MITRA IMAGING INC. EXHIBIT

K982769 · Mitra Imaging, Inc. · LLZ · Nov 3, 1998 · Radiology

Device Facts

• Record ID: K982769
• Device Name: MITRA IMAGING INC. EXHIBIT
• Applicant: Mitra Imaging, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Nov 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols. Images sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device. Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.

Device Story

Exhibit is a PC-based, DICOM-compliant PACS software for teleradiology. It receives DICOM images, converts them into JPEG (for thumbnails) and wavelet formats using standard protocols, and stores them in a transient local cache. Users view images via a Java applet within standard web browsers (e.g., Netscape, Internet Explorer) over hospital intranets or remote internet connections. The system runs on off-the-shelf PC hardware using TCP/IP communication. Clinicians use the software to perform basic image manipulations like window leveling, flipping, rotating, and zooming. By enabling remote access to medical images, the device facilitates timely clinical review and decision-making, benefiting patients through improved access to diagnostic information.

Clinical Evidence

No clinical data. Effectiveness was established through extensive bench testing performed by programmers, non-programmers, quality control staff, and potential customers.

Technological Characteristics

Software-only or PC-based PACS; DICOM-compliant; uses Java applet for browser-based viewing; TCP/IP communication; JPEG and wavelet image compression; runs on off-the-shelf PC hardware (Windows NT).

Indications for Use

Indicated for viewing DICOM images over hospital intranets or remote internet locations. Intended for use by clinicians as a transient viewing tool, not for long-term archiving.

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

• Algotec Systems Ltd. MediSurf (K971347)

Submission Summary (Full Text)

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K982769 P. 1 of 4

3 1998 NOV

# 510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, Mitra Imaging, Inc. is providing a summary of safety and effectiveness information regarding the Exhibit software.

- 1.1 Company Identification
Mitra Imaging, Inc. 115 Randall Drive Waterloo, Ontario, Canada N2V 1C5 Tel: [phone] Fax: [phone]

- 1.2 Official Correspondent
Gary J. Allsebrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA, USA, 94578-1116

- 1.3 Date of Submission
August 6, 1998

- 1.4 Device Name
Classification Name: Common/Usual Name: Proprietary Name:

PACS Teleradiology System Exhibit

- 1.5 Substantial Equivalence
The Exhibit software is substantially equivalent to the Algotec Systems Ltd. Product, MediSurf that is covered under K971347.

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K982769 p. 2 of 4

#### 1.6 Device Description and Intended Use

Exhibit is a software package, which may be marketed as a software only solution, as well as in conjunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.

lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.

Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.

### 1.7 Software Development

Mitra certifies that the Exhibit software is designed, developed, tested and validated according to written procedures. These procedures identify individuals within the organization responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software used in this product is used to convert DICOM images to formats that can be displayed within web browsers.

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K982769 p. 3 of 4

#### 1.8 Safety and Effectiveness

## General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indications for use.

The hardware components specified (but not supplied) are all "off the shelf" computer components.

## Validation and Effectiveness:

Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers.

## Substantial Equivalence:

The Exhibit software is a software package used to receive DICOM images, convert them to a web-browser compatible format, and to transfer those converted images to a viewing applet.

Exhibit is substantially equivalent to the Algotec MediSurf product, in that it receives DICOM images, converts them to wavelet format and displays them within a web browser. The intended use and technological characteristics of the system are virtually identical to MediSurf (K971347). Any differences between the Exhibit software and the equivalent device have no significant influence on safety or effectiveness.

It is our conclusion that there is no software component in the Exhibit product or hardware component which would be used in conjunction with the Exhibit product that we know of whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "Level of Concern" of the Mitra Exhibit product is "minor".

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## 1.9 Substantial Equivalence Chart

| Specification | Exhibit (This submission) | MediSurf (K971347) |
|------------------------------------------------------|------------------------------------|-----------------------------------|
| Graphical User<br>Interface | Yes | Yes |
| | | |
| Uses Java<br>programming<br>language | Yes | Yes |
| | | |
| | | |
| Applets viewed inside<br>web browser | Yes | Yes |
| | | |
| Applets stored on<br>remote server | Yes | Yes |
| | | |
| Communications | TCP/IP | TCP/IP |
| Image Review | Window Level/Flip/Rotate/Zoom | Window Level/Flip/Rotate/Zoom/Pan |
| Server Platform | PC - Windows NT | UNIX |
| Client Platform | Any Java-compatible web<br>browser | Any Java-compatible web browser |
| JPEG for thumbnail<br>view | Yes | No |
| | | |
| Wavelet compression<br>for transmission of<br>images | Yes | Yes |

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Re:

Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the top half of the circle. Inside the circle is a stylized emblem featuring three abstract human figures, represented by flowing lines, positioned closely together.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 1998

MITRA Imaging, Inc. c/o Gary J. Allesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578

K982769 Teleradiology System Dated: August 6, 1998 Received: August 7, 1998 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Allesbrook:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitm diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrividsmardsmamain.html".

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin. Ph.D Director, Division of Reproductiv Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K982769

Device Name: Mitra Imaging Inc., Exhibit

Indications For Use:

Exhibit is a software package, which may be marketed as a software only solution, as well as in coniunction with standard PC hardware. Exhibit is a PC-based, DICOM-compliant PACS device that is able to receive and display DICOM images. Images sent to Exhibit are converted into formats suitable for viewing in a web browser, and stored in a local cache (hard disk). The algorithms used by Exhibit to create JPEG and wavelet images follow known and accepted protocols.

lmages sent to Exhibit can be viewed using a Java applet that runs within a web browser such as Netscape or Internet Explorer. The Exhibit applet can be used for the purposes of viewing images over a hospital intranet, or over the internet from a remote location. Images stored on Exhibit are transient, as Exhibit is not intended to be an archiving device.

Exhibit uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack. The network hardware used to support the TCP/IP stack is superfluous to Exhibit.

(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 901.109)

OR

Over-the-Counter Use

Eminl C. Syzman

Division Sign Off

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982769