CARDIOCT

K070226 · Shina Systems , Ltd. · LLZ · Mar 9, 2007 · Radiology

Device Facts

• Record ID: K070226
• Device Name: CARDIOCT
• Applicant: Shina Systems , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Mar 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.

Device Story

CardioCT is a software application for cardiac CT image analysis. It processes cardiac CT data to visualize coronary anatomy, assess coronary artery state, and perform functional heart analysis. Operation involves segmenting heart tissues and coronary arteries to facilitate detailed evaluations of coronary arteries and ventricular functions. Used in clinical settings by radiologists and cardiologists as an interactive tool for viewing, evaluating, and analyzing images. Output consists of visualized anatomy and functional analysis results, which clinicians use to generate radiology reports and inform clinical decision-making regarding coronary obstructive disease.

Technological Characteristics

Software application for cardiac CT image analysis. Features include segmentation of heart tissues and coronary arteries, visualization of coronary anatomy, and functional analysis of the heart. Operates as a diagnostic reading tool.

Indications for Use

Indicated for use by cardiologists and radiologists to view and analyze cardiac CT data to determine the presence and extent of coronary obstructive disease.

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

• Comprehensive Cardiac Analysis (CCA) module of the Brilliance CT, Private Practice CV configuration CT Scanner (Philips Medical Systems Inc.)

Submission Summary (Full Text)

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K070226

## Summary of Safety and Effectiveness

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR \$807.92.

## Submitter:

Shina Systems Ltd. 11 Bareket Street P.O.B. 3072 North Industrial Park Caesarea 38900. Israel Tel: [phone]. Fax : [phone]

MAR 0 9 2007

Name of the Device: CardioCT

Predicate Device: The CardioCT is substantially equivalent to the Comprehensive Cardiac Analysis (CCA) module of the "Brilliance CT, Private Practice CV configuration" CT Scanner, manufactured by Philips Medical Systems Inc.

Description of the Device: The CardioCT (CCT) is a software application for viewing, evaluating and functionally analyzing cardiac CT images. The application is an interactive tool for radiologists and cardiologists and is used to visualize coronary anatomy, assess the state of the coronary arteries and execute functional analyses of the heart. This is accomplished by segmenting the heart tissues and coronary arteries and performing detailed evaluations of the coronary arteries and ventricular functions.

Intended Use: The system that is comprised of diagnostic reading software is intended for use by radiologists as an interactive tool for analyzing radiological data and generating radiology reports based on their analysis.

Comparison of Technological Characteristics: The technological characteristics of the CardioCT are all found in the predicate device.

January 11, 20076

signature

Date

Mr. Naor Shina, CEO

5

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Shina Systems Ltd. c/o Mr. Eli M. Orbach International Regulatory Consultants POB 6718 Efrat 90435 ISRAEL

MAR 0 9 2007

Re: K070226

Trade/Device Name: CardioCT Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 11, 2007 Received: January 24, 2007

Dear Mr. Orbach:

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.

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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.

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.

ff 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 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 807.97). 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,

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

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Indications For Use (separate page):

Page of of

K070226 510(k) Number (if known)

Device Name_CardioCT

Indications For Use:

The system, which is comprised of diagnostic reading software, is intended for use by cardiologists and radiologists as an interactive tool for viewing and analyzing cardiac CT data for determining the presence and extent of coronary obstructive disease.

(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 Broadon
(Division Sign Off) (Optional Format 1-2-96)

(Division Sion Off) Division of Renanductive, Abdominal and Radiosville Homes 510(k) Nomines ...............................................................................................................................................................

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