MEDICAL LE

• K Number: K020058
• Device Name: MEDICAL LE
• Manufacturer: BARCO NV
• Date Cleared: 2002-04-04 ( 86 days)
• Product Code: LLZ
• Regulation Number: 892.2050
• Type: Traditional
• Panel: Radiology
• Reference & Predicate Devices: K982690
• Predicate For: N/A

Intended 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.

Device Description

The MediCal LE device is a digital image quality management system

AI/ML Overview

Acceptance Criteria and Study Details for Barco MediCal LE

Based on the provided documents, it is not possible to extract the detailed information requested regarding the acceptance criteria and a specific study proving the device meets those criteria. The provided 510(k) summary and FDA clearance letter primarily focus on establishing substantial equivalence to a predicate device and confirming the device's intended use and classification.

Here's a breakdown of what can be inferred and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided documents. The 510(k) summary mentions "digital image quality management system" and "calibrate and perform quality checks on color displays," implying performance related to display calibration and quality assurance. However, specific performance metrics (e.g., luminance accuracy, color uniformity, spatial resolution targets) are not provided.
• Reported Device Performance: Not reported in the provided documents. The documents do not include any tables or descriptions of test results showing how well the MediCal LE performed against any criteria.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not mentioned, as there is no description of a specific performance study or ground truth establishment process.

4. Adjudication Method for the Test Set:

• Not mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not mentioned. The device's nature as a display calibration and QA tool makes an MRMC study (typically for diagnostic image interpretation) less likely or applicable in this context. The focus would be on the device's ability to maintain objective display parameters.

6. Standalone Performance Study (Algorithm Only):

• A standalone study for the algorithm only (without human-in-the-loop performance) is implied to some extent, as the device is a software tool for calibration and QA. However, specific details of such a study are not provided. The documents state: "The MediCal LE device is a software tool used to calibrate and perform QA checks on image displays." This indicates the device's primary function is automated.

7. Type of Ground Truth Used:

• Not explicitly defined, as no specific performance study details are available. For a display calibration and QA tool, the "ground truth" would likely involve objective physical measurements of display characteristics (luminance, chromaticity, uniformity, etc.) using reference instruments that are themselves calibrated to established standards (e.g., DICOM Part 14, CIE color spaces).

8. Sample Size for the Training Set:

• Not mentioned. As a calibration and QA tool, it's less likely to involve a "training set" in the context of machine learning for image interpretation. Its "training" would be more akin to software development and validation that ensures it correctly applies calibration algorithms and performs measurement functions.

9. How the Ground Truth for the Training Set Was Established:

• Not mentioned. (See point 8 for context on "training set" applicability).

Summary of what is known from the provided documents:

• Device Name: MediCal LE
• Manufacturer: Barco NV Display Systems
• Intended Use: "A tool for trained medical practitioners to calibrate and perform quality checks on color displays in home offices and hospitals."
• Technological Characteristics: "A software tool used to calibrate and perform QA checks on image displays."
• Substantial Equivalence: Claimed to Barco NV Display Systems MediCal Display Conformity and Consistency Software (K982690). This is the primary basis for the 510(k) clearance, not a new performance study against specific acceptance criteria.

Conclusion:

The provided 510(k) documents for the Barco MediCal LE indicate that its clearance was based on substantial equivalence to a predicate device (K982690). They do not contain the specific details of acceptance criteria, detailed performance studies, sample sizes, or ground truth establishment methods that would typically be associated with a comprehensive performance evaluation demonstrating conformance to novel acceptance criteria. Such information would likely be found in internal validation reports or more detailed technical documentation not included in this summary.

Summary

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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: [phone]
FAX: [phone]

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

K020058

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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.

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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	[phone]
876.2xxx, 3xxx, 4xxx, 5xxx	[phone]
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	[phone]
892.2xxx, 3xxx, 4xxx, 5xxx	[phone]
Other	[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 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 [phone] or [phone] 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

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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 ________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).