3DI INCLUDING CSCORE

K112530 · Shina Systems , Ltd. · LLZ · Sep 30, 2011 · Radiology

Device Facts

• Record ID: K112530
• Device Name: 3DI INCLUDING CSCORE
• Applicant: Shina Systems , Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.

Device Story

3Di is a PACS software workstation for multimodality medical image management (CT, XA, MR, PET, SPECT, Ultrasound) via DICOM protocol. It provides tools for image visualization, manipulation, and reporting, including volume rendering and multi-planar reconstruction (MPR). The device includes specific clinical applications for cardiac CT (calcium scoring, angiography, coronaries analysis, functional assessment) and CT colonoscopy. Used in clinical settings by radiologists, cardiologists, and specialists to assist in diagnostic interpretation. The system functions as a network-based web server for image archiving and communication. The CScore option processes CT cardiac studies to calculate calcium scores. Clinicians use the output to support diagnostic decision-making. Benefits include enhanced visualization and standardized analysis of complex cardiac and colon imaging data.

Clinical Evidence

Bench testing only. The device's calcium scoring functionality was validated by comparing its output to the Philips Brilliance workstation. Results demonstrated similarity in calcium scoring performance between the subject device and the predicate.

Technological Characteristics

PACS software workstation; supports DICOM protocol; multimodality image processing (CT, XA, MR, PET, SPECT, Ultrasound); features include volume rendering, MPR, and 2D/3D visualization. Connectivity via network/web server. Complies with ISO 14971 safety standards.

Indications for Use

Indicated for professional Radiologists, Cardiologists, and specialists to assist in diagnosis via PACS workstation tools. Supports processing of multimodality images (CT, XA, MR, PET, SPECT, Ultrasound) including Cardiac CT studies (calcium scoring, angiography, coronaries analysis, functional assessment) and CT colonoscopy. Not indicated for mammography interpretation.

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

• Philips Brilliance (K042293)
• 3Di (K093703)

Submission Summary (Full Text)

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K112530

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

Device Name

Proprietary Device Name: 3Di including CScore

## Establishment Name and Registration Number of Submitter

SEP 3 0 2011

Name: Shina Systems Ltd. Corresponding Official: Dan Laor Sireni 6, Haifa 32972, Israel TEL: [phone]

#### Device Classification

| Product Code: | LLZ |
|-----------------------|---------------------------------------------|
| CFR section: | 892.2050 |
| Panel Identification: | Radiology |
| Device Description: | Picture archiving and communications system |
| Classification: | II |

## Reason for 510(k) Submission

Traditional 510(k) Submission

## Identification of Legally Marketed Predicate Devices

K042293 Philips Brilliance K093703 3Di

### Device Description

3Di is a PACS device which enables users to access medical images over a network and to utilize 3Di's image visualization tools to review the images. It provides the following functions: Web server, patient browser, PACS capabilities, multi-modality viewing, CT Cardiac and Colonoscopy clinical applications. The 3Di has been modified to include the 3Di CScore -option, which is intended to process CT cardiac studies for CT Calcium scoring.

#### Intended use and indications for Use

3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls. 3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images. The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.

## Safety & Effectiveness

The device has been designed, verified and validated complying to 21CFR 820.30 regulations. The device has been designed to meet the requirements of ISO 14971 Safety standard. The device Calcium scoring has been validated by comparison the device output to the Calcium scoring output of the Philips Brilliance workstation. The comparison results demonstrate that the 3Di and the Brilliance are very similar in terms of calcium scoring.

## Substantial Equivalency

It is Shina System opinion that the 3Di is substantially equivalent in terms of safety and effectiveness to the predicate devices.

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Public Health Service

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

Shina Systems, Ltd. % Mr. Dan Laor Ouality & Regulatory Advisor 6 Sireni. Haifa, 32972 ISRAEL

SED 30 2011

Re: K112530

Trade/Device Name: 3Di Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 23, 2011 Received: August 31, 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 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 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 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 device to proceed to the market.

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 Patel

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

#### Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: 3Di

Indications For Use:

3Di is a software package of PACS workstation for handling multimodality (CT, XA, MR, PET, SPECT & Ultrasound) images, which are using DICOM protocol. It includes volume rendering, Multi-planar reconstruction (MPR) and viewing of the inner and outer surfaces of organs as well as within their walls.

3Di is intended for use as an interactive tool for assisting professional Radiologists, Cardiologists and specialists to reach their own diagnosis, by providing tools of communication, clinics networking, WEB Serving, image viewing, image manipulation, 2D/3D image visualization, image processing, reporting and archiving. This product is not intended for use with or for diagnostic interpretation of Mammography images.

The 3Di indications for use are processing of Cardiac CT studies, including CT Calcium scoring, CT Cardiac angiography, coronaries analysis, cardiac functional assessment and of CT colonoscopy.

x 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)

Mary S. Petit

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