LLZ, QHA
Regulation Number
892.1600Why did this record match?
Applicant Name (Manufacturer) :
Pie Medical Imaging BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAAS Workstation is a modular software product intended to be used by or under supervision of a cardiologist or radiologist in order to aid in reading, co-registering and interpreting cardiovascular X-Ray images to support diagnoses and for assistance during intervention of cardiovascular conditions.
CAAS Workstation features segmentation of cardiovascular structures, 3D reconstruction of vessel segments and catheter path based on multiple angiographic images, measurement and reporting tools to facilitate the following use:
- Calculate the dimensions of cardiovascular structures;
- Quantify stenosis in coronary and peripheral vessels;
- Quantify the motion of the left and right ventricular wall;
- Perform density measurements;
- Determine C-arm position for optimal imaging of cardiovascular structures;
- Enhance stent visualization and measure stent dimensions;
- Quantify pressure drop in coronary vessels;
- Co-registration of angiographic X-Ray images with IVUS and OCT images.
CAAS Workstation is intended to be used by or under supervision of a cardiologist or radiologist.
Device Description
The CAAS Workstation is designed as a stand-alone software package to run on a PC with a Windows operating system. It can read DICOM X-ray images from an directory, or received from the X-ray or PACS system. Intravascular images (such as intravascular ultrasound (IVUS) and optical coherence tomography (OCT) in DICOM format can be read from a directory, or received from the intravascular imaging console or PACS system. IVUS images can also be received realtime as a video stream from an intravascular imaging console via a DVI streamer. The CAAS Workstation product has a moderate level of concern.
CAAS Workstation is composed out of the following analysis workflows: QCA, QCA3D, QVA, LVA, RVA, StentEnhancer and IV-LINQ of the previously cleared predicate device CAAS Workstation (K151780) for calculating dimensions of coronary and peripheral vessels and the left and right ventricles, quantification of stenosis, performing density measurements, determination of optimal C-arm position for imaging of vessel segments and functionality to enhance the visualization of a stent and to measure stent dimension. Semi-automatic contour detection forms the basis for the analyses. Functionality to co-register X-ray angiographic imaging techniques (such as IVUS and OCT) is added by means of the analysis module IV-LINQ.
In the newly added vFFR workflow the user can calculate the pressure drop and a vFFR value on coronary vessels. To obtain these values for a specific lesion in a coronary vessel, the user has to start with a QCA3D detection using two angiographic images. In each of these images a classic 2D coronary detection is performed after which a reconstruction of the coronary segment is obtained in 3D space. Based on the 3D reconstruction and the user input of systolic and diastolic aortic root blood pressure drop and the vFFR values can be assessed. The functionality is based on a combination of the QCA3D workflow available in predicate device CAAS Workstation (K151780) and technology available in the predicate device CAAS (K052988).
Results can be displayed on the screen, printed or saved in a variety of formats to hard disk, network, PACS system or CD. Results and clinical images with overlay can also be printed as a hardcopy and exported in various electronic formats. The functionality is independent of the type of vendor acquisition equipment.
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K Number
K162112Device Name
CAAS MRV
Manufacturer
Pie Medical Imaging BV
Date Cleared
2016-09-21
(54 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Pie Medical Imaging BV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CAAS MRV features segmentation of cardiovascular structures on different types of MR images as well as measurement and reporting tools to facilitate the following use:
· Quantitative functional and regional analyses of the heart ventricles
· Quantification of T2 and T2* relaxation values
CAAS MRV is intended to be used by or under supervision of a cardiologist. When the results provided by CAAS MRV are used in a clinical setting to support diagnosis of cardiovascular conditions, the results assurts of critic to be regarded as the sole, irrefutable basis for clinical decision making.
Device Description
CAAS MRV is designed as a stand-alone modular software package for viewing and quantification of cardiovascular MR images intended to run on a PC with a Windows operating system. The images for analysis can be read from CD, hard disk or from a PACS system and CAAS MRV provides the functionality to scan the contents of a specific directory and to organize the found DICOM MR images into patients, studies and series.
CAAS MRV contains several analysis workflows of the previously cleared predicate device CAAS MRV (K060941) for quantification of the functional and regional parameters of the heart ventricles. Contour detection performed automatically, semi-automatically or manually forms the bases for the analyses.
Functionality to quantify T2 and T2* relaxation values is added by means of the analysis module Tissue Mapping. For this specific feature, Medis MR-CT VVA is used as a predicate device. This feature is implemented in MR-CT VVA and is very similar in both control and presentation, to the CAAS MRV feature, and yields the same results.
The quantitative results of CAAS MRV support diagnosis of cardiovascular conditions.
The analysis results are available on screen and can be saved to hard-disk to enable re-analysis of the data. Also, the analysis results can be exported in various electronic formats.
The functionality is independent of the type of vendor acquisition equipment.
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