CLEARCANVAS RIS / PACS

K110332 · Clearcanvas, Inc. · LLZ · Mar 24, 2011 · Radiology

Device Facts

• Record ID: K110332
• Device Name: CLEARCANVAS RIS / PACS
• Applicant: Clearcanvas, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.

Device Story

ClearCanvas RIS/PACS is a software-based Picture Archiving and Communication System (PACS) for medical image management. It ingests DICOM-compliant images from various modalities and HL7-compliant patient data from information systems. The system comprises interrelated components: Workstation (client for display/analysis), Webstation (browser-based viewer), ImageServer (storage/distribution), RIS (workflow management), IntegrationServer (HL7 interoperability), and EnterpriseServer (authentication/auditing). Used in radiology reading rooms, clinics, and referring physician offices by trained professionals. It provides tools for image enhancement, manipulation (W/L, zoom, pan, rotation, fusion, MPR), and annotation. Output is displayed on clinical monitors to assist healthcare providers in diagnostic decision-making. The system operates on generic PC hardware, facilitating scalable, enterprise-wide access to medical imaging information.

Clinical Evidence

Bench testing only. The device underwent non-clinical software verification and validation testing, including human factors testing under simulated use conditions. Testing confirmed compliance with DICOM and JPEG standards and verified that design outputs met design inputs. No clinical data was required or provided.

Technological Characteristics

Software-only PACS; operates on off-the-shelf PC hardware. Architecture: client-server (Workstation, Webstation, ImageServer, RIS, IntegrationServer, EnterpriseServer). Connectivity: DICOM (PS 3.3-3.12) and HL7 compliant. Image processing: compression, magnification, value-of-interest manipulation, orientation, fusion, multiplanar reformat. Standards: ISO 13485:2003, ISO 62304. No patient contact; no life-sustaining function. OS: Windows.

Indications for Use

Indicated for hospitals and clinical institutions requiring management, archiving, retrieval, and display of DICOM-compliant medical images (CR, CT, DR, MR, etc.) and associated data. Includes mammography image display and analysis tools. Contraindicated for primary interpretation of lossy compressed mammography or digitized film screen images.

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

• BRIT PACS SYSTEMS (K081168)
• IntelePACS(tm) (K070080)

Submission Summary (Full Text)

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K110332

# MAR 2 4 2011

.

# 510(k) Summary of Safety and Effectiveness

### Date Prepared

November 22, 2010

# Submitter

.

:

ClearCanvas Inc. 439 University Ave., Suite 1920 Toronto, ON M5G 1Y8 " | ways . : が、「私 .. . " -、" Canada

・・

# Contact Person '

Clinton Chau Email: [e-mail] Phone: [phone] Fax: [phone]

# Device Name and Classification

| Trade Name | ClearCanvas RIS/PACS |
|----------------------------|----------------------------------------------------|
| Common Name | Picture Archiving and Communications System (PACS) |
| Device Classification Name | System, Image Processing, Radiological |
| Device Class | Class II |
| Regulation Number | 892.2050 |
| Product Code | LLZ |
| Classification Panel | Radiology |

### Predicate Devices

| Trade Name | BRIT PACS SYSTEMS | IntelePACS(tm) |
|-----------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Model Number | -- | -- |
| Common Name | Picture Archiving and<br>Communication System (PACS) | Picture Archiving and<br>Communication System (PACS) |
| 510(k) Submitter/<br>Holder | BRIT Systems Inc.<br>1909 Hi-Line Dr.<br>Dallas, TX 75207 | Intelerad Medical Systems Inc.<br>Anibal Jodorcovsky<br>460 Ste-Catherine West, Suite 210<br>Montreal, QC Canada H3B 1A7 |
| 510(k) Number | K081168 | K070080 |
| Regulation Number | 892.2050 | 892.2050 |
| Panel | Radiology | Radiology |
| Product Code | LLZ | LLZ |

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#### Device Description and Intended Use

ClearCanvas RIS/PACS is a Picture Archiving and Communication (PACS) software system for the management and review of medical image data, and other digital images. Such data can be received from all DICOMcompliant imaging modalities or imported directly into the system. This data can then be stored, archived, distributed, processed, enhanced, and displayed for review. Enhancement, processing and analysis of the image data includes but is not limited to compression, magnification, value-of-interest manipulation, orientation changes, image fusion and multiplanar reformat. Additional health data, such as patient demographics, from other information systems can be received from HL7-compliant sources.

The ClearCanvas RIS/PACS is a system of interrelated software components:

- . ClearCanvas Workstation – a desktop client that is primarily used to retrieve, display, enhance and analyze medical images. Access to patient demographic data is also possible through the Workstation when working with the RIS server.
- . ClearCanvas Webstation – a browser-based web application that allows the user to retrieve images from the ImageServer for review. Primarily intended for referring physicians and as an image viewer for EMR systems, the images are JPEG-compressed.
- . ClearCanvas ImageServer – a server application that receives images from imaging modalities, stores and archives them, and distributes them to client applications.
- . ClearCanvas RIS – a server application that acts as an online transaction processor for the management of patient and workflow information.
- . ClearCanvas IntegrationServer – a server application composed of optional modules that implement integration and interoperability, such as an inbound and outbound HL7 processor.
- . ClearCanvas EnterpriseServer -- a server application that provides enterprise-wide facilities such as user authentication, authorization and auditing.

Working in concert or stand-alone, each component plays a valuable role in the management information in the radiology reading room, the clinic, the referring physician's office, or any other patient care setting where access to medical imaging information is important.

ClearCanvas RIS/PACS software is primarily written in C#, employing the most current best practices in objectoriented and component-oriented software architecture resulting in a highly scalable and extensible design. The system is also designed to work on generic PC hardware that meets the minimum system requirements.

#### Indications for Use

The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other tools for analyzing mammography images.

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Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at ieast 5 mega-pixel resolution and meets other technical specifications approved by the FDA.

## Technological Characteristics

The ClearCanvas RIS/PACS has no patient contact and does not control any life sustaining devices. It is a software PACS device used in the management of medical imaging information. This device is used by trained and qualified professionals affording ample opportunity for competent human intervention in interpreting the images and information presented. These technological characteristics are identical to those in the predicate devices. Furthermore, the following comparison table summarizes the specific characteristics of the ClearCanvas RIS/PACS and its predicate devices that demonstrate substantial equivalence:

| | Trade Name | Subject Device<br>ClearCanvas RIS/PACS | Predicate Device<br>BRIT PACS SYSTEM | Predicate Device<br>IntelePACS | |
|----|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--|
| | Intended Use | | | | |
| 1 | To be used as a Picture Archive and<br>Communication System (PACS) | Y | Y | Y | |
| 2 | To be used for storing and<br>distributing images | Y | Y | Y | |
| 3 | To be used for displaying,<br>analyzing, manipulating and<br>enhancing of images | Y | Y | Y | |
| | Indications For Use Statement | | | | |
| 4 | Statement uses the term, “picture<br>archive and communication<br>system” or “PACS” | Y | Y | Y | |
| 5 | Statement references the display<br>of medical images | Y | Y | Y | |
| 6 | Statement references receiving<br>images from image sources | Y | Y | Y | |
| | | Subject Device | Predicate Device | Predicate Device | |
| 7 | Statement references multi-planar reformat | N | N | Y | |
| 8 | Statement references mammographic images | Y | Y | Y | |
| | | Standards Met | | | |
| 9 | Conforms to the essential requirements of the DICOM standard for data exchange (PS 3.3-PS 3.12) | Y | Y | Y | |
| 10 | Conforms to the JPEG standard for image compression of digital medical images | Y | Y | Y | |
| | | Design | | | |
| 11 | Software device that operates on off-the-shelf hardware | Y | Y | Y | |
| 12 | Device is a system composed of multiple components that work stand-alone or in concert | Y | Y | Y | |
| 13 | Device components are organized in a client-server architecture | Y | Y | Y | |
| 14 | Medical image viewer, the client application, is a key component of the device system | Y | Y | Y | |
| 15 | Image storage and archive server, the server application, is a key component of the device system | Y | Y | Y | |
| | Subject Device | Predicate Device | Predicate Device | | |
| | Functions and Capabilities | | | | |
| 16 | Query, import, send, receive<br>DICOM images | Y | Y | Y | |
| 17 | Image analysis tools W/L, zoom,<br>pan, stack, rotation, flip | Y | Y | Y | |
| 18 | Measurement and annotation | Y | Y | Y | |
| 19 | Multi-monitor awareness | Y | Y | Y | |
| 20 | Image layout | Y | Y | Y | |
| 21 | Image Thumbnails | Y | Y | Y | |
| 22 | Reference lines and spatial locator<br>for tomographic images | Y | Y | Y | |
| 23 | User annotations of images | Y | Y | Y | |
| 24 | Synchronized stacking | Y | Y | Y | |
| 25 | Probe tool | Y | N | Y | |
| 26 | Shutters | Y | N | Y | |
| 27 | Key Image marking | Y | Y | Y | |
| 28 | Multiplanar Reformat (MPR) | Y | Y | Y | |
| 29 | Lossy and lossless image<br>compression | Y | Y | Y | |
| 30 | Automatic routing of images | Y | Y | Y | |
| 31 | Image archiving | Y | Y | Y | |
| | | Subject Device | Predicate Device | Predicate Device | |
| 32 | Patient information and workflow management components | Y | Partial | Y | |
| 33 | Image streaming from server | Y | Y | N | |
| 34 | Operating System/Platform | Windows | Linux and Windows | Linux and Windows | |
| 35 | DICOM image printing | Y | Y | Y | |
| 36 | Export DICOM images to optical media | Y | Y | Y | |
| 37 | PET/CT fusion | Y | Y | N | |
| | | Other Areas of Comparison | | | |
| 38 | Target population | No restrictions | No restrictions | No restrictions | |
| 39 | Anatomical sites | No restrictions | No restrictions | No restrictions | |
| 40 | Environment for use | No restrictions; to be used by trained professionals only | No restrictions; to be used by trained professionals only | No restrictions; to be used by trained professionals only | |
| 41 | Energy used and/or delivered | Electric power supply to computer hardware only | Electric power supply to computer hardware only | Electric power supply to computer hardware only | |
| 42 | Human factors | Standard windows-based or web-based graphical user interfaces, with standard input devices | Standard windows-based or web-based graphical user interfaces, with standard input devices | Standard windows-based or web-based graphical user interfaces, with standard input devices | |
| | | Subject Device | Predicate Device | Predicate Device | |
| 43 | Performance | Real-time performance requirements not applicable | Real-time performance requirements not applicable | Real-time performance requirements not applicable | |
| 44 | Materials | Not applicable | Not applicable | Not applicable | |
| 45 | Biocompatibility | Not applicable | Not applicable | Not applicable | |
| 46 | Compatibility with environment and other devices | Interoperation with other devices based on consensus standards on data exchange (DICOM) | Interoperation with other devices based on consensus standards on data exchange (DICOM) | Interoperation with other devices based on consensus standards on data exchange (DICOM) | |
| 47 | Sterility | Not applicable | Not applicable | Not applicable | |
| 48 | Electrical safety | Not applicable | Not applicable | Not applicable | |
| 49 | Mechanical safety | Not applicable | Not applicable | Not applicable | |
| 50 | Chemical safety | Not applicable | Not applicable | Not applicable | |
| 51 | Thermal safety | Not applicable | Not applicable | Not applicable | |
| 52 | Radiation safety | Not applicable | Not applicable | Not applicable | |
| | Product Labelling | | | | |
| 53 | Instructions for searching and retrieval of images | Y | Y | Y | |
| 54 | Instructions for displaying of images | Y | Y | Y | |
| | Subject Device | Predicate Device | Predicate Device | | |
| 55 | Instructions for manipulating<br>orientation of images | Y | Y | Y | |
| 56 | Instructions for enhancing images | Y | Y | Y | |
| 57 | Instructions for annotating images | Y | Y | Y | |

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#### Testing

The ClearCanvas RIS/PACS complies with the voluntary DICOM and JPEG standards for device performance and is designed and manufactured according to the process and management system standards set in ISO 13485:2003 and ISO 62304, as discussed in the 510(k) submission.

Performance testing was conducted to verify the design output met the design input requirements and to validate the device conforms to the defined user needs and intended uses. Nonclinical software testing, as well as human factors testing, was conducted under simulated use conditions. Predefined acceptance criteria were met and demonstrated that the device is as safe and as effective as the predicate devices.

#### Substantial Equivalence Conclusions

ClearCanvas concludes that the intended use for the ClearCanvas RIS/PACS is the same as that of the predicate devices, and that the technological characteristics demonstrate that they are equivalent to the predicate devices. A comparison of the technological characteristics of the predicate and legally marketed devices available has been performed.

#### Conclusion

The 510(k) Pre-Market Notification for ClearCanvas RIS/PACS contains adequate information and data to determine that ClearCanvas RIS/PACS is as safe and effective as the legally marketed predicate devices

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Image /page/8/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle.

### 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

ClearCanvas. Inc. % Ms. Paula Wilkerson Sr. Staff Engineer-Medical Devices Intertek Testing Services 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

MAR 2 4 2011

Re: K110332

Trade/Device Name: ClearCanyas RIS/PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 15, 2011 Received: March 16, 2011

Dear Ms. Wilkerson:

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 (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 (2) CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k), remarket 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, perceits 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 advertal Reents 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 tolli the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours.

Mary Pastel

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 Statement

510(k) Number (if known): _K110332

Device Name: ClearCanvas RIS/PACS

Indications for Use:

The ClearCanvas RIS/PACS is an image management system whose intended use is to provide scaleable DICOM compatible PACS solutions for hospitals and related institutions and sites, which will archive, distribute, retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM."For Presentation", and will include standard features and other tools for analyzing mammography images.

Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega-pixel resolution and meets other technical specifications approved by the FDA.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mary S. Patel

Division Sign-Öff Office of In Vitro Diagnostic Device Evaluation and Safety 10332

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