(67 days)
Not Found.
No
The document describes image processing algorithms for quantification and measurement, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on "reused algorithms" with "improvements that do not influence the indications for use," suggesting traditional image analysis techniques.
No.
The device is for quantification and analysis of medical images, which are diagnostic functions, not therapeutic.
Yes
The device quantifies anatomical structures and provides measurements (e.g., dimensions, volumes) that are used to generate absolute measurements. It does not automate diagnosis but it provides data that can be used in the diagnostic process.
Yes
The device description explicitly states "CAAS is a new generation of CAAS medical device software" and "CAAS medical device software". It also describes the device as being composed of "six modules CAL, MEAS, QCA, QVA, LVA biplane and RVA", which are software components. While it processes angiographic X-ray images, the device itself is described as software that performs analysis and management of data from these images. There is no mention of accompanying hardware that is 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- CAAS Functionality: The description of CAAS clearly states its purpose is to analyze angiographic X-ray images to quantify dimensions and volumes of arteries and ventricles. This is image analysis of the patient's anatomy, not analysis of a biological specimen taken from the patient.
- Intended Use/Indications: The intended use and indications for use all relate to analyzing medical images and performing measurements on those images. There is no mention of analyzing biological samples.
Therefore, CAAS falls under the category of medical image analysis software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Quantification of coronary artery dimensions .
- Quantification of peripheral arteries and aorta .
- . Quantification of left and right ventricles
- Management of data resulting of the quantitative analysis .
CAL
Calculate the pixel size of the image to be analyzed
MEAS
Perform basic length, angle and density measurements.
QCA
Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment.
OVA
Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment.
LVA biplane
Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of left ventricular volumes based on several established models for children and adults calculations of derived parameters; quantification of the right ventricular wall.
RVA
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CAAS is a new generation of CAAS medical device software that includes and elaborates on previously developed and marketed CAAS software and modules. CAAS is designed as a modulation in perfously devices that includes the functionality of the previously cleared Pie Medical Imaging software as a nocular sortwale passage that news. CAAS consists of reused algorithm with the addition of several improvements that do not influence the indications for use.
CAAS is composed out of six modules CAL, MEAS, QCA, QVA, LVA biplane and RVA.
Mentions image processing
Image Processing System
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
angiographic X-ray images
Anatomical Site
coronary artery, peripheral vessels, aorta, left ventricle, right ventricle
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.
K945540, K982203, K012475, K033920
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
Image /page/0/Picture/0 description: The image is a black and white abstract pattern. The pattern is composed of various shapes and textures, including lines, dots, and shaded areas. The overall impression is one of complexity and randomness. It is difficult to discern any specific objects or figures within the pattern.
Image /page/0/Picture/1 description: The image contains the text "Pie Medical Imaging Solutions in Cardiovascular Analysis". The text is arranged in three lines, with "Pie Medical Imaging" in a larger, outlined font at the top. Below that, "Solutions in Cardiovascular" is in a smaller font, and "Analysis" is in a bold, black font.
DEC 3 0 2005
510(k) Summary CAAS
This summary statement complies with 21CFR, scction 807.92(c). Date summary prepared: 24 October 2005
This premarket notification has been submitted by Pie Mcdical Imaging BV and covers the CAAS software package. Pic Medical Imaging is located at:
Pie Medical Imaging BV Becanusstraat 13 D 01 6216 BX Maastricht The Netherlands tel +31.43.3281328 fax +31.43.3281329 e-mail: carla.devries(d)pie.nl
The contact person is:
Ms. Carla de Vries, Quality Assurance Officer
The trade name is: CAAS The common name for this type of device is: Cardiovascular Angiography Analysis System 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 software package is substantially equivalent to:
CAAS is a new generation of CAAS medical device software that includes and elaborates on previously developed and marketed CAAS software and modules. CAAS is designed as a modulation in perfously devices that includes the functionality of the previously cleared Pie Medical Imaging software as a nocular sortwale passage that news. CAAS consists of reused algorithm with the addition of several improvements that do not influence the indications for use.
CAAS is composed out of six modules CAL, MEAS, QCA, QVA, LVA biplane and RVA.
The intended use of CAAS is:
- Quantification of coronary artery dimensions .
- Quantification of peripheral arteries and aorta .
- . Quantification of left and right ventricles
- Management of data resulting of the quantitative analysis .
The CAAS is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use.
The CAAS is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pic Medical Imaging.
1
Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized eagle with three wavy lines emanating from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Caria de Vries Pie Medical Imaging BV Becanusstraat 13D 6216 BX Maastricht The Netherlands
DEC 3 0 2005
Re: K052988
Trade/Device Name: CAAS (cardiovascular angiographic software) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 18, 2005 Received: October 24, 2005
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.
Please be advised that FDA 's issuance of a substantial equivalence determination does not mean that IFDA has made a deternination 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.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and in you'ls ought and in the of substantial equivalence of your device to a legally prematice notineation: "The Premier of 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 n you dobt office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0119 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Alloy, process nother general information on your responsibilities under the Act from the 001:57). I Canall 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/cdrl/industry/support/index.html
Sincerely yours,
Nancy C. Brigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
INDICATION FOR USE STATEMENT
CAAS
510(k) number (if known):
Device Name:
Indications For Use:
CAL
Calculate the pixel size of the image to be analyzed
MEAS
Perform basic length, angle and density measurements.
QCA
Detect the contour of the coronary vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the coronary artery segment.
OVA
Detect the contour of the peripheral vessel in the angiographic X-ray image - Generate absolute measurements about the dimensions of the peripheral vessel segment.
LVA biplane
Delineate the outline of the left ventricular wall automatically and/or manually in angiographic X-ray images - either monoplane or biplane analysis; absolute measurements of left ventricular volumes based on several established models for children and adults calculations of derived parameters; quantification of the right ventricular wall.
RVA
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 |
|---|---|
| ------------------------------------------ | ---------------------------------------------------------------------- |
David A. Larson
sion of Reproductive, Abdomin and Radiological Devices
Over-The-Counter Use
(Optional Format 1-2-96)