Philips IntelliSpace Cardiovascular software product is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images, waveforms and data related to cardiology.

Philips IntelliSpace Cardiovascular offers support for third party applications in order to enable the use of commercially available tools and specified applications for analysis, quantification and reporting. It allows multiple users fast access to, and exchange of specific and/or multiple cardiology exams.

Philips IntelliSpace Cardiovascular software runs on standard information technology hardware, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.

The modular design allows configurability to tailor the image import, archive and communications solution to one's particular budgetary and performance needs. The number of modalities and reporting and/or viewing sites can be configured per system.

Device Description

IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient follow-up encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available.

The solution supports a remote deployment model.

AI/ML Overview

The provided text is a 510(k) summary for the Philips IntelliSpace Cardiovascular device. It explicitly states that no clinical studies were required or performed to support the equivalence of this device. Therefore, it does not contain the specific information requested about acceptance criteria or a study proving the device meets those criteria.

However, the document does contain information about how the device's performance was evaluated, which I can summarize with the disclaimer that it is not a clinical study in the traditional sense outlined in your request.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of precise acceptance criteria with corresponding performance metrics. Instead, it describes general verification and validation activities.

Acceptance Criteria Category (Derived from document)	Reported Device Performance
Functionality Requirements	IntelliSpace Cardiovascular meets all defined functionality requirements.
Performance Claims	IntelliSpace Cardiovascular meets all defined performance claims.
Safety Testing	Performed, addressing findings from Risk Analysis. (Implied: device is safe)
Compliance with Standards	Complied with requirements specified in international and FDA-recognized consensus standards.
Equivalence to Predicate	Found substantially equivalent to Philips Xcelera (K061995) in design features, fundamental scientific technology, intended use, and safety and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for test sets, data provenance, or whether testing was retrospective or prospective. It refers to general "system level tests, performance tests, and safety testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided because no clinical studies involving ground truth assessment by experts are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

5. 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 MRMC comparative effectiveness study was done. The device is an image and information management system, not an AI-assisted diagnostic tool in the sense that would typically require such a study for its clearance as described here.

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

The device is a software product designed for image and information management, with human users ("clinicians," "users of the equipment"). A standalone algorithm-only performance study as typically understood for AI diagnostics is not applicable and was not performed. The performance evaluation focused on the system's functionality and its equivalence to a predicate device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Since no clinical studies or diagnostic performance evaluations were conducted to establish "ground truth" for diagnostic accuracy, this information is not applicable and not provided. The testing focused on technical and functional verification rather than diagnostic accuracy against a ground truth.

8. The sample size for the training set

This information is not applicable and not provided. The device is not described as an AI/ML system that would require a "training set" in the context of diagnostic algorithm development.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no mention of a training set for an AI/ML algorithm.

In summary, the Philips IntelliSpace Cardiovascular device (K153022) was cleared through the 510(k) pathway by demonstrating substantial equivalence to a predicate device (Philips Xcelera K061995) based on non-clinical testing. This non-clinical testing included risk analysis, product specifications, design reviews, and verification and validation activities to ensure the device met its defined functionality and performance requirements and complied with relevant standards. No clinical studies or human performance evaluations were deemed necessary or conducted for its clearance.

Summary

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

November 18, 2015

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

Re: K153022

Trade/Device Name: Philips Intellispace Cardiovascular Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 5, 2015 Received: November 6, 2015

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.

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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 O'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) K153022

Device Name Philips IntelliSpace Cardiovascular

Indications for Use (Describe)

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

IntelliSpace Cardiovascular

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

Date Prepared: September 30, 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:	Dave J.W. BierhuizenQuality and Regulatory ManagerPhone: +31 40 2764366E-mail: dave.bierhuizen@philips.com

II. Device information

Device Name:	IntelliSpace Cardiovascular
Common Name:	Cardiovascular Image and Information Management System
Classification:	Classification name:	Picture Archiving and Communications System
	Device class:	Class II
	Classification regulation:	21 CFR 892.2050
	Classification panel:	Radiology
	Product code:	LLZ

III. Predicate device information

Predicate Device:	Trade name:	Philips Xcelera
	Manufacturer:	Philips Medical Systems Nederland B.V.
	510(k) clearance:	K061995
	Classification name	Picture Archiving and Communications System
	Device class:	Class II
	Classification regulation:	21 CFR 892.2050
	Classification panel:	Radiology
	Product code:	LLZ

IV. Device Description

The solution supports a remote deployment model.

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V. Intended use/ Indications for Use

Intended Use

Indication for Use

Philips IntelliSpace Cardiovascular software runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using standard protocols. Philips IntelliSpace Cardiovascular will also be made available for use on specified Cardiovascular Monitoring Systems, which use suitable hardware components.

VI. Comparison of Technological Characteristics with the Predicate Device

Philips IntelliSpace Cardiovascular (ISCV) software is an integrated multimodality image and information system, which employs and further builds on the same fundamental scientific technology as the Philips Xcelera software.

IntelliSpace Cardiovascular software runs on standard information technology hardware and software.

IntelliSpace Cardiovascular does not interact with the patient, and does not apply any radiation or contrast agent to the patient.

A comparison matrix (please see Table 5-1 below) shows the similarities and differences. The ISCV software with the listed enhancements is comparable to the previously cleared Xcelera product as the changes do not impact the Intended Use or patient population. Enhancements relate to upgrades in current standard IT application and technology environment or clinical practices to improve customer workflows. All changes are implemented and tested utilizing released design and change control processes. No new issues of safety or effectiveness are raised as compared to the predicate device.

#	Specification / Feature	IntelliSpace Cardiovascular(Subject device)	Xcelera(Predicate device - K061995)
	Intended Use / Target population
1.	Intended Use	Philips IntelliSpace Cardiovascular softwareproduct is an integrated multimodality imageand information system designed to performthe necessary functions required for import,export, storage, archival, review, analysis,quantification, reporting and databasemanagement of digital medical images.	Philips Xcelera software product is anintegrated multimodality image andinformation system designed to perform thenecessary functions required for import,export, storage, archival, review, analysis,quantification, reporting and databasemanagement of digital medical images.
2.	Target population	Patients undergoing radiology proceduresand the users of the equipment.	Patients undergoing radiology proceduresand the users of the equipment.
#	Specification / Feature	IntelliSpace Cardiovascular(Subject device)	Xcelera(Predicate device - K061995)
	Technology
3.	Hardware Platform	Standard IT hardware	Standard IT hardware
	requirements
4.	Operating Platformrequirements	Current industry standard versions of serverand desktop operating systems.	Industry standard versions of server anddesktop operating systems.
5.	Browser support	Thin clients are supported on HTML5capable browsers.	Not supported
6.	Virtualization	Server virtualization enabled with VMWare	Not supported
7.	Imaging and OtherCommunicationsProtocols	TCP/IP, DICOM, DSR, HL7, NFS, FTP	TCP/IP, DICOM, DSR, HL7, NFS, FTP
8.	Support for launching 3rdparty medical devices	Plug-in support for: ultrasound,cardiovascular X-ray, nuclear medicine,computed tomography, magneticresonance, and electrophysiology studies.URL launch of 3rd party medical devices(that allow URL launch)	Plug-in support for: ultrasound,cardiovascular X-ray, nuclear medicine,computed tomography, magneticresonance, and electrophysiology studies.
9.	EMR/HIS Interface	A mechanism to launch from the EMRsystem directly into ISCV, and into the EMR.	Not supported
10.	Integration with Philipsinformation managementsystems	TSM (Table Side Module) Xper IM Philips CVIS	TSM (Table Side Module) Xper IM
11.	System entry screen	Browser-based workspace with applets,system extensions and workflow modules.Provides two layers: user-centric, for searchand configurable worklist functionality;patient-centric: for detailed cardiovascularhistory.	Main window including configurable worklist.
	Archiving
12.	Automatic Studyplacement and foldercreation	Yes	Yes
13.	Study and PatientManagement, incl. deleteimages from study, studysplit, merge, andenterprise master patientindex	Yes	Not supported
14.	Study Type	Ultrasound, Nuclear medicine, X-ray (cathand invasive vascular), all other modalitytypes related to cardiology.	Ultrasound, Nuclear medicine, X-ray (cath)
15.	DICOM SR MappingTooling	Yes	Not supported
16.	Customizedmeasurements andcalculations tool	Yes	Yes
17.	PDF Import	Import reports that are in PDF format fromexternal sources.	Not supported
18.	Data Mining	Supported	Supported
	Viewing
19.	Supported Data andModalities	All DICOM formats as stated in theDICOM, including but not limited to:Ultrasound, Cath, CT and MR. Philips' proprietary ultrasound imageformat (DSR-TIFF).	All DICOM formats as stated in theDICOM, including but not limited to:Ultrasound, Cath, CT and MR. Philips' proprietary ultrasound imageformat (DSR-TIFF).
20.	Cath Viewer	Yes	Yes
21.	Echo Viewer	Yes	Yes
22.	Remote Viewing (thinclient)	Zero-install (thin) client, browser basedtechnology (HTML5) to perform review-onlyof series, runs, loops and images.	Not supported
	Quantification and
	Reporting
23.	Cath Viewer	Simple distance measurements (non-	Simple distance measurements (non-
	Measurements	persistent)	persistent)
#	Specification / Feature	IntelliSpace Cardiovascular (Subject device)	Xcelera (Predicate device - K061995)
24.	Cath Quantitative Analysis	Yes	Yes
25.	Echo Measurements and Calculations	2D Doppler MMode Trending graph of measurements and z-scores Z-scores: Michigan data	2D Doppler MMode Trending graph of measurements and z-scores Z-scores: Michigan data
26.		Z-scores: extensions of z-scores data (Boston)	Not supported
27.		Blood Pressure import from DICOM SR files from vendors (Philips, GE, Siemens, Toshiba)	Not supported
28.	Diagnostic Guidance	Consistency check mechanism that will allow clinicians to predefine a set of rules.	Not supported
29.	Remote reporting (tele-cardiology)	View the study from a remote location and perform reporting tasks on the study.	Not supported
30.	Remote Echo Reporting (thin client)	Thin client, browser based technology (HTML5) to perform diagnostic review and 2D measurements on echo images. Supported on standard PC hardware; not supported on mobile devices.	Not supported
Other
31.	System access	Define user rights based on institute level.	Global user rights
32.	Single access to configuration	Configure ISCV in a singular place	Not supported

Table 5-1 Comparison Table of the modified ISCV to the predicate Xcelera product.

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Philips Medical Systems Nederland B.V.

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Philips Medical Systems Nederland B.V.

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VII. Performance Data

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. IntelliSpace Cardiovascular was tested in accordance with Philips verification and validation processes. Quality Assurance measures were applied to the system design and development, including:

Risk Analysis
Product Specifications
. Design Reviews
Verification & Validations .

Summary of Clinical Testing

The subject of this premarket submission, IntelliSpace Cardiovascular software did not require clinical studies to support equivalence.

Conclusions drawn from the Non-clinical and Clinical testing

Verification and Validation activities required to establish performance and functionality of IntelliSpace Cardiovascular were performed. Testing involved system level tests, performance tests, and safety testing from Risk Analysis. Testing performed demonstrated the IntelliSpace Cardiovascular meets all defined functionality requirements and performance claims.

VIII.Conclusion

The IntelliSpace Cardiovascular is substantially equivalent to the predicate device Xcelera (K061995) in terms of design features, fundamental scientific technology, intended use, and safety and effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance testing, which complied with the requirements specified in the international and FDA-recognized consensus standards. The non-clinical performance tests provided in this 510(k) premarket notification demonstrate that the subject IntelliSpace Cardiovascular is as safe and effective as its predicate device 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).