CEDARA WEBACCESS, MODEL: 2.4

K092915 · Cedara Software Corp. · LLZ · Jun 23, 2010 · Radiology

Device Facts

• Record ID: K092915
• Device Name: CEDARA WEBACCESS, MODEL: 2.4
• Applicant: Cedara Software Corp.
• Product Code: LLZ · Radiology
• Decision Date: Jun 23, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data. Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose. Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Device Story

Cedara WebAccess 2.4 is a thin-client, browser-based medical image processing software; enables remote access to diagnostic-quality images, reports, and patient data via TCP/IP networks. Input: multi-modality medical images (DICOM/non-DICOM) and associated patient data. Operation: software runs within standard internet browsers without local installation; provides tools for image manipulation (zoom, pan, window/level, MPR, CINE, measurement). Output: interactive display of medical data for clinician review. Context: used by medical professionals in clinical environments; supports cross-enterprise document sharing (XDS). Benefit: facilitates remote diagnostic review and planning; does not provide automated diagnosis; clinical decision-making remains the responsibility of the user.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed the device meets design requirements and intended use. Compliance with NEMA DICOM 3.0, ISO/IEC 10918-1 (JPEG), and ISO/IEC 15948 (PNG) standards was demonstrated.

Technological Characteristics

Thin-client software; browser-based; TCP/IP connectivity. Supports DICOM and non-DICOM data. Image compression: JPEG (lossy), PNG (lossless). Features: MPR, CINE, measurement tools. Security: HTTPS encryption, user/password access control, audit logging. Standards: NEMA DICOM 3.0, ISO/IEC 10918-1, ISO/IEC 15948.

Indications for Use

Indicated for medical professionals requiring remote access to multi-modality medical images, reports, and patient data for diagnostic review, planning, and reporting. Contraindicated for primary interpretation of lossy compressed mammographic images and 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

• Cedara I-SoftView (K022881)
• WebPax (K051325)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Merge Healthcare. The logo consists of the word "MERGE" in large, bold, sans-serif font, with a trademark symbol next to the "E". Below the word "MERGE" is the word "Healthcare" in a smaller, sans-serif font. The text is black against a white background.

# 510(k) SUMMARY

| Submitter: | Merge OEM, a division of Merge Healthcare<br>6303 Airport Road, Suite 500<br>Mississauga, Ontario<br>Canada L4V 1R8 | JUN 2 3 2010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Carol Nakagawa<br>Director, Quality and Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone] | |
| Date: | June 21, 2010 | |
| Trade Names: | Cedara WebAccess™ Model 2.4 | |
| Common Name: | Medical image processing software | |
| Classification Name: | Picture Archiving and Communications System (PACS) | |
| Product Code: | LLZ | |
| Device Class: | Class II | |
| Regulation No.: | 21 CFR §892.2050 | |

### Predicate Devices:

| Trade Name | 510(k) Submitter/Manufacturer | 510(k) Number |
|-------------------|---------------------------------|---------------|
| Cedara I-SoftView | Cedara Software Corp. | K022881 |
| WebPax | Heart Imaging Technologies, LLC | K051325 |

### Device Description:

Cedara WebAccess 2.4 provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

With no application-specific installation required on the user's computer, qualified medical professionals can use Cedara WebAccess 2.4 with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Imaging Series and file attachments.

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Image /page/1/Picture/0 description: The image shows the logo for Merge Healthcare. The word "MERGE" is in large, bold, sans-serif font, with a trademark symbol in the upper right corner. Below the word "MERGE" is the word "Healthcare" in a smaller, sans-serif font.

Cedara WebAccess 2.4 was designed with an easy and convenient workflow providing image viewing tools including zoom, pan, contrast, series/layout change, toggle on/off image text, MPR, CINE, reset and measurement.

The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.

# Indications for Use:

Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

### Comparison to Predicate:

The intended use and technological characteristics of the Cedara WebAccess 2.4 software are substantially equivalent, in the opinion of Merge OEM, to those of the predicate devices and do not pose any new issues of safety and effectiveness.

| Category | Cedara WebAccess | Cedara I-SoftView<br>(predicate device) | WebPax<br>(predicate device) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Annotation and<br>Measurement Tools | Line, Rectangle,<br>Ellipse, ROI, Angle,<br>Cobb Angle, Parallel<br>Lines, Ratio<br>Measurement, Text | Line, rectangle,<br>curve, parallel line,<br>mid point, angle and<br>Cobb angle, pixel<br>statistics | Line, ROI |
| Category | Cedara WebAccess | Cedara I-SoftView | WebPax |
| | | (predicate device) | (predicate device) |
| User Installation<br>Requirements | Thin Client<br>No installation<br>required on users<br>machine – runs<br>within browser | Thick Client<br>Files installed on<br>user's machine. | Thin Client<br>No installation<br>required on users<br>machine – runs<br>within browser |
| Cross-Enterprise<br>Document Sharing<br>(XDS) functionality<br>XDS is an IHE<br>initiative that provides a<br>framework that enables<br>the sharing of<br>documents between<br>various healthcare<br>enterprises such as<br>private physicians'<br>offices, clinics, acute<br>care in-patient facilities<br>and electronic health<br>record systems. | Yes | No | No |
| Data Types Supported | DICOM, Non-<br>DICOM | DICOM | DICOM, Non-<br>DICOM |
| Image<br>View/Manipulation | Zoom, Pan, Window<br>Level, Auto Window<br>Level, Reset, Scout<br>Lines, Image Rotate,<br>Image Flip, Magnify,<br>Image Invert Image,<br>Mirror, Cine, MPR,<br>MRA, Tag Images. | Zoom, Pan, Window<br>Level, Auto Window<br>Level, Reset, Scout<br>Lines, Image<br>Rotate/Flip, Magnify,<br>Image Invert, Cine,<br>MPR, Flip, Mirror,<br>Tag Images, 3D<br>Correlation, MRA. | Zoom, Pan, Image<br>Invert, Window<br>Level, Cine,<br>Add/Edit<br>Annotations |
| Data Encryption | HTTPS | No data encryption<br>on transmission | HTTPS |
| User and Password | Can either use built in<br>access control or | No access control.<br>Uses Microsoft | Uses built in |
| Category | Cedara WebAccess | Cedara I-SoftView<br>(predicate device) | WebPax<br>(predicate device) |
| Control | when launched from<br>parent application<br>utilize its access<br>control | Windows User<br>Management | access control |
| Data Security | Stored on server | Stored on workstation | Stored on server |
| Audit Trails | Audit trail logged | Audit trail logged | Audit trail logged |
| User Management | Provides grouping of<br>users into domains. | No advanced user<br>management | Not enough<br>information to<br>determine user<br>management. |
| Transmission Modes | Via the web with<br>Internet browsers | Standalone | Via the web with<br>Internet browsers |
| File Types Used | JPEG for Lossy Data,<br>PNG for Lossless<br>data | DICOM | GIF<br>(WebPax<br>potentially utilizes<br>other file types) |

# Table - Comparison of Cedara WebAccess vs Predicate Devices

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Image /page/2/Picture/0 description: The image shows the logo for Merge Healthcare. The logo consists of the word "MERGE" in large, bold, sans-serif font, with the letters slightly spaced apart. To the right of the "E" in "MERGE", there is a small "TM" symbol, indicating a trademark. Below the word "MERGE", there is the word "Healthcare" in a smaller, sans-serif font.

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Image /page/3/Picture/0 description: The image shows the logo for MERGE Healthcare. The word "MERGE" is in large, bold, black letters, with the letters connected to each other. The letters are in all caps, and there is a trademark symbol after the letter E. Below the word "MERGE" is the word "Healthcare" in a smaller, thinner font.

# Summary of Testing:

Nonclinical verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised. The results also demonstrated that the device complies with industry standards for medical data: the NEMA DICOM 3.0 standard for Digital Imaging and Communications in Medicine, the JPEG standard ISO/IEC 10918-1 for the Digital Compression and Coding of Continuous-Tone Still Images, and the ISO/IEC 15948 standard for Portable Networks Graphics (PNG).

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol, with three curved lines representing the bird's body and wings. The logo is black and white.

#### 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

Ms. Carol Nakagawa Director, Quality and Regulatory Affairs Merge OEM, a division of Merge Healthcare 6303 Airport Road, Suite 500 Mississauge, Ontario, L4V 1R8 CANADA

#### JUN 2 3 2010

Re: K092915

Trade/Device Name: Cedara WebAccess 2.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 7, 2010 Received: June 9, 2010

Dear Ms. Nakagawa:

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 (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/ReportalProblem/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.

Donald J. Trump

Donald J. St.Pierre Acting 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): K092915

Device Name:

Cedara WebAccess 2.4

Indications for Use:

Cedara WebAccess 2.4 is a software application that provides internet access to multi-modality softcopy medical images, reports and other patient related information for conducting diagnostic review, planning, and reporting through the interactive display and manipulation of medical data.

Cedara WebAccess 2.4 is capable of being configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.

Display monitors used for reading medical images for diagnostic purposes must comply with applicable regulatory approvals and with quality control requirements for their use and maintenance.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.

Prescription Use Yes (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 In Vitro Diagnostic Devices (OIVD)

Robert M. Becker
(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. K0929/5

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