(399 days)
No
The summary describes a medical display and calibration software. There is no mention of AI or ML capabilities, image processing beyond display calibration, or any data related to training or testing AI/ML models.
No.
The device is a display for viewing digital images, not for providing therapy or treatment.
No
The device is a medical display, used for viewing and analyzing digital images, but it does not perform diagnostic functions itself. Its purpose is to present images to trained medical practitioners for their review and analysis, not to make a diagnosis. The "Intended Use" specifically states "displaying and viewing of digital images, for review and analysis by trained medical practitioners" and explicitly excludes "primary image diagnosis in mammography."
No
The device description explicitly states it is a "30" color display for medical viewing" and includes hardware specifications (resolution, Look Up Table, 10 bit panel). While it includes software (QUBYX PerfectLum), the device itself is a combination of hardware and software.
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 of digital images, for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the technical specifications of a display and calibration software, designed for accurate image presentation. It doesn't mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: IVD devices typically involve reagents, assays, or other methods for analyzing biological specimens (blood, urine, tissue, etc.) to provide diagnostic information. This device does not have any of these characteristics.
The device is clearly intended for the display and analysis of medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL U3014 must only be used in conjunction with QUBYX PerfectLum. The device must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system and does not contact with the patient.
Product codes
PGY
Device Description
The DELL U3014 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560x1600 resolution with an adjustable Look Up Table and a 10 bit panel.
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.
Mentions image processing
Not Found
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
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
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 in accordance 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
Not Found
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
K131601
6.1
Page 1 of 5
JUL 0 7 2014
510(K) Summary
as required by 807.92
- Company Identification QUBYX Limited
80, rue Marechal Joffre 06000 Nice, France Tel: +33 4 97 03 23 00
-
Official Correspondent Mr. Marc Leppla President and CTO (Chief Technical Officer) leppla@gubyx.com
-
Date of Submission May 21. 2013
-
Device Trade name DELL U3014 with QUBYX PerfectLum bundle
-
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
-
Predicate device 1 Name: UltraSharp U3011 Manufacturer: DELL Inc. 510(k) number: K111385
Predicate device 2 Name: MD301 C4 Manufacturer: NEC Display Solutions Ltd. 510(k) number: K111237
- Device description
The DELL U3014 with QUBYX PerfectLum is a 30" color display for medical viewing. It provides 2560x1600 resolution with an adjustable Look Up Table and a 10 bit panel.
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.
1
- Intended use
The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, for review and analysis by trained medical practitioners.
The DELL U3014 must only be used in conjunction with QUBYX PerfectLum. The
device must not be used in primary image diagnosis in mammography. The device can not be used for a life-support system and does not contact with the patient.
- Comparison table - predicate device 1
| | DELL U3014 with
PerfectLum | Predicate device DELL
U3011 with PerfectLum
510(k) number: K111385 |
|-----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Panel Type | IPS | IPS |
| Panel size | 30" viewable | 30" viewable |
| Native Resolution | 2560 x 1600 | 2560 x 1600 |
| Aspect Ratio | 16:10 | 16:10 |
| Pixel Pitch | 0.25 mm | 0.25 mm |
| Brightness (typical) | 350 cd/m2 | 370 cd/m2 |
| Contrast Ratio (typical) | 1:1000 | 1:1000 |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. |
| Displayable Colors | 1.07 billion colors | 1.07 billion colors |
| Backlight | RGB LED | CCFL |
| DICOM calibration and
AAPM verification software | bundled | bundled |
| Indications for Use | The DELL U3014 with
QUBYX PerfectLum is
intended to be used for
displaying and viewing
medical images, for
review and analysis by
trained medical
practitioners. The DELL
U3014 can be used only
in conjunction with
QUBYX PerfectLum.
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 does
not contact with the
patient. | The DELL U3011 with
QUBYX
PerfectLum is intended to
be used for displaying and
viewing medical images,
for review and analysis by
trained medical
practitioners.
The DELL U3011 can be
used only in conjunction
with QUBYX PerfectLum.
The device can not be
used in primary image
diagnosis in
mammography.
The device can not be
used for a life-support
system. |
2
Conclusion
DELL U3014 is the direct successor of the DELL U3011 model in the product line of UltraSharp displays, so the DELL U3014 with PerfectLum has exactly the same technical characteristics that predicate device 1 (DELL U3011 with PerfectLum) except maximum luminance (maximum luminance of the U3011 model is 370 cd/m2, while maximum luminance of the U3014 display is 350 cd/m2) and backlight type.
Both devices are compliant with DICOM Part 14 GSDF and AAPM TG18 standards, which is tested and verified by University of Arizona. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed by QUBYX.
Details of testing:
To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PerfectLumsoftware and an X-Rite i1 Display Pro measurement device. The test procedure was generated by the software in accordance 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.
The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and indented use
| | DELL U3014 with PerfectLum | Predicate device NEC
MD301C4,510(k)
number: K111237 |
|-------------------|----------------------------|-----------------------------------------------------------|
| Panel Type | IPS | IPS |
| Panel size | 30" viewable | 29.8" viewable |
| Native Resolution | 2560 x 1600 | 2560 x 1600 |
11. Comparison table - predicate device 2
3
| Aspect Ratio | 16:10 | 16:10 |
|---|---|---|
| Pixel Pitch | 0.25 mm | 0.25 mm |
| Brightness (typical) | 350 cd/m2 | 350 cd/m2 |
| Contrast Ratio (typical) | 1:1000 | 1:1000 |
| Viewing Angle (typical) | 178° Vert., 178° Hor. | 178° Vert., 178° Hor. |
| Displayable Colors | 1.07 billion colors | 1.07 billion colors |
| Backlight | RGB LED | LED |
| DICOM calibration and | ||
| AAPM verification software | bundled | no software, pre- |
| calibrated to DICOM, | ||
| compliant with AAPM | ||
| TG 18 | ||
| Indications for Use | The DELL U3014 with | |
| QUBYX PerfectLum is | ||
| intended to be used for | ||
| displaying and viewing | ||
| medical images, for review | ||
| and analysis by trained | ||
| medical practitioners. | ||
| The DELL U3014 can be | ||
| used only in conjunction | ||
| with QUBYX PerfectLum. | ||
| 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 does not | ||
| contact with the patient. | MD3OIC4 is intended to | |
| be used for displaying | ||
| and viewing of digital | ||
| images for diagnosis by | ||
| trained physicians. | ||
| Caution: MD3OIC4 | ||
| cannot be used for a | ||
| life-support system. | ||
| This unit is designed | ||
| as component of a | ||
| final system which is | ||
| compliance to | ||
| IEC60601-1-1 | ||
| requirements. MD3OI | ||
| C4 must not be used | ||
| in digital | ||
| mammography. |
Conclusion
1
DELL U3014 with PerfectLum and NEC MD301C4 have substantially equivalent technical characteristics, such as resolution, luminance, pixel pitch, viewing angle. The diagonal size of the NEC MD301C4 monitor is 0.2" smaller than that of the subject 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 performed by QUBYX. AAPM and DICOM conformance of the subject device is tested and verified by University of Arizona.
Details of testing:
To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PerfectLumsoftware and an X-Rite i1 Display Pro measurement device.
The test procedure was generated by the software in accordance 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.
6.4
4
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 devices are substantially equivalent in this regard.
Both devices are intended to be used for displaying of digital images for diagnosis by trained physicians; both cannot be used for a life-support system and must not be used in digital mammography. The predicate device is designed as component of a final system which is compliant with IEC60601-1-1 requirements, while the indications for use for the new device do not specify what final system it will be used in. The DELL U3014 with PerfectLum is not intended for use in direct contact with the patient, while indications for use of the predicate device do not specify that.
We believe that these differences do not effect the safety and effectiveness of the DELL U3014 with PerfectLum to be substantially equivalent to the predicate device. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and indented use.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved lines that resemble a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
QUBYX Limited % Ms. Alice Kotlyarenko Marketing and Sales Assistant 80, rue Marechal Joffre 06000 Nice FRANCE
Re: K131601
Trade/Device Name: Dell U3014 with QUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 6, 2013 Received: June 17, 2014
Dear Ms. Kotlyarenko:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
6
Page 2-Ms. Kotlyarenko
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara
For
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use Form
510(k) Number (if known): K131601
Device Name: Dell U3014 with QUBYX PerfectLum bundle
Indications for Use: The DELL U3014 with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DELL U3014 can be used only in conjunction with QUBYX PerfectLum. 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 does not contact with the patient. The device is intended for prescription use.
AND/OR Over-The-Counter Use _ Prescription Use No (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K131601 510(k)________________________________________________________________________________________________________________________________________________________________________
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