K Number
K092915
Device Name
CEDARA WEBACCESS, MODEL: 2.4
Date Cleared
2010-06-23

(274 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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. 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.
More Information

Not Found

No
The summary describes a medical image viewing and access software with standard image manipulation tools. There is no mention of AI, ML, or any features that suggest algorithmic interpretation or analysis of the images beyond basic display and manipulation.

No
The device is a software application for viewing and manipulating medical images and patient information for diagnostic review, not for providing medical treatment or therapy.

Yes
The "Intended Use / Indications for Use" section states that the software provides internet access to medical images and reports "for conducting diagnostic review, planning, and reporting." Additionally, the "Device Description" states it provides "diagnostic quality images." Although the software itself does not interpret or provide a diagnosis, it is explicitly designed to support diagnostic activities performed by medical professionals.

Yes

The device is described as a "software application" that provides "internet access" to medical images and data for "diagnostic review, planning, and reporting" through "interactive display and manipulation of medical data." It explicitly states "no application-specific installation required on the user's computer" and is used with a "standard internet browser." The description focuses solely on the software's functionality and does not mention or include any hardware components as part of the device itself. While it interacts with medical images and requires a display monitor, the device itself is presented as a software solution.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: Cedara WebAccess 2.4 is a software application for accessing, displaying, and manipulating medical images and related patient information. It facilitates the review and planning process for medical professionals.
  • Lack of Biological Sample Analysis: The device does not involve the analysis of any biological samples from a patient. Its function is centered around the display and manipulation of existing medical imaging data and reports.
  • Intended Use: The intended use clearly states "providing 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." This aligns with image viewing and management, not in vitro testing.

Therefore, Cedara WebAccess 2.4 falls under the category of medical image management and viewing software, not an in vitro diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

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.
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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multi-modality

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical specialists / Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K022881, K051325

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).

0

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
6303 Airport Road, Suite 500
Mississauga, Ontario
Canada L4V 1R8 | JUN 2 3 2010 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Carol Nakagawa
Director, Quality and Regulatory Affairs
Tel: 905.364.8000
Fax: 905.364.8100 | |
| 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 Name510(k) Submitter/Manufacturer510(k) Number
Cedara I-SoftViewCedara Software Corp.K022881
WebPaxHeart Imaging Technologies, LLCK051325

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.

1

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

Table - Comparison of Cedara WebAccess vs Predicate Devices

2

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.

.

3

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).

4

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

5

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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 .

6

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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