Philips IntelliSite Pathology Solution

K241871 · Philips Medical Systems Nederland B.V. · PSY · Dec 2, 2024 · Pathology

Device Facts

• Record ID: K241871
• Device Name: Philips IntelliSite Pathology Solution
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: PSY · Pathology
• Decision Date: Dec 2, 2024
• Decision: SESE
• Submission Type: Traditional
• 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 Philips PP27QHD display or a Beacon C411W 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

Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system. System components include Ultra Fast Scanner (UFS), Image Management System (IMS), and clinical display (Philips PP27QHD or Beacon C411W). UFS scans coverslipped glass slides to produce whole slide images (WSI). IMS software manages storage, retrieval, and viewing of WSI and patient data. Pathologists use IMS Viewer on a clinical display to review images, organize workload, and perform annotations. Device facilitates digital review of slides otherwise viewed via conventional light microscopy. No automated image analysis or computer-aided detection/diagnosis is included. Pathologist remains responsible for interpretation validity.

Clinical Evidence

Bench testing only. No clinical data. Performance was validated through a display equivalency study comparing the Beacon C411W to the predicate Barco PP27QHD using IDMS v 1.03 test methods. Metrics included spatial resolution (MTF), pixel defects, image retention, temporal response, luminance/contrast, grayscale mapping, luminance uniformity, stability, reflection coefficients, and color accuracy. Results confirmed the subject display meets or exceeds performance requirements for digital pathology.

Technological Characteristics

System comprises UFS (optical/mechanical/electronic scanner), IMS (server/viewer software), and clinical display. Beacon C411W display: Thin Film Transistor technology, built-in front calibration sensor, 0.2331 mm pixel pitch. Calibration via Beacon QA Manager software. Connectivity: Client-server architecture. Standards: IEC 60601-1, IEC 60601-1-6, IEC 62471, ISO 14971.

Indications for Use

Indicated for use by pathologists to review and interpret 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.

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K241871

B Applicant

Philips Medical Systems Nederland B.V.

C Proprietary and Established Names

Philips IntelliSite Pathology Solution

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PSY | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |

## II Review Summary:

A Purpose for Submission:

Addition of a new display (monitor) C411W from manufacturer Shenzhen Beacon.

B Type of Test:

The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing, and management system.

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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 Philips PP27QHD display or a Beacon C411W 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.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

## IV Device/System Characteristics:

## A Device Description:

The Philips IntelliSite Pathology Solution (PIPS) is an automated digital slide creation, viewing and management system. 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. The PIPS does not include any automated image analysis applications that would constitute computer aided detection or diagnosis. The pathologists only view the scanned images and utilize the image review manipulation software in the PIPS.

PIPS consists of two subsystems and a display component:

- Ultra Fast Scanner (UFS)
- Image Management System (IMS)
- Clinical Display

The UFS subsystem scans coverslipped glass slides to produce whole slide images (WSI) of the tissue material mounted on the pathology glass slides. The slides are placed in racks which are then placed in rack slots in the UFS. The scanning procedure requires minimal user interaction. The UFS consists of optical, mechanical, and electronic elements as well as software components.

The IMS is a software only subsystem and consists of the IMS Application Server and Storage software and IMS Viewer software installed on compatible server hardware. Functionality of the IMS includes the ability to view WSIs, organize workload, and annotate and bookmark scanned slide images. The pathologist uses the IMS Viewer to interact with the IMS Server to store and retrieve the pathology data (digitized slide images, patient data).

The new display Beacon C411W is connected to a client computer with access to the IMS Viewer. The display is calibrated using the built-in calibration sensor and software tool, which automatically perform a periodic calibration. The pathologist uses the display for viewing Whole Slide images using the IMS Viewer software.

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V Substantial Equivalence Information:

A Predicate Device Name(s):

Philips Intellisite Pathology Solution

B Predicate 510(k) Number(s):

K192259

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K241871 | K192259 |
| --- | --- | --- |
| Device Trade Name | Philips Intellisite Pathology Solution | Same |
| General Device Characteristic Similarities | | |
| 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 Philips PP27QHD display or a Beacon C411W display. The PIPS is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for | 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 |

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| | 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. | 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. |
| --- | --- | --- |
| Display Pixel Pitch | 0.2331 mm x 0.2331mm | Same |
| Display Calibration hardware | Built-in front sensor | Same |
| General Device Characteristic Differences | | |
| Display | Shenzhen Beacon C411W | Barco PP27QHD |
| Technology | Thin Film Transistor | IPS technology with a-Si Thin Film Transistor |
| Physical display size | 646 mm x 423 mm x 91.3 mm | 648.5 mm x 423 mm x 91.3 mm (with backlight disc) |
| Calibration software | Beacon QA Manager software version 1.1 installed on the workstation | MediCal QAWeb Agent software version 1.13.12 installed on the workstation |

VI Standards/Guidance Documents Referenced:

1. FDA Guidance document: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. Guidance for Industry and Food and Drug Administration Staff. April 20, 2016.
2. IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
3. IEC 60601-1-6 (4th Ed) Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral Standard Usability.
4. IEC 62471:2006 Photobiological safety of lamps and lamp systems.
5. ISO 14971: 2019 Medical devices – Application of risk management to medical devices.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility:

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Not applicable

2. Linearity: Not applicable
3. Analytical Specificity/Interference: Not applicable
4. Accuracy (Instrument): Not applicable
5. Carry-Over: Not applicable

# B Other Supportive Instrument Performance Characteristics Data:

# Display Equivalency Study:

Technical performance testing for the Beacon C411W display was performed and compared with the Barco PP27QHD display. The test results are summarized in the Table 1 below. In addition, the existing functional, safety, user and system integration requirements related to the display were verified and validated.

Table 1: Display Equivalency Test

| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device Beacon C411W | Predicate Device Barco PP27QHD |
| 1. Spatial resolution | Measurement of the Modulation Transfer Function (MTF) IDMS v 1.03, section 7.7 | Both horizontal and vertical MTFs are greater than 86% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| 2. Pixel defects | Measurements (counts) of pixel defects IDMS v 1.03, section 7.6 Defective Pixels | Total number of pixel defects ≤ 5 Total number of bright and dark pixels within a circle of 10 mm ≤ 1 | Total amount of pixel defects ≤ 6 Total number of bright and dark pixels within a circle of 10 mm ≤ 3 |
| 3. Artifacts | Measurement of image retention after 1 hour IDMS v 1.03, section 10.4 Artifacts and Irregularities | 0.43% | < 0.65% |
| 4. Temporal response | Measurement of response time IDMS v 1.03, 10.2 (section 10.2.2 Response Time) | The response time is 16.39 ms | The response time is 15 ms |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device Beacon C411W | Predicate Device Barco PP27QHD |
| 5. Maximum luminance and contrast ratio | Maximum and minimum luminance (achievable and recommended) and contrast ratio
IDMS v 1.03, section 2.4 Vantage-Point Suite of Measurements | Minimum achievable: 0.375 cd/m²
Maximum achievable: 357 cd/m²
Calibrated to max. recommended: 350 cd/m²
The contrast ratio is 933.33:1 | Minimum achievable: ≤ 0.3 cd/m²
Maximum achievable: 550 cd/m²
Calibrated to max. recommended: 350 cd/m²
The contrast ratio is 1000:1 |
| 6. Grayscale | Measurement of the mapping between image values and the luminance
IDMS v1.03, section 6.1 Gray Scale | Maximum luminance error from sRGB transfer function (ΔL) = 0.72 cd/m² at DLL=120; Maximum luminance error over reference luminance (ΔL/L) = 2.9% at DLL=15 | Maximum error from sRGB transfer function ≤ 0.99% |
| 7. Luminance uniformity | Luminance uniformity testing
IDMS v 1.03, section 8.1.1 Sampled Contrast Uniformity | Non-uniformity is 20% at 80% video level. | Non-uniformity is < 21% at 80% video level 80% |
| 8. Stability of luminance and chromaticity response with temperature and lifetime | Luminance and chromaticity characteristics of the display measured with temperature and time based on IDMS v 1.03, section 10 Temporal Measurements | Luminance deviation from target (350 cd/m²) with temperature: 7.8%; Luminance deviation from target (350 cd/m²) over time: 1.24%; Chromaticity deviation from target (D65): (0.317,0.334) | Deviation from target luminance (350 cd/m²) with temperature: < 10%
Variations for luminance and chromaticity over time: < 2%deviation |
| 9. Bidirectional reflection coefficients | Measurement of specular and diffuse reflection coefficient
IDMS v 1.03, section 11.12 Reflection Measurements | Specular reflection coefficient, averaged between 400 nm and 740 nm: 1.83%
Diffuse reflection coefficient, averaged between 400 nm and 740 nm: 2.33% | Specular reflection coefficient: 1.69%
Diffuse reflection coefficient:2.21% |
| 10. Gray tracking | Measurement of gray tracking (stability of neutral grey colors) | | |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device
Beacon C411W | Predicate Device
Barco PP27QHD |
| | IDMS v 1.03, section 6.15 Gray-scale Color Changes | White point deviation from D65 = 0.0013 Δu’v’ | White point at D65: ≤ 0.002 Δu’v’ |
| 11. Color Scale | Determine the color error
IDMS v1.03, section 6.2 Primary Color-Scale | Average color error = 0.95 ΔE_{00}
Maximum color error = 1.47ΔE_{00}
Color signal white ratio = 1.00 | Average color error < 2 ΔE_{00}
Maximum color error < 5 ΔE_{00}
Color signal white ratio = 1.00 |
| 12. Color gamut volume | Measurement of the color gamut volume
IDMS v1.03, section 5.18.1 Relative Gamut Area | 2D color gamut area with respect to sRGB: 110.4%
2D color gamut area overlapped with sRGB: 98.5% | 2D color gamut area with respect to sRGB: 98.6%
2D color gamut area overlapped with sRGB: 97.7% |

VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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