(238 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML - Not Found" and describes the device as solely for viewing, interpreting, and managing digital images without any indication of AI functionalities for analysis or diagnosis.
No
The device is described as a software-only tool for viewing and managing digital images of pathology slides, intended to aid pathologists in diagnosis. It does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" section states, "AISight Dx is an aid to the pathologist to review, interpret, and manage digital images of these slides for primary diagnosis." The "Device Description" also mentions it "aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis." These statements clearly indicate its role in the diagnostic process.
Yes
The 510(k) summary explicitly states multiple times that AISight Dx is a "software only device" and a "web-based, software-only device." Its intended use and device description focus solely on the viewing, interpretation, and management of digital images, with performance studies verifying image reproduction, clinical non-inferiority to glass slides, turnaround time, measurement accuracy, and human factors, all consistent with a software-centric medical device. The hardware components mentioned (scanners, displays, web browsers) are external, interoperable devices, not part of the core AISight Dx device itself.
Yes
The device is described as aiding pathologists in viewing, interpreting, and managing digital images of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue for primary diagnosis. This involves analyzing biological specimens (tissue slides) to provide diagnostic information, which falls under the definition of an In Vitro Diagnostic (IVD) device. The clinical studies compare its performance to traditional microscopy for diagnostic purposes, further supporting its IVD nature.
Yes
The clearance letter explicitly states: "This submission provided a PCCP that PathAI will follow to validate compatibility of additional FDA-cleared displays, additional FDA-cleared scanners and file formats and additional web browsers." It further clarifies that "With inclusion of the PCCP, future changes to add additional FDA-cleared pathology displays, additional FDA-cleared whole slide imaging scanners and file formats, and additional browsers to the labeling can be made in accordance with the PCCP without a premarket submission."
Intended Use / Indications for Use
For In Vitro Diagnostic Use
AISight Dx is a software only device 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 these slides for primary diagnosis. AISight Dx 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. AISight DX is intended to be used with interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices.
Product codes
QKQ
Device Description
AISight Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation, and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner or Leica Aperio GT 450 DX scanner (Table 1). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Whole slide images (WSI) of scanned surgical pathology slides. Scanners include Hamamatsu NanoZoomer S360MD Slide scanner and Leica Aperio GT 450 DX scanner.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathology professionals in a laboratory setting. A qualified pathologist makes the diagnosis.
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
Pixel-wise Comparison Testing: A pixel-wise comparison test was performed to compare images which were reproduced by AISight Dx for the same image that has been generated by the Leica Aperio GT 450 DX as SVS and DICOM files to validate identical image reproduction. Test results showed that the maximum pixelwise difference between the file formats when displayed in AISight Dx was 0 CIEDE2000, indicating that the output images are pixelwise identical.
Clinical Study: Two separate clinical studies were conducted to support the performance of the AlSight Dx system for reading WSIs compared to the reference method (glass slides read using a traditional light microscope) for the pathology primary diagnosis indication when WSIs are created by Hamamatsu NanoZoomer S360MD (Hamamatsu scanner) or Leica Aperio GT 450 DX scanner (Leica scanner). The clinical studies were conducted to demonstrate that viewing, reviewing, and diagnosing WSIs of H&E stained FFPE tissue slides using AISight Dx [manual digital read (MD)] is non-inferior to glass slide reads using optical (light) microscopy [manual optical (MO)]. The primary endpoint of the study was the difference in major discordance rates between MD and MO when compared to the reference (main) diagnosis, which was the original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution. The differences in major discordance rates between MD and GT compared to MO and GT for the Hamamatsu NanoZoomer S360MD Slide scanner were –1.18% (95% CI, -3.49, 1.16) for all cases across the 3 reading pathologists. The differences in major discordance rates between MD and GT compared to MO and GT for the Leica Aperio GT 450 DX were –0.26% (95% CI, -2.71, 2.52) for all cases across the 3 reading pathologists. The upper limit of the CI for the difference in the major discordance rate was 1.16% for the Hamamatsu NanoZoomer S360MD and 2.52% for the Leica Aperio GT 450 DX, which are less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study.
Turnaround Time Testing: Turnaround times for image processing, image loading, panning, and zooming were tested using Google Chrome and Microsoft Edge using WSIs over a range of sizes. Test results showed these to be adequate for the intended use of the subject device.
Measurements of Area and Distance: Measurement accuracy has been verified by comparing the measurements of markings made in the AISight Dx viewer to the measurements of markings on a NIST calibrated cross scale slide with known sizes. The tests were used to validate the measurement accuracy of the subject device. Tests verified that the distance and area measurements made in the AISight Dx viewer accurately reflected the distance and area of the markings on an image of the calibrated slide. These results show that AISight Dx performed accurate measurements with respect to its intended use.
Human Factors Validation Study: AISight Dx has been found to be safe and effective for the intended users, uses, and use environments.
Key Metrics
Major discordance rates between MD and GT compared to MO and GT for the Hamamatsu NanoZoomer S360MD Slide scanner were –1.18% (95% CI, -3.49, 1.16).
Major discordance rates between MD and GT compared to MO and GT for the Leica Aperio GT 450 DX were –0.26% (95% CI, -2.71, 2.52).
Noninferiority threshold: 4%.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
This submission provided a PCCP that PathAI will follow to validate compatibility of additional FDA-cleared displays, additional FDA-cleared scanners and file formats and additional web browsers. The PCCP specifies the testing methods, validation activities, and performance requirements to implement those modifications such that the device remains as safe and as effective as the predicate device. With inclusion of the PCCP, future changes to add additional FDA-cleared pathology displays, additional FDA-cleared whole slide imaging scanners and file formats, and additional browsers to the labeling can be made in accordance with the PCCP without a premarket submission. The PathAI website will provide information on additional FDA-cleared WSI components (mentioned above) that are compatible with the AISight Dx and allow users to request updated versions of the system labeling.
§ 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.
FDA 510(k) Clearance Letter - AISight Dx
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
PathAI, Inc.
Carrene Plummer
Head of Regulatory Affairs
1325 Boylston Avenue
Suite 10000
Boston, MA 02215
June 26, 2025
Re: K243391
Trade/Device Name: AISight Dx
Regulation Number: 21 CFR 864.3700
Regulation Name: Whole slide imaging system
Regulatory Class: Class II
Product Code: QKQ
Dated: October 31, 2024
Received: November 1, 2024
Dear Carrene Plummer:
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.
Page 2
2K243391 - Hisani Madison
FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.
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).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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
Page 3
3K243391 - Hisani Madison
requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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,
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K243391
Device Name
AISight Dx
Indications for Use (Describe)
For In Vitro Diagnostic Use
AISight Dx is a software only device 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 these slides for primary diagnosis. AISight Dx 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. AISight DX is intended to be used with interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary - AISight Dx
DATE PREPARED: June 25, 2025
SUBMITTER/510(k) HOLDER
PathAI, Inc.
1325 Boylston Avenue
Boston, MA 02215
Primary Contact Person:
Carrene Plummer
Head of Regulatory
Telephone (520) 405-1462
DEVICE
Proprietary Name: AISight Dx
Viewer Version: V 2.9
Classification Name: Whole Slide Imaging System
Regulation Number: 21 CFR 864.3700
Product Code: QKQ
Regulatory Classification: Class II
Review Panel: 88 - Pathology
Common Name: Digital Pathology Image Viewing and Management Software
Submission Number: K243391
PREDICATE DEVICES
Proprietary Name: NanoZoomer S360MD Slide scanner system
Submission Number: K233027
Proprietary Name: Aperio GT 450 DX
Submission Number: K232202
INDICATIONS FOR USE
For In Vitro Diagnostic Use
AISight Dx is a software only device 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 these slides for primary diagnosis. AISight Dx 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. AISight DX is intended to be used with
Page 6
interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices.
DEVICE DESCRIPTION
AISight Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation, and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner or Leica Aperio GT 450 DX scanner (Table 1). It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.
Table 1: Interoperable devices of AISight Dx
| Scanner | Scanner Output File format | Viewing Software | Display |
|---|---|---|---|
| Leica Aperio GT 450 DX | SVS, DICOM | AISight Dx | Barco MDPC8127, Dell UP3017, Dell U3023E, Dell U3223QE |
| Hamamatsu S360MD Slide scanner | NDPI | AISight Dx | JVC Kenwood JD-C24BN01A |
AISight Dx is operated as follows:
-
A lab technician prepares and scans slides onto the WSI scanner. Once the image is acquired, the technician reviews slide quality in accordance with the WSI scanner's quality control process and standard lab procedures.
-
The AISight Dx workflow is initiated when the WSI from the scanner is ingested into the AISight Dx image management system via one of the supported ingestion methods: manual upload, bulk ingestion, or LIS ingestion.
-
The reading pathologist selects a case from the dashboard or case management page. The accession then opens in the slide viewer page for assessment.
-
The reading pathologist uses AISight Dx to view and interpret the images including, but not limited to, the following features:
- Zoom and pan the image
- Measure distances and areas in the image
- Annotate the image
- View multiple images side by side
-
The above steps are repeated as needed for all WSIs that apply to the case.
-
After viewing all images for the case, the pathologist will make a diagnosis. The diagnosis will be entered by the pathologist and transferred to the laboratory's reporting system, e.g., a Laboratory Information System (LIS).
-
After case diagnosis is completed by the pathologist, the case workflow is terminated by clicking "Finalize" in AISight Dx.
Page 7
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 acceptable quality for diagnostic purposes per their laboratory standards. Additional details of the quality control procedures are provided in the device's user manual.
The device interoperable components and computer environment/system requirements are provided in the tables below.
Table 1: WSI scanner
| Manufacturer | Model |
|---|---|
| Hamamatsu | NanoZoomer S360MD Slide scanner |
| Leica | Aperio GT 450 DX |
Table 2: WSI display
| Manufacturer | Model |
|---|---|
| JVC Kenwood | JD-C240BN01A |
| BARCO | MDPC-8127 |
| Dell | UP3017 |
| Dell | U3023E |
| Dell | U3223QE |
Table 3: Computer environment/System Requirements
| Workstation Component | Specifications |
|---|---|
| Memory | 4 GB RAM, Capable of supporting at least one of the supported web browsers. |
| Network connectivity | Internet access, Outbound traffic enabled on port 443, 25 Mbps download and upload speed |
| Supported browsers | Google Chrome version 111.0 or later, Microsoft Edge version 111.0 or later |
Page 8
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICES
The subject device AISight Dx, is similar to the predicate, in terms of indications for use, intended use and technological characteristics as its predicate devices. The similarities and differences between the AISight Dx and the predicate devices, NanoZoomer S360MD Slide scanner system and Aperio GT 450 DX are summarized in Table 4 below.
| Specification | Predicate Device (K233027) | Predicate Device (K232202) | Subject Device (K243391) |
|---|---|---|---|
| Device Trade Name | NanoZoomer S360MD Slide scanner system | Aperio GT 450 DX | AISight Dx |
| Product Code | PSY | PSY | QKQ |
| Regulation | 21 CFR 864.3700 | 21 CFR 864.3700 | 21 CFR 864.3700 |
| Regulation Name | Whole Slide Imaging System | Whole Slide Imaging System | Whole Slide Imaging System (Digital pathology image viewing and management software) |
| Classification | II | II | II |
General Device Characteristics - Similarities
Indications for Use:
Predicate Device (K233027): 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
Predicate Device (K232202): 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 GT 450 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 1: Interoperable components of Aperio GT 450 DX
Subject Device (K243391): AISight Dx is a software only device 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 these slides for primary diagnosis. AISight Dx 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. AISight DX is intended to be used
Page 9
| Specification | Predicate Device (K233027) | Predicate Device (K232202) | Subject Device (K243391) |
|---|---|---|---|
| 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 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. | with interoperable displays, scanners and file formats, and web browsers that have been 510(k) cleared for use with the AISight Dx or 510(k)-cleared displays, 510(k)-cleared scanners and file formats, and web browsers that have been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying interoperable devices. |
| Scanner Hardware | Scanner Output file format | Interoperable Viewing Software | Interoperable Displays |
|---|---|---|---|
| Aperio GT 450 DX scanner | SVS | Aperio WebViewer DX | Barco MDPC8127, Dell UP3017, Dell U3023E, Dell U3223QE |
| 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 |
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. 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 Aperio GT 450 DX.
| Scanner | Hamamatsu NanoZoomer S360MD Slide scanner | Aperio Leica GT 450 DX | Hamamatsu NanoZoomer S360MD Slide scanner, Aperio Leica GT 450 DX, or FDA-cleared scanning hardware validated per the PCCP to ensure performance requirements are met prior to modifications being implemented. |
|---|---|---|---|
| Compatible Display | JVC Kenwood JDC24BN01A, BARCO MDPC-8127, or FDA-cleared display validated per the PCCP to ensure performance requirements are met prior to | BARCO MDPC-8127, Dell UP3017, Dell U3023E, Dell U3223QE | JVC Kenwood JD-C24BN01A, BARCO MDPC-8127, Dell UP3017, Dell U3023E, Dell U3223QE, or FDA-cleared display validated per the PCCP to ensure performance requirements are met prior to |
Page 10
| Specification | Predicate Device (K233027) | Predicate Device (K232202) | Subject Device (K243391) |
|---|---|---|---|
| modifications being implemented. | modifications being implemented. | ||
| Specimen Type | Surgical pathology slides prepared from FFPE tissue | Surgical pathology slides prepared from FFPE tissue | Surgical pathology slides prepared from FFPE tissue |
| Image File Format | NDPI | SVS, DICOM | NDPI, SVS, DICOM |
| Image Viewing and Measurement Functions | Panning, zooming, image adjustments, annotations, and distance/area measurements | Panning, zooming, gamma function, annotations, and measurements (distance) | Panning, zooming, image adjustments, annotations, and distance/area measurements |
General Device Characteristics – Differences
| Type of Software Application | Windows based | Internet browser based | Internet browser based |
|---|---|---|---|
| Device Components | Scanner, Image Management Software and Display | Scanner, Image Management Software and Display | Image Management Software |
| Principle of Operation | After WSI are acquired by using NanoZoomer S360MD Slide scanner, the WSI are automatically saved to the hard disk during scanning and may be viewed later by using the included viewing software. During review, the pathologist opens WSI from the image storage attached to local network, performs further QC and reads WSI of the slides to make a diagnosis. | 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 the tissues, and scans the slides. The scanner also automatically 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. | After the WSIs are acquired using the NanoZoomer S360MD Slide scanner or Aperio GT450 DX, the WSIs are stored in customer provided image storage. Images are then ingested into AISight Dx image storage. During image review, the pathologist opens the WSI from AISight Dx image storage; performs further QC and then reads the WSI to make a diagnosis. |
| User Interface | NZViewMD | Aperio WebViewer DX | AISight Dx |
Page 11
PREDETERMINED CHANGE CONTROL PLAN (PCCP)
This submission provided a PCCP that PathAI will follow to validate compatibility of additional FDA-cleared displays, additional FDA-cleared scanners and file formats and additional web browsers. The PCCP specifies the testing methods, validation activities, and performance requirements to implement those modifications such that the device remains as safe and as effective as the predicate device. With inclusion of the PCCP, future changes to add additional FDA-cleared pathology displays, additional FDA-cleared whole slide imaging scanners and file formats, and additional browsers to the labeling can be made in accordance with the PCCP without a premarket submission. The PathAI website will provide information on additional FDA-cleared WSI components (mentioned above) that are compatible with the AISight Dx and allow users to request updated versions of the system labeling.
PERFORMANCE DATA
| Performance data | Description |
|---|---|
| Pixel-wise Comparison Testing | A pixel-wise comparison test was performed to compare images which were reproduced by AISight Dx for the same image that has been generated by the Leica Aperio GT 450 DX as SVS and DICOM files to validate identical image reproduction. Test results showed that the maximum pixelwise difference between the file formats when displayed in AISight Dx was 0 CIEDE2000, indicating that the output images are pixelwise identical. |
| Clinical Study | Two separate clinical studies were conducted to support the performance of the AlSight Dx system for reading WSIs compared to the reference method (glass slides read using a traditional light microscope) for the pathology primary diagnosis indication when WSIs are created by Hamamatsu NanoZoomer S360MD (Hamamatsu scanner) or Leica Aperio GT 450 DX scanner (Leica scanner). The clinical studies were conducted to demonstrate that viewing, reviewing, and diagnosing WSIs of H&E stained FFPE tissue slides using AISight Dx [manual digital read (MD)] is non-inferior to glass slide reads using optical (light) microscopy [manual optical (MO)]. The primary endpoint of the study was the difference in major discordance rates between MD and MO when compared to the reference (main) diagnosis, which was the original sign-out pathologic diagnosis using MO [ground truth, (GT)] rendered at the institution. The differences in major discordance rates between MD and GT compared to MO and GT for the Hamamatsu NanoZoomer S360MD Slide scanner were –1.18% (95% CI, -3.49, 1.16) for all cases across the 3 reading pathologists. The differences in major discordance rates between MD and GT compared to MO and GT for the Leica Aperio GT 450 |
Page 12
| Performance data | Description |
|---|---|
| DX were –0.26% (95% CI, -2.71, 2.52) for all cases across the 3 reading pathologists. The upper limit of the CI for the difference in the major discordance rate was 1.16% for the Hamamatsu NanoZoomer S360MD and 2.52% for the Leica Aperio GT 450 DX, which are less than the prespecified noninferiority threshold of 4%, therefore meeting the primary objective of the study. | |
| Turnaround Time Testing | Turnaround times for image processing, image loading, panning, and zooming were tested using Google Chrome and Microsoft Edge using WSIs over a range of sizes. Test results showed these to be adequate for the intended use of the subject device. |
| Measurements of Area and Distance | Measurement accuracy has been verified by comparing the measurements of markings made in the AISight Dx viewer to the measurements of markings on a NIST calibrated cross scale slide with known sizes. The tests were used to validate the measurement accuracy of the subject device. Tests verified that the distance and area measurements made in the AISight Dx viewer accurately reflected the distance and area of the markings on an image of the calibrated slide. These results show that AISight Dx performed accurate measurements with respect to its intended use. |
| Human Factors Validation Study | AISight Dx has been found to be safe and effective for the intended users, uses, and use environments. |
CONCLUSION
Based on the information provided in the 510(k), the subject device AISight Dx is substantially equivalent to the previously cleared predicate device, when used with the Hamamatsu NanoZoomer S360MD Slide scanner or Leica Aperio GT 450 DX and JVC Kenwood JDC24BN01A, BARCO MDPC-8127, Dell UP3017, Dell U3023E, and Dell U3223QE monitors. Clinical studies were conducted to establish the Substantial Equivalence of the device.