The MFCD 1219 is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
The MFCD 1219 TS is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Device Description

MFCD 1219 is a 19.0" color LCD display for medical viewing. Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.
MFCD 1219 TS is a 19.0" color LCD display for medical viewing, equipped with a 19.0" touchscreen panel. Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

AI/ML Overview

The provided document is a 510(k) summary for two medical flat panel displays, Barco MFCD 1219 and MFCD 1219 TS. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with acceptance criteria and performance metrics typically found in efficacy studies for AI/ML devices or novel therapies.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of device performance in diagnosing or interpreting medical images.

Here's why and what the document does provide:

Type of Device: These are display devices, not diagnostic algorithms. Their "performance" is related to image quality, resolution, and software functionality, not diagnostic accuracy.
Regulatory Pathway: A 510(k) submission primarily establishes that a new device is "substantially equivalent" to a legally marketed predicate device. This means demonstrating that it has the same intended use, technological characteristics, and raises no new questions of safety or effectiveness.
Focus of the Document: The document outlines the technical specifications of the MFCD 1219 and MFCD 1219 TS, compares them to their predicate (MFCD 2320), and states that any differences do not affect safety or efficacy. It also describes the NioWatch software's functionality (setting display functions, test patterns, calibration).

Specifically, the requested information elements are not present because they are not typically part of a 510(k) for a display device:

Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for diagnostic performance or report such performance, as it's a display device.
Sample size for test set and data provenance: Not applicable, as there's no diagnostic test set.
Number of experts used to establish ground truth & qualifications: Not applicable.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not done/applicable as it's not a diagnostic AI aide.
Standalone performance study: Not done/applicable as it's a display, not a standalone diagnostic algorithm.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable, as no algorithm was trained for diagnostic purposes.
How ground truth for training set was established: Not applicable.

In conclusion, the provided 510(k) summary is not designed to present information about diagnostic performance or the types of studies typically conducted for AI-based diagnostic tools. It focuses on technical equivalence to a predicate display device.

Summary

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510(k) Summary In accordance with 21 CFR 807.92

K052478

1. Date of preparation

SEP 2 8 2005

September 06, 2005

2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457

3. Contact person

Lieven De Wandel Official correspondent

4. Device information

Trade name: MFCD 1219 .
Common name: Medical flat panel display .
Classification name: System, Image Processing .
Classification number: 21 CFR 892.2050 / Procode 90LLZ .

5. Predicate device

Name: MFCD 2320 .
510(k) number: K040158 .
. Manufacturer: Barco NV

6. Device description

MFCD 1219 is a 19.0" color LCD display for medical viewing.

Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

"The MFCD 1219 is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

8. Summary of technological characteristics

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The device consists of two components:

One 1.3-megapixel flat panel display .
. NioWatch software

The flat panel display has a resolution of 1280 x 1024 pixels.

The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display and display controller information.

Compared to the predicate device, MFCD 1219 has a different LCD panel with a somewhat smaller screen size and a lower resolution. The display has no built-in optical sensor and cannot be rotated into portrait orientation. The other components of the system are the same.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

9. Conclusion:

The Barco MFCD 1219 is substantially equivalent to the predicate device, MFCD 2320.

The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco MFCD 1219 contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.

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510(k) Summary In accordance with 21 CFR 807.92

1. Date of preparation

September 06, 2005

2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457

3. Contact person

Lieven De Wandel Official correspondent

4. Device information

. Trade name: MFCD 1219 TS
. Common name: medical flat panel display
Classification name: System, Image Processing .
Classification number: 21 CFR 892.2050 / Procode 90LLZ .

5. Predicate device

Name: MFCD 2320 .
510(k) number: K040158 .
Manufacturer: Barco NV .

6. Device description

MFCD 1219 TS is a 19.0" color LCD display for medical viewing, equipped with a 19.0" touchscreen panel.

Niowatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

"The MFCD 1219 TS is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammoqraphy.

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8. Summary of technological characteristics

The device consists of two components:

One 1.3-meqapixel flat panel display .
. NioWatch software

The flat panel display has a resolution of 1280 x 1024 pixels.

The NioWatch software allows to set the display test patterns, calibrate the display and view additional display and display controller information.

Compared to the predicate device, MFCD 1219 TS has a different LCD panel with a somewhat smaller screen size and a lower resolution. The display has no built-in optical sensor and cannot be rotated into portrait orientation. Additionally, the MFCD 1219 TS display is equipped with a 19.0" touchscreen panel. The other components of the system are the same

The device does not come into contact with the patient. It does not control any life sustaining devices either.

9. Conclusion:

The Barco MFCD 1219 TS is substantially equivalent to the predicate device, MFCD 2320.

The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco MFCD 1219 TS contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing the feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk

SEP 2 8 2005

Re: K052478

Trade/Device Name: MFCD 1219 and MFCD 1219 TS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 6, 2005 Received: September 12, 2005

Dear Mr. De Wandel:

BELGIUM

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 rear 20, 1778, and colance 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 do not require approval brontrols 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 (Premarket A poroval), it may be subject to such additional controls. Existing major regulations affecting your Appleo 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 I DA 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 r otes at building, 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms leter with anow you to begin marketing of substantial equivalence of your device to a legally prematication: "The PDA mainly sification 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 If you desire specific advice for your derice on one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notifications the Also, picase note the regulation entitled, "Theorial and on your responsibilities under the Act from the 807.97). Tou may outlin other general informations on your Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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INDICATIONS FOR USE

0(k) Number (if known): Kosz 478 ____________________________________________________________________________________________________________________________________________

Device Name: MFCD 1219

Indications for Use:

"The MFCD 1219 is intended to be used in displaying and viewing digital images for review by The Fire CD 1223 is meetage must not be used in primary image diagnosis in mammography.

Prescription Use XX_

(Part 21 CFR 801 Subpart D) ADD/OR

(21 CFR 801 Subpart C)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Siegerson

(Division Sign-Q Division of Reproductive. Abdor and Radiological D 510(k) Number

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INDICATIONS FOR USE

.0(k) Number (if known): Ko52478_____________________________________________________________________________________________________________________________________________

Device Name: MFCD 1219 TS

Indications for Use:

"The MFCD 1219 TS is intended to be used in displaying and viewing digital images for review by The Fire D 1213 Your international with the used in primary image diagnosis in mammography.

Prescription Use _XX

(Part 21 CFR 801 Subpart D) AND/OR

(21 CFR 801 Subpart C)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Ingram

and Ra 510k) Nu

Regulation Number and Section

N/A