(53 days)
No
The summary mentions image processing, but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The description focuses on standard image management and processing functionalities.
No.
The device is an image management system used for viewing and analyzing medical images and associated data, not for treating diseases or conditions.
Yes
The Illumeo system is described as a "primary interpretation solution for visualization and evaluation a variety of medical images," used by professionals like radiologists for "digital image processing, measurement, manipulation and quantification of images." This implies it provides information used by clinicians to make diagnostic decisions.
Yes
The device description explicitly states "Illumeo system is a software package used with general purpose computing hardware". While it requires hardware to function, the device itself is the software component. The summary focuses on software standards and testing, not hardware verification.
Based on the provided information, the Illumeo system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Illumeo's Function: The description clearly states that Illumeo is an image management system that processes and displays medical images acquired from various imaging modalities (CT, MR, US, etc.). It works with images of the body, not specimens from the body.
- Intended Use: The intended use is for trained professionals to manage, process, and display medical images for clinical evaluation. This is consistent with a medical imaging software system, not an IVD.
Therefore, the Illumeo system falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS) with advanced processing capabilities, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Product codes
LLZ, JAK
Device Description
Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, XA, DX, CR, RF, PET, SC, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including but not limited to radiologists.
clinical environment
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
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on Illumeo system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- I ISO 14971 Medical devices - Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes l
- I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
- l NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Illumeo system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this Special 510(k): Device Modification submission demonstrates that Illumeo system:
- . Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use and user needs.
Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue and white.
Philips Medical Systems Technologies Ltd. % Mr. Yoram Levy QA/RA Consultant Qsite 31 Haavoda Street Binyamina 30500 ISRAEL
January 12, 2018
Re: K173588
Trade/Device Name: Illumeo System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: January 2, 2018 Received: January 8, 2018
Dear Mr. Levy:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D.'Hara
For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173588
Device Name Illumeo system
Indications for Use (Describe)
Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
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) |
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 the only element in the image and it is centered.
510(K) SUMMARY
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.
| Date Prepared: | November 16, 2017 |
|---|---|
| Submission Type | Special 510(k): Device Modification submission |
I. Submitter's name and address
- Manufacturer:
Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration Number: 3003768277
Primary Contact Persons:
Yoram Levy, Qsite 31 Haavoda Street, Binyamina 30500 Israel Phone: (972)4-638-8837 Fax: (972)4-638-0510 E-mail: Yoram@qsitemed.com
Secondary Contact:
Ilana Ben Moshe Quality & Regulatory Affairs Leader Medical Systems Nederland B.V Phone: +972 525233496 E-mail: Ilana.Ben-Moshe@philips.com
II. Device information
Subject Device:
| Device Name: | Illumeo system |
|---|---|
| Common/Usual Name: | Imaging Informatics System |
Classification:
| Classification name: | Picture Archiving and Communications System |
|---|---|
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
2-2
Illumeo System Special 510k Submission
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 centered and takes up most of the frame. The background is plain white.
Primary Product Code: LLZ Secondary Product Code: JAK
Comment: Product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo system for marketing reasons.
Predicate device information III.
Primary Predicate Device:
| Trade name: | I4 (Integrated Intelligent Imaging Informatics) |
|---|---|
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| 510(k) clearance: | K160315 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ, JAK |
Reference Predicate Device:
| Trade name: | Intellispace Portal Platform |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) clearance: | K162025 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |
| Trade name: | Multi-Modality Tumor Tracking (MMTT) Application |
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) clearance: | K162955 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |
5
IV. Device Description
Illumeo is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Illumeo is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. Illumeo interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Comment: Product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo for marketing reasons.
Device modifications
The proposed Illumeo system includes the following minor modifications, compared to the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).
Description of the device modifications:
-
- Improved performance of the software image management system -communication to PACS using dedicated interfaces and automatic preprocessing on data arrival for enhanced performance.
-
- Integration with IntelliSpace PACS improvements in data retrieval through FHIR interface and reporting workflow, interface with Electronic Medical Record (EMR) and Radiology Information System (RIS)
-
- Scalability - Illumeo v2.0 supports up to 50 concurrent users using hosted client and up to 150 concurrent users using enterprise viewer.
-
- Multimodality and Multivendor support: Additional Multimodality supported - SPECT, improved Multivendor support, support for Presentation states (PR), PET/CT fusion of a single study
-
- Patient briefing including additional information such as prior findings, recent Lab Results, Scanned documents, Patient Location and type.
-
- 2D and 3D viewing enhanced additional tools
-
- Findings creation and management improvements including Match finding feature enabling track and measure change over time.
Illumeo System Special 510k Submission
6
Image /page/6/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. The background is white, providing a strong contrast that makes the word stand out.
-
- Comparison and Synchronization enhanced capabilities such as compare mode between current and prior studies, comparison inspector presenting the same region of interest in the same study or compared to prior studies, manual link/unlink datasets.
- Hanging protocols (HP) functionality which enables to present presets that define how 9. a study is displayed (layout), which series will be displayed by default and what viewing parameters are used. Hanging Protocols are multi - modality as per study type.
-
- Vascular Inspection mode/ Vascular Quantification inspector enhanced vascular inspection mode including local vascular inspection mode
-
- User Interface Improvements
-
- Enterprise Viewer Illumeo system includes Enterprise viewer a fully HTML5 based viewer version, embedding Findings Presenter functionalities to address Enterprise clinical review by the specialists. Enterprise viewer zero footprint viewer requires no installation, and runs on most common operating systems and browsers. Enterprise Viewer is not intended to be used on mobile platforms.
The proposed Illumeo system includes modifications which are considered minor technology changes mainly designated to provide users further support in visualization.
The presented device modifications do not affect/change neither Intended Use nor alter the fundamental scientific technology of the device.
Therefore Philips believes a Special 510(k) is the appropriate type of submission
V. Indications for Use
Illumeo system is an image management system intended to be used by trained professionals, including but not limited to radiologists.
Illumeo system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Indications for Use Discussion
The proposed device, Illumeo system, is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment, identical to the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315).
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 centered and takes up most of the frame. The background is white.
Illumeo system software is designed to perform digital image processing, measurement, manipulation and quantification of images, communication and storage with indications for use identical to the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).
The Indications for Use statement for I4 (Integrated Intelligent Imaging Informatics) is identical compared to the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315).
Based on the above, the proposed Illumeo system is considered substantially equivalent to the currently marketed and primary predicate device I4 (Integrated Intelligent Imaging Informatics) system (K160315), in terms of Indications for use.
VI. Comparison of Technological Characteristics with the Predicate Device
The proposed Illumeo system is an evolution of previously cleared I4 (Integrated Intelligent Imaging Informatics) system (K160315), with additional minor modifications deriving from the identified predicate and reference devices.
Illumeo v2.0 is an evolution of llumeo v1.0 system, formerly also known as I4 (Integrated Intelligent Imaging Informatics) System. The product commercial name was changed from I4 (Integrated Intelligent Imaging Informatics) System to Illumeo system, for marketing reasons.
Illumeo system is a software package used with general purpose computing hardware. Illumeo system uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, and standard measurement tools. Both the proposed device and the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315), provide Diagnostic Review Solution for radiology, utilizing client -server technology, storage capabilities, communication and interoperability with hospital systems.
Both the proposed device and the primary predicate device. I4 (Integrated Intelligent Imaging Informatics) system (K160315), offer a primary interpretation solution for visualization and evaluation variety of medical images deriving from various imaging modalities as well as nonimaging information. Illumeo and its primary predicate device interconnect with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
The proposed device, Illumeo system, has implemented features designated to bring the product up to date with current technologies and customer requests.
8
Image /page/8/Picture/0 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 white.
A comparison table below (please see Table No.2- 1 below) provides a comparison which outlines a high-level overview of the differences and similarities between Illumeo system and the primary predicate device, I4 (Integrated Intelligent Imaging Informatics) system (K160315).
| # | Specification /
Feature | Illumeo System
(Proposed device) | I4 (Integrated Intelligent Imaging
Informatics) System
(K160315)
(Primary Predicate Device) |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software Image
management system | Yes | Yes |
| 2. | Hardware Platform
requirements | Yes | Yes |
| System Configuration | | | |
| 3. | Windows Operating
System | Yes | Yes |
| 4. | TCP-IP Network
Protocol | Yes | Yes |
| 5. | Supports High
Resolution
Diagnostic
Monitors | Yes | Yes |
| 6. | Storage capabilities | Yes | Yes |
| 7. | Multiple monitor
support | Yes | Yes |
| Communication and Interoperability with other image management systems | | | |
| 8. | Supports DICOM
studies received
from different
modalities types | Yes
CT, MR, US, XA, DX, CR,
RF, PET, SC, SPECT,
as well as hospital/radiology
information system | Yes |
| 9. | Mammography | No | No |
| 10. | Accepts patient and
exam updates | Yes | Yes |
| Operating Platform requirements | | | |
| 11. | Client-server
technology | Yes | Yes |
| # | Specification /
Feature | Illumeo System
(Proposed device) | I4 (Integrated Intelligent Imaging
Informatics) System
(K160315)
(Primary Predicate Device) |
| 12. | Thin client installer | Yes | Yes |
| 13. | Multiple concurrent
user support | Yes
Up to 50 concurrent users using hosted clientUp to 150 concurrent users using Enterprise Viewer | Yes
Up to 10 concurrent users |
| Management tools | | | |
| 14. | Auditing Tool | Yes | Yes |
| 15. | Client installer | Yes | Yes |
| 16. | System
management | Yes | Yes |
| 17. | Security and
Privacy | Yes | Yes |
| Viewing and Image Processing | | | |
| 18. | Supported Data and
Multi Modalities | Supports receiving, sending,
storing and displaying studies
received from the following
modalities via DICOM:
CT, MR, US, XA, DX, CR,
RF, PET, SPECT and SC as
well as hospital /radiology
information systems. | Supports receiving, sending, storing
and displaying studies received from
the following modalities via DICOM:
CT, MR, US, XA, DX, CR, RF, PET
and SC as well as hospital /radiology
information systems. |
| 19. | 2D viewing
capabilities | Yes | Yes |
| # | Specification /
Feature | Illumeo System
(Proposed device) | 14 (Integrated Intelligent Imaging
Informatics) System
(K160315)
(Primary Predicate Device) |
| 20. | 3D viewing
capabilities | Yes | Yes |
| 21. | Finding creation
and management
tool | Yes | Yes |
| 22. | Comparison and
Synchronization
between volumetric
series | Yes | Yes |
| 23. | Hanging protocols
(HP) | Yes | Yes |
| 24. | Advanced vessel
analysis
visualization and
evaluation mode -
Vascular
Quantification
Inspector (Vascular
Inspection Mode) | Yes | Yes |
| 25. | Incorporation
of
non-imaging data in
patient context
(Patient Briefing) | Yes | Yes |
| 26. | Enterprise
Diagnostic web
viewer | Yes | Yes |
| 27. | Non - Diagnostic
Enterprise web
viewer | Yes | Yes |
Table No.2- 1 Technological characteristics comparison
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 white.
10
Image /page/10/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The word is written in blue color. The background is white.
11
Image /page/11/Picture/1 description: The image shows the word "PHILIPS" in large, bold, blue letters. The letters are evenly spaced and aligned horizontally. The background is plain white, which makes the blue letters stand out.
The proposed device. Illumeo system, has implemented features designated to bring the product up to date with current technologies and customer requests.
Presented technological differences are considered low risk, providing further support to users/clinicians in visualization. All the above listed device modifications were verified and validated demonstrating that the design outputs of the modified device meet the design input requirements and do not raise new questions on safety and/or effectiveness.
These features have not changed the intended use and the fundamental scientific technology of the device.
Therefore, the proposed Illumeo system is substantially equivalent to the currently marketed primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) in terms of technological characteristics.
Conclusion
The proposed Illumeo system is Substantially Equivalent to the currently marketed primary predicate device, I4 (Integrated Intelligent Imaging Informatics) System (K160315), in terms of Indication for Use, design features, fundamental scientific technology, and safety and/or effectiveness
VII. Performance Data
Section 16 'Software' provides a summary of the technical documentation which includes nonclinical verification and validation tests. These tests are performed with regards to the intended use, the technical claims, the requirement specifications and the risk management results, and according to the following International and FDA-recognized consensus standards and FDA guidance document.
The following performance data were provided in support of the substantial equivalence determination.
Summary of Non-clinical testing
No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on Illumeo system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- I ISO 14971 Medical devices - Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes l
Illumeo System Special 510k Submission
12
Image /page/12/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.
- I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
- l NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Illumeo system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this Special 510(k): Device Modification submission demonstrates that Illumeo system:
- . Complies with the aforementioned international and FDA-recognized consensus standards and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use and user needs.
Additionally, the risk management activities show that all risks are sufficiently mitigated, that no new risks are introduced, and that the overall residual risks are acceptable. Therefore, Illumeo system is substantially equivalent to the currently marketed primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) in terms of safety and effectiveness.
Summary of Clinical Testing
The subject of this Special 510(k): Device Modification submission, Illumeo system did not requires clinical studies to support equivalence.
Substantial Equivalence Conclusion VIII.
The Illumeo system is substantially equivalent to the currently marketed primary predicate device (Integrated Intelligent Imaging Informatics) System (K160315) in terms of Indications for Use, design features, fundamental scientific technology, and safety and/or effectiveness. Additionally, substantial equivalence was demonstrated with non-clinical performance testing. Verification and Validation (V&V) activities were performed for proposed Illumeo system and demonstrated that the predetermined acceptance criteria were successfully met. The non-clinical performance tests provided in this Special 510(k): Device Modification submission demonstrated that the proposed Illumeo system is as safe and effective as its primary predicate device I4 (Integrated Intelligent Imaging Informatics) System (K160315) without raising any new safety and/or effectiveness concerns.