K Number
K012475
Device Name
CAAS II QVA
Date Cleared
2001-10-24

(83 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Optimizing the quantitation of artery dimensions to be used in clinical trials and in clinical cath lab 1. environment - 2. Managing of data resulting of the analysis of artery dimensions
Device Description
The CAAS II QVA 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 other vascular analysis software packages. 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. Two methods for obstruction analysis are available, one with automatic reconstruction of the arterial wall to estimate the normal diameter or reference diameter for the obstruction, calculation of the MLD and % stenosis. The second method allows for manual selection of one or more reference position in the arterial segment and based on the MLD and this calculated reference for the position of the MLD the % stenosis is calculated. In the arterial segment under study one or more subsegments can be selected by the user and for all these user defined subsegments the minimum, maximum and mean diameter are calculated. Besides diameter information also cross sectional area is calculated over the arterial positions of interest. These cross sectional areas are calculated based on both circular symmetry of the artery and densitometric analysis of the contrast volume in the artery. The QVA package can be used on arteries up to 50mm in diameter.
More Information

No
The description focuses on automated contour detection and calculation based on geometric and densitometric analysis, without mentioning AI/ML techniques. The absence of AI/ML terms and descriptions of training/test sets further supports this.

No
The device is a software module designed for analyzing artery dimensions from angiography images, providing diagnostic information rather than directly treating a disease or condition.

Yes

The device analyzes artery dimensions, calculates obstruction metrics (MLD, % stenosis), and provides diameter and cross-sectional area information based on image processing of angiography, which are all indicative of providing diagnostic information.

Yes

The device description explicitly states it is a "software module intended to run on the Cardiovascular Angiography Analysis System mark II, CAAS II" and functions as "vascular analysis software packages." It processes image data (angiography) to provide analysis results, without mentioning any proprietary hardware components included with the device itself.

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

  • IVDs analyze samples taken from the human body. The device description clearly states it analyzes angiography images of arteries within the body. It's processing image data, not biological samples like blood, urine, or tissue.
  • The intended use is for optimizing the quantitation of artery dimensions and managing data. This is focused on image analysis and data management related to the physical structure of arteries, not on detecting diseases or conditions through the analysis of biological samples.

The device is a medical image analysis software used in a clinical setting (cath lab) to assist in the assessment of artery dimensions from angiography images. This falls under the category of medical devices, but specifically those that process and analyze medical images, not IVDs.

N/A

Intended Use / Indications for Use

  • Optimizing the quantitation of artery dimensions to be used in clinical trials and in clinical cath lab environment
  • Managing of data resulting of the analysis of artery dimensions

Product codes

LLZ

Device Description

The CAAS II QVA 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 other vascular analysis software packages. 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. Two methods for obstruction analysis are available, one with automatic reconstruction of the arterial wall to estimate the normal diameter or reference diameter for the obstruction, calculation of the MLD and % stenosis. The second method allows for manual selection of one or more reference position in the arterial segment and based on the MLD and this calculated reference for the position of the MLD the % stenosis is calculated.

In the arterial segment under study one or more subsegments can be selected by the user and for all these user defined subsegments the minimum, maximum and mean diameter are calculated.

Besides diameter information also cross sectional area is calculated over the arterial positions of interest. These cross sectional areas are calculated based on both circular symmetry of the artery and densitometric analysis of the contrast volume in the artery.

The QVA package can be used on arteries up to 50mm in diameter.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Artery / Arterial segments

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical trials and 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)

K945540

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

KOI 2475

OCT 2 4 2001

510(k) Summary

CAAS II QVA

This summary statement complies with 21CFR, section 807.92(c). Date summary prepared: 30 July 2001

This premarket notification has been submitted by Pie Medical Imaging BV and covers the CAAS II QVA software package. Pie Medical Imaging is located at:

Pie Medical Imaging BV Becanusstraat 13 D 6216 BX Maastricht The Netherlands tel +31.43.3281328 fax +31.42.3281329 e-mail: pmi@pie.nl

The contact person is: Ms. Carla de Vries, Quality Assurance assistant CAAS II QVA The trade name is: The common name for this type of device is: Quantitative Vascular 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 QVA software package is substantially equivalent to the CAAS II QCA software package known under FDA number K945540.

The CAAS II QVA 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 other vascular analysis software packages. 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. Two methods for obstruction analysis are available, one with automatic reconstruction of the arterial wall to estimate the normal diameter or reference diameter for the obstruction, calculation of the MLD and % stenosis. The second method allows for manual selection of one or more reference position in the arterial segment and based on the MLD and this calculated reference for the position of the MLD the % stenosis is calculated.

In the arterial segment under study one or more subsegments can be selected by the user and for all these user defined subsegments the minimum, maximum and mean diameter are calculated.

Besides diameter information also cross sectional area is calculated over the arterial positions of interest. These cross sectional areas are calculated based on both circular symmetry of the artery and densitometric analysis of the contrast volume in the artery.

The QVA package can be used on arteries up to 50mm in diameter.

The intended use of the CAAS II QVA is:

  • Optimizing the quantitation of artery dimensions to be used in clinical trials and in clinical cath lab 1. environment
  • Managing of data resulting of the analysis of artery dimensions 2.

The CAAS II QVA is equivalent in technological characteristics to the predicate device mentioned in this summary:

  • · The automatic contour detection of the CAAS II QV A software is similar to the contour detection algorithms used in the predicate devices.
  • · The CAAS II QVA software produces similar results as the predicate devices.

The CAAS II QVA is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.

1

Image /page/1/Picture/1 description: The image shows a partial view of a logo or emblem. It features a stylized depiction of what appears to be an eagle or a similar bird, represented by three curved lines that suggest the bird's head and wings. The text "DEPARTMENT OF HEALTH &" is visible, arranged in a circular fashion around the bird symbol, indicating that the logo is likely associated with a health-related department or organization.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2001

Ms. Carla de Vries Quality Assurance Assistant Pie Medical Imaging BV Becanusstraat 13 D 6216 BX Maastricht The Netherlands

Re: K012475

Trade/Device Name: CAAS II QVA Vascular analysis software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: 90 LLZ Dated: July 30, 2001 Received: August 2, 2001

Dear Ms. deVries:

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 (PMA), it may be subject to 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 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.

2

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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:

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" (21 CFR Part 807.97). 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. Brogdon

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 STATEMENTpage 1 of 1
510(k) number (if known): _KO) 2475
Device Name:CAAS II QVA
Indications For Use:
  • Optimizing the quantitation of artery dimensions to be used in clinical trials and in clinical cath lab 1. environment
    1. Managing of data resulting of the analysis of artery dimensions

(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 Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal,

and Radiological Devices

510(k) NumberK012475
------------------------

(Optional Format 1-2-96)