Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.

This device is not to be used for mammography.

Device Description

Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.

This device is not to be used for mammography.

Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

AI/ML Overview

The provided text describes a Special 510(k) submission for the Illumeo system, focusing on its substantial equivalence to a predicate device after minor modifications. It does not contain the specific details about acceptance criteria, device performance, sample sizes, expert qualifications, or MRMC studies that you requested.

The document states that:

Acceptance Criteria and Device Performance: "Verification and Validation (V&V) activities were performed for proposed Illumeo system and demonstrated that the predetermined acceptance criteria were successfully met." However, it does not describe what those acceptance criteria were nor the specific quantitative results of the device performance against them. It only generally states that the system "Meets the acceptance criteria and is adequate for its intended use and user needs."
Study Type: Non-clinical verification and validation tests were performed. No clinical studies were required or conducted to support the equivalence for this submission ("Illumeo system did not requires clinical studies to support equivalence.").
Ground Truth: The document does not discuss ground truth as it would be understood in the context of an AI/ML device relying on diagnostic accuracy, given it's a PACS system subject to a Special 510(k) for modifications.
Sample Sizes (Test/Training): These details are not provided as no diagnostic performance study was conducted.
Experts and Adjudication Methods: Not applicable, as there was no diagnostic performance study involving human readers.
MRMC Comparative Effectiveness Study: Not conducted. The device is a PACS system with improved features, not an AI assisting human readers for a specific diagnostic task.
Standalone Performance: Not applicable as it's not a standalone diagnostic AI algorithm. It's an image management and viewing system.

Summary of available information:

Category	Description
1. Acceptance Criteria & Performance	Acceptance Criteria: "predetermined acceptance criteria were successfully met." (Specific criteria not detailed in the provided text).
	Reported Device Performance: "demonstrated that the design outputs of the modified device meet the design input requirements and do not raise new questions on safety and/or effectiveness." "Meets the acceptance criteria and is adequate for its intended use and user needs." (Specific quantitative performance metrics are not detailed, as this was a Special 510(k) for minor modifications to a PACS system, not a new AI diagnostic device.)
2. Sample Size (Test) & Data Provenance	Not applicable. No diagnostic performance study involving a test set was conducted. The assessment was based on non-clinical verification and validation of software changes.
3. Number & Qualifications of Experts	Not applicable. No diagnostic performance study requiring expert ground truth establishment was conducted.
4. Adjudication Method	Not applicable.
5. MRMC Comparative Effectiveness Study	No. The device is an image management system (PACS) not a diagnostic AI intended to assist human readers in a comparative effectiveness study. The modifications primarily involve improved system performance, integration, scalability, multimodality support, viewing tools, and UI enhancements.
6. Standalone Performance Study	Not applicable. The Illumeo system is an image management system, not a standalone diagnostic algorithm. Its function is to acquire, store, process, and display images for trained professionals.
7. Type of Ground Truth Used	Not applicable. The evaluation focused on software verification and validation, risk management, and compliance with standards, rather than diagnostic accuracy against a specific ground truth like pathology or outcomes data.
8. Sample Size (Training Set)	Not applicable. The document describes a PACS system for which the concept of a "training set" (as in machine learning) is not relevant in the context presented. The system itself is "trained" in a sense through standard software development and testing cycles to perform its functions, rather than learning from a dataset.
9. Ground Truth for Training Set	Not applicable.

The study described is a non-clinical verification and validation effort, demonstrating compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1-3.20 DICOM, and FDA guidance for software in medical devices). The modifications were deemed "minor technology changes mainly designated to provide users further support in visualization" and did not change the intended use or fundamental scientific technology, hence a Special 510(k) was submitted. The conclusion states that "all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable."

Summary

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Philips Medical Systems Technologies Ltd. % Mr. Yoram Levy QA/RA Consultant Qsite 31 Haavoda Street Binyamina 30500 ISRAEL

January 12, 2018

Re: K173588

Trade/Device Name: Illumeo System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: January 2, 2018 Received: January 8, 2018

Dear Mr. Levy:

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 (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. 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.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D.'Hara
For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173588

Device Name Illumeo system

Indications for Use (Describe)

Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.

This device is not to be used for mammography.

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

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.

Date Prepared:	November 16, 2017
Submission Type	Special 510(k): Device Modification submission

I. Submitter's name and address

Manufacturer:
Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277

Primary Contact Persons:

Yoram Levy, Qsite 31 Haavoda Street, Binyamina 30500 Israel Phone: (972)4-638-8837 Fax: (972)4-638-0510 E-mail: Yoram@qsitemed.com

Secondary Contact:

Ilana Ben Moshe Quality & Regulatory Affairs Leader Medical Systems Nederland B.V Phone: +972 525233496 E-mail: Ilana.Ben-Moshe@philips.com

II. Device information

Subject Device:

Device Name:	Illumeo system
Common/Usual Name:	Imaging Informatics System

Classification:

Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology

2-2

Illumeo System Special 510k Submission

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Primary Product Code: LLZ Secondary Product Code: JAK

Comment: Product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo system for marketing reasons.

Predicate device information III.

Primary Predicate Device:

Trade name:	I4 (Integrated Intelligent Imaging Informatics)
Manufacturer:	Philips Healthcare Informatics, Inc.
510(k) clearance:	K160315
Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ, JAK

Reference Predicate Device:

Trade name:	Intellispace Portal Platform
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) clearance:	K162025
Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ
Trade name:	Multi-Modality Tumor Tracking (MMTT) Application
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) clearance:	K162955
Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ

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IV. Device Description

Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.

This device is not to be used for mammography.

Comment: Product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo for marketing reasons.

Device modifications

The proposed Illumeo system includes the following minor modifications, compared to the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).

Description of the device modifications:

1. Improved performance of the software image management system -communication to PACS using dedicated interfaces and automatic preprocessing on data arrival for enhanced performance.
1. Integration with IntelliSpace PACS improvements in data retrieval through FHIR interface and reporting workflow, interface with Electronic Medical Record (EMR) and Radiology Information System (RIS)
1. Scalability - Illumeo v2.0 supports up to 50 concurrent users using hosted client and up to 150 concurrent users using enterprise viewer.
1. Multimodality and Multivendor support: Additional Multimodality supported - SPECT, improved Multivendor support, support for Presentation states (PR), PET/CT fusion of a single study
1. Patient briefing including additional information such as prior findings, recent Lab Results, Scanned documents, Patient Location and type.
1. 2D and 3D viewing enhanced additional tools
1. Findings creation and management improvements including Match finding feature enabling track and measure change over time.

Illumeo System Special 510k Submission

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1. Comparison and Synchronization enhanced capabilities such as compare mode between current and prior studies, comparison inspector presenting the same region of interest in the same study or compared to prior studies, manual link/unlink datasets.
Hanging protocols (HP) functionality which enables to present presets that define how 9. a study is displayed (layout), which series will be displayed by default and what viewing parameters are used. Hanging Protocols are multi - modality as per study type.
1. Vascular Inspection mode/ Vascular Quantification inspector enhanced vascular inspection mode including local vascular inspection mode
1. User Interface Improvements
1. Enterprise Viewer Illumeo system includes Enterprise viewer a fully HTML5 based viewer version, embedding Findings Presenter functionalities to address Enterprise clinical review by the specialists. Enterprise viewer zero footprint viewer requires no installation, and runs on most common operating systems and browsers. Enterprise Viewer is not intended to be used on mobile platforms.

The proposed Illumeo system includes modifications which are considered minor technology changes mainly designated to provide users further support in visualization.

The presented device modifications do not affect/change neither Intended Use nor alter the fundamental scientific technology of the device.

Therefore Philips believes a Special 510(k) is the appropriate type of submission

V. Indications for Use

Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.

This device is not to be used for mammography.

Indications for Use Discussion

The proposed device, Illumeo system, is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment, identical to the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315).

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Illumeo system software is designed to perform digital image processing, measurement, manipulation and quantification of images, communication and storage with indications for use identical to the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).

The Indications for Use statement for I4 (Integrated Intelligent Imaging Informatics) is identical compared to the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315).

Based on the above, the proposed Illumeo system is considered substantially equivalent to the currently marketed and primary predicate device I4 (Integrated Intelligent Imaging Informatics) system (K160315), in terms of Indications for use.

VI. Comparison of Technological Characteristics with the Predicate Device

The proposed Illumeo system is an evolution of previously cleared I4 (Integrated Intelligent Imaging Informatics) system (K160315), with additional minor modifications deriving from the identified predicate and reference devices.

Illumeo v2.0 is an evolution of llumeo v1.0 system, formerly also known as I4 (Integrated Intelligent Imaging Informatics) System. The product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo system, for marketing reasons.

Illumeo system is a software package used with general purpose computing hardware. Illumeo system uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, and standard measurement tools. Both the proposed device and the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315), provide Diagnostic Review Solution for radiology, utilizing client -server technology, storage capabilities, communication and interoperability with hospital systems.

Both the proposed device and the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315), offer a primary interpretation solution for visualization and evaluation variety of medical images deriving from various imaging modalities as well as nonimaging information. Illumeo and its primary predicate device interconnect with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

The proposed device, Illumeo system, has implemented features designated to bring the product up to date with current technologies and customer requests.

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A comparison table below (please see Table No.2- 1 below) provides a comparison which outlines a high-level overview of the differences and similarities between Illumeo system and the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).

#	Specification /Feature	Illumeo System(Proposed device)	I4 (Integrated Intelligent ImagingInformatics) System(K160315)(Primary Predicate Device)
1.	Software Imagemanagement system	Yes	Yes
2.	Hardware Platformrequirements	Yes	Yes
System Configuration
3.	Windows OperatingSystem	Yes	Yes
4.	TCP-IP NetworkProtocol	Yes	Yes
5.	Supports HighResolutionDiagnosticMonitors	Yes	Yes
6.	Storage capabilities	Yes	Yes
7.	Multiple monitorsupport	Yes	Yes
Communication and Interoperability with other image management systems
8.	Supports DICOMstudies receivedfrom differentmodalities types	YesCT, MR, US, XA, DX, CR,RF, PET, SC, SPECT,as well as hospital/radiologyinformation system	Yes
9.	Mammography	No	No
10.	Accepts patient andexam updates	Yes	Yes
Operating Platform requirements
11.	Client-servertechnology	Yes	Yes
#	Specification /Feature	Illumeo System(Proposed device)	I4 (Integrated Intelligent ImagingInformatics) System(K160315)(Primary Predicate Device)
12.	Thin client installer	Yes	Yes
13.	Multiple concurrentuser support	YesUp to 50 concurrent users using hosted clientUp to 150 concurrent users using Enterprise Viewer	YesUp to 10 concurrent users
Management tools
14.	Auditing Tool	Yes	Yes
15.	Client installer	Yes	Yes
16.	Systemmanagement	Yes	Yes
17.	Security andPrivacy	Yes	Yes
Viewing and Image Processing
18.	Supported Data andMulti Modalities	Supports receiving, sending,storing and displaying studiesreceived from the followingmodalities via DICOM:CT, MR, US, XA, DX, CR,RF, PET, SPECT and SC aswell as hospital /radiologyinformation systems.	Supports receiving, sending, storingand displaying studies received fromthe following modalities via DICOM:CT, MR, US, XA, DX, CR, RF, PETand SC as well as hospital /radiologyinformation systems.
19.	2D viewingcapabilities	Yes	Yes
#	Specification /Feature	Illumeo System(Proposed device)	14 (Integrated Intelligent ImagingInformatics) System(K160315)(Primary Predicate Device)
20.	3D viewingcapabilities	Yes	Yes
21.	Finding creationand managementtool	Yes	Yes
22.	Comparison andSynchronizationbetween volumetricseries	Yes	Yes
23.	Hanging protocols(HP)	Yes	Yes
24.	Advanced vesselanalysisvisualization andevaluation mode -VascularQuantificationInspector (VascularInspection Mode)	Yes	Yes
25.	Incorporationofnon-imaging data inpatient context(Patient Briefing)	Yes	Yes
26.	EnterpriseDiagnostic webviewer	Yes	Yes
27.	Non - DiagnosticEnterprise webviewer	Yes	Yes

Table No.2- 1 Technological characteristics comparison

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The proposed device. Illumeo system, has implemented features designated to bring the product up to date with current technologies and customer requests.

Presented technological differences are considered low risk, providing further support to users/clinicians in visualization. All the above listed device modifications were verified and validated demonstrating that the design outputs of the modified device meet the design input requirements and do not raise new questions on safety and/or effectiveness.

These features have not changed the intended use and the fundamental scientific technology of the device.

Therefore, the proposed Illumeo system is substantially equivalent to the currently marketed primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) in terms of technological characteristics.

Conclusion

The proposed Illumeo system is Substantially Equivalent to the currently marketed primary predicate device, I4 (Integrated Intelligent Imaging Informatics) System (K160315), in terms of Indication for Use, design features, fundamental scientific technology, and safety and/or effectiveness

VII. Performance Data

Section 16 'Software' provides a summary of the technical documentation which includes nonclinical verification and validation tests. These tests are performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results, and according to the following International and FDA-recognized consensus standards and FDA guidance document.

The following performance data were provided in support of the substantial equivalence determination.

Summary of Non-clinical testing

No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on Illumeo system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

I ISO 14971 Medical devices - Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes l

Illumeo System Special 510k Submission

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I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
l NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
. Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

Illumeo system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.

The test results in this Special 510(k): Device Modification submission demonstrates that Illumeo system:

. Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
Meets the acceptance criteria and is adequate for its intended use and user needs.

Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable. Therefore, Illumeo system is substantially equivalent to the currently marketed primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) in terms of safety and effectiveness.

Summary of Clinical Testing

The subject of this Special 510(k): Device Modification submission, Illumeo system did not requires clinical studies to support equivalence.

Substantial Equivalence Conclusion VIII.

The Illumeo system is substantially equivalent to the currently marketed primary predicate device (Integrated Intelligent Imaging Informatics) System (K160315) in terms of Indications for Use, design features, fundamental scientific technology, and safety and/or effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance testing. Verification and Validation (V&V) activities were performed for proposed Illumeo system and demonstrated that the predetermined acceptance criteria were successfully met. The non-clinical performance tests provided in this Special 510(k): Device Modification submission demonstrated that the proposed Illumeo system is as safe and effective as its primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) without raising any new safety and/or effectiveness concerns.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).