CAAS WORKSTATION

{0}------------------------------------------------ **MAR 2 5 2014** KB33993 PIE MEDICAL Page 1 of 4 IMAGING | 510(k) Summary | CAAS Workstation | [GEN1632]v2.0 | | New Device | Predicate Device | Predicate Device | Predicate Device | 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| Submitter/Owner Name | Pie Medical Imaging BV | | Device name | CAAS Workstation | CAAS | CAAS QxA3D | IC-PRO System | | Address | Philipsweg 1, 6227 AJ Maastricht, The Netherlands | | Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Pie Medical Imaging | Paieon | | Phone Number | +31 43 32 81 328 | | 510(k) number | | K052988 | K100292 | K110256 | | Fax Number | +31 43 32 81 329 | | Data type | X-Ray Angiography<br>data in DICOM format<br>(vendor independent) | X-Ray Angiography<br>data in DICOM format<br>(vendor independent) | X-Ray Angiography<br>data in DICOM format<br>(vendor independent) | X-Ray Angiography<br>data in DICOM format<br>(vendor independent) | | Contact Person: | Florie Daniels, Product Registration Coordinator | | Import of Patient<br>Data | Manual through<br>keyboard<br>Command line<br>interface | Manual through<br>keyboard<br>Command line<br>interface | Manual through<br>keyboard<br>Command line<br>interface | Manual through<br>keyboard<br>Command line<br>interface | | Email Address | Florie.Daniels@pie.nl | | Contour<br>Definition | Manual and semi-<br>automatic centerline<br>definition based<br>contour detection of<br>coronary and<br>peripheral vessel<br>Manual and semi-<br>automatic left<br>ventricular contour<br>definition<br>Manual right<br>ventricular contour<br>definition<br>Manual stent contour<br>definition<br>Contour correction and<br>restriction | Manual and semi-<br>automatic centreline<br>definition based<br>contour detection of<br>coronary and<br>peripheral vessel<br>Manual and semi-<br>automatic left<br>ventricular contour<br>definition<br>Manual right<br>ventricular contour<br>definition<br>Contour correction and<br>restriction | Manual and semi-<br>automatic centreline<br>definition based<br>contour detection of<br>coronary and<br>peripheral vessel<br>Contour correction and<br>restriction | Manual stent contour<br>definition<br>Contour correction | | Preparation Date | 24-Dec-2013 | | Image Display | 2D X-Ray image<br>3D coronary vessel<br>reconstruction | 2D X-Ray image | 2D X-Ray image<br>3D coronary and<br>peripheral vessel<br>reconstruction | 2D X-Ray image | | Trade Name | CAAS Workstation | | Image<br>Assessment | Manual and automatic<br>calibration<br>Basic length, diameter,<br>density and angle<br>measurements<br>Vessels and ventricle<br>dimensions (diameters,<br>areas, volumes)<br>Automatic and manual<br>stenosis assessment<br>3D coronary vessel<br>reconstruction<br>Left and right | Manual and automatic<br>calibration<br>Basic length, diameter,<br>density and angle<br>measurements<br>Vessels and ventricle<br>dimensions (diameters,<br>areas, volumes)<br>Automatic and manual<br>stenosis assessment<br>Left and right<br>ventricular wall motion | Automatic calibration<br>Automatic and manual<br>stenosis assessment<br>3D coronary and<br>peripheral vessel<br>reconstruction | Enhanced stent<br>visualization<br>Stent dimensions | | Common Name | Cardiovascular Angiography Analysis System (CAAS) | | | Left and right | Left ventricular | | | | Classification | Classification Name: Angiographic X-ray System<br>Regulation Class: Class II<br>Regulation number: 21 CFR 892.1600<br>Classification Product Code: IZI<br>Subsequent Product Code: LLZ | | | | | | | | Predicate Devices | CAAS (K052988)<br>CAAS QxA3D (K100292)<br>IC-PRO System (K110256) | | | | | | | | Device Description | CAAS Workstation is designed as a stand-alone modular software product for<br>viewing and quantification of X-ray angiographic images intended to run on a PC<br>with a Windows operating system. CAAS Workstation contains the analysis<br>modules QCA, QCA3D, QVA, LVA, RVA and StentEnhancer.<br>The analysis modules QCA, QCA3D, QVA, LVA and RVA contain functionality<br>of the previously cleared predicate devices CAAS (K052988) and CAAS QxA3D<br>(K100292) for calculating dimensions of coronary and peripheral vessels and the<br>left and right ventricles, quantification of stenosis, performing density<br>measurements and determination of optimal C-arm position for imaging of vessel<br>segments. Semi-automatic contour detection forms the basis for the analyses.<br>Functionality to enhance the visualization of a stent and to measure stent<br>dimension is added by means of the analysis module StentEnhancer. This<br>functionality is based on the StentOptimizer module of the IC-PRO System<br>(K110256).<br>The quantitative results CAAS Workstation support diagnosis and intervention of<br>cardiovascular conditions.<br>The analysis results are available on screen, and can be exported in various<br>electronic formats.<br>The functionality is independent of the type of vendor acquisition equipment. | | | | | | | | Intended Use | CAAS Workstation is a modular software product intended to be used by or under<br>supervision of a cardiologist or radiologist in order to aid in reading and<br>interpreting cardiovascular X-Ray images to support diagnoses and for assistance<br>during intervention of cardiovascular conditions. | | | | | | | {1}------------------------------------------------ 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; - Determine C-arm position for optimal imaging of cardiovascular structures; · Enhance stent visualization and measure stent dimensions. 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. Technological Characteristics Comparison A comparison of the technological characteristics of the predicate and subject device is given the table below. {2}------------------------------------------------ | | New Device | Predicate Device | Predicate Device | Predicate Device | |--------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------|------------------| | Device name | CAAS Workstation | CAAS | CAAS QxA3D | IC-PRO System | | Manufacturer | Pic Medical Imaging | Pie Medical Imaging | Pie Medical Imaging | Paeion | | 510(k) number | | K052988 | K100292 | K110256 | | | ventricular wall motion Left ventricular myocardium dimensions Enhanced stent visualization Stent dimensions | myocardium dimensions | | | | Storage of Results | Printout Images XML DICOM SC PDF | Printout Images XML DICOM SC DICOM SR | Printout Images XML DICOM SC DICOM SR | Printout Images | | Operating System | Windows | Windows | Windows | Windows | All technological characteristics of the subject device are similar to the cleared predicate devices. Conformance Standards The device complies with the following conformance standards: - ISO 14971:2007, Medical devices Application of risk management to � medical devices - . NEMA PS 3.1 - 3.20 (2011), Digital Imaging and Communication in Medicine (DICOM) Set. (Radiology) - IEC 62304 First edition 2006-05, Medical device software Software life . cycle processes System requirements - derived from the intended use and indications for use - as Performance Data well as risk control measures are verified by system testing. For each analysis module a validation approach is created and the proper functioning of the algorithms is validated. For analysis modules already implemented in earlier versions of CAAS regression testing is performed to verify equivalence in numerical results. The test results demonstrate safety and effectiveness of CAAS Workstation in relation to its intended use and that CAAS Workstation is considered as safe and effective as the predicate devices. - Substantial Equivalence The analysis modules QCA, QVA, I.VA, RVA in the previously cleared device CAAS' (K052988) and the analysis module QCA3D in the previously cleared device 'CAAS QxA3D' (K100292) are available in CAAS Workstation and are similar in terms of intended use and indications for use and in functionality. The analysis module 'StentEnhancer' has been added in CAAS Workstation and is similar in terms of intended use, indications for use and technology as the · StentOptimizer module available in 'The IC-PRO System' (K110256). - The testing reported in this 510(k) demonstrates that CAAS Workstation is Conclusion substantially equivalent to a combination of the predicate devices in terms of intended use, indications for use, technological characteristics, measurements and operating environment. As such CAAS Workstation is considered as safe and effective as its predicate devices and performs as well as the predicate devices. {3}------------------------------------------------ K133993 Page 4 of 4 . {4}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2014 Pie Medical Imaging, B.V. % Ms. Florie Daniels Regulatory Affairs Coordinator Philipsweg I Maastricht Limburg, 6227 AJ THE NETHERLANDS Re: K133993 Trade/Device Name: CAAS Workstation Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: IZI, LLZ Dated: December 24, 2013 Received: December 26, 2013 Dear Ms. Daniels: 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. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {5}------------------------------------------------ Page 2-Ms. Daniels If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Smh.7) for Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K133993 Device Name CAAS Workstation 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: - Determine C-arm position for optimal imaging of cardiovascular structures; - Enhance stent visualization and measure stent dimensions. CAAS Workstation is intended to be used by or under supervision of a cardiologist. 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Smh.7) This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." 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