CAAS WORKSTATION

• K Number: K133993
• Device Name: CAAS WORKSTATION
• Manufacturer: PIE MEDICAL IMAGING
• Date Cleared: 2014-03-25 ( 89 days)
• Product Code: IZI LLZ
• Regulation Number: 892.1600

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 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.

Predicate Devices

K052988, K100292, K110256

Reference Devices

K052988, K100292, K110256

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the analysis modules as based on "Semi-automatic contour detection" and functionality from previously cleared predicate devices, without mentioning AI/ML.

Therapeutic

No
The device aids in reading and interpreting images for diagnosis and intervention but does not directly treat a patient.

Diagnostic

Yes

The device is intended to "aid in reading and interpreting cardiovascular X-Ray images to support diagnoses" and its results are used in a clinical setting "to support diagnoses and for assistance during intervention of cardiovascular conditions."

SaMD (Software as a Medical Device)

Yes

The device is explicitly described as a "stand-alone modular software product" intended to run on a standard PC with a Windows operating system. It processes existing X-ray angiographic images and does not include any proprietary hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• CAAS Workstation's Function: The CAAS Workstation is a software product that analyzes X-ray angiographic images. These images are generated in vivo (within the living body) during a medical procedure. The software processes and quantifies information from these images to aid in the interpretation of cardiovascular structures and conditions.
• No Sample Analysis: The device does not analyze biological samples taken from the patient. Its input is image data, not biological material.

Therefore, while the CAAS Workstation is a medical device used to support diagnosis and intervention, its function falls under the category of medical image analysis software rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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 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.

Product codes

IZI, LLZ

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray Angiography

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

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.

Key Metrics

Not Found

Predicate Device(s)

K052988, K100292, K110256

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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
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	[phone]		510(k) number		K052988	K100292	K110256
Fax Number	[phone]		Data type	X-Ray Angiography
data in DICOM format
(vendor independent)	X-Ray Angiography
data in DICOM format
(vendor independent)	X-Ray Angiography
data in DICOM format
(vendor independent)	X-Ray Angiography
data in DICOM format
(vendor independent)
Contact Person:	Florie Daniels, Product Registration Coordinator		Import of Patient
Data	Manual through
keyboard
Command line
interface	Manual through
keyboard
Command line
interface	Manual through
keyboard
Command line
interface	Manual through
keyboard
Command line
interface
Email Address	[e-mail]		Contour
Definition	Manual and semi-
automatic centerline
definition based
contour detection of
coronary and
peripheral vessel
Manual and semi-
automatic left
ventricular contour
definition
Manual right
ventricular contour
definition
Manual stent contour
definition
Contour correction and
restriction	Manual and semi-
automatic centreline
definition based
contour detection of
coronary and
peripheral vessel
Manual and semi-
automatic left
ventricular contour
definition
Manual right
ventricular contour
definition
Contour correction and
restriction	Manual and semi-
automatic centreline
definition based
contour detection of
coronary and
peripheral vessel
Contour correction and
restriction	Manual stent contour
definition
Contour correction
Preparation Date	24-Dec-2013		Image Display	2D X-Ray image
3D coronary vessel
reconstruction	2D X-Ray image	2D X-Ray image
3D coronary and
peripheral vessel
reconstruction	2D X-Ray image
Trade Name	CAAS Workstation		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
3D coronary vessel
reconstruction
Left and right	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	Automatic calibration
Automatic and manual
stenosis assessment
3D coronary and
peripheral vessel
reconstruction	Enhanced stent
visualization
Stent dimensions
Common Name	Cardiovascular Angiography Analysis System (CAAS)			Left and right	Left ventricular
Classification	Classification Name: Angiographic X-ray System
Regulation Class: Class II
Regulation number: 21 CFR 892.1600
Classification Product Code: IZI
Subsequent 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 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.
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 and
interpreting cardiovascular X-Ray images to support diagnoses and for assistance
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.

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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.

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 [phone] or [phone] 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 [phone] or [phone] 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

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

Smh.7)

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