CAAS

K052988 · Pie Medical Imaging BV · LLZ · Dec 30, 2005 · Radiology

Device Facts

• Record ID: K052988
• Device Name: CAAS
• Applicant: Pie Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: Dec 30, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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 .

Device Story

CAAS is a cardiovascular angiographic software package for quantitative analysis of X-ray images. It consists of six modules: CAL (pixel size calibration); MEAS (basic measurements); QCA (coronary artery contour detection/dimension measurement); QVA (peripheral vessel contour detection/dimension measurement); LVA biplane (left ventricular wall delineation/volume calculation); and RVA (right ventricular wall delineation/volume calculation). The software processes angiographic X-ray images to provide clinicians with absolute measurements of vessel dimensions, ventricular volumes, and wall motion. It supports both monoplane and biplane analysis. The system is used by clinicians to assist in cardiovascular assessment and data management. By providing automated or semi-automated contour detection and quantitative metrics, the device aids in clinical decision-making regarding cardiovascular disease states.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and the reuse of previously cleared algorithms.

Technological Characteristics

Software-based image processing system for cardiovascular angiography. Modules include CAL, MEAS, QCA, QVA, LVA biplane, and RVA. Utilizes established mathematical models for volume and dimension calculations. Operates on angiographic X-ray image inputs. Software is a modular package designed for integration into existing clinical imaging workflows.

Indications for Use

Indicated for quantification of coronary/peripheral arteries, aorta, and left/right ventricles in angiographic X-ray images. Applicable to both pediatric and adult patient populations for vessel dimension, volume, and wall motion analysis.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• CAAS II (K945540)
• CAAS II LVA biplane (K982203)
• CAAS II QVA (K012475)
• CAAS II RVA (K033920)

Submission Summary (Full Text)

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K052988

# 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 [phone] fax [phone] 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:

- . K945540 CAAS II
- . K982203 CAAS II LVA biplane
- . K012475 CAAS II QVA
- . K033920 CAAS II RVA

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.

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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.

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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 [phone] or [phone] 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

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# 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<br>(Per 21 CFR 801.109) | <div style="display:inline-block; vertical-align:middle;">✓</div> OR |
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David A. Larson

sion of Reproductive, Abdomin and Radiological Devices

Over-The-Counter Use

(Optional Format 1-2-96)