(60 days)
Not Found
No
The summary describes image processing features but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
Explanation: The device is intended for use by radiologists for analyzing radiological data and generating reports, which are diagnostic functions. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "is comprised of diagnostic reading software," indicating its role in the diagnostic process.
No
The device description explicitly states it is based on off-the-shelf PCs and 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 clearly states that the system is for analyzing radiological data and generating reports based on that analysis. This involves interpreting medical images, which is a diagnostic process performed by a healthcare professional (radiologist).
- Device Description: The description focuses on viewing and processing radiological images and generating reports. It does not mention any analysis of biological samples (blood, urine, tissue, etc.) which is the hallmark of an IVD.
- Lack of IVD Characteristics: There is no mention of reagents, assays, or any other components typically associated with in vitro diagnostic testing.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. This device operates on medical images, not biological samples.
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 (comma separated list FDA assigned to the subject device)
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 PCs running Windows 2000/XP operating systems 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 Angiography MIP, Vessel Tracking and Tissue Definition.
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
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): 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.
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
Algotec Systems Ltd.
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.
8
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:
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 and K023936.
- The MediPrime is a multi-modality radiology reading and Description of the Device: reporting station for viewing and processing radiological images and generating and viewing radiology reports. It is based on off-the shelf PCs running Windows 2000/XP operating systems 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 Angiography MIP, Vessel Tracking and Tissue Definition.
- 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.
September 23, 2003
Mace Bey
Date
Dr. Menashe Benjamin, President
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure with outstretched arms, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" at the bottom and "USA" at the top.
NOV 2 5 2003
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: K033013 Trade/Device Name: MediPrime Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: 90 LLZ Dated: September 23, 2003 Received: November 10, 2003
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 such 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 (OS) 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 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the 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" (21CFR Part 807.97) you may obtain. 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.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
3 Indications For Use (separate page):
Page ____ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known) _ K 6 3 3 6 1 3
Device Name: MediPrime
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.
9
Danila. Lynn
(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number
(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