(16 days)
Not Found
No
The device description focuses on the display hardware, calibration, and quality control functions, none of which indicate the use of AI or ML for image analysis or processing. The performance studies are standard tests for display characteristics.
No
The device is described as a display for showing radiological images for review, analysis, and diagnosis, not for treating a condition or disease.
Yes
The device is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The term "diagnosis" directly indicates a diagnostic purpose.
No
The device is a physical LCD display with associated firmware and PC application for calibration and management. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The UMD5-21B01 is a display device. Its function is to display radiological images for review, analysis, and diagnosis. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying radiological images... for review, analysis, and diagnosis". This is a function related to image visualization and interpretation, not in vitro testing.
Therefore, the UMD5-21B01 falls under the category of a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Product codes
PGY
Device Description
UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of UMD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Manage is a PC application for managing a group of displays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiological images (including full-field digital breast tomosynthesis)
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)
The performance data bench tests below were performed on the UMD5-21B01 following the instructions in "Guidance for Industry and Food and Drug Administration Staff: Display Devices for Diagnostic Radiology":
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Measurement of pixel aperture ratio
- The maximum number allowed for each type of pixel defects/faults
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of temporal response Performance data (provided by Innolux, LCD panel vender)
- Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values
- Verification of the conformance to DICOM GSDF as specified in TG18 quideline
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of display reflections including specular, diffuse and glare components
- Measurement of small-spot contrast ratio
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ACULA Technology Corp. % Tzu-Wei Li Third Party Contact Center For Measurement Standards Of Industrial Bldg. 16, 321 Kuang Fu Rd.sec2 HSINCHU. TAIWAN
June 13, 2024
Re: K241499
Trade/Device Name: 21.3" 5MP Color LCD Display UMD5-21B01 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 28, 2024 Received: May 28, 2024
Dear Tzu-Wei Li:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb, Ph.D., Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K241499
Device Name
21.3" 5MP Color LCD Display UMD5-21B01
Indications for Use (Describe)
UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
| 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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3
K241499 510(k) Summary
I. SUBMITTER
ACULA Technology Corp. Address: No. 11, Alley 21, Lane 20, Rd. Dashing Luchu Dist., Taoyuan City, Taiwan 33862 Phone: +886-3-3135577 Fax: +886-3-3233355
Contact Person: Sheng-Sung Jian Email: SSJian@acula.com.tw Date Prepared: Apr. 22, 2024
II. DEVICE
Name of Device: 21.3" 5MP Color LCD Display UMD5-21B01 Common or Usual Name: UMD5-21B01 Classification Name: Display, Diagnostic Radiology (21 CFR 892.2050) Regulatory Class: II Product Code: PGY
III. PREDICATE DEVICE
510(k) Number: K200864 Model Name: 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ Applicant: Shenzhen Beacon Display Technology Co., Ltd. Common Name: 5MP LCD Monitors C53S+, C53SP+, G53S+, G53SP+ Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2
4
IV. DEVICE DESCRIPTION
UMD5-21B01 is a 5 mega pixels 21.3" color LCD display for viewing medical images including mammography and digital breast tomosynthesis. The resolution of the display is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm and wide angle LCD technology (IPS) support Dual-link DVI and Displayport signals from workstation or personal computer.
Since factory calibrated 3 display modes, each of which is characterized by a specific curve (including DICOM GSDF), a specific luminance range and a pre-defined color temperature, are stored in Lookup Table (LUT) within the display, the tone curve is e.g. DICOM compliant regardless of the display controller used.
AcuCal, a general name for the calibration and quality control functions of UMD-series product, includes corresponding firmware (AcuCal-Pro) and management application of PC (AcuCal Manage). AcuCal-Pro is the controlling firmware of this LCD display. AcuCal-Pro can perform the luminance calibration without PC or workstation and also includes the quality control scheme to make sure display quality, especially DICOM conformance. AcuCal Manage is a PC application for managing a group of displays.
V. INDICATIONS FOR USE
The UMD5-21B01 is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The comparison table below provides information to support the substantial equivalence between the proposed device Color LCD Display UMD5-21B01 and predicate device Color LCD Display C53S+, C53SP+ (K200864) in terms of intended use, application and technological characteristics.
5
| Comparison
Item | Proposed Device
21.3" 5MP Color LCD
Display UMD5-21B01 | Predicate Device
21.3" 5MP Color LCD
Display C53S+,
C53SP+ | Explanation of
Differences |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Unknown | K200864 | |
| Intended Use | The UMD5-21B01 is
indicated for use in
displaying radiological
images (including
full-field digital
mammography and
digital breast
tomosynthesis) for
review, analysis, and
diagnosis by trained
medical practitioners | The 5MP Color LCD
Monitors C53S+,
C53SP+ and 5MP
Monochrome LCD
Monitors G53S+,
G53SP+ are intended
to be used in
displaying and
viewing medical
images for diagnosis
by trained medical
practitioners or
certified personnel.
They're intended to
be used in digital
mammography
PACS, digital breast
tomosynthesis and
modalities including
FFDM | Same |
| Screen
Technology | TFT Color LCD Panel
(IPS) | TFT Color LCD Panel
(IPS) | Same |
| Viewing angle | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | CR>10
Horizontal: Typ.178
Vertical: Typ.178 | Same |
| Resolution | 5MP (2048 x 2560) | 5MP (2048 x 2560) | Same |
| Aspect ratio | 4:5 | 4:5 | Same |
| Display area | Horizontal: 337.92mm
Vertical: 422.4mm | Horizontal: 337.92mm
Vertical: 422.4mm | Same |
| Pixel pitch | Horizontal: 0.165mm
Vertical: 0.165mm | Horizontal: 0.165mm
Vertical: 0.165mm | Same |
| Response time
(Typ.) | 25ms (On/Off) | 25ms (On/Off) | Same |
| Maximum
luminance | Min. 920cd/m2
Typ. 1,150cd/m2 | Min. 920cd/m2
Typ. 1,150cd/m2 | Same |
| DICOM
calibrated
luminance | 500cd/m2 | 500cd/m2 | Same |
| Contrast ratio | Min. 1600:1
Typ. 2000:1 | Min. 1600:1
Typ. 2000:1 | Same |
| Backlighting | LED | LED | Same |
| Grayscale
Tones | 10-bit (DisplayPort):
1.073 billion
1024 from a palette of
16,384 tones
8-bit(DVI): 16.77
million 256 from a
palette of 16,384
tones | 10-bit (DisplayPort):
1.073 billion
1024 from a palette of
16,384 tones
8-bit(DVI): 16.77
million 256 from a
palette of 16,384
tones | Same |
| Luminance
non-uniformity
Compensation | - | - | Same |
| Input Video
Signals | DVI-D x1
DisplayPort x1 | DVI-D x1
DisplayPort x1 | Same |
| Scanning
Frequency | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Landscape:
Horizontal: 104.852KHz
Vertical: 50Hz | Same |
| Dot Clock | 285 MHz | 285 MHz | Same |
| Power
Requirements | AC100-240V,
50/60Hz | DC 12V, 6.67A | Different between
built-in power supply
and built-out power
supply |
| Power
Consumption /
Save Mode | 85W
Less than 1W | 80W
Less than 5W | In comparison with
predicate device,
UMD5-21B01
maximum power is
higher, but it
consumes less
power in standby |
| | | | mode. |
| Power
Management | DVI DPMS,
DisplayPort 1.2a | DVI DPMS,
DisplayPort 1.2 | Different spec.
version between
DisplayPort 1.2 and
DisplayPort 1.2a |
| QC Software | AcuCal | Beacon Monitor
Manage | Different design |
| Sensors | Built-in Front Sensor
Built-in ambient Light
Sensor
Built-in Backlight
Sensor | Built-in Front Sensor
(Only for C53SP+)
Built-in ambient Light
Sensor
Built-in Backlight
Sensor | Same |
| USB Ports /
Standard | 1 upstream,
3 downstream / Rev.
2.0 | 1 upstream,
2 downstream / Rev.
2.0 | In comparison with
predicate device,
UMD5-21B01 has
one more
downstream USB
Port for service use |
| Dimensions
w/o Stand
(W x H x D) | 359 x 458 x 75.9 mm | 395.3 x 549.6/629.6 x 234.8 mm | Different industrial
design |
UMD5-21B01 510(k) Submission
6
7
According to the above table, UMD5-21B01 is a medical device which has the same intended use as the predicate device. The difference in the above statement does not change the intended use. As a result, both devices have fundamentally the same intended use.
8
VII. PERFORMANCE DATA
The performance data bench tests below were performed on the UMD5-21B01 following the instructions in "Guidance for Industry and Food and Drug Administration Staff: Display Devices for Diagnostic Radiology":
- Measurement of spatial resolution expressed as modulation transfer function (MTF)
- Measurement of pixel aperture ratio
- The maximum number allowed for each type of pixel defects/faults
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of temporal response Performance data (provided by Innolux, LCD panel vender)
- Measurements of the maximum and minimum luminance that the device outputs as used in the application under recommended conditions and the achievable values
- Verification of the conformance to DICOM GSDF as specified in TG18 quideline
- Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
- Measurement of noise expressed as noise power spectrum (NPS)
- Measurement of display reflections including specular, diffuse and glare components
- Measurement of small-spot contrast ratio
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
9
XIII. CONCLUSIONS
After analyzing all testing data and comparing it with the predicated device, it can be concluded that UMD5-21B01 is substantially equivalent to the predicate device (K200864) with respect to technological characteristic, application and intended use.
The specifications of the primary component employed by the proposed device are the same as those of the predicate device, and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.