(20 days)
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No
The document describes a medical display and calibration software, with no mention of AI or ML capabilities. The performance studies focus on display calibration and conformance to standards like DICOM and AAPM TG18.
No
The device is a medical display used for viewing and analyzing medical images. It does not exert any direct therapeutic action on a patient.
Yes
The device is a display intended for displaying medical images, including those for mammography, for "review, analysis and diagnosis by trained medical practitioners." This indicates its use in the diagnostic process.
No
The device description explicitly states it is a "21.3" monochrome display for medical viewing," which is a hardware component. While it includes software (QUBYX PerfectLum), it is not solely software.
Based on the provided information, the DIVA ZSP2105CMI with QUBYX PerfectLum is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "displaying and viewing medical images... for review, analysis and diagnosis". This is related to interpreting images generated from the patient's body, not analyzing samples taken from the patient (which is the core of IVD).
- Device Description: The description reinforces its function as a display for medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with IVD devices.
- Patient Contact: The description explicitly states "The device does not contact with the patient," which is consistent with a display device and not an IVD that would interact with patient samples.
In summary, this device is a medical image display system used for diagnostic interpretation of images, not for performing tests on biological samples.
N/A
Intended Use / Indications for Use
The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.
The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.
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 ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
medical images, computed tomography images, digitalized x-ray images, mammography
Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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.
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
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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 a staff with two snakes entwined around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
The Linden Group Corp. % Mr. Marc Leppla Director, CTO Oubyx Ltd. 80, rue Marechal Joffre Nice, 06000 FRANCE
Re: K160328
Trade/Device Name: DIVA ZSP2105CMI with QUBYX PerfectLum bundle Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY, Dated: January 22, 2016 Received: February 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/ResourcesforYou/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 D.'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) K160328
Device Name DIVA ZSP2105CMI with QUBYX PerfectLum bundle
Indications for Use (Describe)
The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing medical images,
including those of mammography, for review, analysis and diagnosis by trained medical practitioners.
The DIVA ZSP2105CMI can be used only in conjunction with QUBYX PerfectLum.
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
- Company Identification
The Linden Group Corp. 2b Wing Dr Cedar Knolls NJ 079271020 ાટ
-
Official Correspondent Mr. Marc Leppla (President and CTO of QUBYX Ltd.) Contact details: email: leppla@qubyx.com Tel: +33 497032300
-
Date of Submission 22/01/2016
-
Device Trade name DIVA ZSP2105CMI with QUBYX PerfectLum bundle
-
Common/Usual Name Image display system, Monochrome LCD Monitor, image monitor/display
-
Classification Number Medical displays classified in Class II per 21 CFR 892.2050
-
Predicate device Name: EIZO RadiForce GX540 Manufacturer: EIZO Corporation 510(k) number: K151883
Description of the device:
The DIVA ZSP2105CMI with QUBYX PerfectLum is a 21.3" monochrome display for medical viewing. It can be used for diagnostic viewing or normal reviewing purpose of medical images like computed tomography images, digitalized x-ray images, etc. It is combined with QUBYX PerfectLum and PerfectLum Remote Management, a user-friendly DICOM calibration and AAPM TG18 verification software suite. The software allows setting the display function to DICOM GSDF, displaying test patterns and performing acceptance and constancy tests according to AAPM TG18.
Indications for use:
The DIVA ZSP2105CMI with QUBYX PerfectLum is intended to be used for displaying and viewing of digital images, including those of mammography, for review, analysis and diagnosis by trained medical practitioners.
The DIVA ZSP2105CMI must only be used in conjunction with QUBYX PerfectLum. The device does not contact with the patient and can not be used for a life-support system. The device is intended for prescription use.
Device comparison table:
| | Subject Device DIVA
ZSP2105CMI with
PerfectLum | Predicate device EIZO
RadiForce GX540 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K160328 | K151883 |
| Panel Type | IPS | IPS |
| Panel size | 21.3" | 21.3" |
| Native Resolution | 2560 x 2048 | 2560 x 2048 |
| Pixel Pitch | 0.165mm × 0.165mm | 0.165mm × 0.165mm |
| Brightness (typical) | 1200 cd/m2 | 1200 cd/m2 |
| Viewing Angle
(typical) | 170° Vert., 170° Hor. | 176° Vert., 176° Hor. |
| Displayable Colors | 1024 grayscale (10-bit) | 10-bit (DisplayPort): 1,024
from a palette of 16,369
tones
8-bit: 256 from a palette of
16,369 tones |
| 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 | 100W | 108W |
| Certification and
Compliance | CE (Medical Device Directive),
93/42/EEC, EN60601-1,
EN60601-2, FCC Class B,
cTUVus (UL 60601-1, CAN/CSA
C22.2 No.60601-1),
CNS14336-1, CNS13438),
VCCI by ITE, Apr.2010, Class B
(Requlation of VCCI V-2 and
VCCI-3 and VCCI V-4), RoHS,
WEEE | CE (Medical Device Directive),
EN60601-1,
UL60601-1, CSA C22.2 No.
601-1,
IEC60601-1,
VCCI-B, FCC-B, Canadian
ICES-003-
B, C-tick,
RoHS, China RoHS, WEEE,
CCC, GOST-R |
| Indications for Use | The DIVA ZSP2105CMI with
QUBYX PerfectLum is intended
to be used for displaying and
viewing medical images,
including those of
mammography, | The EIZO RadiForce GX540 is
intended
to be used in displaying and
viewing
digital images, including
standard and |
| | for review, analysis and
diagnosis by trained medical
practitioners. The DIVA
ZSP2105CMI can be used only
in conjunction with
QUBYX PerfectLum.
The device can not be used for
a life-support system. The
device does not contact with
the patient. | multi-frame
digital mammography, for
review,
analysis and diagnosis by
trained
medical practitioners. It is
specially
designed for
breast tomosynthesis
applications. |
4
5
The comparison table shows that the subject device (DIVA ZSP2105CMI with PerfectLum) has the same intended use as the predicate one.
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 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 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 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.
6
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.
We can conclude that the new and predicate devices are substantially equivalent in terms of performance, indications for use, and principles of operation.