(121 days)
Not Found
No
The document describes image processing and analysis techniques like segmentation, 3D reconstruction, and measurements, but does not mention AI, ML, or related concepts like neural networks or training data. The analysis is based on semi-automatic contour detection and established algorithms.
No
The device is described as aiding in diagnosis and providing assistance during intervention, not as providing therapy itself. It facilitates measurement, quantification, and visualization for medical professionals.
Yes
The "Intended Use / Indications for Use" section explicitly states that the CAAS Workstation is "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." It also mentions features like quantifying stenosis and performing density measurements, which are diagnostic activities.
Yes
The device description explicitly states that the CAAS Workstation is designed as a "stand-alone software package to run on a PC with a Windows operating system." It reads and processes image data from external sources (DICOM files, video streams) but does not include any proprietary hardware components.
Based on the provided information, the CAAS Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CAAS Workstation's Function: The CAAS Workstation analyzes images (X-Ray, IVUS, OCT) of cardiovascular structures. It does not analyze biological specimens taken from the body. Its purpose is to aid in the interpretation and measurement of these images to support diagnoses and interventions.
Therefore, while the CAAS Workstation is a medical device used to support clinical decision-making, its function falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QHA, LLZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray angiography, IVUS, OCT
Anatomical Site
cardiovascular structures, coronary and peripheral vessels, left and right ventricular wall
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologist or radiologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Study Type: Verification and validation.
- Sample Size: Not explicitly stated, refers to "series of X-ray angiographic datasets".
- AUC: Not Found.
- MRMC: Not Found.
- Standalone Performance: Not Found.
- Key Results:
- Equivalence in numerical results for analysis workflows already available in predicate device K151780 was demonstrated with regression testing.
- To demonstrate proper integration of the functionality 'quantification of pressure drop in coronary vessels' from predicate device K052988 into CAAS Workstation, a series of X-ray angiographic datasets with known pressure drops were analysed and compared with K052988 and the new CAAS Workstation.
- The functionality 'quantification of pressure drop in coronary vessels' in the new CAAS Workstation is based on a 3D coronary reconstruction out of 2 angiographic images. In the predicate device K052988, which uses a method based on a single angiographic image, the results were generated for both the angiographic images as used for the 3D reconstruction. The results for the pressure drop were compared and differences (mean and standard deviation) of the calculated pressure drops with respect to known pressure drops of the used datasets were calculated. A Pearson correlation between the known and calculated pressure drop values was also performed.
- This demonstrated that the quantification of pressure drop in coronary vessels in the new CAAS Workstation is improved compared to the predicate device K052988.
- The verification and validation results demonstrate the safety and effectiveness of CAAS Workstation to its intended use and therefore CAAS Workstation can be considered as safe and effective as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Differences (mean and standard deviation) of calculated pressure drops with respect to known pressure drops.
- Pearson correlation between known and calculated pressure drop values.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2019
Pie Medical Imaging B.V. % Annemiek Bouts Regulatory Affairs Coordinator Philipsweg 1 6227 AJ Maastricht, Limburg THE NETHERLANDS
Re: K180019
Trade/Device Name: CAAS Workstation Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: Class II Product Code: QHA, LLZ Dated: March 28, 2018 Received: April 2, 2018
Dear Annemiek Bouts:
This letter corrects our substantially equivalent letter of May 3, 2018.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180019
Device Name CAAS Workstation
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
| ü Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
| 510(k) Summary | CAAS Workstation Pie Medical Imaging BV |
|---|---|
| Submitter/Owner Name | Pie Medical Imaging BV |
| Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands |
| Phone Number | +31 43 32 81 328 |
| Fax Number | +31 43 32 81 329 |
| Contact Person | Annemiek Bouts, Regulatory Affairs Coordinator |
| Email Address | annemiek.bouts@pie.nl |
| Preparation Date | 23-May-19 |
| Trade Name | CAAS Workstation |
| Common Name | CAAS (Cardiovascular Angiographic Analysis System) |
| Classification | Regulation Name: Angiographic X-ray System |
| Regulation Class: Class II | |
| Regulation number: 21 CFR 892.1600 | |
| Classification Product Code: QHA | |
| Subsequent Product Code: LLZ | |
| Predicate Device | CAAS Workstation (K151780, Angiographic X-ray System, 21 CFR 892.1600, IZI, LLZ) |
| CAAS (K052988, Image Processing System, 21 CFR 892.2050, LLZ) |
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.
4
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.
Indications for Use
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.
Substantial equivalence
A comparison of the technological characteristics of the predicate and subject device is given the table below.
| New Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Device name | CAAS Workstation | CAAS Workstation | CAAS |
| Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Pie Medical Imaging |
| 510(k) number | K180019 | K151780 | K052988 |
| Intended use | Intended Use and Indications for Use | ||
| 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 in diagnoses and | |||
| for assistance during intervention | |||
| of cardiovascular conditions. | 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 in diagnoses and | |||
| for assistance during intervention | |||
| of cardiovascular conditions. | The intended use of CAAS is: | ||
| • Quantification of coronary artery | |||
| dimensions; | |||
| • Quantification of peripheral | |||
| arteries and aorta; | |||
| • Quantification of left and right | |||
| ventricles; | |||
| • Management of data resulting of | |||
| the quantitative analysis. |
CAAS is used online or offline in
hospitals and offline for research
purposes. In hospitals, the software
will be used by cathlab personnel
under supervision of cardiologists
and radiologists. In research
institutes, the users are principal
investigators and other research
personnel operating under
supervision of cardiologists and
radiologists as well. |
| Indications for
use | CAAS Workstation features
segmentation of cardiovascular
structures, 3D reconstruction of
vessel segments 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; | CAAS Workstation features
segmentation of cardiovascular
structures, 3D reconstruction of
vessel segments 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: | CAL
Calculate the pixel size of the image
to be analysed.
MEAS
Perform basic length, angle and
density measurements.
QCA
Detect the contour of the coronary
vessel in the angiographic X-ray
image
- Calculate the dimensions of the
coronary artery segment. |
| | | | |
| | • 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. | • Determine C-arm position for
optimal imaging of cardiovascular
structures;
• Enhance stent visualization and
measure stent dimensions;
• 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. When
the results provided by CAAS
Workstation are used in a clinical
setting to support diagnoses and
for assistance during intervention
of cardiovascular conditions, the
results are explicitly not to be
regarded as the sole, irrefutable
basis for clinical decision making. | QVA
Detect the contour of the
peripheral vessel in the
angiographic X-ray image
- Calculate the dimensions of the
peripheral vessel segment.
LVA
Delineate the outline of the left
ventricular wall automatically
and/or manually in angiographic X-
ray images – either monoplane or
biplane analysis; absolute
measurements of left ventricular
volumes; calculations of derived
parameters; quantification of the
motion of the left ventricular wall;
estimations of the dimensions of
the myocardial wall.
RVA
Delineate the outline of the right
ventricular wall semi-automatically
and/or manually in angiographic X-
ray images - either monoplane or
biplane analysis; absolute
measurements of right ventricular
volumes based on several
established models for children and
adults; calculations of derived
parameters; quantification of the
motion of the right ventricular wall. |
| | | Technological Characteristics | |
| Data type | • X-Ray angiography in DICOM
format (vendor independent);
• IVUS and OCT data in DICOM
format (vendor independent);
• IVUS data as video stream | • X-Ray angiography in DICOM
format (vendor independent);
• IVUS and OCT data in DICOM
format (vendor independent;)
• IVUS data as video stream | • X-Ray angiography in DICOM
format (vendor independent);
• n/a
• n/a |
| Import of patient
data | • Manual through keyboard;
• Command line interface | • Manual through keyboard;
• Command line interface | • Manual through keyboard;
• Command line interface |
| Contour
definition | • Manual and semi-automatic
centreline definition based
contour detection of coronary
and peripheral vessels;
• Manual and semi-automatic left
ventricular contour definition;
• Manual right ventricular contour
definition;
• Manual stent contour definition;
• Contour correction and
restriction;
• Manual catheter path definition | • Manual and semi-automatic
centreline definition based
contour detection of coronary
and peripheral vessels;
• Manual and semi-automatic left
ventricular contour definition;
• Manual right ventricular contour
definition;
• Manual stent contour definition;
• Contour correction and
restriction;
• Manual catheter path definition | • Manual and semi-automatic
centreline definition based
contour detection of coronary
and peripheral vessels;
• Manual and semi-automatic left
ventricular contour definition;
• Manual right ventricular contour
definition;
• Manual stent contour definition;
• Contour correction and
restriction;
• Manual catheter path definition |
| Image display | • 2D X-ray image;
• 3D reconstruction based on 2 X-
ray images;
• 2D intravascular image; | • 2D X-ray image;
• 3D reconstruction based on 2 X-
ray images;
• 2D intravascular image; | • 2D X-ray image
• n/a
• n/a
• n/a |
| | reconstruction | reconstruction | |
| Image
assessment | • Manual and automatic
calibration;
• Basic length, diameter, density
and angle measurements;
• Vessels and ventricle dimensions
(diameters, areas, volumes);
• Automatic and manual stenosis
assessment;
• Left and right ventricular wall
motion;
• Left ventricular myocardium
dimensions;
• Enhanced stent visualization;
• Stent dimensions;
• Pressure drop calculation in
coronary vessels;
• Providing common frame of
reference for IVUS and OCT data
with X-ray angiographic data | • Manual and automatic
calibration;
• Basic length, diameter, density
and angle measurements;
• Vessels and ventricle dimensions
(diameters, areas, volumes);
• Automatic and manual stenosis
assessment;
• Left and right ventricular wall
motion;
• Left ventricular myocardium
dimensions;
• Enhanced stent visualization;
• Stent dimensions;
• n/a
• Providing common frame of
reference for IVUS and OCT data
with X-ray angiographic data | • Manual and automatic
calibration;
• Basic length, diameter, density
and angle measurements;
• Vessels and ventricle dimensions
(diameters, areas, volumes);
• Automatic and manual stenosis
assessment;
• Left and right ventricular wall
motion;
• Left ventricular myocardium
dimensions;
• n/a
• n/a
• Pressure drop calculation in
coronary vessels (in stenotic flow
reserve and hemodynamic data
functionality);
• n/a |
| Storage of results | • Printout;
• Images;
• XML;
• DICOM SC;
• PDF
• n/a | • Printout;
• Images;
• XML;
• DICOM SC;
• PDF
• n/a | • Printout;
• Images;
• XML;
• DICOM SC;
• n/a
• DICOM SR |
| Operating system | • Windows | • Windows | • Windows |
5
6
The basic features and technology of the new CAAS Workstation are the same in terms of indications for use and have the same technological characteristics as the predicate devices CAAS Workstation (K151780) and CAAS (K052988). The cardiovascular functions supported by the CAAS Workstation of functions provided by the predicate devices K151780 and K052988. All software applications use the same types of data and operating principles for the user and technology regarding data import, contour definition, image display and storage of results.
Performance Data
Verification and validation of the CAAS Workstation showed that the system requirements – derived from the intended use and indications for use – as well as risk control measures were implemented correctly and that the device meets its specifications including conformance to the following standards:
- · ISO 14971:2007, Medical devices Application of risk management to medical devices
- NEMA PS 3.1 3.20 (2016), Digital Imaging and Communication in Medicine (DICOM)
- · IEC 62304 Ed 1.1, 2015-06, Medical device software Software life cycle processes
- IEC 62336-1 Ed 1.0 2015-02, Medical devices Application of usability engineering to medical devices
For each analysis workflow in CAAS Workstation approach is created and the proper functioning of the algorithms is validated.
- Equivalence in numerical results for the analysis workflows already available in predicate device K151780 was . demonstrated with regression testing.
- . To demonstrate a proper integration of the functionality 'quantification of pressure drop in coronary vessels' from predicate device K052988 into CAAS Workstation, a series of X-ray angiographic datasets with known pressure drops were analysed and compared with K052988 and the new CAAS Workstation. The functionality 'quantification of pressure drop in coronary vessels' in the new CAAS Workstation is based on a 3D coronary reconstruction out of 2 angiographic images. In the predicate device K052988, which uses a method based on a single angiographic image, the results were generated for both the angiographic images as used for the 3D reconstruction. The results for the pressure drop were compared and differences (mean and standard deviation) of the calculated pressure drops with respect to known pressure drops of the used datasets were
7
calculated. A Pearson correlation between the known and calculated pressure drop values was also performed. This demonstrated that the quantification of pressure drop in coronary vessels in the new CAAS Workstation is improved compared to the predicate device K052988.
The verification and validation results demonstrate the safety and effectiveness of CAAS Workstation to its intended use and therefore CAAS Workstation can be considered as safe and effective as its predicate devices.
Conclusion
Based on the application of risk management and performance testing inherent to PMI's QA system (compliant with recognized standards as stated above) we conclude that CAAS Workstation is as safe and effective as its predicate devices in terms of intended use, indications for use, technological characteristics, measurements and operating environment and does not raise any new issues related to safety and effectiveness compared to the predicate devices.