The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.
Device Story
Web-based software application for viewing/managing whole slide images (WSI) of FFPE tissue; input consists of NDPI files from Hamamatsu NanoZoomer S360MD scanner. Pathologists use the viewer in clinical settings to zoom, pan, annotate, and measure digital slides on Barco NV MDPC-8127 displays. Software facilitates primary diagnosis by simulating traditional microscope interaction. Output is a digital image display; aids pathologist in rendering diagnostic decisions. Benefits include efficient digital review of pathology slides; replaces/augments conventional light microscopy.
Clinical Evidence
Bench testing only. Pixel-wise color comparison (180 image pairs from 30 FFPE slides) showed 95th percentile color difference < 3 ΔE00. Turnaround time studies confirmed loading/refresh speeds met targets (e.g., 2.72s initial load). Measurement accuracy testing using calibration slides showed zero deviation from reference values. Human Factors validation with board-certified pathologists confirmed critical tasks performed without use-related errors.
Technological Characteristics
Web-based software application; compatible with Windows 10/Mac OS. Requires quad-core CPU >2GHz, 8GB RAM, 100 Mbps network. Interoperable with Hamamatsu NanoZoomer S360MD scanner (NDPI format) and Barco NV MDPC-8127 display. Functions include image navigation, annotation, and distance/area measurement.
Indications for Use
Indicated for pathologists to view and manage whole slide images of FFPE tissue specimens for primary diagnosis. Not for use with frozen sections, cytology, or non-FFPE specimens.
Regulatory Classification
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.
Special Controls
A whole slide imaging system must comply with the following special controls: (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; (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: (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 factors 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: The intended use statement must include the information described in paragraph (i) (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 paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (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.
*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.
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
## I Background Information:
A 510(k) Number
K250968
B Applicant
PathPresenter Corporation
C Proprietary and Established Names
PathPresenter Clinical Viewer
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QKQ | Class II | 21 CFR 864.3700 | PA-Pathology |
## II Submission/Device Overview:
A Purpose for Submission:
New device
B Type of Test:
Digital pathology software only device
## III Intended Use/Indications for Use:
A Intended Use(s):
For In Vitro Diagnostic Use
The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the Barco NV MDPC-8127 display device.
# B Indication(s) for Use:
Same as Intended Use.
# C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
# IV Device/System Characteristics:
# A Device Description:
The PathPresenter Clinical Viewer (version V1.0.1) is a web-based software application designed for viewing and managing whole slide images (WSIs) generated from scanned glass slides of formalin-fixed, paraffin-embedded (FFPE) surgical pathology tissue. It serves as a diagnostic aid, enabling pathologists to review digital images and render a primary pathology diagnosis. Functions of the viewer include zooming and panning the image, annotating the image, measuring distances and areas in the image, and retrieving multiple images from the slide tray including prior cases and deprecated slides.
The PathPresenter Clinical Viewer is operated as follows: Image acquisition is performed using the intended scanner, with the operator conducting quality control on the whole-slide images according to the scanner's instructions for use and local laboratory procedures to determine if re-scans are needed. The WSIs are then sent to an end-user-provided image storage. Pathologists access the digital image through PathPresenter Clinical Viewer from a worklist. They use various tools to view, annotate and analyze the images, using features like zoom, pan, and measurement. Pathologists review and interpret the digital images to render a diagnosis.
The PathPresenter Clinical Viewer is validated for use with the FDA cleared components specified in Table 1 below.
Table 1: Interoperable Components
| Scanner Hardware | Scanner Output File | Interoperable Display |
| --- | --- | --- |
| Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Barco NV MDPC-8127 |
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Table 2: Computer Environment/System Requirements
| Environment | Component | Minimum Requirements |
| --- | --- | --- |
| Hardware | Processor | CPU: quad core CPU >2GHZ |
| | Memory | 8GB RAM |
| | Network | 100 Mbps connection (1Gbps LAN recommended) |
| | Monitor | Full HD (1920 x 1080 pixels) |
| Software | Operating System | Windows 10 (64-bit); Mac OS |
| | Browser | Google Chrome v114.0.5735.199 or higher Microsoft Edge v114.0.1823.67 or higher |
# B Instrument Description Information:
1. Instrument Name:
PathPresenter Clinical Viewer
2. Specimen Identification:
Glass slides and scanned images are identified based on the previously assigned specimen identifiers such as patient identifiers, barcodes, etc. Digital images of Hematoxylin and Eosin (H&E) stained surgical pathology glass slides prepared from FFPE tissue are obtained using the Hamamatsu NanoZoomer S360MD Slide scanner. A reading pathologist selects a case (patient) from an external worklist, and the subject device retrieves the corresponding images from external image storage. The scanned images are identified using the specimen identifier previously assigned to the case.
3. Specimen Sampling and Handling:
Specimen sampling and handling are performed upstream and independent of the use of the subject device. Specimen sampling includes surgical pathology specimens such as biopsy or resection specimens which are processed using standard histology techniques. The FFPE tissue sections are stained using the Hematoxylin and Eosin (H&E) staining procedure. Then digital images are obtained from these glass slides using the Hamamatsu S360MD Slide scanner.
4. Calibration:
Not Applicable
5. Quality Control:
Prior to using a WSI for diagnosis, it is the responsibility of the laboratory staff, while scanning glass slides and uploading WSIs, and the pathologist, while reviewing the WSIs, to ensure that all scanned slide images have been imported for every case and the images are of
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acceptable quality for diagnostic purposes per their laboratory standards. Additional details of the quality control procedures are provided in the device's user manual.
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V Substantial Equivalence Information:
A Predicate Device Name(s):
NanoZoomer S360MD Slide scanner system.
B Predicate 510(k) Number(s):
K233027
C Comparison with Predicate(s):
| Item | Subject Device (K250968) | Predicate Device (K233027) |
| --- | --- | --- |
| Device Trade Name | PathPresenter Clinical Viewer | NanoZoomer S360MD Slide scanner system |
| General Device Characteristics - Similarities | | |
| Intended Use / Indications for Use | For In Vitro Diagnostic Use
The PathPresenter Clinical Viewer is a software intended for viewing and managing whole slide images of scanned glass sides derived from formalin fixed paraffin embedded (FFPE) tissue. It is an aid to pathologists to review and render a diagnosis using the digital images for the purposes of primary diagnosis. PathPresenter Clinical is not intended for use with frozen sections, cytology specimens, or non-FFPE specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using PathPresenter Clinical software. PathPresenter Clinical Viewer is intended for use with Hamamatsu NanoZoomer S360MD Slide scanner NDPI image formats viewed on the | The NanoZoomer S360MD Slide scanner system (“NanoZoomer System”) is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from Formalin fixed paraffin embedded (“FFPE”) tissue. The NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. The NanoZoomer System is for |
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| Item | Subject Device (K250968) | Predicate Device (K233027) |
| --- | --- | --- |
| | Barco NV MDPC-8127 display device. | creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. 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 the NanoZoomer System. |
| Specimen Type | Same | Surgical pathology slides prepared from FFPE tissue |
| Diagnostic Image File Format | Same | Hamamatsu NDPI File |
| Image Storage | Same | User-supplied network attached storage |
| Image Manipulation Functions | Same | Panning, Zooming, Image Adjustments, applying annotation and distance / area measurements |
| General Device Characteristics - Differences | | |
| Principle of Operation | A digital pathology image management and analysis platform designed for clinical diagnostics. It operates by receiving whole slide NDPI images from the Hamamatsu NanoZoomer S360MD | Hamamatsu NZViewMD is a digital pathology viewing software designed for clinical diagnostics. It operates by receiving whole slide NDPI images scanned by the Hamamatsu NanoZoomer S360MD and enables users to view, navigate, and review these images on a computer display. NZViewMD simulates traditional microscope interaction by providing digital zoom, pan, and slide navigation tools, supporting clinical assessment of digitized pathology slides. |
| Type of SW Application | Internet Browser Based | Desktop |
| Viewer | PathPresenter Clinical Viewer | NZViewMD |
# VI Standards/Guidance Documents Referenced:
1. Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices: Guidance for Industry and Food and Drug Administration Staff, April 20, 2016.
2. Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff February 3, 2016.
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3. Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff September 27, 2023.
4. IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, Medical device software – Software life cycle processes (recognition Number 13-79).
5. ISO 14971 Third Edition 2019-12, Medical devices – Applications of risk management to medical devices (recognition Number 5-125).
6. IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, Application of usability engineering to medical devices (recognition Number 5-129).
## VII Performance Characteristics (if/when applicable):
### A Analytical Performance:
1. **Precision/Reproducibility:**
Not applicable
2. **Linearity:**
Not applicable
3. **Analytical Specificity/Interference:**
Not applicable
4. **Assay Reportable Range:**
Not applicable
5. **Accuracy (Instrument):**
Not applicable
6. **Carry-Over:**
Not applicable
### B Other Supportive Instrument Performance Characteristics Data:
#### 1. Bench Testing – Pixelwise comparison test
Pixel-wise comparison testing to demonstrate identical image reproduction was conducted to compare WSIs reproduced by the subject device and the comparator as listed in Table 3 below. The subject device was compared to the predicate device's image review manipulation software (IRMS, as defined in FDA guidance document, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" dated April 20, 2016) using the quantitative pixel-wise comparison method. The basis for the comparison was the CIEDE2000 color difference equation, $\Delta E00$. The devices were tested as operating with the intended components, including the scanner, specific file format, image management systems [subject device with the intended browsers (Microsoft Edge and Google Chrome), comparator (predicate device IRMS)] and display, as specified in the Table 3 below.
A total of 30 FFPE tissue slides from 15 different anatomical locations such as breast,
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prostate, gastrointestinal tract, lung, lymph node, bone, etc. were used in the study. The 30 glass slides were scanned with a Hamamatsu NanoZoomer S360MD scanner to generate WSI files in the NDPI file format. For each of the 30 slides, 3 regions of interests (ROIs) were manually selected by a board-certified pathologist to represent various features in the tissue samples. The pathologist, blinded to the rest of the pixel-wise comparison study, pre-identified the regions of interest. This ensured that each ROI included relevant biological features while minimizing blank areas. Blank or blurry areas were excluded from the ROI selection. The ROIs were captured at $20\mathrm{x}$ and $40\mathrm{x}$ magnification levels.
For each configuration, 180 image-pairs (30 slides * 3 ROIs * 2 magnification levels) were tested for a total of 360 image pairs (30 slides x 3 ROIs x 2 Zoom Levels x 2 Browsers = 360). For each comparison, screenshots were captured from the subject with NDPI image file format to be opened via subject viewer and the predicate, to form an image-pair. Each image-pair was cropped and registered to be pixelwise comparable. The cropped image included most of the pixels in the image except for those in the viewer-specific user interface areas. The testing data, including the screenshots and cropping/registration information of the testing configurations were provided in the FDA specific format.
For each image-pair, the pixelwise differences between two images were calculated using the CIEDE2000 color difference metric. Two images were considered to be identical if the 95th percentile of the pixelwise color differences is less than 3 CIEDE2000 (< 3 $\Delta$ E00). Based on analysis of the testing data, WSIs reproduced by PathPresenter Clinical Viewer and the predicate were identical, i.e., $< 3$ $\Delta$ E00.
Table 3: Pixelwise Comparison Testing Results
| Scanner/ Image File Format | Subject Device/ Browser | Comparator (Predicate device IRMS/ Browser) | Display | Results |
| --- | --- | --- | --- | --- |
| Hamamatsu NanoZoomer S360MD Slide Scanner/ NDPI | PathPresenter Clinical Viewer/ Edge | NZViewMD/ Edge | Barco NV MDPC-8127 | max (95th percentile ΔE00) = 2.98 min (95th percentile ΔE00) = 1.39 mean (95th percentile ΔE00) = 2.17 |
| | PathPresenter Clinical Viewer/ Chrome | NZViewMD/ Chrome | | max (95th percentile ΔE00) = 2.99 min (95th percentile ΔE00) = 1.39 mean (95th percentile ΔE00) =2.17 |
# 2. Turnaround Time (TAT)
The purpose of this test was to demonstrate that the turnaround time for rendering of images is acceptable. TAT bench studies evaluated the average time required to execute zooming and panning operations, and to refresh the display in response to user input. A minimum of 20 slides were used in this study which evaluated various image manipulation scenarios including opening, zooming (at $5\mathrm{x}$ , $10\mathrm{x}$ , and $40\mathrm{x}$ ), and panning (vertically and horizontally) operations. The sponsor tested these scenarios using both Google Chrome and Microsoft Edge browsers, ensuring consistent performance across platforms. The PathPresenter Clinical Viewer met the test acceptance criteria and showed acceptable turnaround time for
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the intended use of the subject device. Average times required to execute opening, zooming and panning operations, and to refresh the display in response to user input meets established targets.:
- Loading of the first image visible to the user; Target: 8 seconds, Actual: 2.72 seconds.
- Loading of the whole field of view after panning; Target: 2 seconds, Actual: 1.22 seconds.
- Loading of the whole field of view after zooming; Target: 3 seconds, Actual: 0.60 seconds.
## 3. Measurements (area and distance)
The purpose of this test was to demonstrate that PathPresenter Clinical Viewer accurately shows measurement annotations on scanned WSIs from the Hamamatsu S360 scanner. The measurement accuracy of the PathPresenter Annotation feature was evaluated for both length and area across multiple magnification levels. To verify its accuracy, an image of a calibration scale slide with objects of known sizes was used. A series of annotations were created at various magnifications in two intended browsers. The differences between actual and reported measurements were calculated for each annotation. The acceptance criteria required that all measured values match predetermined measurements relevant to the zoom level of the viewer, with no allowable deviation.
Test results demonstrated that the PathPresenter Annotation feature performed accurate measurements of both length and area. All measured values matched the reference values exactly, with zero observed error across multiple magnification settings.
## 4. Human factor (Usability) Testing
Human Factors (HF) validation test was conducted to demonstrate that the PathPresenter Clinical Viewer can be used by pathologists, free from serious use errors or problems under the expected use conditions. A systematic evaluation of task-based usability including critical tasks required for operation of the device were evaluated via a Use-Related Risk Analysis (URRA). The HF validation test was performed by representative users (board-certified pathologists) and conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices (2016). Validation results confirmed that critical tasks were performed accurately and without any use-related errors that could result in patient harm or diagnostic inaccuracies.
## VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
## IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
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