(151 days)
No
The summary describes software for viewing and managing digital pathology images, focusing on image display, manipulation, and integration with existing PACS. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis or interpretation beyond basic viewing and manipulation. The performance studies focus on color reproducibility, turnaround times, measurements, and usability, not on algorithmic performance related to AI/ML.
No.
The device is described as software intended for viewing and management of digital images of scanned surgical pathology slides, and as an aid to the pathologist for diagnosis. It does not directly provide therapy.
Yes
The device aids pathologists in reviewing and interpreting digital images of surgical pathology slides for primary diagnosis, which is a key function of a diagnostic device. The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use."
Yes
The device description explicitly states "Sectra Digital Pathology Module is a software-only device". While it interacts with hardware (scanner, monitor, workstation), the device itself, as described, is solely the software component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for "viewing and management of digital images of scanned surgical pathology slides... as an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnosis.
- Specimen Type: The device works with "digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue," which are biological specimens.
Therefore, based on the provided information, the Sectra Digital Pathology Module is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
QKQ
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).
The subject device is typically operated as follows:
-
- 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.
-
- 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.
-
- 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.
-
- 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital images of scanned surgical pathology slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pathologist / In Vitro Diagnostic Use
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
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:
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.
Key Metrics
Turnaround time:
- 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.
Predicate Device(s)
Reference Device(s)
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.
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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 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.
| 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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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
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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 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).
The subject device is typically operated as follows:
-
- 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.
-
- 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.
-
- 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.
-
- 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
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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 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. | 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 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. | ||
| Specimen type | Surgical pathology slides | |
| prepared from FFPE tissue | Surgical pathology slides | |
| prepared from FFPE tissue | ||
| Item | Subject Device | Predicate |
| Image Storage | Images are stored in an end | |
| user provided image storage | ||
| attached to the local | ||
| network. | Images are stored in an end | |
| user provided image storage | ||
| attached to the local network. | ||
| Image manipulation | ||
| functions | Panning, zooming, gamma | |
| function, annotations, and | ||
| measurements (distance & | ||
| area) | Panning, zooming, gamma | |
| function, annotations, and | ||
| measurements (distance & | ||
| area) | ||
| Image review and | ||
| diagnosis | 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. | 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. | ||
| End User's Interface | Pathology Image Window | |
| (the client component of | ||
| Sectra Digital Pathology | ||
| Module) | Aperio ImageScope DX | |
| Scanner | Sectra Digital Pathology | |
| Module does not include a | ||
| scanner, however, it is | ||
| indicated for use with the | ||
| Aperio AT2 DX | Aperio AT2 DX | |
| Display monitor | Sectra Digital Pathology | |
| Module does not include a | ||
| monitor, however, it is | ||
| indicated for use with the | ||
| Dell 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 been |
| performed 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
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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