I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.

I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process 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

I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.

I4 (Integrated Intelligent Imaging Informatics) 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.

I4 (Integrated Intelligent Imaging Informatics) 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. I4 interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.

AI/ML Overview

This document (K160315) describes the Philips I4 (Integrated Intelligent Imaging Informatics) system, an image management software package. It focuses on demonstrating substantial equivalence to a predicate device, IntelliSpace PACS 4.x (K111804), rather than proving the device meets specific clinical acceptance criteria for a novel diagnostic task.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies for improved reader performance is not present in this 510(k) summary.

The document asserts that the device "Meets the acceptance criteria and is adequate for its intended use" based on non-clinical performance testing and compliance with relevant standards. The "acceptance criteria" here refer to internal development and regulatory compliance criteria, not the performance metrics of a diagnostic AI as one might typically expect with such a request.

Here's a breakdown of what is available based on the provided text, and where information is explicitly missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (as implied by the document):
The device is intended to:

Function as an image management system for trained professionals (e.g., radiologists).
Acquire, store, distribute, process, and display images and associated data in a clinical environment.
Perform digital image processing, measurement, manipulation, and quantification of images, communication, and storage.
Comply with specified international and FDA-recognized consensus standards (ISO 14971, IEC 62304, IEC 62366-1, NEMA-PS 3.1-PS 3.20 DICOM).
Follow the FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
Maintain safety and effectiveness comparable to the primary predicate device (IntelliSpace PACS 4.x, K111804).
Not be used for mammography.
Incorporate advanced visualization and evaluation capabilities from reference predicate devices.

Reported Device Performance (based on non-clinical testing):
The document states that "I4 (Integrated Intelligent Imaging Informatics) 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 results of these tests demonstrate that the system:

"complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document."
"Meets the acceptance criteria and is adequate for its intended use."

Detailed Performance Table:
A table of specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, processing speed, image quality metrics) and matching numerical performance results is not provided in this document. The "acceptance criteria" discussed are overarching regulatory and functional compliance rather than specific diagnostic accuracy metrics.

Additional Requested Information:

Sample size used for the test set and the data provenance:
- Not explicitly stated for clinical performance. The document refers to "non-clinical performance testing" which would involve software verification and validation, possibly using test data sets, but details on the size or provenance of such data (e.g., if it involved medical images) are not provided. The study is not a clinical study directly evaluating diagnostic accuracy on a patient cohort.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As this was a non-clinical performance evaluation focused on substantial equivalence through functional and technological comparison, there was no clinical test set requiring expert ground truth for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. The document explicitly states: "The subject of this premarket submission, I4 (Integrated Intelligent Imaging Informatics) system did not require clinical studies to support equivalence." This indicates no clinical performance study involving human readers or AI assistance in a diagnostic context was conducted or submitted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the sense of a diagnostic AI algorithm. The I4 system is an image management system (PACS), not a standalone diagnostic AI algorithm. Its performance is evaluated on its ability to acquire, store, process, and display images, and its substantial equivalence to an existing PACS system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in a clinical diagnostic sense. The "ground truth" for the non-clinical testing would relate to functional specifications and expected software behavior (e.g., "does the image display correctly?", "does the system store the image as specified?").
The sample size for the training set:
- Not applicable. This is a PACS system, not a machine learning model, so there is no training set in the AI sense.
How the ground truth for the training set was established:
- Not applicable. See point 7.

In summary, the provided document focuses on demonstrating the substantial equivalence of the I4 system to predicate devices based on functional, technological, and regulatory compliance, rather than clinical performance data from a prospective study evaluating diagnostic accuracy. The "acceptance criteria" referred to are related to internal development and regulatory standards for a PACS system, not clinical diagnostic metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, resembling a family or group of people.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 19, 2016

Philips Medical Systems Nederland BV % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313

Re: K160315

Trade/Device Name: 14 (integrated Intelligent Imaging Informatics) System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: February 3, 2016 Received: February 5, 2016

Dear Mr. Job:

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

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160315

Device Name

I4 (Integrated Intelligent Imaging Informatics) system

Indications for Use (Describe)

I4 (Integrated Intelligent Imaging Informatics) 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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and appears to be a logo or brand name.

510(k) Summary

14 (Integrated Intelligent Imaging Informatics)

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

Date Prepared: December 15, 2015

I. Submitter's name and address

Manufacturer:	Philips Medical Systems Nederland B.V.Veenpluis 4-65684 PC BestThe NetherlandsEstablishment Registration Number: 3003768277
Contact Person:	Ilana Ben MosheRegulatory Affairs ExpertPhone: +972 525233496E-mail: Ilana.Ben-Moshe@philips.com

II. Device information

Subject Device:

Device Name:

I4 (Integrated Intelligent Imaging Informatics) 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 Primary Product Code: LLZ Secondary Product Code: JAK

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and appears to be a logo or brand name.

III. Predicate device information

Primary Predicate Device:

Trade name:	IntelliSpace PACS 4.x
Manufacturer:	Philips Healthcare Informatics, Inc.
510(k) clearance:	K111804
Classification name:	Picture Archiving and Communications System
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ

Reference Predicate Devices:

Trade name:	ViewForum 2003
Manufacturer:	Philips Medical Systems North America Company
510(k) clearance:	K032096
Classification name	System, Image Processing
Device class:	Class II
Classification regulation:	21 CFR 892.2050
Classification panel:	Radiology
Product code:	LLZ

Brilliance iCT (Brilliance Volume) Philips Medical Systems(Cleveland), Inc. K060937 System, X-Ray, Tomography, Computed Class II 21 CFR 892.1750 Radiology JAK

Reference Device:

Trade name:

Manufacturer:

Device class:

Product code:

510(k) clearance:

Classification name:

Classification panel:

Classification regulation:

Trade name:	VesselNavigator
Manufacturer:	Philips Medical Systems Nederland B.V.
510(k) clearance:	K151598
Classification name	Image-intensified fluoroscopic x-ray system
Device class:	Class II
Classification regulation:	21 CFR 892.1650
Classification panel:	Radiology
Product code:	OWB, LLZ

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. A thin black line runs underneath the word, emphasizing its presence.

IV. Device Description

I4 (Integrated Intelligent Imaging Informatics) 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.

V. Indications for Use

I4 (Integrated Intelligent Imaging Informatics) 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 I4 (Integrated Intelligent Imaging Informatics) 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, IntelliSpace PACS 4.x (K111804).

I4 (Integrated Intelligent Imaging Informatics) software is designed to perform digital image processing, measurement, manipulation and quantification of images, communication and storage with indications for use similar to the primary predicate device. IntelliSpace PACS 4.x (K111804).

The Indications for Use statement for I4 (Integrated Intelligent Imaging Informatics) is similar, but not identical compared to the primary predicate device, IntelliSpace PACS 4.x (K111804), and the two devices have the same intended use.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and centered in the image.

트 I4 (Integrated Intelligent Imaging Informatics) software provides digital image processing function of performing image manipulation (e.g 3D rendering modes and 3d visualization) with advanced visualization and evaluation capabilities of cleared to market reference predicate devices ViewForum 2003(K032096). Brilliance iCT (Brilliance Volume)(K060937).14 system indications for use are a combination of primary predicate device and reference predicate devices, and falls within the intended use of the primary predicate device.
This difference does not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the primary predicate IntelliSpace PACS 4.x (K111804). Both the proposed and the primary predicate device have the same intended use, a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment.
I I4 (Integrated Intelligent Imaging Informatics) system is not to be used for mammography. This is a reduction of the IntelliSpace PACS 4.x (K111804) Indications for Use scope. This limitation is clearly indicated in the labelling and does not raise new questions on safety and/or effectiveness
Listed above differences do not alter the intended use nor do they affect the safety and effectiveness of the device relative to the primary predicate device, IntelliSpace PACS 4.x (K111804).

Based on the above, the proposed 14 (Integrated Intelligent Imaging Informatics) is considered substantially equivalent to the currently marketed and primary predicate device IntelliSpace PACS 4.x (K111804), in terms of Indications for use.

Comparison of Technological Characteristics with the Predicate Device VI.

I4 (Integrated Intelligent Imaging Informatics) system is an evolution of the primary predicate device IntelliSpace PACS 4.x (K111804) with additional/enhanced functionality deriving from the reference predicate devices ViewForum2003 (K032096), Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).

I4 (Integrated Intelligent Imaging Informatics) is a software package used with general purpose computing hardware.

I4 (Integrated Intelligent Imaging Informatics) system uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, standard measurement tools.

Both the proposed device and the primary predicate device provide Diagnostic Review Solution for radiology, utilizing client -server technology, storage capabilities, communication and interoperability with hospital systems, such as radiology workflow providers and image archive.

A comparison matrix below (please see Table 0-1 below) provides a comparison which outlines a high level overview of the differences and similarities between 14 (Integrated Intelligent

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and centered in the image.

Imaging Informatics) system and the primary predicate device, IntelliSpace PACS 4.x (K111804) , reference predicate devices, ViewForum2003 (K032096),Brilliance iCT (Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).

#	Specification / Feature	Proposed Device:I4 (IntegratedIntelligentImagingInformatics)system	Primary Predicate Device	Reference predicate Devices:Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
1.	Software Imagemanagement system	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
2.	Hardware Platformrequirements	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
	System Configuration
3.	Windows OperatingSystem	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
4.	TCP-IP NetworkProtocol	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
#	Specification / Feature	ProposedDevice:I4 (IntegratedIntelligentImagingInformatics)system	Primary PredicateDeviceIntelliSpace PACS4.x(K111804)	Reference predicateDevices:Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
5.	Supports HighResolution DiagnosticMonitors	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
6.	Storage capabilities	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
7.	Multiple monitorsupport	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
Communication and Interoperability with other image management systems
8.	Supports DICOM studiesreceived from differentmodalities types	Yes -CT, MR, US, XA,DX, CR, RF, PTand SC as well ashospital/radiologyinformationsystems	Yes-CT, MR, NM, US,XA, PET, DX, DR,RF, RT, MG, SC,VL	Yes -CT, MR
9.	Mammography	No	Yes	Not relevant for thissubject comparison as I4system do not supportMammography
#	Specification / Feature	ProposedDevice:I4 (IntegratedIntelligentImagingInformatics)system	Primary PredicateDeviceIntelliSpace PACS4.x(K111804)	Reference predicateDevices:Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
10.	Accepts patient andexam updates via HL7	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
	Operating Platform requirements
11.	Client-server technology	Yes	Yes	No - SW designed foruse on workstationsonly.
12.	Thin client installer	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
13.	Multiple concurrent usersupport	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
	Management tools
14.	Auditing Tool	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
#	Specification / Feature	Proposed Device:	Primary Predicate Device:	Reference predicate Devices:
		I4 (IntegratedIntelligentImagingInformatics)system	IntelliSpace PACS4.x(K111804)	Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
15.	Client installer	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
16.	System management	Yes	Yes	Not relevant for thissubject comparison asthe proposed deviceutilizes similartechnology as theprimary predicate
	Viewing and Image Processing
17.	Supported Data andMulti Modalities	Supportsreceiving, sending,storing anddisplaying studiesreceived from thefollowingmodalities viaDICOM:CT, MR, US, XA,DX, CR, RF, PTand SC as well ashospital /radiologyinformationsystems.	Supports receiving,sending, printing,storing anddisplaying studiesreceived from thefollowing modalitytypes via DICOM:CT, MR, NM, US,XA, PT, DX, DR,RF, RT, MG, SC,VL, as well ashospital/Radiologyinformationsystems.	CT, MR
18.	2D basic viewing:Multiple monitor layoutoptions , Scales image towindow, Cine	Yes	Yes	Yes
#	Specification / Feature	ProposedDevice:I4 (IntegratedIntelligentImagingInformatics)system	Primary PredicateDeviceIntelliSpace PACS4.x(K111804)	Reference predicateDevices:Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
19.	2D Advanced viewing:Compare seriesside-by-side, Multi-Dimensional viewing	Yes	No	Yes- ViewForum2003(K032096)
20.	3D volumetric viewing :Volumetric image	Yes	No	Yes -Brilliance iCT(Brilliance Volume)(K060937)
21.	Multi PlanarReconstruction (MPR)	Yes	No	Yes -Brilliance iCT(Brilliance Volume)(K060937)
22.	3D Rendering modes(MIP, MinIP, VIPSurface MIP,Average(AIP), Volumerendering)	Yes	No	Yes -Brilliance iCT(Brilliance Volume)(K060937)
23.	Comparison andSynchronization betweenvolumetric series	Yes	No	Yes- ViewForum2003(K032096)
24.	Image manipulation:Slab thickness andorientation (for MPRimages), windowing,zoom level, pan	Yes	No	Yes -Brilliance iCT(Brilliance Volume)(K060937)
25.	Measurements andAnnotations tools(for 2D and 3D viewing):Straight Line, CurvedLine, ROI, Angle, text,measurementcomparison	Yes-Measurementsand Annotationstools for 2D and3D viewingmodes	Yes-Measurements andAnnotations toolsfor 2D viewingmode	Yes- Brilliance iCT(Brilliance Volume)(K060937)
26.	Segmentation tools:Bone/Skull removal	Yes	No	Yes- Advance VesselAnalysis (AVA) fromBrilliance iCT(Brilliance Volume),(K060937)
#	Specification / Feature	ProposedDevice:	Primary PredicateDevice	Reference predicateDevices:
		I4 (IntegratedIntelligentImagingInformatics)system	IntelliSpace PACS4.x(K111804)	Brilliance iCT(Brilliance Volume)(K060937)ViewForum2003(K032096)Reference device:VesselNavigator(K151598)
27.	Advanced vessel analysisvisualization andevaluation mode(Vascular InspectionMode)	Yes	No	Yes –ViewForum2003(K032096),Brilliance iCT(Brilliance Volume)(K060937), andVesselNavigator(K151598).I4 incorporatefunctionalities from alllisted reference predicatedevices.
28.	Incorporation of non-imaging data in patientcontext(Mission Briefing)	Yes	No	No

Table 5-1 Technological characteristics comparison

{8}------------------------------------------------

Image /page/8/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are a bright blue color. The word is horizontally oriented and takes up most of the frame. There is a black line underneath the word.

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. The background is plain white.

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. A thin black line is present underneath the word, spanning its entire length.

{11}------------------------------------------------

Image /page/11/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is centered and takes up most of the frame. A thin black line is visible at the bottom of the image.

{12}------------------------------------------------

Image /page/12/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and appear to be a sans-serif font. A thin black line is visible beneath the word, possibly indicating the bottom edge of the image or a design element.

The subject device, I4 (Integrated Intelligent Imaging Informatics) 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 clinicians in visualization. These functionalities are derived from reference predicate devices and reference device, were verified and validated and do not raise new questions on safety and/or effectiveness. These features have not changed the intended use and operational principles of the device. Therefore, the I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of technological characteristics.

Performance Data VII.

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

Summary of Non-clinical testing

{13}------------------------------------------------

Image /page/13/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The font is sans-serif and the letters are evenly spaced. The word is horizontally oriented and appears to be a logo or brand name.

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 14 (Integrated Intelligent Imaging Informatics) system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:

트 ISO 14971 Medical devices – Application of risk management to medical devices
IEC 62304 Medical device software Software life cycle processes ■
I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
트 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

I4 (Integrated Intelligent Imaging Informatics) 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 510(k) premarket notification demonstrate that 14 (Integrated Intelligent Imaging Informatics) 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.

Therefore, I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of safety and effectiveness.

Summary of Clinical Testing

The subject of this premarket submission, 14 (Integrated Intelligent Imaging Informatics) system did not require clinical studies to support equivalence.

VIII. Substantial Equivalence Conclusion

The I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) 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. The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the proposed I4 (Integrated Intelligent Imaging Informatics) system is as safe and effective as its primary predicate device IntelliSpace PACS 4.x (K111804) 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).