(349 days)
Not Found
No
The document describes standard image viewing, navigation, and annotation features for digital pathology slides. There is no mention of AI, ML, or any features that would typically utilize these technologies for image analysis or interpretation. The performance testing focuses on image fidelity, speed, measurement accuracy, and usability, not on the performance of any AI/ML algorithms.
No
Explanation: This device is for viewing and managing digital images of pathology slides to aid pathologists in diagnosis, not for treating or preventing disease.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the software "is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis." This directly indicates its role in assisting with diagnosis.
Yes
The device is described as "Dynamyx Digital Pathology Software" and its components are listed as "Installed Pathologist Client" and "Pathologist Workstation Web Client," both of which are software applications. While it interacts with specific scanners and monitors, the device itself is the software for viewing and managing the digital images. The description focuses on the software's functions and workflow.
Based on the provided information, the Dynamyx Digital Pathology Software is an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use explicitly states that the software is "an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, treatment, or prevention of disease.
- Specimen Type: The software is intended for use with "digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue." These are human specimens used for diagnostic purposes.
- Role in Diagnosis: The software is used by pathologists to review and interpret these images for primary diagnosis, indicating its direct involvement in the diagnostic process.
- Predicate Devices: The predicate devices listed (Leica Aperio AT2 DX System and Philips IntelliSite Pathology Solution (PIPS)) are also digital pathology systems used for diagnostic purposes, further supporting the classification of Dynamyx as an IVD.
While the software itself is a software device, its intended use in the interpretation of human specimens for diagnosis places it within the scope of IVD regulation.
N/A
Intended Use / Indications for Use
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.
Product codes (comma separated list FDA assigned to the subject device)
QKQ
Device Description
Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.
Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the images to the Dynamyx viewer.
Note that Dynamyx has two different applications for two different inputs as specified below.
- The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
- The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.
Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images.
Dynamyx incorporates typical histology/pathology workflow and is operated as follows:
-
- Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx.
-
- Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist.
-
- The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive.
-
- The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image:
- a. Zoom and pan the image at will;
- b. Adjust the apparent image observed magnification level;
- c. Measure distances and areas;
- d. Annotate images and cases;
-
- The above steps are repeated as required.
After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.
Mentions image processing
The two views generated by the subject and predicate IRMS were adjusted and registered by using only the graphical user interface without image processing.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Whole Slide Images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist, Histologist, laboratory
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)
Summary of Non-Clinical Performance Testing:
Technical performance testing for Dynamyx Digital Pathology Software device was performed. The new device was compared to the Image Management Software (IMS) component of the Philips PIPS device and the ImageScope DX viewer software of Leica Aperio AT2 DX System.
Pixel-wise comparison with the predicate device including zooming and panning operations: The equivalence between the subject and predicate image review manipulation software (IRMS, as defined in the FDA guidance titled "Guidance for Industry "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016 [TPA guidance, IV(A)(9)] was supported by bench testing data based on pixel-level comparison. The subject IRMS was tested as operating with the intended components, including the scanner, image management system and display, Scanned images from 33 FFPE tissue glass slides from different anatomic locations were used as the test input. For each region of interest (ROI), the differences between the views generated by the subject and predicate IRMS were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric ΔE for each corresponding pixel pair. The two views generated by the subject and predicate IRMS were adjusted and registered by using only the graphical user interface without image processing. The test cases of ROIs included relevant biological features at different magnification levels such as 40x, 20x and 10x. Horizontal/vertical stitching seams between the tiles were included in the ROIs when possible.
Sixty image pairs at 40x, 20x, and 10x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Leica AT2 DX. Similarly, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Philips PIPS. In addition, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Pathologist Workstation Web Client running in the Chrome browser against Philips PIPS.
The color differences of all pixels within each ROI were reported. The image data of all ROIs were also provided for verification. The test results demonstrated that all image pairs are identical with zero ΔE. The subject device has been found to adequately reproduce digital pathology images at the pixel level with respect to its intended use.
Turnaround Time: Turnaround time test was performed to verify the streaming indicator functionality and to measure the turnaround time for initial image load, panning via mouse drag and zooming with 10 concurrent users using Leica Aperio AT2 DX scanner images and Philips UFS images. Test results are acceptable.
Measurement Accuracy: Measurement accuracy testing was performed to verify the calculated measurement for each annotation (e.g., length and area) is accurate to within 5% of the reference measurement using a certified micron scale image created using a Leica Aperio AT2 DX scanner and a Philips UFS. Test results showed that the subject device performed accurate measurements with respect to its intended use.
Human Factors (Usability) Testing: Formative and summative usability testing was conducted on the Dynamyx Pathology Workstation and the Histologist Workstation interfaces in accordance with FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices, Usability Engineering procedure and the Risk Management Process.
A systematic evaluation of task-based usability including critical tasks required for operation of the device were evaluated at multiple sites using multiple users. All tasks associated with reviewing and reporting results for cases including confirmation that all slides belonging to specific cases are reviewed before reporting results, were included in the study. Overall, the results of the human factors testing were acceptable.
Summary of Clinical Performance Data:
Clinical study results are not required for a substantial equivalence determination. Therefore, this submission contains no clinical study information.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
March 01, 2022
Inspirata, Inc. Richard Morroney Director of Regulatory Compliance One North Dale Mabry Hwy Suite 600 Tampa, FL 33609
Re: K210811
Trade/Device Name: Dynamyx Digital Pathology Software Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: December 15, 2021 Received: December 16, 2021
Dear Richard Morroney:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Soma Ghosh, Ph.D. Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210811
Device Name
Dynamyx Digital Pathology Software
Indications for Use (Describe)
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.
| Type of Use ( Select one or both, as applicable ) | ||
|---|---|---|
| XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | XPrescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| XPrescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
6.0 510(k) Summary
| Date Prepared: | February 28, 2022 |
|---|---|
| Submitter: | Inspirata, Inc. |
| One North Dale Mabry Hwy | |
| Suite 600 | |
| Tampa, FL 33609 | |
| Contact Person: | Richard Morroney, RAC, CQA |
| Director of Regulatory Compliance | |
| Phone: (813) 570-8900 | |
| Fax: (813) 570-8901 |
Submission Date: March 15, 2021
Device Identification
| Proprietary/Trade Name: | Dynamyx Digital Pathology Software |
|---|---|
| Classification Name: | Whole Slide Imaging System |
| Regulation Number: | 21 CFR 864.3700 |
| Product Code: | QKQ |
| Device Classification: | Class II |
| Review Panel: | 88 – Pathology |
| Common Name: | Digital Pathology Image Viewing and Management Software |
Predicate Device Identification
| Proprietary/Trade
Name | Leica Aperio AT2 DX
System | Philips IntelliSite Pathology
Solution (PIPS) |
|---------------------------|----------------------------------------------|--------------------------------------------------|
| 510(k) Number | K190332 | DEN160056 |
| Clearance Date | May 20, 2019 | April 12, 2017 |
| Classification Name | Whole Slide Imaging System | |
| Regulation Number | 21 CFR 864.3700 | |
| Product Code | PSY | |
| Device Classification | Class II | |
| Review Panel | 88 – Pathology | |
| Common Name | Digital Pathology Whole Slide Imaging System | |
Device Description
Dynamyx Digital Pathology Software is a client-server software device used for importing, displaying, navigating, and annotating whole slide images obtained from the Leica Aperio AT2 DX scanner or the Philips Ultra Fast Scanner.
Whole slide images are created by scanning glass microscope slides using a digital slide scanner which are then imported into the Dynamyx Digital Archive server. Dynamyx uses the image decoding libraries licensed by Leica and Philips for the native images. Dynamyx then uses lossless compression to send the images to the Dynamyx viewer.
4
Note that Dynamyx has two different applications for two different inputs as specified below.
-
The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
-
The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.
Whole slide image files are viewed in the Dynamyx image viewer window by histologists and by pathologists who can also navigate (pan and zoom) and annotate the images.
Dynamyx incorporates typical histology/pathology workflow and is operated as follows:
-
- Dynamyx receives whole slide images from the scanner as specified above and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage (Digital Archive). A copy of the image metadata (e.g. the pixel size) is stored in the subject device's database to increase the operational performance (e.g. response times) of Dynamyx.
-
- Depending upon a laboratory's workflow, whole slide images may be reviewed first by histologists to confirm image quality and initiate any slide rescans as necessary prior to being viewed by pathologists. The digital slide review OC status determined by the histologist indicates which slides have been reviewed and approved. The OC status is available to the reading pathologist.
-
- The reading pathologist selects a patient case from a selected worklist within Dynamyx whereby the case images are retrieved from the digital archive.
-
- The reading pathologist uses Dynamyx to view, navigate, annotate, and interpret the digital images. The pathologist can perform the following actions to displayed image:
- a. Zoom and pan the image at will;
- b. Adjust the apparent image observed magnification level;
- c. Measure distances and areas;
- d. Annotate images and cases;
-
- The above steps are repeated as required.
After viewing all images, the pathologist will make a diagnosis which is documented in a laboratory information system.
5
Intended Use Statement
Dynamyx Digital Pathology Software is intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffinembedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Dynamyx Digital Pathology Software is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Dynamyx Digital Pathology Software.
The Dynamyx Digital Pathology Software consists of the Installed Pathologist Client and the Pathologist Workstation Web Client. The Installed Pathologist Client is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor as well as Philips' Ultra Fast Scanner and Philips PP27QHD monitor. The Pathologist Workstation Web Client is intended for use with Philips' Ultra Fast Scanner and Philips PP27QHD monitor.
6
Summary of Technological Characteristics
| Item | Subject Device
Dynamyx | Predicate Device
Philips IntelliSite Pathology
Solution (PIPS)
DEN160056 | Predicate Device
Leica Aperio AT2 DX System
K190332 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | | |
| Indications
for Use | Dynamyx Digital Pathology Software is
intended for viewing and management of
digital images of scanned surgical
pathology slides prepared from formalin-
fixed, paraffin-embedded (FFPE) tissue.
It is an aid to the pathologist to review
and interpret these digital images for the
purposes of primary diagnosis.
Dynamyx Digital Pathology Software is
not intended for use with frozen section,
cytology, or non-FFPE hematopathology
specimens.
It is the responsibility of the pathologist
to employ appropriate procedures and
safeguards to assure the validity of the
interpretation of images using Dynamyx
Digital Pathology Software.
The Dynamyx Digital Pathology
Software consists of the Installed
Pathologist Client and the Pathologist
Workstation Web Client. The Installed
Pathologist Client is intended for use
with Leica's Aperio AT2 DX scanner
and Dell MR2416 monitor as well as
Philips' Ultra Fast Scanner and Philips
PP27QHD monitor. The Pathologist
Workstation Web Client is intended for
use with Philips' Ultra Fast Scanner and
Philips PP27QHD monitor. | The Philips IntelliSite Pathology
Solution (PIPS) is an automated digital
slide creation, viewing, and management
system. The PIPS 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-fix
paraffin embedded (FFPE) tissue. The
PIPS is not intended for use with frozen
section, cytology, or non-FFPE
hematopathology specimens.
The PIPS comprises the Image
Management System (IMS), the Ultra
Fast Scanner (UFS) and Display. The
PIPS is for 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
PIPS. | The Leica Aperio AT2 DX System is an
automated digital slide creation and
viewing system. The Leica Aperio AT2
DX 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
Leica Aperio AT2 DX System is not
intended for use with frozen section,
cytology, or non-FFPE hematopathology
specimens.
The Leica Aperio AT2 DX System is
composed of the Leica Aperio AT2 DX
scanner, the ImageScope DX review
application and Display. The Leica
Aperio AT2 DX System is for 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 Leica Aperio AT2 DX System. |
| Item | Subject Device
Dynamyx | Predicate Device
Philips IntelliSite Pathology
Solution (PIPS)
DEN160056 | Predicate Device
Leica Aperio AT2 DX System
K190332 |
| Specimen
Type | Surgical pathology slides prepared from
FFPE tissue. | Same | Same |
| Image
Storage | Images are stored in end user provided
image storage attached to the local
network | Same | Same |
| Image
Manipulation
Functions | Panning, zooming, image adjustments,
annotations, and distance / area
measurements | Same | Same |
| Image
Review and
Diagnosis | During review, the pathologist opens
WSI images acquired with the WSI
scanner from the image storage,
performs further QC and interprets the
WSI images to make a diagnosis. | Same | Same |
| Diagnostic
Status of
Images | Displays a visual indicator for the
diagnostic status of an image. | Same | Same |
| User Interface | Full-featured image viewer with
integrated case list containing slide
thumbnails. | Same | Same |
| Display
Monitor | Dynamyx does not include a monitor but
is indicated for use with the Dell
MR2416, and Philips PP27QHD
monitor with each system respectively. | Philips PP27QHD | Dell MR2416 |
| Item | Subject Device
Dynamyx | Predicate Device
Philips IntelliSite Pathology
Solution (PIPS)
DEN160056 | Predicate Device
Leica Aperio AT2 DX System
K190332 |
| Performance
Testing | • Color Reproducibility
• Turnaround Time
• Measurement Accuracy
• Usability | Same | Same |
7
8
| Item | Subject Device
Dynamyx | Predicate Device
Philips IntelliSite Pathology
Solution (PIPS)
DEN160056 | Predicate Device
Leica Aperio AT2 DX System
K190332 | | | | |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Differences | | | | | | | |
| Image QC | When used as part of the Philips
system, image QC is embedded in
workflow. Scan techs view slide macro
images on the UFS interface to
confirm all tissue is contained in the
scanned area. Users view the images
to confirm scan quality using the
Dynamyx viewer. QC status available
to pathologist.
When used as part of the Leica Aperio
system, image QC is embedded in
workflow. Scan techs view slide macro
images on the AT2 DX interface to
confirm all tissue is contained in the
scanned area. Users view the images
to confirm scan quality using the
Dynamyx viewer. QC status available
to pathologist. | Image QC embedded in workflow.
Scan techs view slide macro images
on the UFS interface to confirm all
tissue is contained in the scanned area.
Users view the images to confirm scan
quality using the IMS Viewer. | Image QC embedded in workflow.
Scan techs view slide macro images
on the AT2 DX interface to confirm
tissue is contained in the scanned area.
Users view the images to confirm scan
quality using the ImageScope DX
viewer. | | | | |
9
| Item | Subject Device
Dynamyx | Predicate Device
Philips IntelliSite Pathology
Solution (PIPS)
DEN160056 | Predicate Device
Leica Aperio AT2 DX System
K190332 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Differences | | | |
| User
Interface | Dynamyx is a stand-alone medical
device software. | The Image Management System (IMS)
software is an integrated component of
the PIPS. | Leica Aperio ImageScope DX viewer
software is an integrated component of
the AT2 DX system. |
| Microscope
Slide Scanner | Dynamyx is a software only device and
does not include any hardware or
scanner. However, it is indicated for use
with the Leica Aperio AT2 DX Scanner
and the Philips UFS. | Philips Ultra Fast Scanner (UFS) | Leica Aperio AT2 DX Slide Scanner |
| WSI Display
Input | Dynamyx has two applications for two
different inputs.
- The Dynamyx Web Application
running in the Chrome browser can only
display WSI from the Philips Ultra Fast
Scanner. - The Dynamyx Installed Client
Application can display WSI from both
the Leica AT2 DX Scanner and the
Philips Ultra Fast Scanner. | The IMS viewer is browser based and
can display only .iSyntax WSI files | ImageScope viewer is an installed
application and can only display .svs
WSI files |
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Substantial Equivalence Comparison
The major difference between the predicate devices and Dynamyx is that the predicate devices are comprised of a system of hardware and software components, whereas Dynamyx is indicated for use with the same scanners and monitors. Therefore, the predicate device indications for use are slightly different to account for the creation of digital images whereas Dynamyx is intended as a replacement software component used for viewing and management of those images.
Dynamyx has two different applications for two different inputs as specified below.
-
The Dynamyx Web Application running in the Chrome browser can only display WSI from the Philips Ultra Fast Scanner.
-
The Dynamyx Installed Client Application can display WSI from both the Leica AT2 DX Scanner and the Philips Ultra Fast Scanner.
The IMS viewer is browser-based and can display only .iSyntax WSI files. The ImageScope viewer is an installed application and can only display .svs WSI files.
The AT2 DX scanner provides a color-coded status indication on the scanner control panel showing whether or not the scanner was able to focus on the tissue being scanned. The status colors are not an absolute indicator of image quality. They are used as a diagnostic tool alerting the user of possible problems with a scan. This scanner feature is independent of the viewer. The AT2 DX user manual states that regardless of the scan status color, all slides should be reviewed for acceptable image quality. Thus, digital slide image QC is performed using the image viewer.
The Ultra Fast Scanner provides a user interface where macro images of the scanned slide can be viewed to confirm that all the slide tissue was scanned. Digital slide image QC is performed using the Philips IMS viewer. The IMS user manual states that before a slide is used for diagnosis, the pathologist must check the image to ensure that it is suitable for diagnosis.
Using the Dynamyx viewer, a histotechnologist can review the quality of digital slide images and can assign the OC status of the images as rescan or reviewed/approved. The slide image review status (i.e., scan quality is approved or not approved ) is available to the pathologist. Ultimately, it is up to the pathologist to look at digital slide images to verify they are of sufficient quality to perform their task.
Both predicate devices have the ability to confirm scan quality, i.e., check for missing tissue and faint tissue at the scanner. Although Dynamyx does not include a scanner, that doesn't preclude these checks from being performed. Additionally, the check for missing or faint tissue can be performed using the Dynamvx viewer. Both the predicates and Dynamyx require an equivalent manual review of image quality. Therefore, these differences indicate that Dynamyx software does not introduce any new potential safety or efficacy issues.
The Dynamyx Digital Pathology Software when used with the Leica Aperio AT2 DX
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scanner / Dell MR2416 monitor and the Philips UFS scanner / PP27QHD monitor have similar indications for use, functional and technological characteristics as the ImageScope DX viewer and Philips IMS Viewer of the predicate devices and is therefore substantially equivalent to the Leica predicate device (K190332) and the Philips predicate device (DEN160056).
Summary of Non-Clinical Performance Testing:
Technical performance testing for Dynamyx Digital Pathology Software device was performed. The new device was compared to the Image Management Software (IMS) component of the Philips PIPS device and the ImageScope DX viewer software of Leica Aperio AT2 DX System. The following testing was performed:
- Pixel-wise comparison with the predicate device including zooming and panning a. operations
The equivalence between the subject and predicate image review manipulation software (IRMS, as defined in the FDA guidance titled "Guidance for Industry "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices", dated April 20, 2016 [TPA guidance, IV(A)(9)] was supported by bench testing data based on pixel-level comparison. The subject IRMS was tested as operating with the intended components, including the scanner, image management system and display, Scanned images from 33 FFPE tissue glass slides from different anatomic locations were used as the test input. For each region of interest (ROI), the differences between the views generated by the subject and predicate IRMS were evaluated with the 1976 International Commission on Illumination (CIE) color difference metric ΔE for each corresponding pixel pair. The two views generated by the subject and predicate IRMS were adjusted and registered by using only the graphical user interface without image processing. The test cases of ROIs included relevant biological features at different magnification levels such as 40x, 20x and 10x. Horizontal/vertical stitching seams between the tiles were included in the ROIs when possible.
Sixty image pairs at 40x, 20x, and 10x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Leica AT2 DX. Similarly, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Installed Pathologist Client against the predicate Philips PIPS. In addition, sixty image pairs at 40x and 20x were used to test Dynamyx Digital Pathology Software Pathologist Workstation Web Client running in the Chrome browser against Philips PIPS.
The color differences of all pixels within each ROI were reported. The image data of all ROIs were also provided for verification. The test results demonstrated that all image pairs are identical with zero ΔE. The subject device has been found to adequately reproduce digital pathology images at the pixel level with respect to its intended use.
b. Turnaround Time
Turnaround time test was performed to verify the streaming indicator functionality and to measure the turnaround time for initial image load, panning via mouse drag and zooming with 10 concurrent users using Leica Aperio AT2 DX scanner images and Philips UFS images. Test results are acceptable.
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c. Measurement Accuracy
Measurement accuracy testing was performed to verify the calculated measurement for each annotation (e.g., length and area) is accurate to within 5% of the reference measurement using a certified micron scale image created using a Leica Aperio AT2 DX scanner and a Philips UFS. Test results showed that the subject device performed accurate measurements with respect to its intended use.
d. Human Factors (Usability) Testing
Formative and summative usability testing was conducted on the Dynamyx Pathology Workstation and the Histologist Workstation interfaces in accordance with FDA Guidance on Applying Human Factors and Usability Engineering to Medical Devices, Usability Engineering procedure and the Risk Management Process.
A systematic evaluation of task-based usability including critical tasks required for operation of the device were evaluated at multiple sites using multiple users. All tasks associated with reviewing and reporting results for cases including confirmation that all slides belonging to specific cases are reviewed before reporting results, were included in the study. Overall, the results of the human factors testing were acceptable.
Summary of Clinical Performance Data:
Clinical study results are not required for a substantial equivalence determination. Therefore, this submission contains no clinical study information.
Conclusion:
The Dynamyx Digital Pathology Software when used with the Leica Aperio AT2 DX scanner / Dell MR2416 monitor and the Philips Ultra Fast Scanner / Philips PP270HD monitor, has similar indications for use, functional, and technological characteristics as the ImageScope DX viewer application and the IMS Viewer software of the predicate devices. The results of non-clinical testing demonstrate that the subject device is safe and effective and substantially equivalent to the Leica Aperio AT2 DX (K190332) and Philips PIPS (DEN160056) predicate devices.