(84 days)
No
The summary describes image processing and access capabilities but does not mention AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is described as an access engine for clinical images and information, primarily for viewing, processing, storing, and sending data, not for direct diagnosis or treatment.
Yes
The device is intended for use by radiologists and physicians for interpretation of clinical images, teleradiology, and second opinion services, which are activities associated with reaching a diagnosis. Furthermore, the description states it provides "images in full diagnostic quality" and the predicate device is a "Diagnostic Workstation."
No
The device description explicitly states that the MediSurf server is based on an "off-the-shelf UNIX based computer," indicating the inclusion of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description of MediSurf clearly state that it is used to access, display, process, store, and send clinical images (like DICOM images) from devices and networks. It does not involve the analysis of biological samples such as blood, urine, or tissue.
- The focus is on image management and interpretation. The device facilitates access to images, provides image processing capabilities, and is used by radiologists and physicians for interpretation and reporting. This is characteristic of medical imaging software and systems, not IVDs.
Therefore, MediSurf falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) component, rather than an IVD.
N/A
Intended Use / 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.
Product codes
90 LMD
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, physicians, healthcare organization staff
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2020 Medical image communications device.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
0
5971347
Summary of Safety and Effectiveness 2
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 :
ಜೆಪಿಯ
JUL - 3 1997
Algotec Systems Ltd. 4 Hamelacha St. P.O. Box 2408 Industrial Zone, Ra'anana ISRAEL 43000 Tel: +972-9-748-2442 Fax: +972-9-748-2411
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.
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- · 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.
Meorle Bey
April 7, 1997
Date
Dr. Menashe Benjamin, President
Signature, Title
.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
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
Image /page/2/Picture/5 description: The image shows a date, "JUL - 3 1997". The month is July, the day is the 3rd, and the year is 1997. The text is in a simple, sans-serif font and is horizontally aligned.
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 that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 misbranion.
If your device is classified (see above) into either 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 vour 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 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
h7iliau
Lillian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name___________________________________________________________________________________________________________________________________________________________________
Indications For Use:
MediSurf is intended to facilitate access to clinical images and information in distributed locations. Along with imnge 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 NEEDBUS
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971347 |
| Prescription Use | X | OR | Over The Counter Use |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |