(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.

[83 FR 22, Jan. 2, 2018]