(49 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on display calibration and testing software, not AI/ML image analysis.
No
The device is a display for viewing medical images and facilitating analysis by medical practitioners; it does not directly treat or diagnose a medical condition, which are functions of a therapeutic device.
No
The device is described as a medical display intended for "displaying and viewing medical images, for review and analysis by trained medical practitioners." It explicitly states that "The device can not be used in primary image diagnosis in mammography," which indicates it is not for making a diagnosis itself.
No
The device description explicitly states it is a "58" color display for medical viewing" combined with software. This indicates a hardware component (the display) is part of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "displaying and viewing medical images, for review and analysis by trained medical practitioners." This is a function related to medical imaging, not in vitro diagnostics.
- Device Description: The description confirms it's a "color display for medical viewing" combined with calibration software. This aligns with medical imaging display technology.
- Lack of IVD Characteristics: The description and intended use do not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on in vitro analysis.
- Focus on Image Display and Calibration: The performance studies and key results focus on the display's conformance to medical imaging standards (DICOM and AAPM TG18) for accurate image presentation.
In summary, the device's function is to display medical images for interpretation, which falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DIVA ZSP5812CMI 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.
Product codes
PGY
Device Description
The DIVA ZSP5812CMI with QUBYX PerfectLum is a 58" 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.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2015
Qubyx Ltd. % Mr. Marc Leppla Director, CTO 80, rue Marechal Joffre Nice, 06000 FRANCE
Re: K152847
Trade/Device Name: DIVA ZSP5812CMI with OUBYX PerfectLum Bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 16, 2015 Received: September 29, 2015
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,
Robert Oels
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)
Device Name
DIVA ZSP5812CMI with QUBYX PerfectLum bundle
Indications for Use (Describe)
The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners.
The DIVA ZSP5812CMI 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.
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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3
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@qubyx.com
-
Date of Submission 09/16/2015
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Device Trade name DIVA ZSP5812CMI with QUBYX PerfectLum bundle
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Common/Usual Name Image display system, Color LCD Monitor, image monitor/display
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Classification Number Medical displays classified in Class II per 21 CFR 892.2050
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Predicate device 1 Name: EIZO RadiForce RX650 Manufacturer: EIZO Corporation 510(k) number: K134002
8. Device description
The DIVA ZSP5812CMI with QUBYX PerfectLum is a 58" 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.
4
9. Indications for use
The DIVA ZSP5812CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, for review and analysis by trained medical practitioners. The DIVA ZSP5812CMI 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.
| Subject Device | Predicate device | |
|---|---|---|
| DIVA ZSP5812CMI with | ||
| PerfectLum | EIZO RadiForce RX650 | |
| 510(k) number: | K134002 | |
| Panel Type | MVA | IPS |
| Panel size | 58" viewable | 30" viewable |
| Native Resolution | 3840 x 2160 | 3280×2048 0.197 x |
| Pixel Pitch | 0.334 x 0.334 mm | 0.197 mm |
| Brightness (typical) | ||
| Viewing Angle | ||
| (typical) | 400 cd/m2 | 400 cd/m2 |
| 178° Vert., 178° Hor. | 176° Vert., 176° Hor. | |
| Displayable Colors | 1G colors (8-bit+FRC) | 10-bit colors (DisplayPort) : |
| 1.07 billion (maximum) colors; | ||
| 8-bit colors: 16.77 million | ||
| DICOM calibration | ||
| software and AAPM | ||
| verification software | bundled | bundled |
| Backlight | LED | LED |
| DICOM precalibrated | YES | YES |
| Power Requirements | AC 100 to 240 V, | |
| 50 / 60 Hz | AC 100-120 V, 200-240 V, | |
| 50 / 60 Hz | ||
| Power Consumption | 310W | 225W |
| Certification and | ||
| Compliance | cTÜVus (UL 60601-1, CAN/ | |
| CSA C22.2 | ||
| No.60601-1), CB (IEC | ||
| 60601-1), | ||
| TUV/RH (EN 60601- 1), | ||
| FCC, CE, RoHS, WEEE | FCC Class B certified, C-Tick, | |
| ICES-003 Class B, CCC, UL 60601-1, | ||
| RoHS, WEEE, GOST-R, DICOM Part | ||
| 14, FDA 510k, EN 60601-1, IEC | ||
| 60601-1, VCCI Class B, CSA C22.2 | ||
| No. 60601-1, China RoHS | ||
| Indications for Use | The DIVA ZSP5812CMI with | |
| QUBYX PerfectLum is intended to | ||
| be used for displaying and | ||
| viewing medical images, for | ||
| review and analysis by trained | ||
| medical practitioners. | The EIZO RadiForce RX650 is | |
| intended to be used in displaying and | ||
| viewing digital images for review and | ||
| analysis by trained medical | ||
| practitioners. | ||
| It does not support the display of | ||
| mammography | ||
| images for diagnosis. | ||
| The DIVA ZSP5812CMI 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 |
5
Conclusion:
The comparison table shows that the subject device (DIVA ZSP512CMI with PerfectLum) has the same intended use as the predicate. Although the devices have some different technological characteristics, these differences do not make the sub ect device less safe and reliable, so the subject device fits for diagnostic use 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 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.
We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.