(187 days)
No
The document describes a standard PACS viewer with basic image manipulation tools. There is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The focus is on image display and comparison to predicate devices.
No
This device is a software application for viewing medical images and associated reports, intended for reference or diagnostic purposes. It does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "ICIS® View Full Fidelity is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports." Additionally, the "Device Description" mentions that the system is "intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes."
Yes
The device is described as a "software application" and a "picture archiving and communication system (PACS)" which are inherently software-based. While it interacts with hardware like web-browsers, mobile devices, and display monitors, the core functionality and the device itself are defined as software. The testing described focuses on software performance and image quality displayed by the software, not on the hardware itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ICIS® View is a software application for reference viewing of medical images and associated reports. While it has an optional "Full Fidelity" mode for diagnostic use of certain imaging modalities, its primary function is image and report viewing and management within a PACS system.
- Device Description: The device is described as a picture archiving and communication system (PACS). PACS systems are primarily focused on the storage, retrieval, and display of medical images, not on analyzing biological samples or performing tests on specimens.
- Lack of IVD Characteristics: The description does not mention any activities related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Performing chemical, biological, or immunological tests
- Providing information about a patient's health status based on laboratory analysis
The device's function is centered around the management and display of medical images generated by other diagnostic modalities (like CT, MR, US, etc.). While it can be used for diagnostic interpretation of these images, it is not performing an in vitro diagnostic test itself.
N/A
Intended Use / Indications for Use
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.
Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups).
ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.
Product codes
LLZ
Device Description
Agfa's ICIS® View system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks.
The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a web-browser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes.
The optional Full Fidelity functionality allows the retrieval of original lossless renditions of stored CR, DX, CT, MR, and US images for diagnostic purposes on select mobile devices or FDA cleared display monitors when there is no access to a full workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DX, CT, MR, US
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators
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: Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30). No animal or clinical studies were performed.
Sample Size: A sample set of an average of 6 imaging studies per modality (CR, DX, CT, MR, US)
Standalone Performance: Diagnostic image quality was evaluated by qualified medical professionals. Qualified radiologists were asked to provide an acceptable or unacceptable score when comparing the diagnostic quality, including evaluations of contrast, sharpness, artifacts and overall image quality in ICIS® View Full Fidelity mode (both desktop and mobile) to the IMPAX predicate.
Key Results: All results met acceptance criteria. Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicates.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 1, 2015
AGFA Healthcare N.V. % Ms. Shaeann Cavanagh Regulatory Affairs Specialist NA AGFA Healthcare 10 South Academy Street GREENVILLE SC 29601
Re: K143397
Trade/Device Name: ICIS View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2015 Received: April 27, 2015
Dear Ms. Cavanagh:
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,
Robert A Ochs
Robert Ochs, Ph.D. Acting 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) K143397
Device Name
ICIS® View
Indications for Use (Describe)
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.
Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups).
ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------ | ----------------------------------------------------------- |
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510(K) SUMMARY Agfa HealthCare's ICIS® View
Common Name: Picture Archiving and Communications System (PACS) Classification Name: Radiological Image Processing System Regulatory Classification: 21 CFR 892.2050 Product Code: LLZ Proprietary Name: ICIS® View Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jodi Coleman, Prepared: November 26, 2014 Telephone: 519-746-6210 ext. 2485
LEGALLY MARKETED PREDICATE DEVICES A.
This is a 510(k) for Agfa's ICIS® View software, a picture archiving and communications It is substantially equivalent to systems with MIM Software Inc.'s Mobile MIM svstem. (K103785-primary predicate), Agfa HealthCare's IMPAX Workstation (K022292), and Client Outlook Inc.'s eUnity™ (K11164).
DEVICE DESCRIPTION B.
Agfa's ICIS® View system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks.
The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a web-browser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes.
The optional Full Fidelity functionality allows the retrieval of original lossless renditions of stored CR, DX, CT, MR, and US images for diagnostic purposes on select mobile devices or FDA cleared display monitors when there is no access to a full workstation.
Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices. Laboratory data including, performance assessments and image quality evaluations conducted with qualified radiologists confirm that performance is equivalent to the predicates.
C. INTENDED USE
ICIS® View is a software application used for reference viewing of medical images and associated reports and, as such, fulfills a key role in Agfa HealthCare's Imaging Clinical
4
Information System (ICIS). ICIS® View enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images and data from multiple departments and organizations within one multi-disciplinary viewer.
Users may access the product directly via a web-browser, select mobile devices, healthcare portal or within the Electronic Medical Record (EMR). ICIS® View allows users to perform basic image manipulations and measurements (for example window/level, rotation, zoom, and markups).
ICIS® View can optionally be configured for Full Fidelity mode, which is intended for diagnostic use, review and analysis of CR, DX, CT, MR, US images and medical reports. ICIS® View Full Fidelity is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View full fidelity is not intended for the display of digital mammography images for diagnosis.
Intended use has not changed as a result of any labeling modification(s).
D. SUBSTANTIAL EQUIVALENCE SUMMARY
Agfa's ICIS® View system has an Indications For Use statement similar to the predicate devices (K103785, K022292, & K111164). The statements have been combined and simplified. There are no changes to the intended use/indications of the device. Intended uses are the same. The devices have the same technological characteristics.
Both ICIS® View and the primary predicate device, Mobile MIM (K103785) are used to display medical images for diagnostic purposes of multiple modalities inlcuding MR and CT. Both provide wireless and portable access to medical images on select Apple products. Furthermore, ICIS® View and Mobile MIM (K103785) contain a statement that it is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View and eUnity™ (K111164) are indicated to allow image manipulations and display lossy/lossless images. Both ICIS® View and predicate device, IMPAX Workstation (K02292) are indicated to display, review, transfer, store, and archive medical images. ICIS® View and all three predicate devices (K103785, K022292, & K111164) are not indicated for mammography and all the devices accept standard DICOM transfers.
The only difference of the new device and the primary predicate device, Mobile MIM (K103785), is the new device is server based software that connects to an existing PACS; whereas, Mobile MIM contains an App that connects to the existing PACS. However, the other two predicates, IMPAX Workstation (K022292) and eUnity™ (K111164) are also server based software that connects to the existing PACS. Differences in devices do not alter the intended diagnostic effect.
The devices have the same technological characteristics. The new device and the predicate devices (K103785, K022292, & K11164) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's ICIS® View system is substantially equivalent to the predicate devices (K103785, K022292, & K111164) in that it uses precisely the same technology to capture and display medical data. Descriptive characteristics and performance data are adequate to ensure equivalence.
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Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence.
| predicate devices. | ||||
|---|---|---|---|---|
| ICIS® View | ||||
| (New Device) | Mobile MIM | |||
| (Primary | ||||
| PREDICATE- | ||||
| K103785) | IMPAX | |||
| Workstation | ||||
| (PREDICATE- | ||||
| K022292) | eUnity™ | |||
| (PREDICATE- | ||||
| K111164) | ||||
| Communication | Same as predicates | DICOM | DICOM | HL7, DICOM, IHE |
| Mammographic Use | Same as predicates | No | No | No |
| Modalities for | ||||
| Diagnostic Use | CR, DX, CT, MR, US | SPECT, PET, | ||
| CT, MR | Radiology | |||
| (including CR, DX, | ||||
| CT, MR, US) | Radiology | |||
| (including CR, DX, CT, | ||||
| MR, US) | ||||
| Operating System for | ||||
| Diagnostic Viewing | Windows 7 & iOS8 | iOS | Windows 7 & 8 | Windows & iOS |
| Mobile Device | ||||
| Support for | ||||
| Diagnostic Viewing | iPad® 3, iPad® 4 | Apple iOS | ||
| handheld devices | ||||
| Transfer/Storage/Disp | ||||
| lay of Medical Images | Same as predicates | Yes | Yes | Yes |
| Network Access | Same as K022292 & | |||
| K111164 | App that | |||
| connects to | ||||
| existing PACS | Server based | |||
| software, connects to | ||||
| existing PACS | Server based software, | |||
| connects to existing | ||||
| PACS | ||||
| User Authentification | Same as predicates | Yes | Yes | Yes |
| Window Level | Same as predicates | Yes | Yes | Yes |
| Rotate/Pan/Zoom | Same as predicates | Yes | Yes | Yes |
| Measurements | Same as predicates | Yes | Yes | Yes |
| Annotations | Same as predicates | Yes | Yes | Yes |
| Indications for Use | ||||
| Statements | ICIS® View is a software | |||
| application used for | ||||
| reference viewing of | ||||
| medical images and | ||||
| associated reports and, as | ||||
| such, fulfills a key role in | ||||
| Agfa HealthCare's Imaging | ||||
| Clinical Information System | ||||
| (ICIS). ICIS® View enables | ||||
| healthcare professionals, | ||||
| including (but not limited | ||||
| to) physicians, surgeons, | ||||
| nurses, and administrators to | ||||
| receive and view patient | ||||
| images and data from | ||||
| multiple departments and | The Mobile | |||
| MIM software | ||||
| program is used | ||||
| for the | ||||
| registration, | ||||
| fusion, and/or | ||||
| display for | ||||
| diagnosis of | ||||
| medical images | ||||
| from only the | ||||
| following | ||||
| modalities: | ||||
| SPECT, PET, | ||||
| CT, and MRI. | IMPAX Workstations | |||
| with MPR, Digital | ||||
| Subtraction and 3D | ||||
| options are intended | ||||
| for use in the | ||||
| acquisition, display, | ||||
| digital processing, | ||||
| review, transfer, | ||||
| storage, archiving | ||||
| and printing of | ||||
| medical images and | ||||
| patient demographic | ||||
| information. | eUnity™ is a software | |||
| application that displays | ||||
| medical image data and | ||||
| associated clinical reports. | ||||
| eUnity™ performs | ||||
| operations relating to the | ||||
| transfer, storage, display | ||||
| and measurement of | ||||
| image data. | ||||
| eUnity™ allows users to | ||||
| perform image | ||||
| manipulations, including | ||||
| window/level, rotation, | ||||
| Indications for Use | ||||
| Statements continued.. | organizations within one | |||
| multi-disciplinary viewer. | ||||
| Users may access the | ||||
| product directly via a web- | ||||
| browser, select mobile | ||||
| devices, healthcare portal or | ||||
| within the Electronic | ||||
| Medical Record (EMR). |
ICIS® View allows users to
perform basic image
manipulations and
measurements (for example
window/level, rotation,
zoom, and markups).
ICIS® View can optionally
be configured for Full
Fidelity mode, which is
intended for diagnostic use,
review and analysis of CR,
DX, CT, MR, US images
and medical reports. ICIS®
View Full Fidelity is not
intended to replace full
diagnostic workstations and
should only be used when
there is no access to a
workstation.
ICIS® View full fidelity is
not intended for the display
of digital mammography
images for diagnosis. | Mobile MIM
provides wireless
and portable
access to medical
images. This
device is not
intended to
replace full
workstations and
should be used
only when there
is no access to a
workstation.
The device is not
to be used for
mammography. | They are indicated
for use by the
physician to aid in
diagnosis, and by
medical professionals
whenever they would
require or desire
access to medical
images and patient
demographic
information.
MPR and 3D
functions allow the
user to view 3D
image data from
perspectives different
from that in which it
was acquired. Digital
subtraction allows a
user viewing time
series studies to
remove densities not
enhanced by a
contrast medium,
highlighting vascular
structures. | zoom, measurement and
markup.
eUnity™ displays both
lossless and lossy
compressed images. For
lossy images, the medical
professional user must
determine if the level of
loss is acceptable for their
purposes.
Display monitors used for
reading medical images
for diagnostic purposes
must comply with
applicable regulatory
approvals and with
quality control
requirements for their use
and maintenance.
Mammographic images
and digitized film screen
images must not be
reviewed for primary
image interpretations.. |
Table 1 on the below summarizes the similarities and differences between the new device and predicate devices.
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Table 1: Device Predicate Comparison
TECHNOLOGICAL CHARACTERISTICS E.
Agfa's ICIS® View system is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks.
It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.
Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices. The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a webbrowser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new
7
device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes. There are no differences between the device and the predicates (K103785, K022292, & K111164) that impact safety and effectiveness.
F. TESTING
Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30).
No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.
- ICIS® View vs. Agfa IMPAX (K02292) - Requirements & Performance of the full fidelity view were evaluated:
To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 3 platforms:
- ICIS® View Desktop - using an FDA clearaed diagnostic monitor
- ICIS® View Mobile using a calibrated iPad® 3 and iPad® 4 ●
- Agfa's full diagnostic PACS workstation IMPAX 6.6.1 (K022292 predicate) ●
A sample set of an average of 6 imaging studies per modality (CR, DX, CT, MR, US) were evaluated. Qualified radiologists were asked to provide an acceptable or unacceptable score when comparing the diagnostic quality, including evaluations of contrast, sharpness, artifacts and overall image quality in ICIS® View Full Fidelity mode (both desktop and mobile) to the IMPAX predicate.
2. Display Device Assessment - TG18 Testing
The executed validation plan for image quality required calibrated display devices for all assessments.
A direct comparison of all images discussed was conducted such that envrionmental conditions, the evaluator, infrastructure etc. were all identical to make the best comparison assessment possible.
To assess and compare the overall image quality of the display devices used for validation the "Assessment of Display Performance for Medical Imaging Systems" was used (TG18-QC, TG18-BR, TG18-LP).
All results met acceptance criteria.
Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicates.
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The product, manufacturing and development processes conform to product safety and medical imaging standards including:
PRODUCT STANDARD G.
- . ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM).
OUALITY MANAGEMENT STANDARDS
- ISO 14971:2012 Application of Risk Management to Medical Devices
- ISO 13485:2003 Medical Devices Quality Management Systems Requirements For ● Regulatory purposes
RISK ASSESSMENT AND MANAGEMENT SUMMARY H.
During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with a conventional PACS system previously released to the field.
For ICIS® View there are a total of 20 risks in the broadly acceptable region and two risks in the ALARP region. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk.
The benefits of ICIS® View are:
- Image and information review capabilities are enhanced over what is offered by traditional film: ●
- Immediate access to all available prior patient studies. о
- Time independent access to patient records and information. o
- Simultaneous access to multimodality, multi-departmental image review (a chest x-ray, o an, MRI, and CT for example).
- Improved resource utilization of both equipment and staff. ●
- Improved communication between local and geographically separated healthcare o providers promoting collaborative care.
- Authorized Users are able to share same patient record and contribute to that record. O
- Distribution of clinical data either through digital access, distribution or hardcopy print. .
The residual risk of each hazardous situation was analyzed and it was determined that the overall benefits to the patient outweigh the residual risks.
CONCLUSIONS I.
Agfa's ICIS® View system has an Indications For Use statement similar to the predicate devices (K103785, K022292, & K111164). The statements have been combined and simplified. There are no changes to the intended use/indications of the device. Intended uses are the same. The devices have the same technological characteristics.
9
Both ICIS® View and the primary predicate device. Mobile MIM (K103785) are used to display medical images for diagnostic purposes of multiple modalities inlcuding MR and CT. Both provide wireless and portable access to medical images on select Apple products. Furthermore, ICIS® View and Mobile MIM (K103785) contain a statement that it is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. ICIS® View and eUnity™ (K111164) are indicated to allow image manipulations and display lossy/lossless images. Both ICIS® View and predicate device, IMPAX Workstation (K02292) are indicated to display, review, transfer, store, and archive medical images. ICIS® View and all three predicate devices (K103785, K022292, & K111164) are not indicated for mammography and all the devices accept standard DICOM transfers.
The only difference of the new device and the primary predicate device, Mobile MIM (K103785), is the new device is server based software that connects to an existing PACS; whereas, Mobile MIM contains an App that connects to the existing PACS. However, the other two predicates, IMPAX Workstation (K022292) and eUnity™ (K111164) are also server based software that connects to the existing PACS. Differences in devices do not alter the intended diagnostic effect.
The devices have the same technological characteristics. The new device and the predicate devices (K103785, K022292, & K11164) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's ICIS® View system is substantially equivalent to the predicate devices (K103785, K022292, & K111164) in that it uses precisely the same technology to capture and display medical data. Descriptive characteristics and performance data are adequate to ensure equivalence.
Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.
This 510(k) has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health.