Philips IntelliSite Pathology Solution

K192259 · Philips Electronics Nederland B.V. · PSY · Sep 20, 2019 · Pathology

Device Facts

• Record ID: K192259
• Device Name: Philips IntelliSite Pathology Solution
• Applicant: Philips Electronics Nederland B.V.
• Product Code: PSY · Pathology
• Decision Date: Sep 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Indications for Use

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.

Device Story

PIPS is an automated digital pathology system consisting of an Ultra Fast Scanner (UFS), Image Management System (IMS), and a display. The UFS digitizes glass slides prepared from FFPE tissue; the IMS manages these digital images. Pathologists use the display to view and interpret the digital images in a clinical setting, replacing or supplementing manual light microscopy. The system facilitates the review of pathology cases, allowing pathologists to make diagnostic decisions based on digital images. The device benefits patients by enabling digital workflow, potentially improving efficiency and access to pathology expertise. The current submission introduces a new display panel (PP27QHD) to the system.

Clinical Evidence

No clinical data. Substantial equivalence was demonstrated through non-clinical performance testing and verification of the modified display panel against FDA-recognized consensus standards and the Technical Performance Assessment (TPA) guidance.

Technological Characteristics

System components: Ultra Fast Scanner, Image Management System, and Display. Display: Color LCD, IPS technology with a-Si Thin Film Transistor. Server: Microsoft SQL Server 2014, Windows Server 2012R2 (64-bit). Viewer: HTML-based client. Connectivity: Networked environment supporting Chrome, IE, Firefox, and Edge browsers. Sterilization: N/A.

Indications for Use

Indicated for use by pathologists as an aid in reviewing and interpreting digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. Not indicated for frozen section, cytology, or non-FFPE hematopathology specimens.

Regulatory Classification

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.

Special Controls

A whole slide imaging system must comply with the following special controls: (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; (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: (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 factors 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: The intended use statement must include the information described in paragraph (i) (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 paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (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.

*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.

Predicate Devices

• Philips IntelliSite Pathology Solution (K172174)

Submission Summary (Full Text)

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SPECIAL 510(K): DEVICE MODIFICATION OIR DECISION SUMMARY

510(k) Number: K192259

This 510(k) submission contains information/data on modifications made to the applicant’s own class II or class I devices requiring 510(k). The following items are present and acceptable:

1. The name and 510(k) number of the applicant’s previously cleared device. (For a preamendments device, a statement to this effect has been provided.)

K172174

Philips IntelliSite Pathology Solution

2. Applicant’s statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user’s and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

The changes were for

- New LCD panel for display PP27QHD
- Implementation Unique Device Identification (UDI) in product labeling
- SQL/Windows servers, review browser and viewer client application

Verification and validation activities are performed for every change to Philips IntelliSite Pathology Solution. The verification and validation procedures, methods and acceptance criteria for product changes remain the same as those performed for and described in the predicate device, K172174.

4. Comparison Information (similarities and differences) to applicant’s legally marketed predicate device for technical performance characteristics of the display and operating system and programming language.

| Item | Predicate device (K172174) | Subject device (K192259) |
| --- | --- | --- |
| Device Name | Philips IntelliSite Pathology Solutio | Same |

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| Intended Use /Indications for Use | 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. | Same |
| --- | --- | --- |
| LCD Panel technicalcharacteristics | • Panel type: Color LCD • Technology: IPS technology with a-Si Thin Film Transistor • Physical display size: 648.5 mm x 423 mm x 91.3 mm (with backlight disc) | Same |
| LCD Panelmanufacturer | Bi-Search Korea Inc./LG display Co., Ltd. | Innolux Corporation |
| SQL server | Microsoft SQL server 2008 | Microsoft SQL server 2014 |
| Windows server | Windows server 2008R2 | Windows server 2012R2 |
| Server processor architecture | Server software 32-bit | Server software 64-bit |
| Operating system | Windows 7, 8, 8.1 and 10 | Unchanged |
| Review browser | Google Chrome and Internet Explorer | Google Chrome, Internet Explorer, Mozilla FireFox and Microsoft Edge |
| Viewer client application | Silverlight | HTML |

# 5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

Risk assessments for LCD panel changes were performed to assess the impact and potential risks that may exist due to the new LCD panel for PP27QHD. The Risk Analyses took into account device hazards associated with the intended use of the device. This safety risk assessment did not reveal any new safety

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risks or changes to existing safety risks for the display. The risk profiles remain identical and it was concluded that the display with new panel is safe to be used as a component of PIPS.

The following verification and validation studies were performed:

- Non-Clinical performance testing based on the outcome of the safety risk assessment and the test methods described in FDA Guidance “Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices” issued April 20, 2016. The protocol, test methods and acceptance criteria used are the same as those used in predicate device submission K172174.

- Safety testing
- Testing of display device characteristics
- Spatial resolution
- Pixel defects
- Temporal response
- Grayscale
- Luminance uniformity and Mura test
- Stability of luminance and chromaticity
- Specular and diffuse reflection coefficients
- Gray tracking
- Color scale response
- sRGB (standard Red, Green, Blue) color gamut

For each test, acceptance criteria were identified and observed results were compared to expected results. All acceptance criteria were met and all tests passed.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the applicant’s description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The applicant has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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