(24 days)
Not Found
No
The summary describes a standard radiology reading and reporting station with image processing features like MPR, but there is no mention of AI, ML, or related concepts.
No
Explanation: A therapeutic device is used to treat or cure a disease or medical condition. This device is described as a "radiology reading and reporting station" for analyzing radiological data and generating reports, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system "is comprised of diagnostic reading software" and is used for "analyzing radiological data." This indicates its role in the diagnostic process.
No
The device description explicitly states it is based on "off-the shelf Windows 2000 computers and a number of monitors," indicating it includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for radiologists to analyze radiological data and generate reports. This involves interpreting medical images, which is a diagnostic process, but it's based on in vivo (within the living body) imaging data, not in vitro (outside the living body) samples like blood, urine, or tissue.
- Device Description: The description focuses on viewing and processing radiological images, which are generated from imaging modalities applied to the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, this device falls under the category of medical imaging software or a radiology workstation, not an IVD.
N/A
Intended Use / Indications for Use
The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
Product codes
90 LLZ
Device Description
The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality radiology
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
§ 892.2050 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
2 Summary of Safety and Effectiveness
Ko23936
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:
Algotec Systems Ltd. 4 Hamelacha St. P.O.Box 2408 Industrial Zone. Ra'anana ISRAEL 43000 +972-9-748-2442 Tel: +972-9-748-2411 Fax:
DEC 2 0 2002
Name of the Device: MediPrime
- Predicate Device: This is a Special 510(k) for the MediPrime, a Radiology Reading and Reporting Station, that was cleared under K002894.
- Description of the Device: The MediPrime is a multi-modality radiology reading and reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf Windows 2000 computers and a number of monitors (regular or high resolution) that comply with the accepted international standards for computer and monitor systems. The system also comprises software developed and validated by Algotec Systems Ltd. The modified device contains added features, including Multi-Planar Reformatting (MPR).
- Intended Use: The system, that is comprised of diagnostic reading software, is intended for use by radiologists as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
Comparison of Technological Characteristics: The modifications to the MediPrime do not affect the intended use or alter the fundamental scientific technology of the device. The only device modification was to software. There are no labeling changes that affect the intended use of the device. The device modifications raise no new issues of safety or effectiveness.
November 19, 2002
Date
Mule Ber
Dr. Menashe Benjamin, President
Algotec Systems Ltd., 4 Hamelacha St., Indst. Zone, Ra'anana, Israel Phone: +972-9-7482411
8
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Algotec Systems, Ltd. % Dr. Eli M. Orbach Consultant International Regulatory Consultants P.O. Box 6718 Efrat 90435 ISRAEL
Re: K023936 Trade/Device Name: MediPrime Radiology Reading and Reporting Station Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: November 19, 2002 Received: November 26, 2002
Dear Dr. Orbach:
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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act): 21 CFR 1000-1050.
2
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), please contact the Office of Compliance at one of the following numbers, based on the regulation. number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Henry C. Snigdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
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3 Indications For Use (separate page):
Page __ /_ of ________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known) _ KO23936
Device Name: MediPrime
Indications For Use:
The system, that is comprised of diagnostic reading software, is intended for use rne systems as an interactive tool for analyzing radiological data and generating and viewing radiology reports based on their analysis.
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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devic 510(k) Number
Over The Counter I
Prescription Use_ (Per 21 CFR 801.109)
OR