(88 days)
No
The summary does not mention AI, ML, or any related terms, and the description focuses on standard image processing and networking functionalities.
No
The device is described as software for networking, selection, processing, and filming of multimodality DICOM images, intended for use by trained professionals, but it does not mention any therapeutic function.
No
The device description states that the software allows "networking, selection, processing and filming of multimodality DICOM images," and its intended use is to "allow multiple users [to access] clinical applications." It explicitly states, "The device is not intended for diagnosis of lossy compressed images," and does not claim to perform diagnostic functions. Its purpose is primarily for image management and access, not direct diagnosis.
Yes
The device is explicitly described as a "software medical device" in both the Intended Use and Device Description sections. It is designed to run on "off-the-shelf PC computer technology" and does not include any proprietary hardware components.
Based on the provided information, the Philips IntelliSpace Portal Platform is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "networking, selection, processing and filming of multimodality DICOM images." This involves handling and manipulating medical images, which are typically generated from imaging modalities like CT, MRI, X-ray, etc.
- Device Description: The description reinforces that the system communicates with "imaging systems of different modalities using the DICOM-3 standard."
- Lack of Biological Samples: IVD devices are designed to perform tests on biological samples (blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. There is no mention of the device interacting with or analyzing biological samples.
- Focus on Image Processing: The device's function revolves around processing and managing medical images, not analyzing biological specimens.
Therefore, the Philips IntelliSpace Portal Platform is a medical device focused on image management and processing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications .
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
The IntelliSpace Portal Platform communicates with imaging systems of different modalities using the DICOM-3 standard.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multimodality DICOM images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to physicians and medical technicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ı ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software - Software life cycle processes
- . 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
The ISPP system was tested in accordance with Philips verification 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 ISPP:
- complies with the aforementioned international and FDA-recognized consensus standards and l FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use.
The subject of this premarket submission, ISPP does not require clinical studies to support equivalence.
Verification and Validation activities required to establish performance and functionality of IntelliSpace Portal Platform were performed. Testing involved system level tests, performance tests, and safety testing from Risk Analysis. Testing performed demonstrated the IntelliSpace Portal Platform meets all defined functionality requirements and performance claims.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K060937, K130278, K032096, K111804, K111336
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V. C/O MARK JOB RESPONSIBLE THIRD PARTY OFFICIAL 1394 25TH STREET, NW BUFFALO MN 55313
Re: K162025
Trade/Device Name: IntelliSpace Portal Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 7, 2016 Received: October 11, 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.
October 18, 2016
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) K162025
Device Name IntelliSpace Portal Platform
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users clinical applications from compatible computers on a network.
The system allows networking, selection, processing and filming of multimodality DICOM images.
This software is for use with off-the-shelf PC computer technology that meets defined minimum specifications .
Philips IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
IntelliSpace Portal Platform
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Date prepared: | September 18, 2016 |
|---|---|
| ---------------- | -------------------- |
I. Submitter's name and address
| Establishment name: | Philips Medical Systems Nederland B.V. |
|---|---|
| Establishment address: | Veenpluis 4-6 |
| 5684 PC Best | |
| The Netherlands | |
| Establishment | |
| registration: | 3003768277 |
| Contact person: | Ilana Ben Moshe |
| Regulatory Affairs Expert | |
| Phone: +972 525233496 | |
| Email: Ilana. Ben-Moshe@philips.com |
II. Device information
| Trade name: | IntelliSpace Portal Platform |
|---|---|
| Common name: | Image and Information Management Platform |
| Classification name: | Picture Archiving and Communications System (21 CFR 892.2050, |
| Product Code LLZ) | |
| Device classification: | Class II |
III. Predicate device information
| Trade name: | AW Server |
|---|---|
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | GE Medical System, LLC |
| Classification name: | Picture Archiving and Communications System |
| Device classification: | Class II |
| 510(k) clearance number: | K081985 |
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| Reference device no 1 | |
|---|---|
| Trade name: | Extended Brilliance Workplace a component of Brilliance iCT |
| (Brilliance Volume) | |
| Common name: | Workstation |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |
| Classification name: | System, X-Ray, Tomography, Computed (21 CFR 992.1750, Product |
| Code JAK) | |
| Device classification: | Class II |
| 510(k) clearance number: | K060937 |
| Reference device no 2 | |
| Trade name: | MR Permeability Application |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050, |
| Product Code LLZ) | |
| Device classification: | Class II |
| 510(k) clearance number: | K130278 |
| Reference device no 3 | |
| Trade name: | ViewForum 2003 |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050, |
| Product Code LLZ) | |
| Device classification: | Class II |
| 510(k) clearance number: | K032096 |
| Reference device no 4 | |
| Trade name: | IntelliSpace PACS 4.x |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050, |
| Product Code LLZ) | |
| Device Classification | Class II |
| Clearance Number | K111804 |
| Trade name: | EBW NM 2.0 |
| Common name: | Picture Archiving and Communication System |
| Manufacturer: | Philips Medical Systems (Cleveland), Inc. |
| Classification name: | Picture Archiving and Communication System (21 CFR 892.2050, |
| Product Code LLZ) | |
| Device classification: | Class II |
| 510(k) clearance number: | K111336 |
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Reference device no 5
IV. Device description
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
The IntelliSpace Portal Platform communicates with imaging systems of different modalities using the DICOM-3 standard.
V. Intended use
Philips IntelliSpace Portal Platform is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images. This software is for use with offthe-shelf PC computer technology that meets defined minimum specifications.
IntelliSpace Portal Platform is intended to be used by trained professionals, including but not limited to physicians and medical technicians.
This medical device is not to be used for mammography.
The device is not intended for diagnosis of lossy compressed images.
VI. Technological characteristics
Philips believes that IntelliSpace Portal Platform product is substantially equivalent to the predicate GE A W Server legally marketed product with additional/enhanced functionality deriving from the reference devices:
- (K032096) ViewForum2003
- (K060937) Brilliance iCT (Brilliance Volume) EBW Workstation component
- (K130278) MR Permeability including details on IntelliSpace Portal component the next generation of the EBW product,
- I (K111804) IntelliSpace PACS 4.4
- l (K111336) EBW NM 2.0
Below is the comparison table to summarize the similarities and differences of the subject, predicate, and reference devices.
See Conclusion statement at the end of this section for substantial equivalency assessment of the differences indicated in the table.
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| # | Feature/ | IntelliSpace Portal | AW Server | Various (see details |
|---|---|---|---|---|
| Capability | Platform | Predicate Device | below) | |
| Subject Device | (K081985) | Reference Devices | ||
| System Configuration | ||||
| 1 | Standard off the | |||
| Shelf Hardware | ||||
| and Operating | ||||
| System (OS) | ||||
| requirements | Yes | Yes | Not supported | |
| 2 | VMware | |||
| Support | Yes | Yes | Not supported | |
| 3 | Thin client- | |||
| server | ||||
| technology | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 4 | Dual monitor | |||
| support | 1024x768 and up to | |||
| 3MP | 1024x768 and up to | |||
| 3MP | Not supported | |||
| 5 | Client multi- | |||
| resolution | ||||
| display support | 1024x768 and up to | |||
| 3MP | 1024x768 and up to | |||
| 3MP | Not supported | |||
| System Applications and Functionality | ||||
| 6 | Multiple | |||
| concurrent user | ||||
| support | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 7 | Patient | |||
| directory / | ||||
| Report/ Film / | ||||
| Worklist | ||||
| application | Yes | Not supported | Yes | |
| (K032096) ViewForum | ||||
| 8 | Presentation | |||
| State Support | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 9 | Pre-processing | |||
| and background | ||||
| processing | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 10 | CD/DVD | |||
| burning | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 11 | USB device | |||
| support | Yes | Not supported | Yes | |
| (K111804) IntelliSpace | ||||
| PACS 4.4 | ||||
| # | Feature/ | |||
| Capability | IntelliSpace | |||
| Portal Platform | ||||
| Subject Device | AW Server | |||
| Predicate | ||||
| Device | ||||
| (K081985) | Various (see details | |||
| below) | ||||
| Reference Devices | ||||
| 12 | Speech Recognition | |||
| software | ||||
| (PowerScribe) for | ||||
| reporting | Yes | Unknown | Yes | |
| (K032096) ViewForum | ||||
| 13 | Bookmarks: creating, | |||
| saving, and loading | Yes | Yes | Not supported | |
| 14 | Support of Lossy | |||
| Compression for | ||||
| improved | ||||
| performance | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 15 | Licensing | Yes | Unknown | Yes |
| (K130278) MR | ||||
| Permeability including | ||||
| IntelliSpace Portal | ||||
| 16 | Support of Data Pre- | |||
| Fetch from remote | ||||
| devices | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 17 | Management tool | Yes | Yes | Yes |
| (K032096) ViewForum | ||||
| Review Modes and Image Manipulation | ||||
| 18 | Support multi- | |||
| modality data | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| 19 | 2D slice view, Thin | |||
| slab/MPR view, | ||||
| 3D Volume | ||||
| Rendering/MIP view | ||||
| /MiniP | Yes | Unknown | Yes | |
| (K032096) ViewForum | ||||
| 20 | Fusion viewing | Yes | Unknown | Yes |
| (K032096) ViewForum | ||||
| (K111336) EBW NM 2.0 | ||||
| 21 | MR Segmentation | Yes | Unknown | Yes |
| (K032096) ViewForum | ||||
| 22 | Cine viewing | Yes | Yes | Yes |
| (K032096) ViewForum | ||||
| 23 | Image | |||
| Manipulation: | ||||
| scroll/pan/ | ||||
| zoom/rotate/ | ||||
| comparison/ merge | Yes | Yes | Yes | |
| (K032096) ViewForum | ||||
| # | Feature/ | IntelliSpace Portal | AW Server | Various (see details |
| Capability | Platform | Predicate Device | below) | |
| Subject Device | (K081985) | Reference Devices | ||
| 24 | Send images | Yes | Yes | Yes |
| and views to | (K032096) ViewForum | |||
| film application | ||||
| 25 | Send images | Yes | Yes | Yes |
| and views to a | (K032096) ViewForum | |||
| reporting | ||||
| application | ||||
| 26 | Create image | Yes | Yes | Yes |
| annotations | (K032096) ViewForum | |||
| 27 | Measurement | Yes | Yes | Yes |
| and graphics: | (K032096) ViewForum | |||
| ROI, angle, text | ||||
| Communication and Interoperability | ||||
| 28 | Integration with | Yes | Yes | Yes |
| institution's | (K032096) ViewForum | |||
| HIS, RIS, EMR | ||||
| 29 | PACS | Yes | Yes | Not supported |
| integration | ||||
| 30 | Data Streaming | Yes | Unknown | Not supported |
| tool integration | ||||
| 31 | Multi-vendor | Yes | Yes | Not supported |
| Application | ||||
| 32 | plug-in | |||
| Enterprise | Yes | Yes | Not supported | |
| deployment | ||||
| (scalability | ||||
| feature) | ||||
| 33 | Multimodality | Yes | Not supported | Not supported |
| Web Viewer | ||||
| (with any | ||||
| computer) | ||||
| 34 | Multimodality | Yes | Not supported | Not supported |
| Web Viewer - | ||||
| Mobile non- | ||||
| diagnostic | ||||
| viewing | ||||
| (Collaboration | ||||
| Viewer) |
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Listed above technological differences are considered low risk, providing further support to clinicians in visualization or administrative functions. The majority of these functionalities are derived from reference devices and 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.
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Therefore, the IntelliSpace Portal Platform is substantially equivalent to the currently marketed predicate device GE AW Server (K081985) in terms of technological characteristics.
Conclusion:
The IntelliSpace Portal Platform is substantially equivalent to the currently marketed predicate device, AW Server (K081985) in terms of indication for use, design features, fundamental scientific technology, and safety and/or effectiveness.
VII. Brief discussion of the nonclinical tests submitted, referenced or relied on
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 ISPP and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ı ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software - Software life cycle processes
- . 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
The ISPP system was tested in accordance with Philips verification 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 ISPP:
- complies with the aforementioned international and FDA-recognized consensus standards and l FDA guidance document, and
- . Meets the acceptance criteria and is adequate for its intended use.
Therefore, ISPP is substantially equivalent to the currently marketed predicate device GE AW Server (K081985) in terms of safety and effectiveness.
VIII, Brief discussion of clinical tests submitted referenced or relied on
The subject of this premarket submission, ISPP does not require clinical studies to support equivalence.
IX. The conclusions drawn from the nonclinical and clinical tests
Verification and Validation activities required to establish performance and functionality of IntelliSpace Portal Platform were performed. Testing involved system level tests, performance tests, and safety testing from Risk Analysis. Testing performed demonstrated the IntelliSpace Portal Platform meets all defined functionality requirements and performance claims.
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| X. Overall conclusion: | The IntelliSpace Portal Platform is substantially equivalent to the predicate device AW Server (K081985) in terms of design features, fundamental scientific technology, indications for 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 Portal Platform is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns. |
| ------------------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|