(132 days)
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. The PIPS 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 PIPS is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
The PIPS comprises the Image Management System (IMS), the Ultra Fast Scanner (UFS) and Display. The PIPS 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 PIPS.
The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, management, viewing and analysis system.
The PIPS consists of two subsystems and a display:
- Ultra Fast Scanner (UFS) (for software UFS1.7.1.1); ●
- Image Management System (IMS) (for software IMS2.5.1.1); ●
- . Display (PS27QHDCR).
The UFS consists of optical, mechanical, electronic and software elements to scan FFPE tissue mounted on glass slides at a resolution of 0.25 um per pixel, which is equivalent to a 40x objective, to create digital Whole Slide Images (WSI). The UFS has a capacity of 300 slides (15 glass slide racks with up to 20 slides per rack). After the slide racks are loaded into the UFS, the UFS automatically detects and starts scanning the slides. CCD cameras are used to capture color images from the back-lit tissue specimen. An LED light source employs toplit illumination to capture the barcode and back-lit illumination for tissue scanning. The stage (STG) and Image Capturing Unit (ICU) are fixed to each other and to the base frame to ensure correct positioning of the slide and to suppress external disturbances. Proprietary software is used for image processing during acquisition. Philips' proprietary format, iSyntax, is used to store and transmit the images between the UFS and the IMS.
The IMS is a software only subsystem to be used with the Display. Functionality of the IMS includes the ability to view images, organize workload, and annotate and bookmark scanned images. The user manual for PIPs specifies compatible computer environment hardware and software that is not included as part of the system.
The different subsystems of the PIPS are connected over an IT network at the user site. The IT hardware/software that supports the IMS Application Server & Storage software is not provided as part of the PIPS, but may be located in a central server room separate from the workstation with the IMS viewing software and Display. The communication of data between UFS and IMS is via a customer provided wired network or a direct connected cable between these subsystems. PIPS includes a display that has been validated as part of the pivotal clinical study.
The PIPS allows pathologists to view and evaluate digital images of formalin-fixed, paraffinembedded (FFPE) tissue slides that would otherwise be appropriate for manual visualization by conventional brightfield (light) microscopy. The PIPS does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.
The provided text describes the regulatory acceptance criteria and supporting studies for the Philips IntelliSite Pathology Solution (PIPS), a digital whole slide imaging (WSI) system for pathology.
Here's an breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The regulatory document outlines specific performance characteristics that the PIPS device must meet, primarily focusing on showing non-inferiority to traditional optical microscopy for diagnostic purposes and demonstrating precision and reproducibility.
| Acceptance Criteria Category | Specific Criteria (Implicitly Derived from Studies) | Reported Device Performance |
|---|---|---|
| Clinical Performance | Non-inferiority of Manual Digital (MD) major discordance rate to Manual Optical (MO) major discordance rate, with an upper bound of 95% CI for MD-MO difference |
§ 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.