(264 days)
No
The document describes a medical display and calibration software, with no mention of AI or ML capabilities. The performance studies focus on display standards compliance.
No
The device is a medical display used for viewing medical images for review and analysis, not for treatment or therapy. It explicitly states it "can NOT be used for a life-support system."
No
The device is a medical display, used for viewing medical images, not for generating or interpreting them. While it's used by medical practitioners for review and analysis, it explicitly states it "CAN NOT be used in primary image diagnosis in mammography." Its function is to display images, not to diagnose.
No
The device description explicitly states it is a "21" color display for medical viewing," indicating a hardware component is included.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "displaying and viewing medical images, for review and analysis by trained medical practitioners." This describes a device used for visualizing existing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The device is a "21" color display for medical viewing" combined with calibration software. This further reinforces its role as a display tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or treatment. This device's function is to present images for interpretation by a medical professional.
N/A
Intended Use / Indications for Use
The OptikView GUP2103CM1 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The device can NOT be used in primary image diagnosis in mammography.
The device can NOT be used for a life-support system.
The device is intended for prescription use.
Product codes
PGY
Device Description
The OptikView GUP2103CMI with QUBYX PerfectLum is a 21" color display for medical viewing.
It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
The main difference from the predicate monitor is enhanced screen luminance. All other technological characteristics are similar to the predicate device
Mentions image processing
Yes
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 / Not Found
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)
To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software with the requirements of the DICOM standard. It consisted of measurement steps, where the meter measured display's characteristics and the software recorded them. Then the software analyzed the results in comparison with target values, defined by DICOM standard, and generated the report, stating that the display is DICOM-conformant.
The display device has successfully passed DICOM conformance test, so it is compliant with DICOM Part 14 GSDF standard. So is the predicate device, so the two devices are substantially equivalent in this regard.
To verify AAPM TG18 conformance, an acceptance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the AAPM TG18 standard and consisted of measurement and visual parts.
During the measurement steps, the meter measured display's characteristics and the software recorded them. During the visual steps, the user analyzed test patterns, generated by the software in accordance with AAPM standard. The software recorded the user's answers. Then the software analyzed the results in comparison with target values, defined by AAPM standard, and generated the report, stating that the display passes AAPM TG18 acceptance test.
The display device has successfully passed AAPM TG18 acceptance test, so it is compliant with AAPM TG18 standard and can be used as a primary category display for interpretation of medical images. The same is true for the predicate device, so the two devices are substantially equivalent in this regard.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DICOM-conformant, passes AAPM TG18 acceptance test.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
March 16, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
The Linden Group Corp. % Mr. Marc Leppla Director QUBYX Software Technologies Inc. 501 Silverside Road, Suite 105 WILMINGTON DE 19809
Re: K191705
Trade/Device Name: OptikView GUP2103CMI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: February 20, 2020 Received: February 24, 2020
Dear Mr. Leppla:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191705
Device Name OptikView GUP2103CMI
The OptikView GUP2103CM1 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The device can NOT be used in primary image diagnosis in mammography.
The device can NOT be used for a life-support system.
The device is intended for prescription use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary as required by 807.92 K191705
- Company Identification
The Linden Group Corp. 2B Wing Drive Cedar Knolls, NJ 07927 USA
-
Official Correspondent Dr. Marc Leppla President and CTO (Chief Technical Officer) leppla@gubyx.com
-
Date of Submission 07/19/2018
-
Device Trade name OptikView GUP2103CMI
-
Common/Usual Name Image display system, Color LCD Monitor, image monitor/display
-
Classification Number Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and Communications System
7.Predicate device Name: Nio Color 3MP (MDNC-3421) Manufacturer: BARCO NV 510(k) number: K170837 Classification Number: Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and Communications System
- Device description
The OptikView GUP2103CMI with QUBYX PerfectLum is a 21" color display for medical viewing.
It is combined with QUBYX PerfectLum and PerfectLum remote management, a userfriendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM, displaying test pattern and performing acceptance and constancy tests.
The main difference from the predicate monitor is enhanced screen luminance. All other technological characteristics are similar to the predicate device
- Indications for use
The OptikView GUP2103CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The device can NOT be used in mammography.
The device can NOT be used for a life-support
system.
The device is intended for prescription use.
4
10. Comparison of technological characteristics
| Specification | GUP2103СМІ | Nio Color 3MP (MDNC-3421) |
|---|---|---|
| Screen technology | Color TFT Normally Black | TFT AM Color LCD IPS |
| Active screen size (diagonal) | 540 mm (21.3") | 540 mm (21.3") |
| Active screen size (H x V) | 433.15 (H) x 324.86 (V) mm | 433 x 325 mm (17.0 x 12.8") |
| Aspect ratio (H:V) | 4:3 | 4:3 |
| Resolution | 3MP (2048 x 1536 pixels) | 3MP (2048 x 1536) |
| Pixel pitch | 0.2155 mm | 0.2155 mm |
| Color imaging | Yes | Yes |
| Gray imaging | Yes | Yes |
| Viewing angle (H, V) | 178° | 176° |
| Backlight Output Stabilization | Yes | Yes |
| Maximum luminance | 1000 cd/m2 | 800 cd/m2 |
| DICOM calibrated luminance | 500 cd/m2 | 400 cd/m2 |
| Contrast ratio (typical) | 1400:1 | 1400:1 |
| Response time (Tr + Tf) | 30 ms | 40 ms |
| Video input signals | DVI-D Dual Link, DisplayPort, VGA | DVI-D Dual Link, DisplayPort |
| USB ports | 1 upstream (endpoint), 2 downstream | 1 upstream (endpoint), 2 downstream |
| USB standard | 2.0 | 2.0 |
| Power consumption (nominal) | 80W | 50W |
| Power save mode | Yes | Yes |
| Dimensions with stand (W x H x D) | Portrait: 377 x 473~607,5 | Portrait: 378 x 528~628 |
| Net weight with stand | 11,3 kg | 12.8 kg |
| Intended use | The OptikView GUP2103CMI is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The device can NOT be used in primary image diagnose in mammography The device can NOT be used for a life-support system. | The Nio Color 3MP LED Medical Flat Panel Display System is intended to be used for displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners. |
5
11. Details of testing:
To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software with the requirements of the DICOM standard. It consisted of measurement steps, where the meter measured display's characteristics and the software recorded them. Then the software analyzed the results in comparison with target values, defined by DICOM standard, and generated the report, stating that the display is DICOM-conformant.
The display device has successfully passed DICOM conformance test, so it is compliant with DICOM Part 14 GSDF standard. So is the predicate device, so the two devices are substantially equivalent in this regard.
To verify AAPM TG18 conformance, an acceptance test was performed, using QUBYX PerfectLum software and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance with the requirements of the AAPM TG18 standard and consisted of measurement and visual parts.
During the measurement steps, the meter measured display's characteristics and the software recorded them. During the visual steps, the user analyzed test patterns, generated by the software in accordance with AAPM standard. The software recorded the user's answers. Then the software analyzed the results in comparison with target values, defined by AAPM standard, and generated the report, stating that the display passes AAPM TG18 acceptance test.
The display device has successfully passed AAPM TG18 acceptance test, so it is compliant with AAPM TG18 standard and can be used as a primary category display for interpretation of medical images. The same is true for the predicate device, so the two devices are substantially equivalent in this regard.
Both devices have the same indications for use, except for predicate device it is not specified that it will not contact with the patient.
We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.
International standards: TÜV (ANSI/AAMI ES60601-1 and CAN/CSA C22.2 NO.60601-1); CE (IEC/EN 60601-1; EN60601-1-2); BSMI; CCC
12. Conclusion:
The comparison table shows that the subject device (OptikView GUP2103CMI) has the same intended use as the predicate. The main difference from the predicate monitor is enhanced screen luminance. All other technological characteristics are similar to the predicate device.
Both devices are compliant with DICOM Part 14 GSDF and AAPM TG18 standards. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed by QUBYX.