(22 days)
Unknown
The description mentions "automatic detection" of the arterial contour and "automatic reconstruction" of the vessel, which could potentially involve AI/ML techniques for image analysis and reconstruction. However, the document does not explicitly state the use of AI, ML, or related terms like neural networks or deep learning. Without further information or explicit mention, it's impossible to definitively confirm the presence of AI/ML.
No.
The device is described as a software module that quantifies coronary arteries from angiographic X-ray images, providing measurements and analysis of stenosis, which are diagnostic functions, not therapeutic.
Yes
The device detects the contour of coronary vessels from angiographic X-ray images and generates absolute measurements and calculations (e.g., % of stenosis, area, and diameter) related to the dimensions of the coronary arterial segment in 3D space. These functions provide quantitative information about the patient's anatomy to aid in diagnosis or treatment planning.
Yes
The device description explicitly states it is a "software module intended to run on the Cardiovascular Angiography Analysis System mark. CAAS." It describes software functions for image analysis and measurement, without mentioning any accompanying hardware components that are part of the device itself.
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.
- Device Function: The CAAS OCA 3D software analyzes angiographic X-ray images of the coronary arteries. It processes images and performs measurements based on these images.
- No Biological Samples: The device does not interact with or analyze any biological samples taken from the patient. Its input is image data.
Therefore, since the device operates on medical images and not biological samples, it falls outside the definition of an In Vitro Diagnostic device. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
The intended use of the CAAS OCA 3D is:
- 1 . Optimizing the quantification of artery dimensions to be used in clinical trials and in clinical cath lab environment
-
- Management of data resulting of the quantitative analysis
Indications For Use: Detect the contour of the coronary vessel from a set of angiographic X-ray images – Generate absolute measurements about the dimensions of the coronary arterial segment in 3D space to improve accuracy by elimination of out-of-plane and foreshortening errors.
Product codes
LLZ
Device Description
The CAAS QCA 3D software package.
The CAAS OCA 3D is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark. CAAS. It functions in the same manner as other vascular analysis software packages. The OCA-3D module allows accurate and reproducible quantification of the coronary arteries from a set of angiographic X-ray images. The analyst selects between 2 and 5 angiographic images obtained from different X-Ray projections. On each of the images a classic 2D arterial detection is performed, after which from all images a reconstruction of the arterial segment is obtained in 3D space. Indication of a common point in each of the images is used to obtain an exact spatial relationship between the images. After the selection of the arterial segment of interest the contour of this arterial segment is automatically detected. Based on the contour information a number of analysis results can be calculated. Three analysis methods are available: The first method is an automatic reconstruction of the diseased arterial vessel by means of computing the reference along the arterial vessel to reconstruct the healthy arterial vessel, calculation of main result the % of stenosis. The second method allows for manual definition of the reference along the arterial segment by means of selecting one or more reference positions in the arterial segment, calculation of main result the % of stenosis. The third analysis method enables the user to define one or more subsegments, within each user defined subsegment the minimum, maximum and mean area are calculated. Besides area information also diameter results for each image used to reconstruct the vessel into 3D space are calculated over the arterial positions of interest. These diameter results will be corrected for out of plane calibration and length measurements will be corrected for foreshortening errors.
Mentions image processing
Image Processing System
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic X-ray images
Anatomical Site
coronary arteries, arterial segment, coronary vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical trials and in clinical cath lab environment
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)
Not Found
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
This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 20 September 2006
NOV 28 2006
This premarket notification has been submitted by Pie Medical Imaging BV and covers the CAAS QCA 3D software package. Pie Medical Imaging is located at:
Pie Medical Imaging BV Becanusstraat 13 D 6216 BX Maastricht The Netherlands tel +31.(0)43.3281328 fax +31.(0)43.3281329 e-mail: carla.devries@pie.nl
Ms. Carla de Vries, Quality Assurance Officer The contact person is:
The trade name is:
CAAS OCA 3D
The common name for this type of device is:
Cardiovascular Angiography Analysis System Quantitative Coronary Analysis 3D and the classification name is:
Image Processing System (LLZ).
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.
The CAAS QCA 3D software package is substantially equivalent to the CAAS system known under FDA number K052988.
The CAAS OCA 3D is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark. CAAS. It functions in the same manner as other vascular analysis software packages.
The OCA-3D module allows accurate and reproducible quantification of the coronary arteries from a set of angiographic X-ray images. The analyst selects between 2 and 5 angiographic images obtained from different X-Ray projections. On each of the images a classic 2D arterial detection is performed, after which from all images a reconstruction of the arterial segment is obtained in 3D space. Indication of a common point in each of the images is used to obtain an exact spatial relationship between the images. After the selection of the arterial segment of interest the contour of this arterial segment is automatically detected. Based on the contour information a number of analysis results can be calculated.
Three analysis methods are available: The first method is an automatic reconstruction of the diseased arterial vessel by means of computing the reference along the arterial vessel to reconstruct the healthy arterial vessel, calculation of main result the % of stenosis. The second method allows for manual definition of the reference along the arterial segment by means of selecting one or more reference positions in the arterial segment, calculation of main result the % of stenosis. The third analysis method enables the user to define one or more subsegments, within each user defined subsegment the minimum, maximum and mean area are calculated.
Besides area information also diameter results for each image used to reconstruct the vessel into 3D space are calculated over the arterial positions of interest. These diameter results will be corrected for out of plane calibration and length measurements will be corrected for foreshortening errors.
The indications for use remain the same. CAAS consists of reused algorithms with the addition of several improvements that do not influence the indications for use.
1
The intended use of the CAAS OCA 3D is:
- 1 . Optimizing the quantification of artery dimensions to be used in clinical trials and in clinical cath lab environment
-
- Management of data resulting of the quantitative analysis
The CAAS QCA 3D is equivalent in technological characteristics to the predicate device mentioned in this summary:
- The automatic contour detection of the CAAS QCA 3D software is similar to the contour detection algorithms used in the predicate device.
- · The CAAS QCA 3D software produces similar results as the predicate device.
CAAS QCA 3D is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
The CAAS QCA 3D software package is substantially equivalent to:
- . K052988 CAAS system
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol, indicating the name of the department and its country.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
OV 28 2006
Ms. Carla de Vries Submission Correspondent Pie Medical Imaging by Becanusstraat 13D 6216 BX Maastricht THE NETHERLANDS
Re: K063344
Trade/Device Name: CAAS QCA 3D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 26, 2006 Received: November 6, 2006
Dear Ms. de Vries:
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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo is for the FDA Centennial, celebrating the years 1906-2006. The letters FDA are in a bold, stylized font in the center of the logo. The word "Centennial" is written in a cursive font below the letters FDA.
ting Public . I
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Page 2 -
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); 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,
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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Notification - CAAS QCA 3D
| INDICATION FOR USE STATEMENT | page 1 of 1 | |
|---|---|---|
| 510(k) number (if known): | K 063344 | |
| Device Name: | CAAS QCA 3D | |
| Indications For Use: | Detect the contour of the coronary vessel from a set of angiographic X-ray images – Generate absolute measurements about the dimensions of the coronary arterial segment in 3D space to improve accuracy by elimination of out-of-plane and foreshortening errors. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Optional Format 1-2-96) |
Nancy Brogdon
(Division Sign Off)
(Division Sign-Off)
Division Sign-Off Devices (Off)
Division Sign-Organive, Abdominal,
and Radiologicosi Devices (Oly 334) (Oly 334) (Al