(168 days)
The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
The Barco MWD 321 Medical Workstation is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MWD 321 device is a workstation display.
The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images.
This is a medical display workstation, which is a hardware device. The provided text doesn't contain a study that proves the device meets acceptance criteria in the way one would evaluate an AI/software medical device (e.g., diagnostic accuracy, sensitivity, specificity).
The "study" in this context refers to the substantial equivalence comparison made by FDA to legally marketed predicate devices. The acceptance criteria for such a device are primarily based on its technical specifications and performance characteristics being comparable to, and not raising new questions of safety or effectiveness compared to, predicate devices.
Here's the breakdown based on the information provided:
Acceptance Criteria and Device Performance
Since this is a hardware device (medical display workstation), the acceptance criteria are not typically presented as performance metrics like sensitivity/specificity for a diagnostic algorithm. Instead, they relate to technical specifications that ensure it functions as intended for displaying medical images for review and analysis. The "performance" being evaluated is its ability to perform the intended function comparably to predicate devices.
| Acceptance Criteria (Inferred from Substantial Equivalence and Device Description) | Reported Device Performance (Inferred from Substantial Equivalence and Device Description) |
|---|---|
| Intended Use: Displaying and viewing digital images for review and analysis by trained medical practitioners. | The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners. |
| Technological Characteristics: High resolution monitor with electronic capabilities for evaluation of high resolution medical images. | The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images. |
| Safety and Effectiveness: Comparable to legally marketed predicate devices. | The device was found substantially equivalent to predicate devices, implying comparable safety and effectiveness for its intended use. |
Study Information (as applicable for a hardware device submission)
-
Sample size used for the test set and the data provenance: Not applicable in the context of an AI/software diagnostic study. For a hardware device like a display, "testing" would involve engineering validation against specifications, not a diagnostic performance study on a test set of medical images in the same way as an AI algorithm. The FDA's substantial equivalence determination relies on comparing the device to existing predicate devices.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as in diagnostic accuracy is not established for a display monitor.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a display monitor, not an AI-assisted diagnostic tool.
-
If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a hardware device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a display workstation is its technical specifications and its ability to accurately render images, not a diagnostic ground truth for medical conditions.
-
The sample size for the training set: Not applicable. Hardware devices are not "trained" with data in the same way AI algorithms are.
-
How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
3975
510(k) SUMMARY
JAN - 2 1998
| A. | Manufacturer: | Barco NV/Display SystemsTheodoor Sevenslaan 1068500 KortrijkBelgium |
|---|---|---|
| ---- | --------------- | --------------------------------------------------------------------------------- |
Ferguson Medical Submitted By: Consultant to Barco NV
- +32(0)56 23 32 11 Phone: B. Contact Information: +32(0)56 23 3 74 FAX:
- C. System, immage communication Classification Name: (accessory), cathode tube, or, display, ray medical.
Common/usual Name: Workstation, image workstation, and others.
Barco MWD 321 Medical Workstation Proprietary Name: Display
- Classification Number: D. 90LMD or 74DXJ
- E. Substantial Equivalence: Sony Medical Systems Division, Sony PGM-1001MD Trinitron Color Graphic Monitor (K970999), Medical Systems Division, Sony Sony Trinitron Color Video Monitor PVM-1343MD (K885042), Technology, Aurora Diagnostic Workstation Aurora Inc., Netra Workstation System (K962589), ScImage, and Netra MD Software (K960911), Applicare Medical B.V., Radworks Medical Imaging Software Imaging Accuimage, Inc., Accuimage, (K962699), and Inc. (K961023), Processor GE Medical Image Display Systems, GE Advantage Windows Review Workstation (K960613), and others.
- F. The MWD 321 device is a workstation Device Description: display.
- G. Intended Use: The Barco MWD 321 device is intended to be used in displaying and viewing digital images for and analysis review by trained medical practitioners.
- H. Technological Characteristics: The Barco MWD 321 is a monitor high resolution with electronic capabilities for evaluation of high resolution medical images.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 2 1998
Frank Ferguson Official Correspondent Consultant for Barco NV Display Systems 3407 Bay Avenue Chico, California 95973
Re: K972701
Barco MWD 321 Medical Workstation Display Dated: November 12, 1997 Received: November 19, 1997 Regulatory class: Unclassified Procode: 90 LMD
Dear Mr. Ferguson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
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 80) and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours.
W.Liau Yu
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
.
.
.
.
.
.
{2}------------------------------------------------
510(k) Number (If known):
Barco MWD 321 Medical Workstation Display Qevice Name:
Índications For Use:
}
ﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴﺴ
The Barco MWD 321 Medical Workstation is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lichard L. Ingram
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Device
510(k) Number K972701
Prescription Use √
(Per 21 CFR 801.109)
Over-The-Counter Use _
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.