(90 days)
Not Found
No
The description mentions "semi-automatically" outlining, which could potentially involve some form of automated image processing, but it explicitly states the use of "several well established volume models" and the "well known Centerline model" for analysis. There is no mention of AI, ML, or any learning-based algorithms. The lack of information on training or test sets further supports the absence of AI/ML.
No.
The device is described as software that analyzes angiographic X-ray images to delineate the right ventricular wall, measure volumes, and quantify wall motion. It provides diagnostic information but does not directly treat or prevent a disease.
Yes
The device analyzes angiographic X-ray images to determine right ventricular volumes, wall motion, and related parameters, which are used to assess the state of the heart and aid in diagnosis.
Yes
The device is described as a "software module" intended to run on an existing system (CAAS II). The description focuses entirely on the software's functionality (image analysis, calculations, quantification) and does not mention any new or specific hardware components included with this particular device. The predicate device is also described as a "software package."
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 II RVA software analyzes angiographic X-ray images of the heart. It processes these images to measure the size, volume, and motion of the right ventricle.
- No Biological Samples: The device does not interact with or analyze any biological samples taken from the patient. Its input is purely 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
Delineate the outline of the right ventricular wall semi-automatically or manually on . either one (monoplane) or two sets of two angiographic X-ray images of the heart.
Absolute measurements of right ventricular volumes at the End Diastolic and End . Systolic phase of a heart cycle, based on several established models for children and adults, together with the Fjection Fraction and other to these volumes related parameters.
. Quantification of the motion of the right ventricular wall between the End Diastolic and End Systolic phase of a heart cycle.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The CAAS II RVA is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II. It functions in the same manner as left ventricular analysis software packages. In the End Diastolic (ED) and End Systolic (ES) images (of a monoplane or biplane run), available from various image sources, the outline of the left ventricular contour is either drawn manually or semi-automatically. From these contours the ventricular volumes, the ejection fraction and other related parameters are determined using several well established volume models for the right ventricle. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall between ED and ES is quantified from these ventricular contours using the well known Centerline model. All results of the analysis are available on screen as well as hardcopy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
angiographic X-ray
Anatomical Site
right ventricular wall
Indicated Patient Age Range
children and adults
Intended User / Care Setting
Not Found
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 II RVA
This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 8 December 2003
This premarket notification has been submitted by Pie Medical Imaging BV and covers the CAAS II RVA software package. Pie Medical Imaging is located at:
Pie Medical Imaging BV Becanusstraat 13 D 01 6216 BX Maastricht The Netherlands tel +31.43.3281328 fax +31.42.3281329 e-mail: carla.devries@pie.nl
The contact person is: Ms. Carla de Vries, Quality Assurance Officer
The trade name is: CAAS II RVA The common name for this type of device is: Right Ventricular Analysis software 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 II RVA software package is substantially equivalent to the CAAS II LVA-Biplane Option software package known under FDA number K982203.
The CAAS II RVA is one of the software modules intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II. It functions in the same manner as left ventricular analysis software packages. In the End Diastolic (ED) and End Systolic (ES) images (of a monoplane or biplane run), available from various image sources, the outline of the left ventricular contour is either drawn manually or semi-automatically. From these contours the ventricular volumes, the ejection fraction and other related parameters are determined using several well established volume models for the right ventricle. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall between ED and ES is quantified from these ventricular contours using the well known Centerline model. All results of the analysis are available on screen as well as hardcopy.
The intended use of CAAS II RVA is:
- Delineate the outline of the right ventricular wall semi-automatically or manually on . either one (monoplane) or two sets of two angiographic X-ray images of the heart.
- Absolute measurements of right ventricular volumes at the End Diastolic and End . Systolic phase of a heart cycle, based on several established models for children and adults, together with the Fjection Fraction and other to these volumes related parameters.
- . Quantification of the motion of the right ventricular wall between the End Diastolic and End Systolic phase of a heart cycle.
1
The CAAS II RVA is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use.
The CAAS II RVA is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an emblem of an eagle with three bars, symbolizing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carla de Vries Quality Assurance Officer Pie Medical Imaging bv Becanusstraat 13D 01 6216 BX Maastricht THE NETHERLANDS
Re: K033920
MAR 1 7 2004
Trade/Device Name: CAAS II RVA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 8, 2003 Received: December 18, 2003
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. Ilisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Codc 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); 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,
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
| INDICATION FOR USE STATEMENT | page 1 of 1 | |
|---|---|---|
| 510(k) number (if known): _ | 2,292 0 | |
| Device Name: | CAAS II RVA |
Indications For Use:
Delineate the outline of the right ventricular wall semi-automatically or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of right ventricular volumes based on several established models for children and adults - calculations of derived parameters; quantification of the motion of the right ventricular wall.
(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_
Nancy C. Brogdon
(Division Sign-C Division of Reproductive, Ab and Radiological Devices 510(k) Number _
(Optional Format 1-2-96)