COR ANALYZER

K110071 · Rcadia Medical Imaging , Ltd. · LLZ · Jan 31, 2011 · Radiology

Device Facts

• Record ID: K110071
• Device Name: COR ANALYZER
• Applicant: Rcadia Medical Imaging , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jan 31, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.

Device Story

COR Analyzer is a post-processing software application for standalone workstations; inputs Computed Tomography (CTA) images. Device performs automated location, segmentation, and labeling of major coronary arteries (RCA, LM, LAD, LCX) and their branches; processes artery volume changes; detects deviations from expected values; displays findings in 3D view with unique coloring. Used by physicians in clinical settings to assist in visualizing coronary anatomy and pathology. Output allows clinicians to identify lesions and abnormalities, supporting clinical decision-making regarding coronary health. Modifications include expanded segmentation to major branches and improved user interface.

Clinical Evidence

No clinical trials performed. Performance validated by comparing processing results against experienced radiologists' interpretations of the same data and against the predicate device's processing results. Results demonstrated the device meets required specifications.

Technological Characteristics

Post-processing software application; runs on standalone server/workstation. Features automated segmentation and 3D visualization of coronary arteries and branches. Complies with ISO 14971 safety standards. Software-based processing.

Indications for Use

Indicated for trained physicians to analyze CT Angiographic images for visualization of major coronary vessels and lesions; assists in visualizing coronary anatomy and pathology; includes vessel segmentation and abnormality processing. Not for mammography.

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

• COR Analyzer II (K072242)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness (in accordance to 21 CFR 807.87(h))

#### Device Name

Proprietary Device Name: COR Analyzer

# JAN 3 1 2011 .

### Establishment Name and Registration Number of Submitter

Name: RCADIA Medical Imaging Ltd. (RCADIA hereafter) Registration: 3006850219 Submission contact: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

#### Device Classification

| Product Code: | LLZ |
|----------------------|-------------------------------------------------|
| Regulation Number: | 892.2050 |
| Common Name: | PACS - Picture archiving &communications system |
| Classification Name: | Picture archiving and communications system |
| Regulatory class: | Class II |

#### Reason for 510(k) Submission

Modification of legally marketed device - Special 510(K)

#### Identification of Legally Marketed Predicate (un modified) Device

K072242 COR Analyzer II Manufacturer : RCADIA

#### Description of the Device Modifications

The COR Analyzer (unmodified) device is a post processing software application which runs on a standalone server, work-station. The device input is Computed Tomography (CTA) set of images. The Device Software provides the location and segmentation of the (RCA, LM, LAD & LCX) coronary arteries. The software also labels these arteries and displays them uniquely colored in a 3D view. Artery changes of volumes are processed and deviations from expected values are detected. When a deviation exceeds threshold value it is displayed on the 3D view. The device has been modified to include also the location, segmentation & processing of major branches (of the RCA, LM, LAD & LCX) arteries. The device reliability & user interface have been modified to improve convenience of use.

#### Indications for use

The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing

#### Safety & Effectiveness

The device has been designed, verified and validated complying with 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. Its performance has been validated by comparison the processing results to experienced radiologists' interpretation of the same data and to the processing results of the predicate device. The comparison results demonstrate that the COR Analyzer meets the required specifications for use. No adverse affects have been detected.

#### Substantial Equivalency

It is Rcadia Medical Imaging Ltd. opinion that the COR Analyzer is substantially equivalent in terms of indications for use, safety and effectiveness to the unmodified predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or body.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Dan Laor Quality & Regulatory affairs Advisor Rcadia Medical Imaging Ltd. 6 Sireni Haifa 32972 ISRAEL

JAN 3 1 201

Re: K110071

Trade/Device Name: COR Analyzer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 5, 2011 Received: January 10, 2011

Dear Mr. Laor:

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 includions for use stated in the enclosure) to legally marketed predicate devices marketed in intenstate 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 dryine to

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Mary Postel

Mary Pastel, ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

proceed to the market.

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## Indications for Use

510(k) Number (if known): K110071

Device Name: COR Analyzer

#### Indications For Use:

The COR Analyzer is intended to assist a trained physician to analyze Computed Tomography (CT) Angiographic images. The device is not intended for use with mammography. The COR Analyzer is specifically indicated to provide visualization of the major coronary vessels and lesions, thus assisting the physician in visualizing the coronary anatomy and pathology. COR Analyzer has abilities for coronary vessels segmentations, abnormalities display and processing.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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