K Number
K162196
Device Name
Dell UP3216Q with QUBYX PerfectLum bundle
Date Cleared
2016-08-15

(10 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DELL UP3216Q can be used only in conjunction with OUBYX 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.
Device Description
The DELL UP3216Q with QUBYX PerfectLum is a 31.5" color display for medical viewing. It provides 3840x2160 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.
More Information

Not Found

No
The description focuses on display calibration and testing software, with no mention of AI or ML capabilities for image analysis or processing.

No
The device is a medical display intended for viewing medical images, not for providing therapy or treatment.

Yes
The device is described as "intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners," which directly supports its role in the diagnostic process.

No

The device description explicitly states it is a "31.5" color display for medical viewing" and is combined with software. This indicates a hardware component (the display) is part of the medical device.

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 is a function related to the visualization of medical images, not the analysis of biological samples or substances from the human body.
  • Device Description: The device is a "color display for medical viewing" combined with calibration software. This further reinforces its role as a display device for medical images.
  • Lack of IVD Characteristics: The description explicitly states:
    • "The device does not contact with the patient." IVDs typically involve contact with patient samples.
    • There is no mention of analyzing biological samples, substances, or any in vitro procedures.

IVDs are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. This device's function is to display images generated by other medical devices (like X-rays, CT scans, MRIs), which are then interpreted by a medical professional.

Therefore, this device falls under the category of a medical image display device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.

The DELL UP32160 can be used only in conjunction with OUBYX 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.

Product codes

PGY

Device Description

The DELL UP3216Q with QUBYX PerfectLum is a 31.5" color display for medical viewing. It provides 3840x2160 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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 (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150145

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Auqust 15, 2016

QUBYX Software Technologies, Inc. % Mr. Marc Leppla Director, CTO 501 Silverside Road, Suite 105 WILMINGTON DE 19809

Re: K162196

Trade/Device Name: DELL UP32160 with OUBYX PerfectLum bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 26, 2016 Received: August 5, 2016

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. 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.

1

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K162196

Device Name Dell UP3216Q with QUBYX PerfectLum bundle

Indications for Use (Describe)

The DELL UP3216Q with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.

The DELL UP32160 can be used only in conjunction with OUBYX 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

as required by 807.92

  1. Company Identification Qubyx Software Technologies Inc. 501 Silverside Road, Suite 105 Wilmington, DE 19809 USA Tel: +1 518 618 1012

  2. Official Correspondent Mr. Marc Leppla President and CTO (Chief Technical Officer) leppla@qubyx.com

  3. Date of Submission July 26, 2016

  4. Device Trade name DELL UP3216Q with QUBYX PerfectLum bundle

  5. Common/Usual Name Image display system, Color LCD Monitor, image monitor/display

  6. Classification Number Medical displays classified in Class II per 21 CFR 892.2050

  7. Predicate device 1 Name: NEC MultiSync MD322C8 Manufacturer: NEC Display Solutions Inc. 510(k) number: K150145

8. Device description

The DELL UP3216Q with QUBYX PerfectLum is a 31.5" color display for medical viewing. It provides 3840x2160 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.

4

9. Intended use

The DELL UP3216Q 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 UP3216Q 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.

| | DELL UP3216Q
with PerfectLum | Predicate device NEC
MultiSync MD322C8
510(k) number: K150145 |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Panel Type | IPS | IPS |
| Panel size | 31.5" viewable | 31.5" viewable |
| Native Resolution | 3840 x 2160 | 3840 x 2160 |
| Aspect Ratio | 16:9 | 16:9 |
| Pixel Pitch | 0.182mm | 0.182mm |
| Brightness (typical) | 300 cd/m2 | 350 cd/m2 |
| Contrast Ratio (typical) | 1:1000 | 1:1000 |
| Viewing Angle (typical) | 178° Vert., 176° Hor. | 178° Vert., 178° Hor. |
| Displayable Colors | 1.07 billion colors | 1.07 billion colors |
| Backlight | LED | LED |
| DICOM calibration and
AAPM verification software | bundled | bundled |
| Indications for Use | The DELL UP3216Q with
QUBYX PerfectLum is
intended to be used for
displaying and viewing
medical images, for review
and analysis by trained
medical practitioners.
The DELL UP3216Q 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 NEC MultiSync
MD322C8 intended to be
used for displayingand
viewing of digital images for
diagnosis by trained
physicians. The device must
only be used in conjunction
with NEC approved display
controllers.
The device can not be used
in primary image diagnosis
in mammography.
The device can not be used
for a life-support system.
This device is designed for
exclusive interconnection
with IEC60601-1-1 certified
equipment. |

10. Comparison table - predicate device 1

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Conclusion

Explaining the difference in brightness characteristics, it shoud be noted that according to AAPM quidelines, the major acceptable criteria for primary/ secondary displays is maximum luminance of greater than 170/100 cd/m2. The DELL UP3216Q has brightness of 300cd/ m2 which is ehough for the display to be medical. The comparison table shows that the subject device (DELL UP3216Q with PerfectLum) has the same intended use as the predicate device.

Although the devices have some different technological characteristics, these differences do not make the subject device less safe and reliable, so the subject device fits for displaying and viewing of digital images for diagnosis by trained physicians as the predicate device does.

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 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.

Both devices have the same indications for use.

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