(87 days)
Not Found
No
The summary describes image processing techniques for 3D reconstruction and measurement but does not mention AI, ML, or related concepts like neural networks or deep learning. The description of "automatic contour detection" is a common image processing technique that doesn't necessarily imply AI/ML.
No.
The device is described as software used to support diagnoses and interventional treatment by providing 3D reconstruction and analysis of vessels, and assisting in the positioning of implantable devices; it does not directly treat or restore health.
Yes
The device explicitly states its purpose is "to support diagnoses and interventional treatment of cardiovascular conditions," and it generates "analysis results" and "vessel dimensions" from images, which are used to assess vessel geometry.
Yes
The device description explicitly states that CAAS QxA 3D covers "software modules" intended to run on an existing system (CAAS). The functions described are all software-based image processing and analysis tasks. There is no mention of new or modified hardware being part of this submission.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples from the human body. The description clearly states that the device processes "angiographic X-ray images" of "coronary arteries and peripheral vessels." This is image analysis, not the analysis of biological samples like blood, urine, or tissue.
- The intended use is image-based analysis and planning. The functions described are 3D reconstruction, dimension calculation, acquisition parameter determination, and assisting in device positioning, all based on medical images.
- The device description focuses on image processing techniques. It mentions "automatic contour detection" and "3D reconstruction" from 2D images.
IVDs are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device operates on medical images, which falls under the category of medical imaging software or image analysis software, not IVD.
N/A
Intended Use / Indications for Use
CAAS QxA 3D is used for:
- 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray images;
- Calculation of dimensions of the vessel corrected for out-of-plane magnification and foreshortening errors;
- To determine acquisition parameters for optimal imaging of part of interest on a vessel tree;
- To assist in the positioning of implantable devices in the vessel segment of interest.
The CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist.
Indications for use: CAAS QCA 3D: coronary arteries CAAS QVA 3D: peripheral vessels
Product codes
LLZ
Device Description
The CAAS QxA 3D covers the QCA 3D and QVA 3D software modules intended to run on the Cardiovascular Angiography Analysis System (CAAS). The CAAS QxA-3D is designed for objective, accurate and reproducible assessment of the vessel geometry from a set of angiographic X-ray images from different projections. The variant QCA 3D is intended for coronaries and the variant QVA 3D is intended for peripheral vessels.
On each of the 2D images an arterial segment is selected resulting in automatic contour detection. The detected 2D arterial contours in each image are used to generate a 3D reconstruction of the arterial segment. A number of analysis results can be calculated.
- Vessel dimensions such as area, diameter and length;
- Reconstruction of healthy vessel shape;
- User defined subsegments analysis.
Results are corrected for out-of-plane magnification and foreshortening errors. CAAS QxA 3D features a virtual display of an implantable device on the 2D images and assists to plan its position based on the 3D reconstruction.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic X-ray images
Anatomical Site
coronary arteries and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or under supervision of a cardiologist or radiologist in clinical practice.
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)
The testing reported in this 510(k) establishes that CAAS QxA 3D 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)
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)(63) number: K5100292
510(k) Summary
CAAS QxA 3D
[QA376] v.2.0
APR 3 0 2010
Submitter Name Submitter Address Contact Person: Phone Number Fax Number Email Address Preparation Date
Pie Medical Imaging BV Becanusstraat 13 D; 6216 BX Maastricht, The Netherlands Saskia Lloyd, Quality Assurance Officer +31 43 32 81 328 +31 43 32 81 329 Saskia.lloyd@pie.nl 17 March 2010
Cardiovascular Angiography Analysis System
Class II (21 CFR, part 892.2050, LLZ)
CAAS QxA 3D
CAAS QCA 3D CAAS QVA 3D
Trade Name Common Name
Regulation Class
Predicate Devices
CAAS, cleared for marketing under K052988 CAAS QCA 3D, cleared for marketing under K063344 IC-Pro, cleared under K083745
Device Description
The CAAS QxA 3D covers the QCA 3D and QVA 3D software modules intended to run on the Cardiovascular Angiography Analysis System (CAAS). The CAAS QxA-3D is designed for objective, accurate and reproducible assessment of the vessel geometry from a set of angiographic X-ray images from different projections. The variant QCA 3D is intended for coronaries and the variant QVA 3D is intended for peripheral vessels.
On each of the 2D images an arterial segment is selected resulting in automatic contour detection. The detected 2D arterial contours in each image are used to generate a 3D reconstruction of the arterial segment. A number of analysis results can be calculated.
- Vessel dimensions such as area, diameter and length; 1.
Reconstruction of healthy vessel shape; 2.
User defined subsegments analysis. 3.
Results are corrected for out-of-plane magnification and foreshortening errors. CAAS QxA 3D features a virtual display of an implantable device on the 2D images and assists to plan its position based on the 3D reconstruction.
Intended Use
CAAS QxA 3D is used as follows:
- 3D Reconstruction of coronary arteries and peripheral vessels from a set of 】. angiographic X-ray images;
- Calculation of dimensions of the vessel corrected for out-of-plane 2. magnification and foreshortening errors;
- To determine acquisition parameters for optimal imaging of part of interest on 3. a vessel tree;
- To assist in the positioning of implantable devices in the vessel segment of 4. interest.
CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist.
•
1
CAAS QxA 3D is developed, tested, validated and produced under the same Performance Data 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 QxA 3D are substantial equivalent to a combination of the intended use and technological characteristics of the predicate devices. The testing reported in this 510(k) establishes that CAAS QxA 3D is substantial Conclusion equivalent to a combination of predicate devices and is safe and effective for its intended use.
2
Image /page/2/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract eagle design with three stylized wing segments. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
APR 30 2010
Mr. Saskia Lloyd Submission Correspondent-Quality Assurance Officer Pie Medical Imaging b.v. Becanusstraat 13D, 6216 BX Maastricht THE NETHERLANDS
Re: K100292
Trade/Device Name: CAAS QxA 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 30, 2010 Received: April 5, 2010
Dear Mr. Lloyd:
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
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, -
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
510(k) Notification - CAAS QxA 3D
INDICATION FOR USE STATEMENT
page 1 of 1
K100292 510(k) number (if known): ___
CAAS QxA 3D Device Name:
Indications For Use:
CAAS QxA 3D is used for:
- 3D Reconstruction of coronary arteries and peripheral vessels from a set of angiographic X-ray 1. images;
- Calculation of dimensions of the vessel corrected for out-of-plane magnification and 2. foreshortening errors;
- To determine acquisition parameters for optimal imaging of part of interest on a vessel tree; 3.
- To assist in the positioning of implantable devices in the vessel segment of interest. 4.
The CAAS QxA 3D software is designed for use in clinical practice to support diagnoses and interventional treatment of cardiovascular conditions. The software is used by or under supervision of a cardiologist or radiologist.
Indications for use: CAAS QCA 3D: coronary arteries CAAS QVA 3D: peripheral vessels
Prescription Use OR (Per 21 CFR 801.109)
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
Robert Becker
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K100292
(Optional Format 1-2-96)