← Product Code [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ) · K143044 # CAAS A-Valve (K143044) _Pie Medical Imaging BV · LLZ · Feb 6, 2015 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K143044 ## Device Facts - **Applicant:** Pie Medical Imaging BV - **Product Code:** [LLZ](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ.md) - **Decision Date:** Feb 6, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 892.2050 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Software as a Medical Device ## Intended Use CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. Based on angiographic X-ray images an analysis is performed: To assist in C-arm projection selection to optimize visualization during treatment; To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors; To provide an objective and reproducible grading method for aortic regurgitation based on time versus density curves extracted from an aortogram. The software is used by or under supervision of a cardiologist. When the results provided by CAAS A-Valve are used in a clinical setting to support diagnoses or 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 Story Standalone PC software; processes DICOM X-ray angiographic images. Two workflows: Optimal Projection and quantitative Regurgitation Analysis (qRA). Optimal Projection: user defines aortic root contours; software generates 3D reconstruction; calculates optimal C-arm projection and dimensions. qRA: user defines aortic root and left ventricle contours; software subtracts static background; calculates time-versus-contrast density curves; computes regurgitation grade and dynamic color map for left ventricle. Used in clinical settings by cardiologists/radiologists to assist in aortic root treatment planning and intervention. Output displayed on screen, printed, or saved to PACS/network. Assists clinical decision-making by providing objective measurements and visualization; not intended as sole basis for diagnosis. ## Clinical Evidence Bench testing only. Verification and validation performed for optimal C-arm projection, aortic root dimensions, time-versus-density curves, and aortic regurgitation grading. Results demonstrate safety and effectiveness equivalent to predicates. ## Technological Characteristics Standalone software for Windows PC. Inputs: DICOM X-ray angiography. Outputs: 2D/3D visualizations, measurements, XML reports. Conformance: ISO 14971 (risk management), NEMA PS 3.20 (DICOM), IEC 62304 (software lifecycle). ## Regulatory Identification A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements. ## Special Controls *Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). ## Predicate Devices - CAAS A-Valve ([K113076](/device/K113076.md)) - CAAS ([K052988](/device/K052988.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 6, 2015 Pie Medical Imaging B.V. % Ms. Florie Daniels Regulatory Affairs Coordinator Philipsweg 1 Maastricht, Limburg 6227 AJ THE NETHERLANDS Re: K143044 Trade/Device Name: CAAS A-Valve Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 6, 2015 Received: January 12, 2015 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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, Robert A Ochs Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143044 Device Name CAAS A-Valve #### Indications for Use (Describe) CAAS A-Valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. Based on angiographic X-ray images an analysis is performed: To assist in C-arm projection selection to optimize visualization during treatment; To calculate dimensions of the aortic root corrected for out-of-plane magnification and foreshortening errors; To provide an objective and reproducible grading method for aortic regurgitation based on time versus density curves extracted from an aortogram. The software is used by or under supervision of a cardiologist. When the results provided by CAAS A-Valve are used in a clinical setting to support diagnoses or 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) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ solutions in cardiovascular analysis Image /page/3/Picture/1 description: The image shows the logo for PIE MEDICAL IMAGING. The logo consists of a stylized geometric shape on the left and the text "PIE MEDICAL IMAGING" on the right. The geometric shape is made up of interconnected squares and lines, creating a modern and abstract design. The text is in a sans-serif font and is arranged in two lines, with "PIE MEDICAL" on the top line and "IMAGING" on the bottom line. | 510(k) Summary | CAAS A-Valve | [GEN1446]v4.0 | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------------------------------| | 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: | Florie Daniels, Regulatory Affairs Coordinator | | | | Email Address | Florie.Daniels@pie.nl | | | | Preparation Date | 20 October 2014 | | | | Trade Name | CAAS A-Valve | | | | Common Name | CAAS A-Valve | | | | Regulation Class | Class II (21 CFR, part 892.2050, LLZ) | | | | Classification Name | Picture Archiving and Communications System | | | | Predicate Devices | CAAS A-Valve (K113076)
CAAS (K052988) | | | | Device Description | CAAS A-Valve is a stand-alone software application, intended to run on a PC
with a Windows operating system. The images for analysis can be read from a
directory or from an X-ray system or PACS through a command line interface.
The results can be displayed on the screen, printed or saved in a variety of
formats to a hard disk, network, PACS system or CD. Results and clinical images
with overlay can also be printed as a hardcopy. | | | | | CAAS A-Valve consists of two separate workflows, Optimal Projection and qRA
(quantitative Regurgitation Analysis). | | | | | With CAAS A-Valve - Optimal Projection, angiographic images of the aortic
root can be analyzed to determine a good projection for visualization of the aortic
root and to perform basic measurements. As input for analysis, two angiographic
images of the aortic root can be selected. On both images the contour of the aortic
root is defined manually by the user. The 2D aortic root contours in each image
are used to generate a 3D reconstruction of the aortic root. By indicating the right
coronary cusp in both projections the software determines the recommended
projection (PRL projection). This projection can be used to acquire an aortogram
with the cusps in a line and all cusps visible. Additionally it is possible to perform
diameter and length measurements based on the 3D reconstruction. | | | | | The Optimal Projection workflow is 510(k) cleared under K113076. | | | | | CAAS A-Valve - qRA is used to determine aortic regurgitation (also referred to
as aortic insufficiency). This is done based on a multi-frame image showing the
aortic root and the left ventricle while contrast liquid is injected in the aorta
during the X-ray acquisition; also known as an aortogram. | | | | The user draws the contour of the aortic root and the left ventricle and indicates
the basal plane. Next a static background, which is obtained from the images
before contrast injection, is subtracted resulting in an image sequence in which
the intensities correlate to the amount of contrast liquid. Based on this image
sequence combined with the user input, time versus contrast density curves are
calculated and visualized for both the aortic root and the left ventricle. The ratio
between the area under the curve of the aortic root and the area under the curve of
the left ventricle represents the amount of contrast liquid flowing from the aortic
root to the left ventricle and is a measure for regurgitation. Additionally a
dynamic color map is shown for the left ventricle. This color map is achieved by
showing the accumulative area under the curve at each image frame as a movie
with the same frame rate as used during the acquisition of the multi-frame image.
CAAS A-Valve is designed for use in clinical practice to support the physician
during or in preparation of treatment of the aortic root. | | | | | Intended Use | CAAS A-Valve has been developed to support the interventionalist during or in
preparation of treatment of the aortic root.
Based on angiographic images CAAS A-Valve quantifies:
• Dimensions of the aortic root and assists in C-arm positioning;
• Time versus density curves of the ventricle.
The software is used by or under supervision of a cardiologist or radiologist. | | | | Indications for Use | CAAS A-Valve has been developed to support the interventionalist during or in
preparation of treatment of the aortic root.
Based on angiographic X-ray images an analysis is performed:
• To assist in C-arm projection selection to optimize visualization during
treatment;
• To calculate dimensions of the aortic root corrected for out-of-plane
magnification and foreshortening errors;
• To provide an objective and reproducible grading method for aortic
regurgitation based on time versus density curves extracted from an
aortogram.
The software is used by or under supervision of a cardiologist or radiologist.
When the results provided by CAAS A-Valve are used in a clinical setting to
support diagnoses or 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 predicates and subject
device is given the table below. | | | | | New Device | Predicate Device | Predicate Device | | Device name | CAAS A-Valve | CAAS A-Valve | CAAS | | Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Pie Medical Imaging | | 510(k) number | Unknown | K113076 | K052988 | | 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) | | Import of Patient Data | • Manual through keyboard
• Automatic import with
image file | • Manual through keyboard
• Automatic import with
image file | • Manual through keyboard
• Automatic import with
image file | | Contour Definition | • Manual Contour Definition | • Manual Contour Definition | • Manual and Automatic
Contour Definition | | Image Display | • 2D X-Ray image
• 3D Reconstruction | • 2D X-Ray image
• 3D Reconstruction | • 2D X-Ray image
• n/a | {4}------------------------------------------------ {5}------------------------------------------------ | | New Device | Predicate Device | Predicate Device | |--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Device name | CAAS A-Valve | CAAS A-Valve | CAAS | | Manufacturer | Pie Medical Imaging | Pie Medical Imaging | Pie Medical Imaging | | 510(k) number | Unknown | K113076 | K052988 | | Image Assessment | • Optimal projection
• Diameter and length measurements
• Time versus density curves of the left ventricle
• Grading method for Aortic Regurgitation
• Color map based on curves | • Optimal projection
• Diameter and length measurements
• n/a
• n/a
• n/a | • n/a
• Diameter and length measurements
• Densitometry and density measurements
• n/a
• n/a | | Storage of Results | • Printout
• Images
• XML | • Printout
• Images
• XML | • Printout
• Images
• XML | | Operating System | • Ms Windows | • Ms Windows | • Ms Windows | Substantial Equivalence Compared to the predicate devices: - CAAS A-Valve (K113076) 0 The intended use and indications for use of the predicate device CAAS A-Valve (K113076) are modified to include the quantification of time versus density curves of the ventricle which had been added in the new device CAAS A-Valve. Like the predicate device CAAS A-Valve (K113076), the subject device is intended to support the interventionalist during and in preparation of treatment of the aortic root. All technological characteristics, except the quantification of time versus density curves of the ventricle, of the subject device are the same as the cleared predicate device CAAS A-Valve (K113076). - CAAS (K052988) 0 Quantification of time versus density curves for regurgitation analysis is technologically similar to the densitometry measurements of the predicate device CAAS (K052988) howe… --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K143044](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/LLZ/K143044) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com