MEDISURF

K971347 · International Regulatory Consultants · LMD · Jul 3, 1997 · Radiology

Device Facts

• Record ID: K971347
• Device Name: MEDISURF
• Applicant: International Regulatory Consultants
• Product Code: LMD · Radiology
• Decision Date: Jul 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1
• Attributes: Software as a Medical Device

Indications for Use

MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can be also used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.

Device Story

MediSurf is a teleradiology server acting as an access engine for clinical images. It retrieves DICOM images from servers/networks using adaptive progressive compression for efficient transfer over intranets, Internet, or dial-up lines. The system provides software applets for display, processing, storage, and transmission of clinical data. Operated by radiologists, physicians, and healthcare staff in clinical settings, it enables remote interpretation and second opinions. Users interact with the server via a remote Web browser (e.g., Netscape Navigator, Microsoft Explorer) using Java. The device facilitates clinical decision-making by providing diagnostic-quality images for reports and patient records, improving access to clinical information across distributed healthcare environments.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological and functional comparison to the predicate device.

Technological Characteristics

Standard off-the-shelf UNIX-based workstation. Connectivity via DICOM networks, intranets, Internet, and dial-up lines. Features adaptive progressive compression for image transfer. Software includes archiving, communication, and image processing applets. User interface utilizes Java-based Web browsers.

Indications for Use

Indicated for radiologists, physicians, and healthcare staff to access, display, process, store, and transmit clinical images and information for teleradiology, second opinions, and clinical reporting. No specific age or gender restrictions; intended for professional clinical use.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• ProVision Diagnostic Workstation (K954678)

Submission Summary (Full Text)

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Algotec Systems Ltd.
MediSurf Premarket Notification
K971347

# 2 Summary of Safety and Effectiveness

This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## Submitter :

JUL - 3 1997

Algotec Systems Ltd.
4 Hamelacha St.
P.O. Box 2408
Industrial Zone, Ra'anana
ISRAEL 43000
Tel: [phone]
Fax: [phone]

**Name of the Device :** MediSurf.

**Predicate Device :** ProVision Diagnostic Workstation manufactured by Algotec Systems Ltd. (K954678).

**Description of the Device :** The MediSurf server is an access engine to healthcare information. MediSurf provides its end-users with easy access to DICOM devices and networks for the retrieval of images in full diagnostic quality using adaptive progressive compression for efficient transfer over different communication links. The server also provides the user with the software applets needed to display, process, store, and send the retrieved clinical data.

The MediSurf server is based on off-the-shelf UNIX based computer that complies with the accepted international standards for computer systems. The system also comprises software developed and validated by Algotec Systems Ltd..

**Intended Use :** MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can be also used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.

**Comparison of Technological Characteristics :** MediSurf and its predicate device, the ProVision Diagnostic Workstation, share many implementation and functional characteristics:

- Both systems are implemented on a standard off-the-self UNIX based workstation.
- Both systems share many common software components such as Archiving and Communication subsystems. Most of the MediSurf software was originally developed for the ProVision workstation.

2

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Algotec Systems Ltd.
MediSurf Premarket Notification

- Both systems provide standard image viewing tools such as: window/level, zoom and pan. No tools are implemented in the MediSurf, that do not exist in the ProVision.
- Both systems provide access to any standard DICOM image server.

There are no new features affecting safety or effectiveness in the MediSurf that do not exist in the ProVision. There is, however, a single technical difference between the user interface of the two systems. The user interaction with the ProVision is facilitated by using the system’s mouse, keyboard, monitor and dedicated interface software. The interaction with MediSurf, however, is facilitated by using a remote Web browser running Java, such as Netscape’s Navigator or Microsoft’s Explorer. As a result, the MediSurf has slower interaction with the user but all the other standard viewing capabilities are kept.

The differences between the two systems raise no new issues of safety or effectiveness.

April 7, 1997
Date


Dr. Menashe Benjamin, President
Signature, Title

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Algotec Systems, Ltd.
c/o Dr. Eli Orbach
International Regulatory Consultants
P.O. Box 6718
Efrat 90435
ISRAEL

JUL - 3 1997

Re: K971347
MediSurf (Teleradiology Device)
Dated: April 7, 1997
Received: April 10, 1997
Unclassified/Procode: 90 LMD

Dear Dr. Orbach:

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 requirement, as set forth in the Quality System Regulation (QS) 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 vitro 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/cdrh/dsmamain.html".

Sincerely yours,


Enclosure

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P. 2

510(k) Number (if known) K971347

Device Name MediSurf

Indications For Use:

MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with image processing capabilities, MediSurf can be used by radiologists for on-call teleradiology over "intranets", Internet, direct or dial-up lines, and for providing second opinion services. It can also be used by physicians for enhanced interpretation of cases through the inclusion of images in imaging related reports and in patient records in general. Similarly it can be used by healthcare organization staff for facilitated access to clinical images throughout the healthcare organization.

(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 801.109)

OR

Over The Counter Use ☐ (Optional Format 1-2-90)