(265 days)
For In Vitro Diagnostic Use
Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Sectra Digital Pathology Module (3.3) 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 (3.3).
Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display.
The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device.
The system capabilities include:
- retrieving and displaying digital slides,
- support for remote intranet access over computer networks,
- tools for annotating digital slides and entering and editing metadata associated with digital slides, and
- displaying the scanned slide images for primary diagnosis by pathologists.
The subject device is designed to accurately display colors. The monitor is not part of the subject device.
Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window.
Image acquisition will be managed by the scanner which is not part of the subject device:
- The scanner delivers images with a tag in the file header that identifies the originating scanner.
- The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide).
The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance | Met? |
|---|---|---|
| Primary Endpoint: The upper bound of the 2-sided 95% CI of the difference between the overall major discrepancy rates of WSIR diagnosis and MSR diagnosis when compared to the reference diagnosis shall be ≤4%. | The upper bound of the 95% CI of the estimated difference in major discrepancy rates was 1.69%. | Yes |
| Secondary Endpoint: The upper bound of the 2-sided 95% CI of the major discrepancy rate between WSIR diagnosis and the reference diagnosis shall be |
§ 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.