(86 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description focuses on calibration and QA checks, which are typically rule-based processes.
No
The device is intended for quality assurance and calibration of displays used by medical practitioners, not for direct therapeutic intervention on a patient.
No
The device is used to calibrate and perform quality assurance checks on color displays, which are tools used in diagnostics, but the device itself does not diagnose medical conditions.
Unknown
The summary describes a "digital image quality management system" and mentions "image processing," which could be software. However, it also mentions calibrating and performing QA checks on "color displays," which are hardware. The summary does not explicitly state that the device is software-only or that it does not include any hardware components. The predicate device is described as "Display Conformity and Consistency Software," which leans towards software, but without a clear statement about the subject device's composition, it's impossible to definitively say it's software-only.
Based on the provided information, the MediCal LE device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "calibrate and perform QA checks on color displays." This is related to the performance and quality control of medical imaging displays, not the analysis of biological samples or specimens from the human body.
- Device Description: It's described as a "digital image quality management system." This aligns with its intended use of managing the quality of images displayed on monitors.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on biological samples.
The device's function is focused on ensuring the accuracy and consistency of medical image displays, which is a crucial aspect of medical imaging but distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Barco MediCal LE device is intended to be used as a tool for trained medical practitioners to calibrate and perform quality checks on color displays in home offices and hospitals.
Product codes
90LLZ
Device Description
The MediCal LE device is a digital image quality management system
Mentions image processing
System, image processing
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
trained medical practitioners, home offices and hospitals
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
APR 0 4 2002
510(K) SUMMARY
Manufacturer:
Barco NV Display Systems
Theodoor Sevenslaan 106
8500 Kortrijk
Belgium
Submitted By:
Ferguson Medical
Consultant to Barco NV
Contact Information:
Phone: +32(0) 56 23 32 11
FAX: +32(0) 56 23 3 74
Classification Name:
System, image processing
Common/Usual Name:
Consistency software, image conformity
software, QA software package, DICOM
conformance tool, and others
Proprietary Name:
MediCal LE
Classification Number:
21 CFR 892.2050/Procode 90LLZ
Substantial Equivalence:
Barco NV Display Systems MediCal Display
Conformity and Consistency Software
(K982690)
Device Description:
The MediCal LE device is a digital image quality
management system
Intended Use:
The Barco MediCal LE device is intended to be
used as a tool for trained medical practitioners
to calibrate and perform quality checks on
color displays in home offices and hospitals
Technological Characteristics:
The MediCal LE device is a software tool used
to calibrate and perform QA checks on image
displays
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Barco NV Display Systems % Mr. Frank Ferguson Official Correspondent Ferguson Medical P.O. Box 12038 LA JOLLA CA 92039-2038 APR - 4 2002
Re: K020058
Trade/Device Name: MediCal LE Display system calibrator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving
and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: December 21, 2001 Received: January 8, 2002
Dear Mr. Ferguson:
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
B
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 yours,
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
510(k) Number (If known):
Device Name: MediCal LE
Indications For Use:
The MediCal LE device is intended to be used as a tool for trained medical practitioners to calibrate and perform QA checks on color displays in home offices and hospitals.
Please do not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K020058
Prescription Use __ ర్లు (Per 21 CFR 801.109)
OR
Over-The- Counter Use ________________________________________________________________________________________________________________________________________________________