It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.

Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Device Description

Sectra Digital Pathology Module is a software-only device running under the Microsoft Windows operating system for displaying and manipulating digital pathology images (scanned slides) obtained from the Aperio AT2 DX scanner.

Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000).

The Sectra Pathology Import Server (SPIS) is used for importing digital pathology images (scanned slides) from the scanner. These images are viewed and manipulated by end users in the Pathology Image Window which is displayed on the Sectra Workstation IDS7 (using the Dell MR2416 monitor).

AI/ML Overview

Here's an analysis of the acceptance criteria and the study conducted for the Sectra Digital Pathology Module, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Color Reproducibility	Pixel-wise comparison towards Aperio ImageScopeDX (predicate) across multiple tiles, including zooming and panning operations. Sectra Digital Pathology Module was found to reproduce colors adequately and was non-inferior to ImageScopeDX.
Turnaround Time (Case Load)	When selecting a case, it should not take longer than 7 seconds until the image is fully loaded, provided system requirements are fulfilled.
Turnaround Time (Panning)	When panning the image (one quarter of the monitor), it should not take longer than 0.5 seconds until the image is fully loaded, provided system requirements are fulfilled.
Measurements	Measurement accuracy has been verified using a test image containing objects with known sizes. The device was found to perform accurate measurements.
Human Factors	Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users. The device was found to be safe and effective for the intended users, uses, and use environments.

2. Sample Size for Test Set and Data Provenance:

The document does not explicitly state the sample size for any specific test set regarding color reproducibility, turnaround time, or measurements. It mentions a "test image containing objects with known sizes" for measurements, and "multiple tiles" for color reproducibility.

The data provenance is not specified (e.g., country of origin). The testing seems to be internal development and verification testing rather than involving external patient data.

3. Number of Experts for Ground Truth and Qualifications:

The document does not mention the use of experts to establish ground truth for the technical performance tests described (color reproducibility, turnaround time, measurements, human factors). These appear to be objective, quantifiable tests directly comparing the device's output to a known standard or the predicate device's output.

For "Human factors testing," it states "Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users." While suggesting involvement of intended users (pathologists likely), the number and specific qualifications of these users are not detailed.

4. Adjudication Method for Test Set:

No adjudication method is mentioned. The tests described are primarily objective comparisons or measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states: "Substantial equivalence determination is not based upon clinical study results."

6. Standalone (Algorithm Only) Performance Study:

Yes, standalone (algorithm only, meaning the software itself without human interaction for diagnostic purposes) performance was done. The studies listed under "Non-clinical test results" (Color Reproducibility, Turnaround times, Measurements) evaluate the technical performance of the software. The device itself is described as a "software-only device."

7. Type of Ground Truth Used:

Color Reproducibility: Ground truth was implicitly the visual output and pixel data of the predicate device (Aperio ImageScopeDX).
Turnaround Time: Ground truth was the pre-defined maximum acceptable time limits (7 seconds for case load, 0.5 seconds for panning).
Measurements: Ground truth was a "test image containing objects with known sizes."
Human Factors: Ground truth was established by assessing usability (intuitiveness, safety, effectiveness) through "task-based usability tests" likely with intended users.

8. Sample Size for the Training Set:

The document does not mention a training set. The Sectra Digital Pathology Module is described as a "software intended for viewing and management of digital images," rather than an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established:

Since no training set is mentioned for an AI/ML algorithm, this question is not applicable based on the provided text. The device is a viewer and management tool, not an AI diagnostic algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 31, 2020

Sectra AB % Peter Altman Quality Officer 14 Mercer Road Savannah, GA 31411-1433

Re: K193054/S001

Trade/Device Name: Sectra Digital Pathology Module Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: QKQ Dated: October 25, 2019 Received: November 1, 2019

Dear Peter Altman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Soma Ghosh, Ph.D. Chief Molecular Pathology and Cytology Branch Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K193054

Device Name Sectra Digital Pathology Module

Indications for Use (Describe)

For In Vitro Diagnostic Use

Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module.

Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

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)

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."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "SECTRA" in large, bold, gray letters. The letters are evenly spaced and fill most of the frame. The background is white, providing a strong contrast that makes the text stand out. The font appears to be sans-serif, giving the word a modern and clean look.

510(k) Summary

30 March 2020 Date Prepared:

Submitter's Information:

Sectra AB Teknikringen 20 SE-583 30 Linköping Sweden Establishment Registration Number: 9615992

Contact Persons:

Name:	Edoardo Mastrovito
Title:	Quality and Regulatory Affairs Mgr.
Telephone:	+46 13 235206
Facsimile:	n/a

Device Identification:

Proprietary/Trade Name:	Sectra Digital Pathology Module
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:	Digital Pathology Image Viewing and Management Software

Predicate Device Identification:

Proprietary/Trade Name:	Aperio AT2 DX System
510(k) Number:	K190332
Clearance Date:	May 20, 2019
Classification Name:	Whole Slide Imaging System
Regulation Number:	21 CFR 864.3700
Product Codes:	PSY
Device Class:	Class II
Review Panel:	88 – Pathology
Common Name:	Digital Pathology Image Management System

Sectra AB

Teknikringen 20, 583 30 Linköping, Sweden VAT: SE556064830401 Tel: +46 13 23 52 00 | Fax: +46 13 21 21 85 info@sectra.com | www.sectra.com

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "SECTRA" in large, bold, gray letters. The letters are sans-serif and appear to be a solid color. The word is centered and takes up most of the frame. The background is white.

Device Description:

Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000).

The subject device is typically operated as follows:

1. The subject device receives quality-controlled images from the scanner and extracts a copy of the images' metadata. The unaltered images are then sent to the external image storage. A copy of the image metadata (e.g. the pixel size) is stored locally in the subject device to increase the operational performance (e.g. response times) of the subject device.
1. The reading pathologist selects a case (patient) from a worklist external to the subject device whereby the subject device fetches the associated images from the external image storage.
1. The reading pathologist uses the subject device to view and interpret the images:
- The pathologist can adjust zoom and pan the image at will. a.
- b. The pathologist can adjust focus (when different focus depths are available).
- c. The pathologist can measure distances and areas in the image.
- d. The pathologist can annotate images.
- The pathologist can choose to view multiple images side by side in a synchronized e. fashion.
1. The above steps are repeated as required.

After viewing all images, the pathologist will make a diagnosis will be documented in another system, e.g. a Laboratory Information System (LIS).

Indications for Use/Intended Use:

For In Vitro Diagnostic Use

Sectra Digital Pathology Module device 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 and interpret these digital images for the purposes of primary diagnosis. Sectra Digital Pathology Module is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module. Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.

Sectra AI

+46 13 23 52 00 | Fax: +46 13 21 info@sectra.com | www.sectra.c

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "SECTRA" in large, bold, gray letters. The letters are evenly spaced and fill most of the frame. The font is sans-serif and appears to be a blocky, modern style. The background is plain white, providing a high contrast that makes the word stand out.

Summary of Technological Characteristics:

Item	Subject Device	Predicate
Indications for Use	For In Vitro Diagnostic UseSectra Digital PathologyModule device is a softwareintended for viewing andmanagement of digitalimages of scanned surgicalpathology slides preparedfrom formalin-fixed paraffinembedded (FFPE) tissue. Itis an aid to the pathologist toreview and interpret thesedigital images for thepurposes of primarydiagnosis. Sectra DigitalPathology Module is notintended for use with frozensection, cytology, or non-FFPE hematopathologyspecimens. It is theresponsibility of thepathologist to employappropriate procedures andsafeguards to assure thevalidity of the interpretationof images using SectraDigital Pathology Module.Sectra Digital PathologyModule is intended for usewith Leica's Aperio AT2DX scanner and DellMR2416 monitor.	The Aperio AT2 DX Systemis an automated digital slidecreation and viewing system.The Aperio AT2 DX Systemis intended for in vitrodiagnostic use as an aid to thepathologist to review andinterpret digital images ofsurgical pathology slidesprepared from formalin-fixedparaffin embedded (FFPE)tissue. The Aperio AT2 DXSystem is not intended foruse with frozen section,cytology, or non-FFPEhematopathology specimens.The Aperio AT2 DX Systemis composed of the AperioAT2 DX scanner, theImageScope DX reviewapplication and Display. TheAperio AT2 DX System isfor creation and viewing ofdigital images of scannedglass slides that wouldotherwise be appropriate formanual visualization byconventional lightmicroscopy. It is theresponsibility of a qualifiedpathologist to employappropriate procedures andsafeguards to assure thevalidity of the interpretationof images obtained using theAperio AT2 DX System.
Specimen type	Surgical pathology slidesprepared from FFPE tissue	Surgical pathology slidesprepared from FFPE tissue
Item	Subject Device	Predicate
Image Storage	Images are stored in an enduser provided image storageattached to the localnetwork.	Images are stored in an enduser provided image storageattached to the local network.
Image manipulationfunctions	Panning, zooming, gammafunction, annotations, andmeasurements (distance &area)	Panning, zooming, gammafunction, annotations, andmeasurements (distance &area)
Image review anddiagnosis	During review, thepathologist opens WSIimages acquired with theWSI scanner from the imagestorage, performs further QCand reads WSI images of theslides to make a diagnosis.	During review, thepathologist opens WSIimages acquired with theWSI scanner from the imagestorage, performs further QCand reads WSI images of theslides to make a diagnosis.
End User's Interface	Pathology Image Window(the client component ofSectra Digital PathologyModule)	Aperio ImageScope DX
Scanner	Sectra Digital PathologyModule does not include ascanner, however, it isindicated for use with theAperio AT2 DX	Aperio AT2 DX
Display monitor	Sectra Digital PathologyModule does not include amonitor, however, it isindicated for use with theDell MR2416	Dell MR2416

Sectra AB

Teknikringen 20, 583 30 Linköping, Sweden VAT: SE556064830401 Tel: +46 13 23 52 00 | Fax: +46 13 21 21 85 info@sectra.com | www.sectra.com

{6}------------------------------------------------

Performance data	Description
Color reproducibility	Pixel-wise comparison towards Aperio ImageScopeDX has beenperformed including zooming and panning operations across

Sectra AB

Teknikringen 20, 583 30 Linköping, Sweden VAT: SE556064830401 Tel: +46 13 23 52 00 | Fax: +46 13 21 21 85 info@sectra.com | www.sectra.com

{7}------------------------------------------------

	multiple tiles. Sectra Digital Pathology Module has been found to reproduce colors adequately with respect to its intended use.
Turnaround time	Provided that the system requirements are fulfilled:- When selecting a case, it should not take longer than 7 seconds until the image is fully loaded.- When panning the image (one quarter of the monitor) it should not take longer than 0.5 seconds until the image is fully loaded.
Measurements	Measurement accuracy has been verified using a test image containing objects with known sizes.
Human factors testing	Sectra Digital Pathology Module has been found to be safe and effective for the intended users, uses, and use environments.

Substantial Equivalence Comparison:

The major difference between the subject and predicate device is that the predicate device includes the Aperio AT2 DX scanner and the Dell MR 2416 Monitor, whereas the subject device is indicated for use with the same scanner and monitor. Therefore, the indications for use are slightly different in that the Aperio AT2 DX System Indication for use includes a section regarding the creation of digital images and the Sectra Digital Pathology Module is only focused on viewing those digital images.

The proposed Sectra Digital Pathology Module when used with the Aperio AT2 DX scanner and Dell MR2416 has similar Indications for Use, Functional, and Technological Characteristics as the ImageScope DX viewer application software of the predicate device and is therefore substantially equivalent to the Aperio predicate device (K190332).

Summary of Studies:

Non-clinical test results:

Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:

Color Reproducibility Testing demonstrated that the color reproducibility in Sectra Pathology Image Window was non-inferior to the color reproducibility in ImageScopeDX and that the Sectra Digital Pathology Module reproduced colors adequately with respect to its intended use.

Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.

The subject device has been found to perform accurate measurements with respect to its intended use.

Conducted per FDA's Guidance on Applying Human Factors and Usability Engineering to Medical Devices:

VAT: SE55606483040 Tel: +46 13 23 52 00 | Fax: +46 13 21 21 info@sectra.com | www.sectra.com

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "SECTRA" in large, bold, gray letters. The letters are evenly spaced and fill most of the frame. The background is plain white, which makes the gray letters stand out. The font appears to be sans-serif.

Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users.

Clinical tests results:

Substantial equivalence determination is not based upon clinical study results.

Conclusion:

The proposed Sectra Digital Pathology Module when used with the Aperio AT2 DX scanner and Dell MR2416 has similar Indications for Use, Functional, and Technological Characteristics as the ImageScope DX viewer application software of the predicate device. The results of non-clinical testing demonstrate the device is safe and effective and substantially equivalent to the Aperio predicate device (K190332).

Sectra AB

Teknikringen 20, 583 30 Linköping, Sweden VAT: SE556064830401 Tel: +46 13 23 52 00 | Fax: +46 13 21 21 85 info@sectra.com | www.sectra.com

Regulation Number and Section

§ 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.