(56 days)
BenQ LCD monitor (MD310C, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).
The provided document is a 510(k) premarket notification for a medical LCD monitor (MD310C, MD310G, MD210G). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study as seen with novel high-risk devices.
Here's an analysis of the acceptance criteria and the study performed, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria for image quality parameters or a direct measure of device performance against such criteria. Instead, it states that "All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device." (Section 5.8)
The comparison tables (starting on page 5) show the specifications of the subject device (BenQ LCD Monitor) against three predicate devices. These specifications implicitly act as the "performance" for this type of device, and the "acceptance criteria" is that the differences do not adversely impact safety and effectiveness.
Here's a summary of the key performance parameters compared, with the understanding that "acceptance" for this submission means demonstrating that differences do not present new safety/effectiveness concerns:
| Performance Parameter | BenQ LCD Monitor (Subject Device) | Predicate Devices (Examples from K153354, K150821, K143076) | Acceptance Criteria (Implicit) | Reported Device Performance (Implicitly Met) |
|---|---|---|---|---|
| Intended Use | Displaying and viewing digital images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography). | Same (or very similar wording, excluding mammography). | Intended use must be substantially equivalent. | Met (Same intended use). |
| Technology | TFT color/monochrome LCD panel (IPS) | TFT color/monochrome LCD panel (IPS, Dual Domain IPS, Monochrome TFT) | Technology must be substantially equivalent or differences justified. | Met (Similar panel technologies; differences justified). |
| Backlight | LED | LED | Same. | Met (Same). |
| Panel Size | 21.3", 20.1" | 21.3", 20.8", 20.1" | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Display Size (H x V) | Varies (e.g., 433.1 x 324.8 mm for 3MP) | Varies (e.g., 433.2 mm x 324.9 mm for 3MP predicate) | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Megapixels | 3 megapixel (MD310C/G), 2 megapixel (MD210G) | 3 megapixel, 2 megapixel | Same pixel count for corresponding models. | Met (Same). |
| Native Resolutions (H x V) | 2048 x 1536 (3MP models), 1600 x 1200 (2MP models) | 2048 x 1536, 1600 x 1200 | Same resolution for corresponding models. | Met (Same). |
| Pixel Pitch (H x V) | Varies (e.g., 0.2115 x 0.2115 mm for 3MP) | Varies (e.g., 0.2115 mm x 0.2115 mm for 3MP predicate) | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Viewing Angle (H, V) | 176°/176°, 170°/170° | 178°/178°, 176°/176°, 170°/170° | Differences not adversely impacting safety/effectiveness. | Met (Slight differences, justified as not adverse). |
| Response Time | 40 ms (Typ.) | 25 ms (Typ.), 30 ms (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Brightness | 800 cd/m² (Typ.), 1700 cd/m² (Typ.), 1000 cd/m² (Typ.) | 1000 cd/m² (Typ.), 1200 cd/m² (Typ.), 1000 cd/m² (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Contrast Ratio | 1400:1 (Typ.), 1400:1 (Typ.) | 1500:1 (Typ.), 1200:1 (Typ.), 1000:1 (Typ.) | Differences not adversely impacting safety/effectiveness. | Met (Differences noted, justified as not adverse). |
| Connectivity | DVI-D, DisplayPort, USB ports | DVI-D, DisplayPort, USB ports, VGA, DVI-I | Substantially equivalent. | Met (Similar or justified differences). |
| Safety Tests | Performed (Reliability, Software, EMC/Electrical, Function, Usability) | - | Device must meet safety test requirements. | Met (All tests demonstrate compliance). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." (Section 5.9). Therefore, there is no clinical test set, sample size, or data provenance from patient data for this submission. The "test set" for this device consists of the physical units undergoing non-clinical engineering and performance testing. The provenance of this would be internal to BenQ's testing facilities (Taiwan, based on the submitter's address).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical test data was used, there was no ground truth based on patient images established by medical experts for this submission. The "ground truth" for non-clinical tests would be defined by engineering standards and specifications, validated by internal company experts (e.g., engineers, quality control personnel). No specific number or qualifications of these internal experts are mentioned.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The submission explicitly states no clinical test data was used (Section 5.9).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is an LCD monitor, not an AI algorithm. Therefore, the concept of "standalone performance" for an AI algorithm is not applicable. The device's performance is its ability to accurately and reliably display medical images as intended. This performance was evaluated through non-clinical testing (reliability, software validation, electromagnetic compatibility, electrical safety, function test, usability test – Section 5.8).
7. The Type of Ground Truth Used
For non-clinical testing, the "ground truth" would be the engineering specifications, industry standards, and regulatory requirements (e.g., electrical safety standards, image display quality standards relevant to medical monitors). These are deterministic and measurable, without requiring expert consensus on clinical findings.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device (LCD monitor), not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of Approach:
The BenQ LCD Monitor K170944 submission followed the Traditional 510(k) pathway which relies on demonstrating substantial equivalence to existing predicate devices. For a medical display monitor, this involves comparing technical specifications and proving through non-clinical laboratory tests (reliability, safety, function, usability) that any differences from the predicate devices do not adversely affect the safety or effectiveness of the device for its intended use. Clinical studies are typically not required for this type of device unless there are significant technological differences that could introduce new questions of safety or efficacy.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
BenO Corporation % Mr. Calvin KT Chang Project Manager 16 Jihu Road. Neihu Taipei. 114 Taiwan REPUBLIC OF CHINA
May 25, 2017
Re: K170944
Trade/Device Name: LCD Monitor (MD310C, MD310G, MD210G) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 10, 2017 Received: March 30, 2017
Dear Mr. Chang:
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
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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.
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,
Robert Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
LCD Monitor (MD310C, MD310G, MD210G)
Indications for Use (Describe)
BenQ LCD monitor (MD310G, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review. analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
| 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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Traditional 510(k) Section 5 - 510 (k) Summary
510(k) SUMMARY
| 5.1 | Type of Submission: | Traditional |
|---|---|---|
| 5.2 | Date of Summary: | March 10, 2017 |
| 5.3 | Submitter: | BenQ Corporation |
| Address: | 16 Jihu Road, Neihu, Taipei 114, Taiwan | |
| (R.O.C.) | ||
| Phone: | +886-2-2658-8880 | |
| Fax: | +886-3-359-3376 | |
| Contact: | Calvin KT Chang | |
| (Calvin.KT.Chang@BenQ.com) |
Identification of the Device: 5.4
| Proprietary/Trade name: | LCD Monitor |
|---|---|
| Model Number: | MD310C, MD310G, MD210G |
| Regulation Description: | Picture archiving and communicationssystem |
| Review Panel: | Radiology |
| Regulation Number: | 892.2050 |
| Device Class: | II |
| Product Code: | PGY |
5.5 Identification of the Predicate Devices:
| Predicate Device Name: | 3MP Color LCD Monitor, RadiForce RX350 |
|---|---|
| Manufacturer: | EIZO Corporation |
| Regulation number: | 892.2050 |
| Device Class: | II |
| Product Code: | PGY |
| 510(k) Number: | K153354 |
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Traditional 510(k) Section 5 - 510 (k) Summary
| Predicate Device Name: | Nio 3MP LED (MDNG-3220) |
|---|---|
| Manufacturer: | Barco N.V. |
| Regulation number: | 892.2050 |
| Device Class: | II |
| Product Code: | PGY |
| 510(k) Number: | K150821 |
| Predicate Device Name: | 20.1 inch (51 cm) Monochrome LCDMonitor ME205 (ML20205) |
| Manufacturer: | JVC KENWOOD CORPORATION |
| Regulation number: | 892.2050 |
| Device Class: | II |
| Product Code: | PGY |
| 510(k) Number: | K143076 |
5.6 Intended Use/ Indications for Use of the Device
BenQ LCD monitor (MD310C, MD310G and MD210G) is intended to be used in displaying and viewing digital images for review, analysis and diagnosis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
5.7 Device Description
BenQ LCD monitor (MD310C, MD310G and MD210G) is for viewing medical images other than those of mammography. MD310C is a 21.3" color LCD monitor with the resolution 1,536 x 2,048 pixels (3MP) and MD310G is a 21.3" Monochrome LCD monitor with the same resolution. MD210G is a 20.1" Monochrome LCD monitor with the resolution 1,200 x 1,600 pixels (2MP).
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5.8 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, LCD Monitor (MD310C, MD310G, MD210G).
- Reliability test
- Software Validation
- . Electromagnetic compatibility and electrical safety
- . Function test
- . Usability test
All test results demonstrate that LCD Monitor (MD310C, MD310G, MD210G) meets the requirements of its pre-defined acceptance criteria, and is substantially equivalent to the predicate device.
5.9 Clinical Testing
No clinical test data was used to support the decision of substantial equivalence.
5.10 Substantial Equivalence Determination
The LCD Monitor (MD310C, MD310G, MD210G) has the same intended use, principle of operation and technological characteristics with the 3MP Color LCD Monitor, RadiForce RX350 (K153354), Nio 3MP LED (MDNG-3220) (K150821) and 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) (K143076). A series of tests were performed and demonstrated substantial equivalence between the subject and the predicate device. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
|---|---|---|---|
| Proprietaryname | LCD monitor | 3MP Color LCD Monitor | NA |
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| Model | MD310C | RadiForce RX350 | NA |
|---|---|---|---|
| 510(k) No. | K153354 | NA | |
| Intended use | BenQ LCD monitor(MD310C, MD310G andMD210G) is intended to beused in displaying andviewing digital images forreview, analysis anddiagnosis by trainedmedical practitioners. Itdoes not support the displayof mammography imagesfor diagnosis. | This product is intended tobe used in displaying andviewing digital images forreview, analysis anddiagnosis by trainedmedical practitioners. Itdoes not support thedisplay of mammographyimages for diagnosis. | The subjectdevice has thesame intended useas the predicatedevice. |
| LCD panel | |||
| Technology | TFT color LCD panel(IPS) | Color (IPS) | Same |
| Backlight | LED | LED | Same |
| Panel size(diagonal) | 21.3" (54.1 cm) | 21.3" (54.1 cm) | Same |
| Display size(H x V) | 433.1 x 324.8 mm | 433.2 mm x 324.9 mm | Slightly differentbut does notadversely impactsafety andeffectiveness ofsubject device |
| Mega pixels | 3 megapixel | 3 megapixel | Same |
| Nativeresolutions (Hx V) | 2048 x 1536 | 2048 x 1536 | Same |
| Pixel pitch (Hx V) | 0.2115 x 0.2115 mm | 0.2115 mm x 0.2115 mm | Same |
| Viewingangle (H, V) | 176°/176° | 178°/ 178° | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| Responsetime | 40 ms (Typ.) | 25 ms (Typ.) | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| Brightness | 800 cd/m² (Typ.) | 1,000 cd/m² (Typ.) | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| Contrast ratio | 1400:1 (Typ.) | 1500 : 1 (Typ.) | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| Aspect ratio | 4 : 3 | 4 : 3 | Same |
| Display colors | 1.07 billion colors(maximum) | 1.07 billion colors(maximum) | Same |
| Luminancenon-uniformitycompensation | Digital UniformityEqualizer | Digital UniformityEqualizer | Same |
| Connectivity | |||
| Inputterminals | DVI-D (Dual Link)DisplayPort | DVI-D (dual link)DisplayPort | Same |
| USBports/standard | 1 upstream,2 downstream/ Rev. 2.0 | 1 upstream,2 downstream/ Rev. 2.0 | Same |
| Scanningfrequency (H,V) | Different but | ||
| 31-127 kHz / 29-61.5 Hz | does not | ||
| V: 50~76Hz, H: | (VGA Text: 69 - 71 Hz) | adversely impact | |
| 30KHz~80KHz | Frame synchronous mode: | safety and | |
| 29.5 - 30.5 Hz, 59 - 61 Hz | effectiveness of | ||
| subject device | |||
| Power supply | |||
| AC 100-240V, | AC 100-240V, | Same | |
| Power input | 50~60 Hz | 50 / 60 Hz | |
| Different but does | |||
| not adversely | |||
| Power | 95 W (Maximum) | 89 W / Less than 1 W | impact safety and |
| consumption | effectiveness of | ||
| subject device | |||
| Different but does | |||
| DVI DMPM, DisplayPort1.1a | DVI DMPM,DisplayPort 1.2a | not adversely | |
| Power | impact safety and | ||
| management | effectiveness of | ||
| subject device | |||
| Physical | |||
| Portrait:369 x 490.4 x 94.4 mmLandscape:490.4 x 369 x 94.4 mm | 354 x 462 x 78 mm | Different but | |
| Dimensions | does not | ||
| w/o stand | adversely impact | ||
| (W x H x D) | safety and | ||
| effectiveness of | |||
| subject device | |||
| Mounting | 100 x 100 mm VESA | 100 x 100 mm VESA | Same |
| compliant | compliant | ||
| Miscellaneous Features/Specifications | |||
| QC software | N/A | RadiCS | BenQ LCD |
| Monitor is | |||
| calibrated in | |||
| factory beforeshipment | |||
| Sensors | Backlight Sensor,Eco(Presence) Sensor,Front Sensor,Ambient Light Sensor | Backlight Sensor,Presence Sensor,Integrated Front Sensor,Ambient Light Sensor | Same |
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Section 5 - Traditional 510(k)
Section 5 - 510 (k) Summary
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| Item | Subject device | Predicate device | Substantialequivalencedetermination | |
|---|---|---|---|---|
| Proprietaryname | LCD monitor | Nio 3MP LED | NA | |
| Model | MD310G | MDNG-3220 | NA | |
| 510(k) No. | K150821 | NA | ||
| Intended use | BenQ LCD monitor(MD310C, MD310G andMD210G) is intended to beused in displaying andviewing digital images forreview, analysis anddiagnosis by trainedmedical practitioners. Itdoes not support the displayof mammography imagesfor diagnosis. | The Nio 3MP LED(MDNG-3220) MedicalFlat Panel Display Systemis intended to be used as atool in displaying andviewing digital images(excluding digitalmammography) for reviewand analysis by trainedmedical practitioners. | The subjectdevice has thesame intended useas the predicatedevice. | |
| LCD panel | ||||
| Technology | TFT monochrome LCDpanel (IPS) | TFT AM LCD DualDomain IPS | Same | |
| Backlight | LED | LED | Same | |
| Panel size(diagonal) | 21.3" (54.1 cm) | 20.8" (52.0 cm) | Different but doesnot adversely | |
| impact safety andeffectiveness ofsubject device | ||||
| Display size(H x V) | 433.1 x 324.8 mm | 424 mm x 318 mm | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device | |
| Mega pixels | 3 megapixel | 3 megapixel | Same | |
| Nativeresolutions (H x V) | 2048 x 1536 | 2048 x 1536 | Same | |
| Pixel pitch (H x V) | 0.2115 x 0.2115 mm | 0.207 mm x 0.207 mm | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device | |
| Viewingangle (H, V) | 176°/176° | 176°/176° | Same | |
| Responsetime | 40 ms (Typ.) | 30 ms (typical) | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device | |
| Brightness | 1700 cd/m² (Typ.) | 1200 cd/m² typical | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device | |
| Contrast ratio(typical) | 1400:1 | 1200:1 | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device | |
| effectiveness of | ||||
| subject device | ||||
| Aspect ratio(H:V) | 4 :3 | 4:3 | Same | |
| Color imaging | No | No | Same | |
| Gray imaging | Yes | Yes | Same | |
| Connectivity | ||||
| Input | DVI-D (Dual Link) | DVI-D Dual Link | ||
| terminals | DisplayPort | DisplayPort | Same | |
| USB | 1 upstream, | 1 upstream, | ||
| ports/standard | 2 downstream | 2 downstream | Same | |
| / Rev. 2.0 | / Rev. 2.0 | |||
| Different but | ||||
| Scanning | V: 50 | 15-129 kHz; 25-98 Hz | does not | |
| frequency (H, | adversely impact | |||
| V) | safety and | |||
| effectiveness of | ||||
| subject device | ||||
| Power supply | ||||
| Power input | AC 100-240V, | AC 100-240V, | Same | |
| 50~60 Hz | ||||
| 80 W (Maximum) | 50 W (nominal) | Different but does | ||
| Power | not adversely | |||
| consumption | impact safety and | |||
| effectiveness of | ||||
| subject device | ||||
| Physical | ||||
| Dimensionsw/o stand(W x H x D) | Portrait: | 378 x 491 x 84 mm | Different but | |
| 369 x 490.4 x 94.4 mm | does not | |||
| Landscape: | adversely impact | |||
| 490.4 x 369 x 94.4 mm | safety and | |||
| effectiveness of | ||||
| subject device | ||||
| Mounting | 100 x 100 mm VESAcompliant | 100 x 100 mm VESAcompliant | Same |
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| Item | Subject device | Predicate device | Substantialequivalencedetermination |
|---|---|---|---|
| Proprietaryname | LCD monitor | 20.1 inch (51 cm)Monochrome LCD MonitorME205 | NA |
| Model | MD210G | ML20205 | NA |
| 510(k) No. | – | K143076 | NA |
| Intended use | BenQ LCD monitor(MD310C, MD310G andMD210G) is intended to beused in displaying andviewing digital images forreview, analysis anddiagnosis by trainedmedical practitioners. Itdoes not support the displayof mammography imagesfor diagnosis. | 20.1 inch (51 cm)Monochrome 2M pixelLCD Monitor ME205(ML20205) is intended tobe used in displaying andviewing medical imagesfor diagnosis by trainedMedical practitioners. It isnot meant to be used indigital mammography. | The subjectdevice has thesame intended useas the predicatedevice. |
| LCD panel | |||
| Technology | TFT Monochrome LCDPanel | Monochrome TFT | Same |
| Backlight | LED | LED | Same |
| Panel size(diagonal) | 20.1" (51.1 cm) | 20.1" | Same |
| Display size | 408 x 306 mm | 408 x 306 mm | Same |
| (H x V) | |||
| Mega pixels | 2 megapixel | 2 megapixel | Same |
| Nativeresolutions (Hx V) | 1600 x 1200 | 1600 x 1200 | Same |
| Pixel pitch (Hx V) | 0.255 x 0.255 mm | 0.255 x 0.255 mm | Same |
| Viewingangle (H, V) | 170°/170° | 170°/170° | Same |
| Brightness | 1000 cd/m² (Typ.) | 1000 cd/m² typ. | Same |
| Contrast ratio | 1400:1 (Typ.) | 1000:1 (Typ.) | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| Connectivity | |||
| Inputterminals | VGADVI-DDisplayPort | DVI-I 29-pin connectorDisplayPort connector | Different but doesnot adverselyimpact safety andeffectiveness ofsubject device |
| USBports/standard | 1 upstream,2 downstream/ Rev. 2.0 | 1 upstream,2 downstream/ Rev. 2.0 | Same |
| Scanningfrequency (H,V) | Digital: 31.47 – 80 kHz, 60Hz, Analog: 31.47 - 80 kHz,55 - 76 Hz | Horizontal: 30 - 75 kHz,Vertical: 55 - 60 Hz | Different butdoes notadversely impactsafety andeffectiveness ofsubject device |
| Power supply | |||
| Power input | AC 100-240V, 50~60 Hz | AC 100-240V, 50~60 Hz | Same |
| Power consumption | 55 W (Maximum) | 38WPower management feature | Different but does not adverselyimpact safety andeffectiveness ofsubject device |
| Physical | |||
| Dimensionsw/o stand(W x H x D) | Portrait:369 x 490.4 x 94.4 mmLandscape:490.4 x 369 x 94.4 mm | Portrait:353 x 512 – 573 x 220 mmLandscape:453 x 462 – 523 x 220 mm | Different butdoes notadversely impactsafety andeffectiveness ofsubject device |
| Mounting | 100 x 100 mm VESAcompliant | 100 x 100 mm VESAcompliant |
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Traditional 510(k) Section 5 - 510 (k) Summary
5.11 Similarity and Difference
The LCD Monitor, model MD310C, MD310G and MD210G has been compared with "3MP Color LCD Monitor, RadiForce RX350," "Nio 3MP LED (MDNG-3220)" and "20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205") respectively. The subject device has the same intended use, principle of operation and technological characteristics as these predicate devices. Although there are several specification that are different between two devices, the comparison analysis has been completed to demonstrate that the differences between these parameters would not adversely impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problems of substantial equivalence. The subject device is substantially equivalent to the predicate devices in intended use, safety and performance claims.
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Traditional 510(k) Section 5 - 510 (k) Summary
5.12 Conclusion
After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that LCD Monitor (MD310C, MD310G, MD210G) is substantially equivalent to the predicate devices.
§ 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).