Philips IntelliSpace Cardiovascular

K153022 · Philips Medical Systems Nethrlands BV · LLZ · Nov 18, 2015 · Radiology

Device Facts

• Record ID: K153022
• Device Name: Philips IntelliSpace Cardiovascular
• Applicant: Philips Medical Systems Nethrlands BV
• Product Code: LLZ · Radiology
• Decision Date: Nov 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

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 medical images.

Device Story

IntelliSpace Cardiovascular (ISCV) is a multimodality image and information management system for cardiology departments. It ingests digital cardiovascular images, waveforms, and data from various modalities (ultrasound, X-ray, CT, MR, nuclear medicine). The system provides a centralized platform for clinicians to review, analyze, quantify, and report on patient studies. It supports remote deployment, thin-client browser-based access (HTML5), and integration with hospital information systems (HIS/EMR). Clinicians use the system to access patient cardiovascular history, perform measurements, and generate reports. The modular design allows for configurable workflows and data exchange via standard protocols (DICOM, HL7). By consolidating data and providing diagnostic tools, the device facilitates efficient clinical decision-making and patient management across the cardiovascular care continuum. It does not interact directly with the patient and does not apply radiation or contrast agents.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical performance testing, including system-level tests, performance tests, and safety testing derived from risk analysis, demonstrating that the device meets all defined functionality requirements.

Technological Characteristics

Software-based PACS; runs on standard IT hardware and server/desktop operating systems. Supports virtualization (VMWare) and thin-client (HTML5) browser access. Connectivity via TCP/IP, DICOM, DSR, HL7, NFS, FTP. Integrates with Philips TSM/Xper IM. Features include automated study placement, DICOM SR mapping, and consistency check mechanisms for diagnostic guidance. No patient-contacting components; no radiation/contrast application.

Indications for Use

Indicated for patients undergoing radiology procedures and users of the equipment. The system performs import, export, storage, archival, review, analysis, quantification, reporting, and database management of digital cardiovascular images, waveforms, and data.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Philips Xcelera (K061995)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dave J.W. Bierhuizen<br>Quality and Regulatory Manager<br>Phone: [phone]<br>E-mail: [e-mail] |

#### 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

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.

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#### V. Intended use/ Indications for Use

#### Intended Use

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 medical images.

#### Indication for Use

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 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.

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.

#### 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<br>(Subject device) | Xcelera<br>(Predicate device - K061995) |
|-------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Intended Use / Target population | | |
| 1. | Intended Use | Philips IntelliSpace Cardiovascular software<br>product is an integrated multimodality image<br>and information system designed to perform<br>the necessary functions required for import,<br>export, storage, archival, review, analysis,<br>quantification, reporting and database<br>management of digital medical images. | Philips Xcelera software product is an<br>integrated multimodality image and<br>information system designed to perform the<br>necessary functions required for import,<br>export, storage, archival, review, analysis,<br>quantification, reporting and database<br>management of digital medical images. |
| 2. | Target population | Patients undergoing radiology procedures<br>and the users of the equipment. | Patients undergoing radiology procedures<br>and the users of the equipment. |
| # | Specification / Feature | IntelliSpace Cardiovascular<br>(Subject device) | Xcelera<br>(Predicate device - K061995) |
| | Technology | | |
| 3. | Hardware Platform | Standard IT hardware | Standard IT hardware |
| | requirements | | |
| 4. | Operating Platform<br>requirements | Current industry standard versions of server<br>and desktop operating systems. | Industry standard versions of server and<br>desktop operating systems. |
| 5. | Browser support | Thin clients are supported on HTML5<br>capable browsers. | Not supported |
| 6. | Virtualization | Server virtualization enabled with VMWare | Not supported |
| 7. | Imaging and Other<br>Communications<br>Protocols | TCP/IP, DICOM, DSR, HL7, NFS, FTP | TCP/IP, DICOM, DSR, HL7, NFS, FTP |
| 8. | Support for launching 3rd<br>party medical devices | Plug-in support for: ultrasound,<br>cardiovascular X-ray, nuclear medicine,<br>computed tomography, magnetic<br>resonance, and electrophysiology studies.<br>URL launch of 3rd party medical devices<br>(that allow URL launch) | Plug-in support for: ultrasound,<br>cardiovascular X-ray, nuclear medicine,<br>computed tomography, magnetic<br>resonance, and electrophysiology studies. |
| 9. | EMR/HIS Interface | A mechanism to launch from the EMR<br>system directly into ISCV, and into the EMR. | Not supported |
| 10. | Integration with Philips<br>information management<br>systems | TSM (Table Side Module) Xper IM Philips CVIS | TSM (Table Side Module) Xper IM |
| 11. | System entry screen | Browser-based workspace with applets,<br>system extensions and workflow modules.<br>Provides two layers: user-centric, for search<br>and configurable worklist functionality;<br>patient-centric: for detailed cardiovascular<br>history. | Main window including configurable worklist. |
| | Archiving | | |
| 12. | Automatic Study<br>placement and folder<br>creation | Yes | Yes |
| 13. | Study and Patient<br>Management, incl. delete<br>images from study, study<br>split, merge, and<br>enterprise master patient<br>index | Yes | Not supported |
| 14. | Study Type | Ultrasound, Nuclear medicine, X-ray (cath<br>and invasive vascular), all other modality<br>types related to cardiology. | Ultrasound, Nuclear medicine, X-ray (cath) |
| 15. | DICOM SR Mapping<br>Tooling | Yes | Not supported |
| 16. | Customized<br>measurements and<br>calculations tool | Yes | Yes |
| 17. | PDF Import | Import reports that are in PDF format from<br>external sources. | Not supported |
| 18. | Data Mining | Supported | Supported |
| | Viewing | | |
| 19. | Supported Data and<br>Modalities | All DICOM formats as stated in the<br>DICOM, including but not limited to:<br>Ultrasound, Cath, CT and MR. Philips' proprietary ultrasound image<br>format (DSR-TIFF). | All DICOM formats as stated in the<br>DICOM, including but not limited to:<br>Ultrasound, Cath, CT and MR. Philips' proprietary ultrasound image<br>format (DSR-TIFF). |
| 20. | Cath Viewer | Yes | Yes |
| 21. | Echo Viewer | Yes | Yes |
| 22. | Remote Viewing (thin<br>client) | Zero-install (thin) client, browser based<br>technology (HTML5) to perform review-only<br>of 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.