(105 days)
Not Found.
No
The summary describes image processing and 3D reconstruction techniques but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is a software application that quantifies dimensions and assists in C-arm positioning, which are diagnostic and guidance functions, not therapeutic actions.
Yes
The device is described as quantifying dimensions of the aortic root and assisting in C-arm positioning for treatment preparation and support, which falls under the definition of providing information for diagnosis or treatment planning.
Yes
The device description explicitly states that "The CAAS A-Valve is a stand-alone software application intended to run on a PC with a Windows operating system." It processes existing angiographic images and provides analysis and recommendations, without including any hardware components.
Based on the provided information, the CAAS A-Valve is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- CAAS A-Valve analyzes medical images: The CAAS A-Valve processes and analyzes angiographic X-ray images, which are medical images of the aortic root. It does not interact with or analyze biological samples.
- Intended Use: The intended use clearly states that the device supports interventionalists during or in preparation for treatment of the aortic root by analyzing angiographic images to assist with C-arm positioning and calculate dimensions. This is a diagnostic imaging analysis tool, not an in vitro diagnostic test.
Therefore, the CAAS A-Valve falls under the category of medical image analysis software, not an IVD.
N/A
Intended Use / Indications for Use
CAAS A-valve has been developed to support the interventionalist during or in preparation of treatment of the aortic root. CAAS A-Valve quantifies dimensions of the aortic root and assists in C-arm positioning based on a set of angiographic images. 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 a set of 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.
Product codes
LLZ
Device Description
The CAAS A-Valve is a stand-alone software application intended to run on a PC with a Windows operating system. The CAAS A-Valve is designed for objective, accurate and reproducible assessment of the aortic root geometry from a set of angiographic X-ray images from different projections.
On each of the 2D images the aortic root is segmented. The segmented 2D aortic root contours in each image are used to generate a 3D reconstruction of the aortic root. A number of analysis results can be calculated:
- Optimal C-arm projection to optimize visualization during treatment;
- Dimensions of the aortic root.
Results are corrected for out-of-plane magnification and foreshortening errors.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
angiographic X-ray images
Anatomical Site
aortic root
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
interventionalist, 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)
CAAS A-Valve is developed, tested, validated and produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
The testing reported in this 510(k) establishes that CAAS A-Valve is substantial equivalent to a combination of predicate devices and is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
CAAS QxA 3D, cleared under K100292, IC-Pro, cleared under K110256
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).
0
| 510(k) Summary | CAAS A-Valve | |
|---|---|---|
| Submitter Name | Pie Medical Imaging BV | |
| Submitter Address | Becanusstraat 13 D; 6216 BX Maastricht, The Netherlands | |
| Contact Person: | Florie Daniels, Product Registration Coordinator | JAN 30 2012 |
| Phone Number | +31 43 32 81 328 | |
| Fax Number | +31 43 32 81 329 | |
| Email Address | Florie.Daniels@pie.nl | |
| Preparation Date | 22 December 2011 | |
| Trade Name | CAAS A-Valve | |
| Common Name | Cardiovascular Angiography Analysis System | |
| CAAS A-Valve | ||
| Regulation Class | Class II (21 CFR, part 892.2050, LLZ) | |
| Predicate Devices | CAAS QxA 3D, cleared under K100292 | |
| IC-Pro, cleared under K110256 | ||
| Device Description | The CAAS A-Valve is a stand-alone software application intended to run on a PC | |
| with a Windows operating system. The CAAS A-Valve is designed for objective, | ||
| accurate and reproducible assessment of the aortic root geometry from a set of | ||
| angiographic X-ray images from different projections. |
On each of the 2D images the aortic root is segmented. The segmented 2D aortic
root contours in each image are used to generate a 3D reconstruction of the aortic
root. A number of analysis results can be calculated:
- Optimal C-arm projection to optimize visualization during treatment;
- Dimensions of the aortic root.
Results are corrected for out-of-plane magnification and foreshortening errors. | |
| Intended Use | CAAS A-valve has been developed to support the interventionalist during or in
preparation of treatment of the aortic root. CAAS A-Valve quantifies dimensions
of the aortic root and assists in C-arm positioning based on a set of angiographic
images. 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 a set of 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. | |
| Performance Data | CAAS A-Valve is developed, tested, validated and produced under the same
Quality Assurance system applicable to the development and production of
products currently marketed by Pie Medical Imaging. | |
| Substantial Equivalence | The intended use and technological characteristics of CAAS A-Valve are | |
1
.
The testing reported in this 510(k) establishes that CAAS A-Valve is substantial equivalent to a combination of predicate devices and is safe and effective for its intended use. :
:
ﻟﺴﻴﺮ ﺍﻟﻤ
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Florie Daniels Product Registration Coordinator Pie Medical Imaging BV Becanusstraat 13D 6216 BX MAASTRICHT LIMBURG THE NETHERLANDS
Re: K113076
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: December 22, 2011 Received: December 28, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
JAN 3 0 2012
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K113076
Device Name: CAAS A-Valve
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 a set of 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.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Pastel
Division Sign-C Office of In Vitro Diagnostic Device Evaluation and S
510(k) K113076