Philips IntelliSite Pathology Solution 5.1

K243871 · Philips Medical Systems Nederland B.V. · PSY · Mar 6, 2025 · Pathology

Device Facts

• Record ID: K243871
• Device Name: Philips IntelliSite Pathology Solution 5.1
• Applicant: Philips Medical Systems Nederland B.V.
• Product Code: PSY · Pathology
• Decision Date: Mar 6, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Indications for Use

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. The PIPS 5.1 comprises the Imagement System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP27QHD display, a Beacon C411W display or a Barco MDCC-4430 display. The PIPS 5.1 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 5.1.

Device Story

PIPS 5.1 is an automated digital pathology system for slide creation, viewing, and management. Input: glass slides containing FFPE tissue. Process: scanner (UFS or SG series) digitizes slides; Image Management System (IMS) 4.2 manages digital images; pathologist views images on high-resolution clinical displays (PP27QHD, C411W, or MDCC-4430). Used in clinical settings by pathologists to interpret images as an aid to diagnosis, replacing manual light microscopy. System does not perform automated image analysis or computer-aided diagnosis. Output: digital images for visual review. Benefits: enables digital workflow for pathology interpretation.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing of display performance characteristics, including spatial resolution, luminance uniformity, grayscale accuracy, and color gamut, compared against the predicate display.

Technological Characteristics

Whole slide imaging system comprising scanners (UFS, SG20/60/300), IMS 4.2 software, and clinical displays. Display technology: Color LCD, IPS with a-Si Thin Film Transistor. Connectivity: Networked image management. Standards: IEC 60601-1 (3.2), IEC 60601-1-6, IEC 62471, ISO 14971. Calibration: Built-in front sensor with QAWeb Enterprise software.

Indications for Use

Indicated for use by pathologists to review and interpret digital images of surgical pathology slides prepared from FFPE tissue. Not for use with 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 (PIPS) (K242848)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K243871

B Applicant

Philips Medical Systems Nederland B.V.

C Proprietary and Established Names

Philips IntelliSite Pathology Solution (PIPS) 5.1

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) MDCC-4430 from manufacturer Barco.

B Type of Test:

The Philips IntelliSite Pathology Solution (PIPS) 5.1 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.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K243871 - Page 2 of 7

## B Indication(s) for Use:

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The PIPS 5.1 comprises the Image Management System (IMS) 4.2, Ultra-Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP27QHD display, a Beacon C411W display or a Barco MDCC-4430 display. The PIPS 5.1 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 5.1.

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

Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:

The PIPS 5.1 device is an automated digital slide creation, viewing and management system. PIPS 5.1 consists of the following components:

a. Whole slide imaging scanners:
i. Ultra Fast Scanner (UFS)
ii. Pathology Scanner Second Generation (SG) with different versions for varying slide capacity: Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300
b. Image Management System (IMS) 4.2
c. Philips PP27QHD, Beacon C411W or Barco MDCC-4430 display

There are no changes to the whole slide imaging scanners, IMS 4.2 and PP27QHD display since the previous clearance in K233204. There are no changes to the Beacon C411W display since the previous clearance in K242848. The MDCC-4430 display is a 4MP display.

### V Substantial Equivalence Information:

#### A Predicate Device Name(s):

Philips Intellisite Pathology Solution (PIPS)

#### B Predicate 510(k) Number(s):

K242848

{2}

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K242848 | K243871 |
| --- | --- | --- |
| Device Trade Name | Philips IntelliSite Pathology Solution 5.1 | Philips IntelliSite Pathology Solution 5.1 |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.The PIPS 5.1 comprises the Image Management System (IMS) 4.2, Ultra-Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and Philips PP27QHD display or a Beacon C411W display.The PIPS 5.1 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 | The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. The PIPS 5.1 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 5.1 is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.The PIPS 5.1 comprises the Image Management System (IMS) 4.2, Ultra Fast Scanner (UFS), Pathology Scanner SG20, Pathology Scanner SG60, Pathology Scanner SG300 and PP27QHD display or a Beacon C411W display. The PIPS 5.1 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 |

K243871 - Page 3 of 7

{3}

K243871 - Page 4 of 7

| | pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1. | safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1. |
| --- | --- | --- |
| **General Device Characteristic Differences** | | |
| Display (Monitor) | Barco PP27QHD Shenzhen Beacon C411W | Barco PP27QHD Shenzhen Beacon C411W
Barco MDCC-4430 |
| Physical display size | Barco PP27QHD 648.5 mm x 423 mm x 91.3 mm (with backlight disc) | Barco MDCC-4430 714 mm x 478 mm x 74 mm |
| Calibration software | MediCal QAWeb Agent software version 1.13.12 installed on the workstation | QAWeb Enterprise version 2.14.0 installed on the workstation |
| Display Pixel Pitch | 0.2331 mm x 0.2331mm | 0.256 mm x 0.256 mm |

VI Standards/Guidance Documents Referenced:

- IEC 60601-1 Edition 3.2 (2020) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-6 (4th Ed) Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
- ISO 14971:2019 Medical devices - Application of risk management to medical devices

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility: Not applicable
2. Linearity: Not applicable
3. Analytical Specificity/Interference: Not applicable
4. Accuracy (Instrument): Not applicable

{4}

5. Carry-Over: Not applicable

## B Other Supportive Instrument Performance Characteristics Data:

### Display Equivalency Study:

Technical performance testing for the Barco MDCC-4430 display was performed and compared with the Barco PP27QHD display. The test results are summarized in the Table below.

Summary of Results

| Display Characteristics | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device Barco MDCC-4430 | Predicate Device Barco PP27QHD |
| 1. Spatial resolution | Hans Roehrig, Jerry Gaskill, Jiahua Fan, Ananth Poolla, Chadwick Martin, "In-field evaluation of the modulation transfer function of electronic display devices," Proc. SPIE 5367, Medical Imaging 2004: Visualization, Image-Guided Procedures, and Display, (5 May 2004) https://doi.org/10.1117/12.536250 | Both horizontal and vertical MTFs are greater than 70% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| 2. Pixel defects | Visual assessment – Stuck ON and Stuck OFF per Defective Pixels (Section 7.6 in IDMS version 1.1) | “On Pixels”: 0
“Partial On Pixels”: ≤7
“Off Pixels” + “Dim Pixels”: ≤9
“Partial On Pixels” within a circle of 10 mm diameter <= 2
“Off Pixels” within a circle of 10 mm diameter <= 2 | “On Pixels”: 0
“Partial on Pixels”: ≤6
“Off Pixels”: ≤5
“Partial on Pixels” + “Off Pixels” within a circle of 10 mm diameter <= 3 |
| 3. Artifacts | Visual assessment (section 4.6 in IDMS version 1.1) Image retention | Image retention after 1 hour < 0.65% | Image retention after 1 hour < 0.65% |
| 4. Temporal response | Gray-to-Gray Response time (section 10.2.3 in | Gray-to-gray response time = 8.1ms (minimum), 23.3 | Gray-to-gray response time = 5.2ms (minimum), 9.7ms |

K243871 - Page 5 of 7

{5}

K243871 - Page 6 of 7
| Display Characteristics | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device Barco MDCC-4430 | Predicate Device Barco PP27QHD |
| | IDMS version 1.1) 9x9 points, equal lightness | ms (average) and 39.0 ms (maximum) | (average) and 17.4ms (maximum) |
| 5. Maximum and minimum luminance (achievable and recommended) | Vantage-Point Suite of Measurement (section 2.4 in IDMS version 1.1) Sequential Contrast (IDMS version 1.1, section 5.10) | The maximum and minimum achievable luminance values are 1500 and 0.25 cd/m² respectively. The calibrated luminance is 350 cd/m². The contrast ratio is Typical: 2000:1 Observed: 1741:1 | The maximum and minimum achievable luminance values are 550 and 0.3 cd/m² respectively. The calibrated luminance is 350 cd/m². The contrast ratio is Typical: 1000:1. Observed: 1360:1 |
| 6. Grayscale | Grayscale (IDMS version 1.1, section 6.1) | Maximum luminance error from sRGB transfer function (ΔL): 2.02 cd/m² at DLL=213 Maximum luminance error over reference luminance (ΔL/L): 1.32% at DLL=152 | Maximum luminance error from sRGB transfer function (ΔL): 2.05 cd/m² at DLL=201 Maximum luminance error over reference luminance (ΔL/L): 7.02% at DLL=6 |
| 7. Luminance uniformity | Sampled uniformity (IDMS version 1.1, section 8.1) and area uniformity (IDMS version 1.1, section 8.2) | Non-uniformity is 2.69% at 80% video level. | Non-uniformity is 11.6% at 80% video level. |
| 8. Stability of luminance and chromaticity response with temperature and lifetime | Full-screen white (section 5.3 IDMS version 1.1) | Maximum luminance deviation from target (350 cd/m²) over temperature: 0.36% Maximum luminance deviation from target (350 Cd/m²) over time: 0.46% in 20 hours Maximum chromaticity deviation from target (D65) over time: (Δx=0.0007, Δy=0.0017) in 20 hours | Maximum luminance deviation from target (350 Cd/m²) over temperature: 0.59% Maximum luminance deviation from target (350 Cd/m²) over time: 0.69% in 20 hours Maximum chromaticity deviation from target (D65) over time: (Δx=0.0021, Δy=0.0043) in 20 hours |
| 9. Bidirectional reflection coefficients | Small source reflection (section 11.6 IDMS version 1.1) for specular component. | Specular reflection coefficient: 1.85% Diffuse reflection coefficient: 2.47% | Specular reflection coefficient:1.69% Diffuse reflection coefficient: 2.21% |

{6}

| Display Characteristics | Test Method | Results | |
| --- | --- | --- | --- |
| | | Subject Device Barco MDCC-4430 | Predicate Device Barco PP27QHD |
| | Hemispherical reflection specular excluded (section 11.3 in IDMS version 1.1) with Diagnostic: characterizing hemisphere uniformity (section 11.12) for diffuse component. | | |
| 10. Gray tracking | AAPM Task Group 196 Report, and IDMS version 1.1 section 6.15 | Max Δu’v’ from measured white chromaticity at target D65 (as of L > 5 cd/m²): ± 0.0006 | Max Δu’v’ from measured white chromaticity at target D65 (as of L > 5 cd/m²): ± 0.0010 |
| 11. Color Scale | Primary color scales (section 6.2 IDMS version 1.1) and Color-Signal White (Section 5.4.1 IDMS version 1.1) | Average color error <2 ΔE_{00}
Maximum color error <5 ΔE_{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 | Chromaticity gamut area (IDMS version 1.1, section 5.18 and subsection 5.18.1) | Color gamut area wrt sRGB: 99.13%
sRGB overlap: 98.32% | Color gamut area wrt sRGB: 98.57%
sRGB overlap: 97.70% |

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.

K243871 - Page 7 of 7