CAAS WORKSTATION by PIE MEDICAL IMAGING

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 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 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.

Device Description

CAAS Workstation is designed as a stand-alone modular software product for viewing and quantification of X-ray angiographic images intended to run on a PC with a Windows operating system. CAAS Workstation contains the analysis modules QCA, QCA3D, QVA, LVA, RVA and StentEnhancer.
The analysis modules QCA, QCA3D, QVA, LVA and RVA contain functionality of the previously cleared predicate devices CAAS (K052988) and CAAS QxA3D (K100292) for calculating dimensions of coronary and peripheral vessels and the left and right ventricles, quantification of stenosis, performing density measurements and determination of optimal C-arm position for imaging of vessel segments. Semi-automatic contour detection forms the basis for the analyses.
Functionality to enhance the visualization of a stent and to measure stent dimension is added by means of the analysis module StentEnhancer. This functionality is based on the StentOptimizer module of the IC-PRO System (K110256).
The quantitative results CAAS Workstation support diagnosis and intervention of cardiovascular conditions.
The analysis results are available on screen, and can be exported in various electronic formats.
The functionality is independent of the type of vendor acquisition equipment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CAAS Workstation, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria with corresponding device performance metrics in a clear, tabular format. Instead, it relies on demonstrating substantial equivalence to predicate devices. The performance data section broadly states:

"System requirements - derived from the intended use and indications for use - as 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."

Therefore, the acceptance criterion is substantial equivalence to previously cleared predicate devices (CAAS K052988, CAAS QxA3D K100292, and IC-PRO System K110256) in terms of intended use, indications for use, technological characteristics, measurements, and operating environment. The "reported device performance" is that the device meets this equivalence through system testing, algorithm validation, and regression testing, ensuring comparable safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "system testing," "algorithm validation," and "regression testing" without specifying the number of cases or images used in these tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number or qualifications of experts used to establish ground truth for any test sets. The intended users are "cardiologist or radiologist," suggesting their expertise would be relevant, but details about ground truth establishment are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not specifically described in the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a comparative effectiveness study showing improvement with AI assistance.

6. Standalone Performance Study (Algorithm Only)

The testing performed includes "the proper functioning of the algorithms is validated," which implies a standalone (algorithm only) performance evaluation. However, specific results or detailed methodologies of such a standalone study are not provided beyond the general statement of validation. The device is a "stand-alone modular software product," suggesting its algorithms function independently to produce results that aid clinicians.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for testing (e.g., expert consensus, pathology, outcomes data). Given the nature of the device (quantification of cardiovascular structures from angiographic images), it is highly probable that expert consensus (e.g., manual measurements by cardiologists/radiologists) would have been used as a reference for validation and regression testing, but this is not explicitly stated.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. Given the date of the submission (2014) and the focus on substantial equivalence to predicate devices, it's possible that traditional rule-based algorithms or earlier machine learning approaches were used that might not involve large-scale "training sets" in the modern deep learning sense. The device is presented as offering "semi-automatic" contour detection, which might rely on image processing algorithms rather than extensive machine learning training data.

9. How Ground Truth for the Training Set Was Established

Since no training set details are provided, the method for establishing its ground truth is also not mentioned.

Summary

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MAR 2 5 2014 KB33993
PIE MEDICAL Page 1 of 4
IMAGING

510(k) Summary	CAAS Workstation		New Device	Predicate Device	Predicate Device	Predicate Device
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 Angiographydata in DICOM format(vendor independent)	X-Ray Angiographydata in DICOM format(vendor independent)	X-Ray Angiographydata in DICOM format(vendor independent)	X-Ray Angiographydata in DICOM format(vendor independent)
Contact Person:	Florie Daniels, Product Registration Coordinator	Import of PatientData	Manual throughkeyboardCommand lineinterface	Manual throughkeyboardCommand lineinterface	Manual throughkeyboardCommand lineinterface	Manual throughkeyboardCommand lineinterface
Email Address	Florie.Daniels@pie.nl	ContourDefinition	Manual and semi-automatic centerlinedefinition basedcontour detection ofcoronary andperipheral vesselManual and semi-automatic leftventricular contourdefinitionManual rightventricular contourdefinitionManual stent contourdefinitionContour correction andrestriction	Manual and semi-automatic centrelinedefinition basedcontour detection ofcoronary andperipheral vesselManual and semi-automatic leftventricular contourdefinitionManual rightventricular contourdefinitionContour correction andrestriction	Manual and semi-automatic centrelinedefinition basedcontour detection ofcoronary andperipheral vesselContour correction andrestriction	Manual stent contourdefinitionContour correction
Preparation Date	24-Dec-2013	Image Display	2D X-Ray image3D coronary vesselreconstruction	2D X-Ray image	2D X-Ray image3D coronary andperipheral vesselreconstruction	2D X-Ray image
Trade Name	CAAS Workstation	ImageAssessment	Manual and automaticcalibrationBasic length, diameter,density and anglemeasurementsVessels and ventricledimensions (diameters,areas, volumes)Automatic and manualstenosis assessment3D coronary vesselreconstructionLeft and right	Manual and automaticcalibrationBasic length, diameter,density and anglemeasurementsVessels and ventricledimensions (diameters,areas, volumes)Automatic and manualstenosis assessmentLeft and rightventricular wall motion	Automatic calibrationAutomatic and manualstenosis assessment3D coronary andperipheral vesselreconstruction	Enhanced stentvisualizationStent dimensions
Common Name	Cardiovascular Angiography Analysis System (CAAS)		Left and right	Left ventricular
Classification	Classification Name: Angiographic X-ray SystemRegulation Class: Class IIRegulation number: 21 CFR 892.1600Classification Product Code: IZISubsequent Product Code: LLZ
Predicate Devices	CAAS (K052988)CAAS QxA3D (K100292)IC-PRO System (K110256)
Device Description	CAAS Workstation is designed as a stand-alone modular software product forviewing and quantification of X-ray angiographic images intended to run on a PCwith a Windows operating system. CAAS Workstation contains the analysismodules QCA, QCA3D, QVA, LVA, RVA and StentEnhancer.The analysis modules QCA, QCA3D, QVA, LVA and RVA contain functionalityof the previously cleared predicate devices CAAS (K052988) and CAAS QxA3D(K100292) for calculating dimensions of coronary and peripheral vessels and theleft and right ventricles, quantification of stenosis, performing densitymeasurements and determination of optimal C-arm position for imaging of vesselsegments. Semi-automatic contour detection forms the basis for the analyses.Functionality to enhance the visualization of a stent and to measure stentdimension is added by means of the analysis module StentEnhancer. Thisfunctionality is based on the StentOptimizer module of the IC-PRO System(K110256).The quantitative results CAAS Workstation support diagnosis and intervention ofcardiovascular conditions.The analysis results are available on screen, and can be exported in variouselectronic formats.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 undersupervision of a cardiologist or radiologist in order to aid in reading andinterpreting cardiovascular X-Ray images to support diagnoses and for assistanceduring intervention of cardiovascular conditions.

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Indications for 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.

Technological Characteristics Comparison

A comparison of the technological characteristics of the predicate and subject device is given the table below.

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	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.

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K133993
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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.

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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

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Indications for Use

510(k) Number (if known) K133993

Device Name CAAS Workstation

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.

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.7)

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Regulation Number and Section

§ 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.