(87 days)
MMPC-4127 (PP27QHDCR)
No
The document describes a display system and associated quality assurance software, with no mention of AI or ML capabilities for image analysis or interpretation.
No
The device is a display system used by pathologists to review and interpret digital images for diagnostic purposes, not to directly treat or diagnose patients.
Yes
The document states that the device "is intended for in vitro diagnostic use to display digital images of histopathology slides... for review and interpretation by pathologists." This explicitly identifies its diagnostic purpose.
No
The device description clearly states it is a "stabilized, color-calibrated display system" and lists hardware components like a "27-inch color LCD panel," cables, and an AC power cord. While it includes "QAWeb quality assurance software," the core device is a physical display.
Based on the provided information, the Barco MMPC-4127F1 (PP27QHD) is an IVD (In Vitro Diagnostic) device.
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use..."
- Purpose: The device is intended to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners for review and interpretation by pathologists. This is a core function within the in vitro diagnostic process of examining biological specimens.
- Predicate Device: The predicate device (DEN160056; MMPC-4127 (PP27QHDCR)) is described as a "display component of Philips IntelliSite Pathology Solution," which is a known IVD system for digital pathology. This further supports the IVD nature of the Barco device.
While the device itself is a display, its intended use within the workflow of reviewing and interpreting digital pathology images for diagnostic purposes makes it an IVD device.
N/A
Intended Use / Indications for Use
The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Product codes
PZZ
Device Description
The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated display system designed to review and interpret digital images of surgical pathology slides. The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be calibrated to the sRGB gamut.
Accessories:
- QAWeb quality assurance software
- DisplayPort cable
- USB cable
- AC power cord cables
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologists
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 bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device:
Spatial resolution
Pixel defects
Artifacts
Temporal response
Maximum and minimum luminance
Grayscale
Intrinsic bit-depth of panel
True output bit depth by performing visual test with gradient test pattern
Mapping of image values (DDL) to luminance (cd/m²)
Luminance uniformity and Mura
Stability of luminance and chromaticity
Stability of calibrated luminance over temperature
Stability of calibrated luminance over time
Specular and diffuse coefficients
Gray Tracking
Color scale
Color gamut
Angular dependency of the luminance
Noise
RMS (image variance) for multiple video levels
NPS (Noise Power Spectrum)
Veiling glare
The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
MMPC-4127 (PP27QHDCR), display component of Philips IntelliSite Pathology Solution, cleared under DeNovo no. DEN160056
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
0
Image /page/0/Picture/0 description: The image shows 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.
December 21, 2017
Barco N.V. Lieven De Wandel Regulatory Officer 35 President Kennedypark 8500 Kortrijk, Belgium
Re: K172922
Trade/Device Name: MMPC-4127F1 (PP27QHD) Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PZZ Dated: September 22, 2017 Received: September 25, 2017
Dear Mr. De Wandel:
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 and Part 809); medical device 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
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Reena Philip -S
Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K172922
Device Name MMPC-4127F1
Indications for Use (Describe)
The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---|---|
| 1. Company | Barco N.V. |
| Healthcare Division | |
| 35 President Kennedypark | |
| 8500 Kortrijk | |
| BELGIUM | |
| 2. Contact | |
| person | Lieven De Wandel |
| Regulatory Affairs Officer | |
| 3. Date of | |
| submission | September 22 2017 |
| 4. Device | |
| information | Trade name/model: MMPC-4127F1 |
| Common name: MMPC-4127F1 | |
| Classification name: Whole Slide Imaging System | |
| Classification code: PSY | |
| Regulation number: 864.3700 | |
| 5. Predicate | |
| device | MMPC-4127 (PP27QHDCR), display component of |
| Philips IntelliSite Pathology Solution, cleared under DeNovo no. DEN160056 | |
| 6. Device | |
| description | The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated |
| display system designed to review and interpret digital images of surgical pathology | |
| slides. |
The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be
calibrated to the sRGB gamut.
Accessories:
- QAWeb quality assurance software
- DisplayPort cable
- USB cable
- AC power cord cables |
| 7. Intended Use
of the Device | The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to
display digital images of histopathology slides acquired from IVD-labeled whole-slide
imaging scanners that have been validated for use with this device, for review and
interpretation by pathologists. The display is not intended for use with digital images from
frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE)
hematopathology specimens. |
Image /page/3/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. To the right of the "O" is a symbol that looks like a circle with a horizontal line through the middle, and two smaller circles on either side of the line.
4
| 8. Comparison
of technological
characteristics | Parameter | New Device
MMPC-4127F1
(PP27QHD) | Predicate Device
MMPC-4127
(PP27QHDCR),
Display
component of
Philips IntelliSite
Pathology Solution |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Display Optical Performance | | |
| | Display technology | IPS LCD | IPS LCD |
| | Native Resolution | 2560 x1440 | 2560 x1440 |
| | Display LUT | ≥ 10 bit / sub-pixel | ≥ 10 bit / sub-pixel |
| | Pixel Pitch (Horizontal) (mm) | 0.2331 | 0.2331 |
| | Pixel pitch (Verical) (mm) | 0.2331 | 0.2331 |
| | Active screen (Diagonal) (mm / inch) | 685.8 / 27.0 | 685.8 / 27.0 |
| | Active screen (Width) (mm) | 596.74 | 596.74 |
| | Active screen (Height) (mm) | 335.66 | 335.66 |
| | Contrast Ratio - (typical) | 1000:1 | 1000:1 |
| | Luminance stabilization | +2% / -2%
front sensor | +2% / -2% backlight
sensor |
| | Maximum Luminance (typical) (cd/m²) | 500 | 500 |
| | DICOM Calibrated Luminance (Typical)
(cd/m²) | 350 | 350 |
| | Luminance non-uniformity (per DIN6868-
157), diagnostic room class |