(60 days)
No
The description focuses on display calibration and verification software, with no mention of AI/ML capabilities or image processing beyond display.
No
The device is described as a computer with a color display for viewing medical images, which aids in diagnosis and analysis, but it does not directly treat or alleviate a medical condition.
No
The device is described as a computer with a color display for medical image viewing and analysis, with software for DICOM calibration and AAPM TG18 verification. It is intended for displaying and viewing medical images. While it is used for "review and analysis," it doesn't process or interpret images to provide a diagnosis or aid in diagnosis directly. Its primary function is a display device that meets medical imaging standards.
No
The device description explicitly states it is a "computer with color display" combined with software, indicating it includes hardware (the Apple iMac) in addition to the software.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a computer with a display intended for displaying and viewing medical images. It is used for review and analysis of these images by medical practitioners.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing any tests on materials taken from the body. Its function is solely related to the visual presentation and calibration of medical images.
Therefore, the Apple iMac 27" 5K Retina with PL4.0, as described, falls under the category of a medical image display device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Apple iMac 27" 5K Retina with PL4.0 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.
Product codes
PGY
Device Description
The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) is a computer with color display for medical viewing.
It is combined with QUBYX PerfectLum 4.0 and PerfectLum remote management, a user- friendly 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 PL 4.0 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)
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The word "FDA" is placed inside a blue square. The text is stacked in three lines, with "ADMINISTRATION" on the bottom line.
% Marc Leppla Director Quantum Spectra LLC 501, Silverside Road St 105 Wilmington, Delaware 19809
June 2, 2020
Re: K200889
Trade/Device Name: Apple iMac 27" 5K Retina with PL4.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 21, 2020 Received: April 3, 2020
Dear Marc 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
1
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 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 (OS) 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) K200889
Device Name Apple iMac 27" 5K Retina with PL4.0
Indications for Use (Describe)
The Apple iMac 27" 5K Retina with PL4.0 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.
| 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) |
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510(K) Summary as required by 807.92
- Company Identification
QUANTUM SPECTRA LLC 501 SILVERSIDE RD STE 105 WILMINGTON DE 19809
- Official Correspondent
Mr. Marc Leppla President and CTO (Chief Technical Officer) marc@qs-group.net
-
Date of Submission 01/21/2020
-
Device Trade name Apple iMac 27" 5k Retina with PL 4.0
-
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 Classification Name: Picture Archiving and Communications System
7.Predicate device Name: DELL UP3017 With QUBYX PerfectLum Bundle Manufacturer: DELL and QUBYX 510(k) number: K171229 Classification Number: Medical displays classified in Class II per 21 CFR 892.2050 Classification Name: Picture Archiving and Communications System
8. Device description
The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) is a computer with color display for medical viewing.
It is combined with QUBYX PerfectLum 4.0 and PerfectLum remote management, a user- friendly 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.
Image /page/3/Picture/16 description: The image is a logo featuring a light blue circle with a stylized design inside. The design appears to be a combination of geometric shapes and lines, possibly representing letters or abstract forms. The overall impression is modern and minimalist, with the light blue color giving it a clean and fresh look. The logo is simple, yet visually striking, making it easily recognizable.
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9. Indications for use
The Apple iMac 27″ 5k Retina with PerfectLum 4.0 (PL 4.0) 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.
10. Comparison of technological characteristics
| Specification | Apple iMac 27" 5k Retina
with PL 4.0 | DELL UP3017
with PerfectLum |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Screen technology | Color IPS Retina | Color TFT LCD Panel (IPS) |
| Active screen size (diagonal) | 68 cm / 27" | 30" |
| Resolution | 5120 x 2880 | 2560 x 1600 |
| Pixel pitch | 0.1167 mm | 0.25 mm |
| Color imaging | Yes | Yes |
| Gray imaging | Yes | Yes |
| Maximum luminance | 500 cd/m2 | 350 cd/m2 |
| DICOM calibrated luminance | 350 cd/m2 | 300 cd/m2 |
| Contrast ratio (typical) | 1000:1 | 1000:1 |
| Intended use | The Apple iMac 27″ 5k Retina with
PL 4.0 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 does
not contact with the patient | The DELL U3017 with
QUBYX PerfectLum is
intended to be used for
displaying and viewing
medical images, for review
and analysis by trained
medical practitioners. The
DELL U3017 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 |
5
Details of testing:
To verify DICOM conformance, a DICOM conformance test was performed, using QUBYX PL 4.0 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, 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: Directives: 2014/53/EU 2009/125/EC 2011/65/EU Safety and Health: EN 60950-1:2006+A1:2010+A11:2009+A12:2011+A2:2013 EN 50665:2017 2000-12-21 489-1 V2.2.0 EN 301 489-17 V3.2.0
RF Spectrum Efficiency: EN 300 328 V2.1.1 , EN 301 893 V2.1.1 , EN 300 440 V2.1.1
Additional Compliance: RoHS: EN50581:2012 , Ene
6
Conclusion:
The comparison table shows that the subject device (Apple iMac 27" 5k Retina with PerfectLum 4.0) has the same intended use as the predicate. Although the devices have some different technological characteristics, as a higher resolution and higher maximum luminance, 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. To verify DICOM and AAPM compliance for the subject device, AAPM acceptance test and DICOM conformance test were also performed.