(266 days)
No
The summary describes a whole slide imaging system for creating and viewing digital pathology slides. While it mentions image processing and quality checks, there is no mention of AI, ML, or any algorithms that perform automated analysis or interpretation of the images beyond basic viewing and annotation tools. The intended use explicitly states it is an "aid to the pathologist to review and interpret digital images," implying human interpretation is the primary method of diagnosis.
No
The device is an automated digital slide viewing system intended for diagnostic use as an aid to pathologists for review and interpretation of digital images, not for therapeutic purposes.
Yes
The device is described as "intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides." This directly states its role in the diagnostic process.
No
The device description explicitly states that the Aperio GT 450 DX is comprised of both an image acquisition subsystem (the Aperio GT 450 DX scanner, which is hardware) and an image viewing subsystem (Aperio WebViewer DX software). It is a Whole Slide Imaging (WSI) system, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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." This is the most direct indicator.
- Purpose: The device is used to create and view digital images of tissue slides, which are then used by pathologists for diagnosis. This process falls under the definition of in vitro diagnostics, as it involves examining biological specimens (tissue) outside of the body to obtain information for diagnostic purposes.
- Clinical Studies: The document describes clinical studies (accuracy and precision) conducted to evaluate the performance of the device for diagnostic purposes. This is a requirement for IVD devices to demonstrate their clinical validity.
- Predicate Device: The mention of a predicate device (K190332; Aperio AT2 DX System) which is also a digital pathology system, further supports its classification as an IVD, as predicate devices are typically used to demonstrate substantial equivalence for regulatory purposes for similar types of medical devices, including IVDs.
N/A
Intended Use / Indications for Use
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 GT450 DX is intended to be used with the interoperable components specified in Table 1.
| Scanner Hardware | Scanner Output file format | Interoperable Viewing Software | Interoperable Displays |
|---|---|---|---|
| Aperio GT 450 DX scanner | SVS | Aperio WebViewer DX | Barco MDPC-8127 |
| 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 |
Table 1: Interoperable components of Aperio GT 450 DX
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.
Product codes
PSY
Device Description
The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system, including image acquisition and image viewing components.
Aperio GT 450 DX is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
Image Acquisition Subsystem
The image acquisition subsystem of the Aperio GT 450 DX captures the information from surgical pathology glass slides prepared from FFPE tissue and saves it as a high-resolution digital image file. This subsystem is comprised of the Aperio GT 450 DX scanner and corresponding scanner configuration software, Aperio GT 450 Scanner Administration Manager DX (SAM DX).
The Aperio GT 450 DX scanner is a semi-automated benchtop brightfield WSI scanner that can achieve a scan speed of 32 seconds at the 40x scanning magnification for a 15 mm x 15 mm area. The scanner supports continuous glass-slide loading (Up to 15 racks with a total of 450-slide capacity), priority rack scanning, and automated image quality checks during image acquisition. The Aperio GT 450 DX scanner can be used with Leica Biosystems Imaging, Inc .--manufactured slide racks (Product No. 23RACKGT450) and other supported slide racks (e.g., Prisma® 20-slide basket from Sakura Finetek USA, Inc). The Aperio GT 450 DX scanner detects the racks once loaded in the scanner and scans the slides automatically. Users operate the scanner via a touchscreen interface.
The Aperio GT 450 DX scanner can save digital images in a unique Aperio ScanScope Virtual Slide (SVS) image format or Digital Imaging and Communications in Medicine (DICOM) image format. The digital images are sent to end-user-provided image storage attached to the scanner's local network, where they can be cataloged in image storage software (non-medical device, external to the WSI), including Image Management System (IMS), such as Aperio eSlide Manager, or a Picture Archiving and Communication System (PACS), such as Sectra PACS software.
Aperio GT 450 SAM DX is centralized scanner management software external to the connected scanner(s). This software application enables IT implementation, including configuration, monitoring, and service access of multiple scanners from a single desktop client location. Aperio GT 450 SAM DX is installed on a customer-provided server that resides on the same network as the scanner(s) for image management.
Image Viewing Subsystem
The image viewing subsystem of the WSI device displays the digital images to the human reader. This subsystem comprises Aperio WebViewer DX image viewing software, a workstation PC, and monitor(s). Both the workstation and display are procured by the customer from commercial distributors and qualified for in vitro diagnostic use by Leica Biosystems Imaging, Inc. The Aperio WebViewer DX software is a web-based image viewer that enables users to perform Quality Control of images and to review and annotate digital images for routine diagnosis. The Aperio WebViewer DX also incorporates monitor display image validation checks, which provide the user with the ability to ensure the digital slide images are displayed as intended on their monitor, and that browser updates have not inadvertently affected the image display quality. Aperio WebViewer DX is installed on a server and accessed from an IMS (e.g., Aperio eSlide Manager) or a customer's Laboratory Information System (LIS) using compatible browsers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Brightfield
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained pathologists and clinical pathology histotechnicians
Clinical 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)
Two clinical studies were conducted with the Aperio GT 450 DX: Clinical accuracy and precision.
-
Clinical accuracy study:
Clinical accuracy was evaluated by analyzing the concordance (concordant, minor discrepancy, major discrepancy) of the diagnoses made using the Aperio GT 450 DX (referred to as whole slide image review [WSIR] diagnosis) with the reference diagnoses (original sign-out pathologic diagnosis), and the concordance of traditional light microscope slide review (MSR) diagnoses with the reference diagnoses. Accuracy was assessed by analyzing the major discrepancy rates for WSIR and MSR diagnoses versus the reference diagnoses and calculating the difference in major discrepancy rates between the two modalities. A major discrepancy was defined as a difference in diagnoses that resulted in a clinically important difference in patient management.
The acceptance criteria were met for all endpoints for the clinical accuracy study. These results indicate that diagnoses made using the Aperio GT 450 DX, using both local and remote accessed image data, are accurate and comparable to diagnoses made using a light microscope. -
Precision Study:
The precision of the Aperio GT 450 DX was assessed in 3 substudies:
- Intra-system precision: assessed precision within each of the three independent systems and overall within-system.
- Inter-system/site precision: assessed precision between systems/sites (3 independent systems at three different sites) and overall between systems/sites.
- Intra- and inter-pathologist precision: assessed precision within and between pathologists (using images generated from a single system), overall within pathologists, and overall between pathologists.
The precision was considered acceptable if the lower bounds of the 2-sided 95% CI of the overall agreements for each precision component (intra-system/site, intra-pathologist, and inter-pathologist) were ≥ 85%.
All endpoints were met for the precision study based on the acceptance criteria. These results indicate that the Aperio GT 450 DX has an acceptable level of precision and validates the intended use.
The clinical study results demonstrate that Aperio GT 450 DX is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Accuracy Study - Major Discrepancy Rates:
Full Cohort (WSIRD): Model Major Discrepancy Rate 5.84% (95% CI: 5.01%, 6.80%)
Full Cohort (MSRD): Model Major Discrepancy Rate 3.44% (95% CI: 2.84%, 4.17%)
Difference in Major Discrepancy Rates (WSIRD minus MSRD) for Full Cohort: 2.40% (95% CI: 1.40%, 3.39%)
Local Cohort (WSIRD): Model Major Discrepancy Rate 6.13% (95% CI: 4.99%, 7.51%)
Local Cohort (MSRD): Model Major Discrepancy Rate 3.52% (95% CI: 2.71%, 4.57%)
Difference in Major Discrepancy Rates (WSIRD minus MSRD) for Local Cohort: 2.61% (95% CI: 1.23%, 3.99%)
Remote Cohort (WSIRD): Model Major Discrepancy Rate 5.51% (95% CI: 4.40%, 6.88%)
Remote Cohort (MSRD): Model Major Discrepancy Rate 3.34% (95% CI: 2.52%, 4.40%)
Difference in Major Discrepancy Rates (WSIRD minus MSRD) for Remote Cohort: 2.17% (95% CI: 0.78%, 3.57%)
Precision Study - Agreement Rates:
Intra-System Precision (Overall): 97.1% (95% CI: 95.8%, 98.3%)
Inter-System/Site Precision (Overall): 96.3% (95% CI: 94.9%, 97.6%)
Intra-Pathologist Precision (Overall): 93.5% (95% CI: 92.4%, 94.5%)
Inter-Pathologist Precision (Overall): 91.7% (95% CI: 90.6%, 92.8%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
0
April 16, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Leica Biosystems Imaging, Inc. April Komplin Regulatory Affairs Manager 1360 Park Center Drive Vista. California 92081
Re: K232202
Trade/Device Name: Aperio GT 450 DX Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: PSY Dated: July 25, 2023 Received: July 25, 2023
Dear April Komplin:
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 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 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 (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.
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).
Sincerely.
Shyam Kalavar -S
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology 2 OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232202
Device Name Aperio GT 450 DX
Indications for Use (Describe)
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 GT450 DX is intended to be used with the interoperable components specified in Table 1.
| Scanner Hardware | Scanner Output file format | Interoperable Viewing Software | Interoperable Displays |
|---|---|---|---|
| Aperio GT 450 DX scanner | SVS | Aperio WebViewer DX | Barco MDPC-8127 |
| 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 |
Table 1: Interoperable components of Aperio GT 450 DX
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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary Aperio GT 450 DX, Leica Biosystems Imaging, Inc.
Date Prepared: April 16, 2024
Submitter
Leica Biosystems Imaging, Inc 1360 Park Center Dr. Vista, CA 92081
Contact Person
April Komplin, MS Regulatory Affairs Manager Leica Biosystems Imaging, Inc. 1360 Park Center Drive| Vista, CA 92081 Phone: +1.760.520.5056 Email: april.komplin@leicabiosystems.com
Secondary Contact
Daisy Ni Staff Regulatory Affairs Specialist Leica Biosystems Imaging, Inc. 1360 Park Center Drive| Vista, CA 92081 Phone: +1. 949.685.0047 Email: daisy.ni@leicabiosystems.com
Device Information
Subject Device
| Proprietary Name: | Aperio GT 450 DX |
|---|---|
| Common Name: | Aperio GT 450 DX |
| Classification Name: | Whole Slide Imaging System |
| Regulation Section: | 21 CFR 864.3700 |
| Regulatory | Classification: Class II |
| Product Code: | PSY |
| Review Panel: | 88 – Pathology |
| 510(k) Number: | K232202 |
5
Predicate Device
| Proprietary Name: | Aperio AT2 DX System | ||
|---|---|---|---|
| Submission Number: | K190332 |
I. Intended Use
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 GT450 DX is intended to be used with the interoperable components specified in Table 1.
| Scanner Hardware | Scanner
Output file format | Interoperable Viewing Software | Interoperable Displays |
|--------------------------|-------------------------------|---------------------------------------|---------------------------------------------------------------|
| Aperio GT 450 DX scanner | SVS | Aperio WebViewer DX | Barco MDPC-8127
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 |
Table 1: Interoperable components of Aperio GT 450 DX
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.
6
Device Description II.
The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system, including image acquisition and image viewing components.
Aperio GT 450 DX is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
Image Acquisition Subsystem 1)
The image acquisition subsystem of the Aperio GT 450 DX captures the information from surgical pathology glass slides prepared from FFPE tissue and saves it as a high-resolution digital image file. This subsystem is comprised of the Aperio GT 450 DX scanner and corresponding scanner configuration software, Aperio GT 450 Scanner Administration Manager DX (SAM DX).
The Aperio GT 450 DX scanner is a semi-automated benchtop brightfield WSI scanner that can achieve a scan speed of 32 seconds at the 40x scanning magnification for a 15 mm x 15 mm area. The scanner supports continuous glass-slide loading (Up to 15 racks with a total of 450-slide capacity), priority rack scanning, and automated image quality checks during image acquisition. The Aperio GT 450 DX scanner can be used with Leica Biosystems Imaging, Inc .--manufactured slide racks (Product No. 23RACKGT450) and other supported slide racks (e.g., Prisma® 20-slide basket from Sakura Finetek USA, Inc). The Aperio GT 450 DX scanner detects the racks once loaded in the scanner and scans the slides automatically. Users operate the scanner via a touchscreen interface.
The Aperio GT 450 DX scanner can save digital images in a unique Aperio ScanScope Virtual Slide (SVS) image format or Digital Imaging and Communications in Medicine (DICOM) image format. The digital images are sent to end-user-provided image storage attached to the scanner's local network, where they can be cataloged in image storage software (non-medical device, external to the WSI), including Image Management System (IMS), such as Aperio eSlide Manager, or a Picture Archiving and Communication System (PACS), such as Sectra PACS software.
Aperio GT 450 SAM DX is centralized scanner management software external to the connected scanner(s). This software application enables IT implementation, including configuration, monitoring, and service access of multiple scanners from a single desktop client location. Aperio GT 450 SAM DX is installed on a customer-provided server that resides on the same network as the scanner(s) for image management.
Image Viewing Subsystem 2)
The image viewing subsystem of the WSI device displays the digital images to the human This subsystem comprises Aperio WebViewer DX image viewing software, a reader. workstation PC, and monitor(s). Both the workstation and display are procured by the customer
7
from commercial distributors and qualified for in vitro diagnostic use by Leica Biosystems Imaging, Inc. The Aperio WebViewer DX software is a web-based image viewer that enables users to perform Quality Control of images and to review and annotate digital images for routine diagnosis. The Aperio WebViewer DX also incorporates monitor display image validation checks, which provide the user with the ability to ensure the digital slide images are displayed as intended on their monitor, and that browser updates have not inadvertently affected the image display quality. Aperio WebViewer DX is installed on a server and accessed from an IMS (e.g., Aperio eSlide Manager) or a customer's Laboratory Information System (LIS) using compatible browsers.
| Item | Subject Device | Predicate Device |
|---|---|---|
| Product Name | Aperio GT 450 DX | Aperio AT2 DX System |
| 510(k) No. | K232202 | K190332 |
| Manufacturer | Leica Biosystems Imaging, Inc. | Leica Biosystems Imaging, |
| Inc. | ||
| Intended Use | 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 | The Aperio AT2 DX
System is an automated
digital slide creation and
viewing system. The
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 Aperio
AT2 DX System is not
intended for use with
frozen section, cytology, or
non-FFPE
hematopathology
specimens.
The Aperio AT2 DX
System is composed of the
Aperio AT2 DX scanner,
the ImageScope DX review
application and Display.
The Aperio AT2 DX
System is for creation and
viewing of digital images |
Comparison of technological characteristics with the predicate device III.
8
| | Aperio GT 450 DX scanner | SVS | Aperio WebViewer DX | Barco MDPC-8127
Dell UP3017
Dell U3023E
Dell U3223QE | 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 Aperio AT2 DX System |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|---------------------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. | | | | | |
| Classification Regulation | 21 CFR 864.3700 | | | | 21 CFR 864.3700 |
| Product Code | PSY - Whole Slide Imaging System | | | | PSY - Whole Slide Imaging System |
| Classification Panel | (88) Pathology | | | | (88) Pathology |
| Intended Users | Trained pathologists and clinical pathology histotechnicians | | | | Trained pathologists and clinical pathology histotechnicians |
| Principle of Operation | 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. | | | | The technician loads the slides into the WSI scanner. The scanner scans the slides and generates WSI image for each slide. The acquired WSI images are stored in an end user provided image storage attached to the local network. During 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. |
| Prescription Use | Prescription Use Only | | | | Prescription Use Only |
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| Use
| Environment | Clinical laboratory | Clinical laboratory |
|---|---|---|
| Specimen | ||
| Type | Formalin-Fixed Paraffin-Embedded (FFPE) Specimen | Formalin-Fixed Paraffin-Embedded (FFPE) Specimen |
| Tissue Finding | Automatic | Automatic, manual |
| Focusing | ||
| System | Automatic | Automatic, manual |
| Slide | ||
| Storage/loading | ||
| Capacity | 450 slides, 1x 3-inch slide | 400 slides, 1x 3-inch slide |
| Supported slide | ||
| size | 1 x 3 inch | 1 x 3 inch |
| Scanning | ||
| Resolution at | ||
| 40x | 0.26 µm/pixel | 0.25 µm/pixel |
| Scanning | ||
| Region | ≤ 23.6 mm x 58 mm for 1x 3 inch slide | ≤ 22.9 mm x 54.9 mm for |
| 1x 3-inch slide | ||
| Focusing | ||
| Resolution at | ||
| 40x | +/- 0.125 micron | +/- 0.125 micron |
| Focusing error | ||
| at 40x | +/- 0.5 micron | +/- 0.5 micron |
| Color | ||
| Reproducibility | Max ΔE |