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 PP270HD 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 safeguards to assure the validity of the interpretation of images obtained using PIPS 5.1.

Device Description

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component:

1. A scanner in any combination of the following scanner models
- . Ultra Fast Scanner (UFS)
- . Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20. Pathology Scanner SG60. Pathology Scanner SG300
1. Image Management System (IMS) 4.2
1. Clinical display
- PP27QHD or C411W

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.

AI/ML Overview

This document focuses on the Philips IntelliSite Pathology Solution 5.1 (PIPS 5.1) and its substantial equivalence to a predicate device, primarily due to the introduction of a new clinical display. This is a 510(k) submission, meaning it aims to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than proving de novo effectiveness. Therefore, the study described is a non-clinical performance study to demonstrate equivalence of the new display, not a clinical effectiveness study.

Based on the provided text, a detailed breakdown of acceptance criteria and the proving study is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the evaluation was performed following the FDA's Guidance for Industry and FDA Staff entitled, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" (TPA Guidance), dated April 20, 2016. The acceptance criteria are essentially defined by compliance with the tests outlined in this guidance and relevant international standards.

Acceptance Criteria (Measured Performance Aspect)	Performance Standard/Acceptance Limit (Implicitly based on TPA Guidance & Predicate Equivalence)	Reported Device Performance (Summary from "Conclusion")
TPA Guidance Items related to Display:
Spatial resolution	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Pixel defects	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Artifacts	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Temporal response	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Maximum and minimum luminance	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Grayscale	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Luminance uniformity	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Stability of luminance and chromaticity	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Bidirectional reflection distribution function	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Gray tracking	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Color scale response	As per predicate device and TPA Guidance	Verified to be similar to predicate device
Color gamut volume	As per predicate device and TPA Guidance	Verified to be similar to predicate device
International & FDA-recognized Consensus Standards:	Compliance Required	Compliance Achieved
IEC 60601-1 Ed. 3.2 (Medical electrical equipment - General requirements for basic safety and essential performance)	Compliance	Compliant
IEC 60601-1-6 (4th Ed) (Usability)	Compliance	Compliant
IEC 62471:2006 (Photobiological safety)	Compliance	Compliant
ISO 14971:2019 (Risk management)	Compliance	Compliant
Other:	Compliance Required	Compliance Achieved
Existing functional, safety, and system integration requirements related to the display	Verified to function as intended without adverse impact from new display	Verified to be safe and effective

Reported Device Performance Summary: The non-clinical performance testing of the new display (Beacon C411W) showed that the proposed device has similar technological characteristics compared to the predicate device (using the PP27QHD display) following the TPA Guidance. It is also in compliance with the aforementioned international and FDA-recognized consensus standards. The verification and validation of existing safety, user, and system integration requirements showed that the proposed PIPS 5.1 with the new clinical display is safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a "sample size" in terms of patient cases or images for testing the display. The testing performed was bench testing ("Verification for the new display," "non-clinical performance data"). This implies that the tests were conducted on the display unit itself, measuring its physical and optical properties, and its integration with the system components, rather than on a dataset of patient images reviewed by observers.
Data Provenance: Not applicable in the context of a display characteristic validation study. The study focused on the performance of the hardware (the new display).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This was a technical, non-clinical validation of a display unit's characteristics against engineering specifications and regulatory guidance, not a study requiring expert clinical read-outs or ground truth establishment from patient data.

4. Adjudication Method for the Test Set

Not applicable. This was a technical, non-clinical validation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was NOT done. The document explicitly states: "The proposed device with the new display did not require clinical performance data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes: Intended Use / Indications for Use, Technological characteristics, Non-clinical performance testing, and Safety and effectiveness."
The purpose of this submission was to demonstrate substantial equivalence for a minor hardware change (new display), not to show an improvement in human reader performance with AI assistance. The PIPS system itself does not include "any automated image analysis applications that would constitute computer aided detection or diagnosis." It is a whole slide imaging system for viewing and managing digital slides.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The PIPS 5.1 is a system for creating, viewing, and managing digital slides for human pathologist review. It is not an AI algorithm that produces a diagnostic output on its own. The "standalone" performance here refers to the display's technical specifications.

7. The Type of Ground Truth Used

For the non-clinical performance data, the "ground truth" was established by engineering specifications, international consensus standards (e.g., IEC, ISO), and the FDA's TPA Guidance. The aim was to ensure the new display performed equivalently to the predicate's approved display and met relevant technical requirements.

8. The Sample Size for the Training Set

Not applicable. This was a non-clinical validation of hardware (a display), not a machine learning model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary

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Philips Medical Systems Nederland B.V. Donna Peled Head of Regulatory Affairs - Clinical Informatics Veenpluis 6 Best, 5684 PC Netherlands

December 10, 2024

Re: K242848

Trade/Device Name: Philips IntelliSite Pathology Solution 5.1 Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: PSY Dated: September 20, 2024 Received: September 20, 2024

Dear Donna Peled:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Shyam Kalavar -S

Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242848

Device Name Philips IntelliSite Pathology Solution 5.1

Indications for Use (Describe)

	Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

1.1 General information

December 02, 2024

1.1.1 Company identification

Philips Medical Systems Nederland B.V. Veenpluis 6 5684 PC Best The Netherlands Registration number: 3012563754

1.1.2 Contact Person

Donna Peled Head of Regulatory Affairs - Clinical Informatics Digital & Computational Pathology Phone: +972-52-6145353 Email: donna.peled@philips.com

1.1.3 Identification of the device and classification

Device trade name: Philips IntelliSite Pathology Solution 5.1 Device Class: Class II Classification regulation: 864.3700 Product code: PSY Classification name: Whole Slide Imaging System Classification panel: Pathology 510K number: K242848

Leqally marketed predicate devices to which substantial equivalence is 1.1.4 claimed

Device trade name: Philips IntelliSite Pathology Solution 5.1 510(k) number: K233204 (June 24, 2024) Device Class: Class II CFR section: 864.3700 Product code PSY Classification name: Whole Slide Imaging System Classification panel: Pathology

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1.2 Device description

The Philips IntelliSite Pathology Solution (PIPS) 5.1 is an automated digital slide creation, viewing, and management system. PIPS 5.1 consists of two subsystems and a display component:

1. A scanner in any combination of the following scanner models
- . Ultra Fast Scanner (UFS)
- . Pathology Scanner SG with different versions for varying slide capacity Pathology Scanner SG20. Pathology Scanner SG60. Pathology Scanner SG300
1. Image Management System (IMS) 4.2
1. Clinical display
- PP27QHD or C411W

1.3 Intended use

Compared to the predicate device the Intended Use / Indications for Use statement of the subject device has been updated to reflect the new Beacon C411W display. The Intended use remains unchanged.

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 imaqes 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 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 safequards to assure the validity of the interpretation of images obtained using PIPS 5.1.

1.4 Comparison of technological characteristics with the predicate device

The proposed device has the same technological characteristics compared to the predicate device, with the exception of the following minor modification implemented in the proposed device: Introduction of a new clinical display, C411W, as an alternative option for the current display, PP27QHD.

The proposed device will employ display C411W from manufacturer Beacon as an option for the current display. The new display has similar technological characteristics and pixel resolution as

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compared to the predicate device. Table below describes the modified technological characteristics for the new display in accordance with FDA's Guidance for Industry and FDA Staff entitled, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" (hereafter referred to as TPA Guidance), dated April 20, 2016.

Other TPA guidance items related to the display are not impacted by the new display and remain identical to the predicate device.

TPA Description	Predicate device(K233204)	Proposed device
	Technologicalcharacteristics of thedisplay device	Display type	Color LCD
Manufacturer		Barco N.V.	Shenzhen Beacon DisplayTechnology Co., Ltd
Technology		IPS technology with a-Si ThinFilm Transistor	Thin Film Transistor
Physicaldisplay size		648.5 mm x 423 mm x 91.3mm (with backlight disc)	646 mm x 423 mm x 91.3 mm
Pixel Pitch		0.2331 mm x 0.2331 mm	0.2331 mm x 0.2331 mm
Color calibrationtools (sensorhardware andassociated software)	Calibrationsoftware	MediCal QAWeb Agentsoftware version 1.13.12installed on the workstation	Beacon QA Managersoftware version 1.1 installedon the workstation
	Calibrationhardware	Built in front sensor	Built in front sensor

Table 1.1	Modified technological characteristics for the display
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1.5 Summary of non-clinical performance data

Non-clinical performance testing was performed on the display of the proposed device and demonstrates compliance with the following international and FDA-recognized consensus standards:

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

Following the TPA quidance, the below mentioned sub-set of tests were performed to verify that the technological characteristics of the display were not affected by the new panel.

Spatial resolution .
. Pixel defects
. Artifacts
Temporal response
Maximum and minimum luminance
Grayscale
Luminance uniformity .

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Stability of luminance and chromaticity ●
. Bidirectional reflection distribution function
Gray tracking .
Color scale response ●
Color gamut volume.

In addition, the existing functional, safety and system integration requirements related to the display were verified.

Conclusion:

The verification for the new display showed that the proposed device has similar technological characteristics compared to the predicate device following the TPA quidance and is in compliance with aforementioned international and FDA-recognized consensus standards. Verification and validation of the existing safety, user and system integration requirements showed that the proposed PIPS 5.1 with the new clinical display is safe and effective. The proposed device conforms to its intended use and user needs. Therefore, the proposed device with the new clinical display is substantially equivalent to the predicate device in terms of safety and effectiveness.

1.6 Summary of clinical performance data

The proposed device with the new display did not require clinical performance data since substantial equivalence to the currently marketed predicate device was demonstrated with the following attributes:

. Intended Use / Indications for Use,
. Technological characteristics,
Non-clinical performance testing, and ●
. Safety and effectiveness

These attributes demonstrated that the clinical performance of the modified device is substantially equivalent to the predicate device.

1.7 Conclusions

The proposed PIPS 5.1 with a new clinical display as option for the current display is substantially equivalent to the predicate device in terms of Intended Use/Indications for Use, technological characteristics, and safety and effectiveness.

The change of the display of the proposed device is within the controls and predetermined specifications. Additionally, non-clinical performance tests (bench testing) ensured that the modifications are properly introduced. These tests were used to support substantial equivalence of the proposed device and demonstrated that it is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 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.