(248 days)
Not Found
No
The summary describes software for viewing and managing digital pathology images, with features like zooming, panning, measuring, and annotating. It focuses on image reproduction accuracy and system performance (loading times, measurements). There is no mention of AI or ML being used for image analysis, interpretation, or any other function. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is intended for viewing and management of digital images of scanned surgical pathology slides for primary diagnosis. It is explicitly stated as "For In Vitro Diagnostic Use" and is an aid to the pathologist, not a device that directly treats or prevents disease in patients.
Yes
This device is intended for in vitro diagnostic use, as stated in the "Intended Use / Indications for Use" section. It aids pathologists in reviewing, interpreting, and managing digital images of pathology slides for primary diagnosis, which is a diagnostic activity.
Yes
The device description explicitly states "FullFocus, version 2.29, is a web-based software-only device". While it interoperates with specific hardware (scanners and displays), the device itself is solely the software component for viewing and managing the digital images.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use".
- Intended Use: The software is intended for "viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue" and is an "aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis." This directly relates to the examination of specimens derived from the human body for the purpose of providing information for diagnosis.
- Device Description: The description reinforces its use in the context of "pathology primary diagnosis" by enabling pathologists to "open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed" to "render a diagnosis."
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
FullFocus is a software 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, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table.
Table: Interoperable components of FullFocus
| Scanner Hardware | Scanner Output file format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017 |
| Dell U3023E | ||
| Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE |
| JVC-Kenwood JD-C240BN01A |
Product codes (comma separated list FDA assigned to the subject device)
QKQ
Device Description
FullFocus, version 2.29, is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from FDA cleared digital pathology scanners on FDA cleared displays. FullFocus renders these digitized pathology images for review, management and navigation for pathology primary diagnosis.
Image acquisition is performed using the intended scanner (s), with the operator conducting quality control on the digital WSI images according to the scanner's instructions for use and lab specifications to determine if re-scans are needed. Please see the Intended Use section and below tables for specifics on scanners and respective displays for clinical use.
Once a whole slide image is acquired using the intended scanner and becomes available in the scanner's database file system, a separate medical image communications software (not part of the device), automatically uploads the image and corresponding metadata to persistent cloud storage. Integrity checks are performed during the upload to ensure data accuracy.
The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.
FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below:
| Scanner Hardware | Scanner Output file format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017 |
| Dell U3023E | ||
| Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE |
| JVC-Kenwood JD-C240BN01A |
Table 1: Interoperable Components Intended for Use with FullFocus
FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner.
Table 2: Computer Environment/System Requirements for during the use of FullFocus
| Environment | Component | Minimum Requirements |
|---|---|---|
| Hardware | Processor | 1 CPU, 2 cores, 1.6GHz |
| Memory | 4 GB RAM | |
| Network | Bandwidth of 10Mbps | |
| Software | Operating System | • Windows |
| • macOS | ||
| Browser | • Google Chrome (129.0.6668.90 or higher) | |
| • Microsoft Edge (129.0.2792.79 or higher) |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned surgical pathology slides
Anatomical Site
human anatomical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified pathologist
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
A total of 30 formalin-fixed paraffin-embedded (FFPE) tissue glass slides, representing a range of human anatomical sites, were scanned at 40x magnification using both slide scanner systems. The slides scanned with the Leica Aperio GT450 DX scanner were saved in both DICOM and SVS formats, while the slides scanned with the Hamamatsu NanoZoomer S360MD Slide Scanner were saved in NDPI format. For each WSI, three regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist. Screenshots of these ROIs were captured at two magnification levels (10x and 40x) across multiple displays and browsers as specified in the above table. The testing process ensured comprehensive evaluation across display variations, with all image pairs registered and cropped for analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pixel-wise comparison study was conducted to compare images reproduced by FullFocus, version 2.29, and the comparators (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") as described below for the same image file format generated from the same intended use scanner to validate identical image reproduction on the same intended displays. The acceptance criterion for this testing required that the 95th percentile of the pixel-wise color differences in any image pair across all required screenshots be less than 3.0 delta E00. Test results showed that the 95th percentile of pixelwise differences between FullFocus and the comparators were less than 3 CIEDE2000, indicating that their output images can be considered to be pixel-wise identical. Therefore, FullFocus has been found to visually adequately reproduce digital pathology images to human readers with respect to its intended use.
Turnaround time: The system requirements have been fulfilled: When selecting a case, it should not take longer than 10 seconds until the image is fully loaded. When panning and zooming the image it shall not take longer than 7 seconds until the image is fully loaded.
Measurements: Measurement accuracy has been verified using a test image containing objects with known sizes. FullFocus has been found to perform accurate measurements with respect to its intended use.
Straight Line Measurement in Chrome and Edge browsers, Sample size: 1 Calibration Slide. Acceptance Criteria: The 1 mm measured line should match the reference value exactly 1 mm +/- 0mm. Results: All measurements compared to the reference were exactly 1 mm, with no error.
Area Measurement in Chrome and Edge browsers, Sample size: 1 Calibration Slide. Acceptance Criteria: The measured area must match the reference area exactly 0.2 x 0.2 mm for a total of 0.04 mm squared +/- 0 mm squared. Results: All area measurements compared to the reference value were exactly 0.04mm squared, with no error.
Scalebar Measurement in Chrome and Edge browsers, Sample size: 1 Calibration Slide. Acceptance Criteria: 2mm scalebar is accurate. Results: All Tests Passed.
Human Factors Testing: Human factors study designed around critical user tasks and use scenarios performed by representative users were conducted for previously cleared FullFocus, version 1.2.1, in K201005, per FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices (2016)". Human factors validation testing is not necessary as the user.
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
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January 9, 2025
Paige.AI, Inc Mufaddal Jafferji Director of Quality and Compliance 11 Times Sq, Floor 37 New York, NY 10036
Re: K241273
Trade/Device Name: FullFocus Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKQ Dated: May 6, 2024 Received: May 6, 2024
Dear Mufaddal Jafferji:
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 OS 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 and Part 809); 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-safetyreporting-combination-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
2
Sincerely,
Shyam Kalavar -S
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241273
Device Name FullFocus
Indications for Use (Describe) For In Vitro Diagnostic Use
FullFocus is a software 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, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table.
Table: Interoperable components of FullFocus
| Scanner Hardware | Scanner Output file format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017 |
| Dell U3023E | ||
| Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE |
| JVC-Kenwood JD-C240BN01A |
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
FullFocus
Date Prepared: January 8, 2025
Submitter
Paige.AI, Inc. 11 Times Square, 37th Floor New York, NY 10036
Contact Person
Mufaddal Jafferji Director of Quality and Compliance 11 Times Square, 37th Floor New York, NY 10036 mufaddal.jafferji@paige.ai Phone: (774) 262-3461
Device
| Proprietary Name of the Device: | FullFocus |
|---|---|
| Version: | 2.29 |
| Classification Name: | Whole Slide Imaging System |
| Regulation Number: | 21 CFR 864.3700 |
| Product Codes: | QKQ |
| Device Class: | Class II |
| Review Panel: | 88 – Pathology |
| Common Name: | FullFocus |
| 510(k) Number: | K241273 |
Predicate Devices
Trade name:
-
- Aperio GT450X (K232202) Manufacturer: Leica Biosystems Imaging, Inc.
-
- NanoZoomer S360MD Slide scanner system (K213883) Manufacturer: Hamamatsu Photonics K.K.
Device Class: Class II CFR section: 864.3700 Product code: PSY Classification name: Whole Slide Imaging System
5
Device Description
FullFocus, version 2.29, is a web-based software-only device that facilitates the viewing and navigating of digitized pathology images of slides prepared from FFPE-tissue specimens acquired from FDA cleared digital pathology scanners on FDA cleared displays. FullFocus renders these digitized pathology images for review, management and navigation for pathology primary diagnosis.
Image acquisition is performed using the intended scanner (s), with the operator conducting quality control on the digital WSI images according to the scanner's instructions for use and lab specifications to determine if re-scans are needed. Please see the Intended Use section and below tables for specifics on scanners and respective displays for clinical use.
Once a whole slide image is acquired using the intended scanner and becomes available in the scanner's database file system, a separate medical image communications software (not part of the device), automatically uploads the image and corresponding metadata to persistent cloud storage. Integrity checks are performed during the upload to ensure data accuracy.
The subject device enables the reading pathologist to open a patient case, view the images, and perform actions such as zooming, panning, measuring distances and annotating images as needed. After reviewing all images for a case, the pathologist will render a diagnosis.
FullFocus operates with and is validated for use with the FDA cleared components specified in the tables below:
| Scanner Hardware | Scanner Output file format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | DICOM, SVS | Dell UP3017 |
| Dell U3023E | ||
| Hamamatsu NanoZoomer S360MD Slide Scanner | NDPI | Dell U3223QE |
| JVC-Kenwood JD-C240BN01A |
Table 1: Interoperable Components Intended for Use with FullFocus
FullFocus version 2.29 was not validated for the use with images generated with Philips Ultra Fast Scanner.
Table 2: Computer Environment/System Requirements for during the use of FullFocus
| Environment | Component | Minimum Requirements |
|---|---|---|
| Hardware | Processor | 1 CPU, 2 cores, 1.6GHz |
| Memory | 4 GB RAM | |
| Network | Bandwidth of 10Mbps | |
| Software | Operating System | • Windows |
| • macOS | ||
| Browser | • Google Chrome (129.0.6668.90 or higher) | |
| • Microsoft Edge (129.0.2792.79 or higher) |
6
Intended Use/Indications for Use
FullFocus is a software 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, interpret and manage digital images of pathology slides for primary diagnosis. FullFocus is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and, where necessary, use conventional light microscopy review when making a diagnostic decision. FullFocus is intended to be used with the interoperable components specified in the below Table.
| Scanner Hardware | Scanner Output file format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX | ||
| scanner | DICOM, SVS | Dell UP3017 |
| Dell U3023E | ||
| Hamamatsu NanoZoomer | ||
| S360MD Slide Scanner | NDPI | Dell U3223QE |
| JVC-Kenwood JD-C240BN01A |
Table: Interoperable components of FullFocus
Summary of Technological Characteristics
7
Comparison with Predicate (Aperio GT 450X):
| Item | Subject Device (FullFocus) | Predicate Device (K232202) | |||||
|---|---|---|---|---|---|---|---|
| Device Trade | |||||||
| Name | FullFocus | Aperio GT 450 DX | |||||
| Intended Use | |||||||
| /Indications | |||||||
| for Use | FullFocus is a software 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, interpret and manage digital | |||||||
| images of pathology slides for primary diagnosis. | |||||||
| FullFocus is not intended for use with frozen | |||||||
| sections, cytology, or non-FFPE hematopathology | |||||||
| specimens. |
It is the responsibility of a qualified pathologist to
employ appropriate procedures and safeguards to
assure the quality of the images obtained and,
where necessary, use conventional light
microscopy review when making a diagnostic
decision. FullFocus is intended to be used with the
interoperable components specified in the below
Table. | | | The Aperio GT 450 DX is an automated digital slide creation and
viewing system. The Aperio GT 450 DX 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 Aperio GT 450 DX is
for creation and viewing of digital images of scanned glass slides
that would otherwise be appropriate for manual visualization by
conventional light microscopy.
Aperio GT 450 DX is comprised of the Aperio GT450 DX scanner,
which generates images in the Digital Imaging and Communications
in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file
formats, the Aperio WebViewer DX viewer, and the displays. The
Aperio GT 450 DX is intended to be used with the interoperable
components specified in Table 1. | | | |
| | Table: Interoperable components of FullFocus | | | Table 1: Interoperable components of Aperio GT 450 DX | | | |
| | Scanner
Hardware | Scanner
Output
file
format | Interoperable
Displays | Scanner
Hardware | Scanner
Output
file
format | Interoperable
Viewing
Software | Interoperable
Displays |
| | Leica Aperio
GT 450 DX
scanner | DICOM,
SVS | Dell UP3017
Dell U3023E
Dell U3223QE | Aperio GT
450 DX
scanner | SVS | Aperio
WebViewer
DX | Barco MDPC-8127
Dell UP3017
Dell U3023E
Dell U3223QE |
| | Hamamatsu
NanoZoomer
S360MD Slide
Scanner | NDPI | JVC-Kenwood
JD-
C240BN01A | Aperio GT
450 DX
scanner | SVS | Sectra Digital
Pathology
Module (3.3) | Dell U3223QE |
| | | | | Aperio GT
450 DX
scanner | DICOM | Sectra Digital
Pathology
Module (3.3) | Dell U3223QE |
| Specimen
Type | Digitized surgical pathology slides prepared
from FFPE tissue | | | Same | | | |
| Image file
format | SVS & DICOM - Aperio GT450 DX
NDPI - Hamamatsu NanoZoomer S360MD
Slide scanner | | | SVS & DICOM | | | |
| Image
Manipulation
Functions | Panning, zooming, annotations, and
measurements | | | Same | | | |
| Type of
Software
Application | Internet browser-based application | | | Same | | | |
| Device
Components | FullFocus | | | Scanner, Webviewer DX, Display | | | |
| End User's
Interface | FullFocus | | | WebViewer DX, Sectra Digital Pathology Module (3.3) | | | |
| Principle of
Operation | After WSI images are successfully acquired by
using Aperio GT 450 DX scanner or Hamamatsu
NanoZoomer S360MD Slide scanner, the WSI | | | The Aperio GT 450 DX is a WSI system. The technician places the
slides into the Aperio GT 450 DX scanner. The Aperio GT 450 DX
scanner automatically loads the slides, takes the micro images, finds | | | |
8
| | pathologist opens WSI images from storage,
perform further QC and reads WSI images of the
slides render a diagnosis. | performs quality control (QC) and notifies the user of any image
quality issue during the image acquisition. The image data is sent to
end-user-provided image storage attached to the local network. During
the review, the pathologist opens WSI images acquired with the WSI
scanner from the image storage, performs further QC, and reads WSI
images of the slides to make a diagnosis. |
|------------------|----------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image
Storage | Images are stored in the cloud | Images are stored in the end-user provided image storage attached to
the local network |
Comparison with Predicate (Hamamatsu NanoZoomer S360MD slide scanner system)
| Item | Subject Device (FullFocus) | Predicate Device (K213883) |
|---|---|---|
| Device Trade | ||
| Name | FullFocus | NanoZoomer S360MD Slide scanner system |
| Intended Use | ||
| /Indications | ||
| for Use | FullFocus is a software 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, interpret and | ||
| manage digital images of pathology slides for primary | ||
| diagnosis. FullFocus is not intended for use with frozen | ||
| sections, cytology, or non-FFPE hematopathology specimens. |
It is the responsibility of a qualified pathologist to employ
appropriate procedures and safeguards to assure the quality of
the images obtained and, where necessary, use conventional
light microscopy review when making a diagnostic decision.
FullFocus is intended to be used with the interoperable
components specified in the below Table. | 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 the JVC Kenwood JDC240BN01A display.
The NanoZoomer 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 NanoZoomer System. |
| Table: Interoperable components of FullFocus | | |
| Scanner Hardware | Scanner Output file
format | Interoperable
Displays |
| Leica Aperio GT 450
DX scanner
Hamamatsu
NanoZoomer S360MD
Slide Scanner | DICOM,
SVS
NDPI | Dell UP3017
Dell U3023E
Dell U3223QE
JVC-Kenwood
JD-C240BN01A |
| Specimen
Type | Digitized surgical pathology slides prepared from FFPE
tissue | Same |
| Image file
format | SVS & DICOM - Aperio GT450 DX
NDPI - Hamamatsu NanoZoomer S360MD Slide scanner | NDPI |
| Image
Manipulation
Functions | Panning, zooming, annotations, and measurements | The NZViewMD software provides the user with a
continuous view across the XY plane of the WSI with the
ability to: View images with continuous panning and
zooming, Annotate and bookmark images, Track visited
areas and a software only subsystem with functionality that
includes the ability to: View images and patient data,
Organize workload, Annotate, bookmark, and/or tag
images, Manually score images, Invite and join others for a
shared session annotations, Export images to a network
server, Discrete Z-axis displacement |
| Type of
Software | Internet browser-based application | PC-based installed application |
9
| Application | ||
|---|---|---|
| Device | ||
| Components | FullFocus | Scanner, NZViewMD, Display |
| End User's | ||
| Interface | FullFocus | NZViewMD |
| Principle of | ||
| Operation | After WSI images are successfully acquired by using Leica | |
| Aperio GT 450 DX scanner or Hamamatsu NanoZoomer | ||
| S360MD Slide scanner, the WSI images are stored in the | ||
| cloud. During review, the pathologist opens WSI images | ||
| from storage, perform further QC and reads WSI images of | ||
| the slides render a diagnosis. | 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 | ||
| formalinfixed paraffin embedded ("FFPE") tissue. The | ||
| NanoZoomer System is not intended for use with frozen | ||
| section, cytology, or non-FFPE hematopathology | ||
| specimens. The system's embedded image processing | ||
| software is responsible for image acquisition and the | ||
| processing of individual tiles prior to image composition or | ||
| stitching. Hamamatsu's NZAcquireMD software organizes | ||
| all WSI tiles into a single NDPi file, which is a proprietary | ||
| file format. During the review, the pathologist opens the | ||
| WSI on the NZViewMD software to render a diagnosis. | ||
| Image | ||
| Storage | Images are stored in the cloud | Images are stored in the end-user provided image storage |
| attached to the local network |
Summary of Performance Testing Data
| Test | Result | ||||
|---|---|---|---|---|---|
| Pixel-wise | |||||
| comparison | Pixel-wise comparison study was conducted to compare images reproduced by FullFocus, version 2.29, and the comparators (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") as described below for the same image file format generated from the same intended use scanner to validate identical image reproduction on the same intended displays. | ||||
| Scanner | Image | ||||
| File | |||||
| Format | Subject Device | ||||
| (Viewer/Browser) | Comparator (Predicate | ||||
| device IRMS) | Displays | ||||
| Leica Aperio | |||||
| GT450DX | |||||
| scanner | DICOM | FullFocus/Chrome | Sectra UniView/Chrome | Dell UP3017 | |
| FullFocus/Edge | Sectra UniView/Edge | Dell U3023E | |||
| SVS | FullFocus/Chrome | Aperio WebViewer | |||
| DX/Chrome | Dell U3223QE | ||||
| FullFocus/Edge | Aperio WebViewer | ||||
| DX/Edge | JVC-Kenwood | ||||
| JD-C240BN01A | |||||
| Hamamatsu | |||||
| NanoZoomer | |||||
| S360MD | |||||
| Slide scanner | NDPI | FullFocus/Chrome | NZViewMD | ||
| FullFocus/Edge | NZViewMD | ||||
| A total of 30 formalin-fixed paraffin-embedded (FFPE) tissue glass slides, representing a |
10
| range of human anatomical sites, were scanned at 40x magnification using both slide scanner systems. The slides scanned with the Leica Aperio GT450 DX scanner were saved in both DICOM and SVS formats, while the slides scanned with the Hamamatsu NanoZoomer S360MD Slide Scanner were saved in NDPI format. For each WSI, three regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist. Screenshots of these ROIs were captured at two magnification levels (10x and 40x) across multiple displays and browsers as specified in the above table. The testing process ensured comprehensive evaluation across display variations, with all image pairs registered and cropped for analysis. Every pixel of each screenshot was sampled to calculate the pixel-wise color difference using the CIEDE2000 ( $\Delta$ E00) metric. The acceptance criterion for this testing required that the 95th percentile of the pixel-wise color differences in any image pair across all required screenshots be less than 3.0 $\Delta$ E00. Test results showed that the 95th percentile of pixelwise differences between FullFocus and the comparators were less than 3 CIEDE2000, indicating that their output images can be considered to be pixel-wise identical. Therefore, FullFocus has been found to visually adequately reproduce digital pathology images to human readers with respect to its intended use. | ||||
|---|---|---|---|---|
| Turnaround | ||||
| time | The system requirements have been fulfilled: | |||
| • When selecting a case, it should not take longer than 10 seconds until the image is fully loaded. | ||||
| • When panning and zooming the image it shall not take longer than 7 seconds until the image is fully loaded. | ||||
| Measurements | Measurement accuracy has been verified using a test image containing objects with known sizes. FullFocus has been found to perform accurate measurements with respect to its intended use. See the overview of the test results below. | |||
| Description | Sample size | Acceptance Criteria | Results | |
| Straight Line | ||||
| Measurement in | ||||
| Chrome and Edge | ||||
| browsers | 1 Calibration Slide | The 1 mm measured line | ||
| should match the reference | ||||
| value exactly 1 mm ± 0mm | All measurements compared | |||
| to the reference were exactly | ||||
| 1 mm, with no error. | ||||
| Area Measurement | ||||
| in Chrome and | ||||
| Edge browsers | 1 Calibration Slide | The measured area must | ||
| match the reference area | ||||
| exactly 0.2 x 0.2 mm for a | ||||
| total of 0.04 mm2 ± 0 mm2 | All area measurements | |||
| compared to the reference | ||||
| value were exactly 0.04mm2, | ||||
| with no error. | ||||
| Scalebar | ||||
| Measurement in | ||||
| Chrome and Edge | ||||
| browsers | 1 Calibration Slide | 2mm scalebar is accurate | All Tests Passed | |
| Human | ||||
| Factors | ||||
| Testing | Human factors study designed around critical user tasks and use scenarios performed by representative users were conducted for previously cleared FullFocus, version 1.2.1, in K201005, per FDA guidance “Applying Human Factors and Usability Engineering to Medical Devices (2016)". Human factors validation testing is not necessary as the user |
Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision of FullFocus to the predicate devices.