(14 days)
No
The summary describes standard image processing and management functions typical of a PACS system and does not mention AI, ML, or any related terms.
No
The device is described as an image management system for displaying and processing images, not for directly treating a disease or condition.
No
Explanation: The device is an image management system for acquiring, storing, distributing, processing, and displaying medical images. While it processes and manipulates images, the description does not indicate that it provides a diagnosis or assists in making a diagnosis itself. It is a tool for visualizing and evaluating images, which is a precursor to diagnosis made by a trained professional.
Yes
The device is described as a "software package used with general purpose computing hardware" and a "medical software system," with no mention of proprietary hardware components being part of the device itself. The performance testing also focuses on software standards and guidance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description of I4 clearly states its purpose is to acquire, store, distribute, process, and display medical images and associated data. It works with imaging modalities like CT, MR, US, etc.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its focus is on the management and processing of visual medical data.
Therefore, I4 falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, JAK
Device Description
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
I4 (Integrated Intelligent Imaging Informatics) is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Supports receiving, sending, storing and displaying studies received from the following modalities via DICOM: CT, MR, US, XA, DX, CR, RF, PT and SC as well as hospital /radiology information systems.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 I4 (Integrated Intelligent Imaging Informatics) system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes
- IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
- NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
I4 (Integrated Intelligent Imaging Informatics) system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this 510(k) premarket notification demonstrate that I4 (Integrated Intelligent Imaging Informatics) system:
- complies with the aforementioned international and FDA-recognized consensus standards . and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.
Summary of Clinical Testing
The subject of this premarket submission, I4 (Integrated Intelligent Imaging Informatics) system did not require clinical studies to support equivalence.
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.
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
February 19, 2016
Philips Medical Systems Nederland BV % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO MN 55313
Re: K160315
Trade/Device Name: 14 (integrated Intelligent Imaging Informatics) System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ, JAK Dated: February 3, 2016 Received: February 5, 2016
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160315
Device Name
I4 (Integrated Intelligent Imaging Informatics) system
Indications for Use (Describe)
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
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
14 (Integrated Intelligent Imaging Informatics)
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92.
Date Prepared: December 15, 2015
I. Submitter's name and address
| Manufacturer: | Philips Medical Systems Nederland B.V.
Veenpluis 4-6
5684 PC Best
The Netherlands
Establishment Registration Number: 3003768277 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ilana Ben Moshe
Regulatory Affairs Expert
Phone: +972 525233496
E-mail: Ilana.Ben-Moshe@philips.com |
II. Device information
Subject Device:
Device Name:
I4 (Integrated Intelligent Imaging Informatics) system Common/Usual Name: Imaging Informatics System Classification: Classification name: Picture Archiving and Communications System Device class: Class II Classification regulation: 21 CFR 892.2050 Classification panel: Radiology Primary Product Code: LLZ Secondary Product Code: JAK
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III. Predicate device information
Primary Predicate Device:
| Trade name: | IntelliSpace PACS 4.x |
|---|---|
| Manufacturer: | Philips Healthcare Informatics, Inc. |
| 510(k) clearance: | K111804 |
| Classification name: | Picture Archiving and Communications System |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |
Reference Predicate Devices:
| Trade name: | ViewForum 2003 |
|---|---|
| Manufacturer: | Philips Medical Systems North America Company |
| 510(k) clearance: | K032096 |
| Classification name | System, Image Processing |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.2050 |
| Classification panel: | Radiology |
| Product code: | LLZ |
Brilliance iCT (Brilliance Volume) Philips Medical Systems(Cleveland), Inc. K060937 System, X-Ray, Tomography, Computed Class II 21 CFR 892.1750 Radiology JAK
Reference Device:
Trade name:
Manufacturer:
Device class:
Product code:
510(k) clearance:
Classification name:
Classification panel:
Classification regulation:
| Trade name: | VesselNavigator |
|---|---|
| Manufacturer: | Philips Medical Systems Nederland B.V. |
| 510(k) clearance: | K151598 |
| Classification name | Image-intensified fluoroscopic x-ray system |
| Device class: | Class II |
| Classification regulation: | 21 CFR 892.1650 |
| Classification panel: | Radiology |
| Product code: | OWB, LLZ |
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IV. Device Description
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
I4 (Integrated Intelligent Imaging Informatics) is a medical software system offering a primary interpretation solution for visualization and evaluation a variety of medical images deriving from various imaging modalities as well as non-imaging information. I4 interconnects with clinical imaging and non-imaging data sources to present in addition to images non-imaging data in patient context.
V. Indications for Use
I4 (Integrated Intelligent Imaging Informatics) is an image management system intended to be used by trained professionals, including but not limited to radiologists.
I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, manipulation and quantification of images, communication and storage.
This device is not to be used for mammography.
Indications for Use Discussion
The proposed device I4 (Integrated Intelligent Imaging Informatics) system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment, identical to the primary predicate device, IntelliSpace PACS 4.x (K111804).
I4 (Integrated Intelligent Imaging Informatics) software is designed to perform digital image processing, measurement, manipulation and quantification of images, communication and storage with indications for use similar to the primary predicate device. IntelliSpace PACS 4.x (K111804).
The Indications for Use statement for I4 (Integrated Intelligent Imaging Informatics) is similar, but not identical compared to the primary predicate device, IntelliSpace PACS 4.x (K111804), and the two devices have the same intended use.
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-
트 I4 (Integrated Intelligent Imaging Informatics) software provides digital image processing function of performing image manipulation (e.g 3D rendering modes and 3d visualization) with advanced visualization and evaluation capabilities of cleared to market reference predicate devices ViewForum 2003(K032096). Brilliance iCT (Brilliance Volume)(K060937).14 system indications for use are a combination of primary predicate device and reference predicate devices, and falls within the intended use of the primary predicate device.
This difference does not alter the intended use of the device nor does it affect the safety and effectiveness of the device relative to the primary predicate IntelliSpace PACS 4.x (K111804). Both the proposed and the primary predicate device have the same intended use, a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. -
I I4 (Integrated Intelligent Imaging Informatics) system is not to be used for mammography. This is a reduction of the IntelliSpace PACS 4.x (K111804) Indications for Use scope. This limitation is clearly indicated in the labelling and does not raise new questions on safety and/or effectiveness
Listed above differences do not alter the intended use nor do they affect the safety and effectiveness of the device relative to the primary predicate device, IntelliSpace PACS 4.x (K111804).
Based on the above, the proposed 14 (Integrated Intelligent Imaging Informatics) is considered substantially equivalent to the currently marketed and primary predicate device IntelliSpace PACS 4.x (K111804), in terms of Indications for use.
Comparison of Technological Characteristics with the Predicate Device VI.
I4 (Integrated Intelligent Imaging Informatics) system is an evolution of the primary predicate device IntelliSpace PACS 4.x (K111804) with additional/enhanced functionality deriving from the reference predicate devices ViewForum2003 (K032096), Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).
I4 (Integrated Intelligent Imaging Informatics) is a software package used with general purpose computing hardware.
I4 (Integrated Intelligent Imaging Informatics) system uses the standard principles of operation typically seen in PACS systems such as database and image management systems, image processing tools, standard measurement tools.
Both the proposed device and the primary predicate device provide Diagnostic Review Solution for radiology, utilizing client -server technology, storage capabilities, communication and interoperability with hospital systems, such as radiology workflow providers and image archive.
A comparison matrix below (please see Table 0-1 below) provides a comparison which outlines a high level overview of the differences and similarities between 14 (Integrated Intelligent
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Imaging Informatics) system and the primary predicate device, IntelliSpace PACS 4.x (K111804) , reference predicate devices, ViewForum2003 (K032096),Brilliance iCT (Brilliance Volume) (K060937), and reference device VesselNavigator (K151598).
| # | Specification / Feature | Proposed Device:
I4 (Integrated
Intelligent
Imaging
Informatics)
system | Primary Predicate Device | Reference predicate Devices:
Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Software Image
management system | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 2. | Hardware Platform
requirements | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| | System Configuration | | | |
| 3. | Windows Operating
System | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 4. | TCP-IP Network
Protocol | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| # | Specification / Feature | Proposed
Device:
I4 (Integrated
Intelligent
Imaging
Informatics)
system | Primary Predicate
Device
IntelliSpace PACS
4.x
(K111804) | Reference predicate
Devices:
Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
| 5. | Supports High
Resolution Diagnostic
Monitors | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 6. | Storage capabilities | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 7. | Multiple monitor
support | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 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, PT
and SC as well as
hospital/radiology
information
systems | Yes-
CT, MR, NM, US,
XA, PET, DX, DR,
RF, RT, MG, SC,
VL | Yes -
CT, MR |
| 9. | Mammography | No | Yes | Not relevant for this
subject comparison as I4
system do not support
Mammography |
| # | Specification / Feature | Proposed
Device:
I4 (Integrated
Intelligent
Imaging
Informatics)
system | Primary Predicate
Device
IntelliSpace PACS
4.x
(K111804) | Reference predicate
Devices:
Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
| 10. | Accepts patient and
exam updates via HL7 | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| | Operating Platform requirements | | | |
| 11. | Client-server technology | Yes | Yes | No - SW designed for
use on workstations
only. |
| 12. | Thin client installer | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 13. | Multiple concurrent user
support | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| | Management tools | | | |
| 14. | Auditing Tool | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| # | Specification / Feature | Proposed Device: | Primary Predicate Device: | Reference predicate Devices: |
| | | I4 (Integrated
Intelligent
Imaging
Informatics)
system | IntelliSpace PACS
4.x
(K111804) | Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
| 15. | Client installer | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| 16. | System management | Yes | Yes | Not relevant for this
subject comparison as
the proposed device
utilizes similar
technology as the
primary predicate |
| | Viewing and Image Processing | | | |
| 17. | 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, PT
and SC as well as
hospital /radiology
information
systems. | Supports receiving,
sending, printing,
storing and
displaying studies
received from the
following modality
types via DICOM:
CT, MR, NM, US,
XA, PT, DX, DR,
RF, RT, MG, SC,
VL, as well as
hospital/
Radiology
information
systems. | CT, MR |
| 18. | 2D basic viewing:
Multiple monitor layout
options , Scales image to
window, Cine | Yes | Yes | Yes |
| # | Specification / Feature | Proposed
Device:
I4 (Integrated
Intelligent
Imaging
Informatics)
system | Primary Predicate
Device
IntelliSpace PACS
4.x
(K111804) | Reference predicate
Devices:
Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
| 19. | 2D Advanced viewing:
Compare series
side-by-side, Multi-
Dimensional viewing | Yes | No | Yes- ViewForum2003
(K032096) |
| 20. | 3D volumetric viewing :
Volumetric image | Yes | No | Yes -Brilliance iCT
(Brilliance Volume)
(K060937) |
| 21. | Multi Planar
Reconstruction (MPR) | Yes | No | Yes -Brilliance iCT
(Brilliance Volume)
(K060937) |
| 22. | 3D Rendering modes
(MIP, MinIP, VIP
Surface MIP,
Average(AIP), Volume
rendering) | Yes | No | Yes -Brilliance iCT
(Brilliance Volume)
(K060937) |
| 23. | Comparison and
Synchronization between
volumetric series | Yes | No | Yes- ViewForum2003
(K032096) |
| 24. | Image manipulation:
Slab thickness and
orientation (for MPR
images), windowing,
zoom level, pan | Yes | No | Yes -Brilliance iCT
(Brilliance Volume)
(K060937) |
| 25. | Measurements and
Annotations tools
(for 2D and 3D viewing):
Straight Line, Curved
Line, ROI, Angle, text,
measurement
comparison | Yes-
Measurements
and Annotations
tools for 2D and
3D viewing
modes | Yes-
Measurements and
Annotations tools
for 2D viewing
mode | Yes- Brilliance iCT
(Brilliance Volume)
(K060937) |
| 26. | Segmentation tools:
Bone/Skull removal | Yes | No | Yes- Advance Vessel
Analysis (AVA) from
Brilliance iCT
(Brilliance Volume),
(K060937) |
| # | Specification / Feature | Proposed
Device: | Primary Predicate
Device | Reference predicate
Devices: |
| | | I4 (Integrated
Intelligent
Imaging
Informatics)
system | IntelliSpace PACS
4.x
(K111804) | Brilliance iCT
(Brilliance Volume)
(K060937)
ViewForum2003
(K032096)
Reference device:
VesselNavigator
(K151598) |
| 27. | Advanced vessel analysis
visualization and
evaluation mode
(Vascular Inspection
Mode) | Yes | No | Yes –
ViewForum
2003(K032096),
Brilliance iCT
(Brilliance Volume)
(K060937), and
VesselNavigator
(K151598).
I4 incorporate
functionalities from all
listed reference predicate
devices. |
| 28. | Incorporation of non-
imaging data in patient
context
(Mission Briefing) | Yes | No | No |
Table 5-1 Technological characteristics comparison
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The subject device, I4 (Integrated Intelligent Imaging Informatics) system, has implemented features designated to bring the product up to date with current technologies and customer requests. Presented technological differences are considered low risk, providing further support to clinicians in visualization. These functionalities are derived from reference predicate devices and reference device, were verified and validated and do not raise new questions on safety and/or effectiveness. These features have not changed the intended use and operational principles of the device. Therefore, the I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of technological characteristics.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination.
Summary of Non-clinical testing
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No performance standards for PACS systems or components have been issued under the authority of Section 514. Non-clinical performance testing has been performed on 14 (Integrated Intelligent Imaging Informatics) system and demonstrates compliance with the following International and FDA-recognized consensus standards and FDA guidance document:
- 트 ISO 14971 Medical devices – Application of risk management to medical devices
- IEC 62304 Medical device software Software life cycle processes ■
- I IEC 62366-1 Medical devices – Part 1:Application of usability engineering to medical devices
- 트 NEMA-PS 3.1- PS 3.20 Digital Imaging and Communications in Medicine (DICOM)
- . Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
I4 (Integrated Intelligent Imaging Informatics) system was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics claims, requirement specifications and the risk management results.
The test results in this 510(k) premarket notification demonstrate that 14 (Integrated Intelligent Imaging Informatics) system:
- complies with the aforementioned international and FDA-recognized consensus standards . and FDA guidance document, and
- Meets the acceptance criteria and is adequate for its intended use.
Therefore, I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of safety and effectiveness.
Summary of Clinical Testing
The subject of this premarket submission, 14 (Integrated Intelligent Imaging Informatics) system did not require clinical studies to support equivalence.
VIII. Substantial Equivalence Conclusion
The I4 (Integrated Intelligent Imaging Informatics) system is substantially equivalent to the currently marketed primary predicate device IntelliSpace PACS 4.x (K111804) in terms of indications for use, design features, fundamental scientific technology, and safety and/or effectiveness.
Additionally, substantial equivalence was demonstrated with non-clinical performance testing. The non-clinical performance tests provided in this 510(k) premarket notification demonstrated that the proposed I4 (Integrated Intelligent Imaging Informatics) system is as safe and effective as its primary predicate device IntelliSpace PACS 4.x (K111804) without raising any new safety and/or effectiveness concerns.