(33 days)
No
The document describes standard medical image viewing and manipulation tools, including MPR, MIP, 3D rendering, and calcium scoring using "clinically accepted calcium scoring algorithms." There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an image viewing and manipulation application for diagnostic review, planning, and reporting, which aids in interpretation but does not provide direct therapy or treatment.
No
The device description explicitly states: "The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user." This indicates it is a viewing and manipulation tool, not a diagnostic device itself. While it aids in the diagnostic review, it does not perform the diagnosis.
Yes
The device description explicitly states "IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks" and "With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser". This indicates the device is primarily software providing access and manipulation capabilities, not a physical hardware device.
Based on the provided text, the IBM iConnect Access application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of IBM iConnect Access focuses entirely on the display, manipulation, and analysis of medical images and patient data already acquired from imaging modalities. It does not involve the testing of biological samples.
- The intended use and device description clearly outline its function as a medical image viewer and processing tool. It provides access to images, reports, and patient information for diagnostic review, planning, and reporting.
- The device description explicitly states that the software "does not interpret or provide a diagnosis." This further reinforces that it is a tool for healthcare professionals to use in their diagnostic process, not a device that performs diagnostic testing on biological samples.
Therefore, while it is a medical device used in the diagnostic process, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:
o Displaying DICOM compliant medical images and non-DICOM content using XDS
o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
o Creating individually captured DICOM images that can be displayed and stored in a PACS
o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
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. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.
With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments.
IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, cine, link series, line/ angle/ ROI measurements, and MPR.
The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.
The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations.
IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment.
IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy medical images, tomographic medical image data
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional, Reading physicians, referring physicians, and other appropriate healthcare personnel
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)
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that IBM iConnect Access product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
Clinical studies were not required to demonstrate the safety and effectiveness of IBM iConnect Access.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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/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.
September 25, 2018
Merge Healthcare Incorporated Tracey Fox Global Regulatory Affairs Program Manager 900 Walnut Ridge Drive HARTLAND, WI 53209
Re: K182290
Trade/Device Name: IBM iConnect Access Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 22, 2018 Received: August 23, 2018
Dear Tracey Fox:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about mediation-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,
Hse 2. Mild
for Robert A. 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) K182290
Device Name IBM iConnect Access
Indications for Use (Describe)
The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:
o Displaying DICOM compliant medical images and non-DICOM content using XDS
o Reformatting images. including creation of MPRs. MIPS. MinIPs. color/monochrome 3D volume rendered images o Manipulating displayed images via control of slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
o Creating individually captured DICOM images that can be displayed and stored in a PACS
o Measuring coronary calcium, which is intended for non-invasive identification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
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. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.
| 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) |
| X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Submitter: | Merge Healthcare Incorporated
900 Walnut Ridge Drive
Hartland, Wisconsin 53209 USA |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 22, 2018 |
| Contact Person: | Tracey Fox
Global Regulatory Affairs Program Manager
Phone: (262) 369-3156
Email: tracey.fox@ibm.com or med.reg.contact@ca.ibm.com |
| Secondary Contact: | Meg Mucha
Sr. RA/QA Leader
Phone: (262) 912-3514
Email: meg.mucha@ibm.com |
| Trade Name: | IBM iConnect Access |
| Common Name: | Picture Archiving and Communication System (PACS) |
| Classification Name: | Radiological Image Processing System
21 CFR 892.2050 |
| Product Code: | LLZ |
| Device Class: | Class II |
| Predicate Devices: | Cedara Web Access 2.4 (K092915)
Zero-Download 3D Solution (K143318) |
Device Description
IBM iConnect Access provides healthcare professionals with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP networks.
With no application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view studies and patient information including but not limited to the following content: Diagnostic Reports, Key Images, Presentation Series, Modality Imaging, Scope/ Surgery Videos, Visible Light, and File Attachments.
4
IBM iConnect Access was designed with an easy and convenient workflow providing image viewing and manipulation capabilities including but not limited to zoom, pan, window/ level, scroll, cine, link series, line/ angle/ ROI measurements, and MPR.
The software displays patient studies and other patient data but does not interpret or provide a diagnosis. Medical diagnosis is the responsibility of the user.
The IBM iConnect Access 3D advanced imaging solution supports MIP (maximum intensity project). MPR (multiplanar reconstruction). 3D volume rendering, and cardiac calcium scoring. Reading physicians, referring physicians, and other appropriate healthcare personnel can employ advanced image processing and display from local or remote locations.
IBM iConnect Access can be used to query retrieve content from the IBM iConnect Enterprise Archive. IBM iConnect Enterprise Archive is a software system that supports storage and communications of medical images and data. Qualified system administrators monitor and maintain the software in their healthcare enterprise environment.
IBM iConnect Access along with IBM iConnect Enterprise Archive comprise a cloud based solution marketed as iConnect Cloud Archive. The IBM iConnect Access 3D advanced imaging solution option is not available on iConnect Cloud Archive.
Intended Use/ Indications for Use
The IBM iConnect Access application provides internet access to multi-modality softcopy medical images, reports, and other patient-related information to conduct diagnostic review, planning and reporting through the interactive display and manipulation of medical data. IBM iConnect Access provides healthcare professional tools to aid in interpreting medical images including:
- Displaying DICOM compliant medical images and non-DICOM content using XDS .
- . Reformatting images, including creation of MPRs, MIPS, MinIPs, color/monochrome 3D volume rendered images
- . Manipulating displayed images via control of slice thickness, slice interval, obliquity, perspective, rotation, window/ level, crop, zoom, color/monochrome transformations, seqmentation, sculpting, straightening the display of curved structures, and creating images perpendicular to a curvilinear path.
- . Creating individually captured DICOM images that can be displayed and stored in a PACS
- . Measuring coronary calcium, which is intended for non-invasive identification and quantification of calcified atherosclerotic plaques in the coronary arteries using tomographic medical image data and clinically accepted calcium scoring algorithms.
Image /page/4/Picture/12 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or atom to the left of the text "Watson Health". The text is in a bold, sans-serif font. There is a green bar above the logo.
5
The IBM iConnect Access application can be configured to provide either lossless or lossy compressed images for display. The medical professional user must determine the appropriate level of image data compression that is suitable for their purpose.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by FDA.
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. Use of IBM iConnect Access application on mobile devices such as iPhones and iPads is not intended for diagnostic use.
Comparison with Predicate
The primary predicate, Cedara Web Access 2.4 cleared under K092915, was rebranded iConnect Access after the full transition of Cedara into Merqe Healthcare. The reference predicate, Zero Download 3D Viewer cleared under K143318 by DR Systems, will now be offered as an option branded, IBM iConnect Access 3D advanced imaging solution. DR Systems was acquired by Merge Healthcare in February 2015. The indications for use of IBM iConnect Access have been expanded to include the indications for use of the IBM iConnect Access 3D advanced imaging solution. Feature enhancements include an RGB channel filter, a real-time collaboration feature, an additional user interface option and other non-significant changes.
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | TBD | K092915 | K143318 | Information
Only |
| 510(K)
Applicant | Merge Healthcare
Incorporated | Cedara Software
Company | DR Systems, Inc. | Information
Only |
| Common
Name of
Device/
Classification/
Product Code | Picture Archiving and
Communications System
(PACS)
21 CRF 892.2050
LLZ - Radiological Image
Processing System | Picture Archiving
and
Communications
System (PACS)
21 CRF 892.2050
LLZ - Radiological
Image Processing
System | Digital Image Processing
21 CRF 892.2050
LLZ – Radiological Image
Processing System | Information
Only |
| Intended
Use/Indications
for Use | The IBM iConnect Access
application provides
internet access to multi-
modality softcopy medical
images, reports, and other
patient-related information
to conduct diagnostic
review, planning and
reporting through the
interactive display and | Cedara
WebAccess 2.4 is
a software
application that
provides internet
access to multi-
modality softcopy
medical images,
reports and other
patient related | DR Systems Z3D is
intended to provide reading
physicians, referring
physicians, and other
appropriate healthcare
professionals' tools to aid
in interpreting medical
images, including: | Substantially
Equivalent -
Proposed
device
combines
both
predicate
indications
for use with
minor |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| | manipulation of medical
data. IBM iConnect Access
provides healthcare
professional tools to aid in
interpreting medical images
including:
Displaying DICOM
compliant medical
images and non-
DICOM content using
XDS Reformatting images,
including creation of
MPRS, MIPS, MinIPs,
color/monochrome 3D
volume rendered
images Manipulating displayed
images via control of
slice thickness, slice
interval, obliquity,
perspective, rotation,
window/ level, crop,
zoom,
color/monochrome
transformations,
segmentation,
sculpting, straightening
the display of curved
structures, and
creating images
perpendicular to a
curvilinear path. Creating individually
captured DICOM
images that can be
displayed and stored
in a PACS Measuring coronary
calcium, which is
intended for non-
invasive identification
and quantification of
calcified
atherosclerotic
plaques in the
coronary arteries using
tomographic medical
image data and
clinically accepted
calcium scoring
algorithms. The IBM iConnect Access
application can be
configured to provide either
lossless or lossy
compressed images for | information for
conducting
diagnostic review,
planning, and
reporting through
the interactive
display and
manipulation of
medical data.
Cedara
WebAccess 2.4 is
capable of being
configured to | Displaying DICOM
compliant medical
image volumes,
such as CT, MRI,
and PET Reformatting
images, including
creation of MPRs,
MIPS, MinIPs,
color/monochrome
3D volume
rendered images Manipulating
displayed images
via control of slice
thickness, slice
interval, obliquity,
perspective,
rotation,
window/level,
crop, zoom,
color/monochrome
transformations,
segmentation,
sculpting,
straightening the
display of curved
structures, and
creating images
perpendicular to a
curvilinear path. Creating series of
DICOM images
and individually
captured images
that can be
displayed and
stored in a PACS. Measuring
coronary calcium,
which is intended
for non- invasive
identification and
quantification of
calcified
atherosclerotic
plaques in the
coronary arteries
using tomographic
medical image
data and clinically
accepted calcium | modifications
for
clarification.
Addition of
statement
that mobile
use is not for
diagnostic
viewing. |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| | display. The medical
professional user must
determine the appropriate
level of image data
compression that is
suitable for their purpose.
Lossy compressed
mammographic images
and digitized film screen
images must not be
reviewed for primary image
interpretations.
Mammographic images
may only be interpreted
using an FDA approved
monitor that offers at least
5 MP resolution and meets
other technical
specifications reviewed and
accepted by FDA.
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.
Use of IBM iConnect
Access application on
mobile devices such as
iPhones and iPads is not
intended for diagnostic use. | provide either
lossless or lossy
compressed
images for display.
The medical
professional user
must determine
the appropriate
level of image data
compression that
is suitable for their
purpose.
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.
Lossy compressed
mammographic
images and
digitized film
screen images
must not be
reviewed for
primary image
interpretations.
Mammographic
images may only
be interpreted
using an FDA
approved monitor
that offers at least
5 MP resolution
and meets other
technical
specifications
reviewed and
accepted by FDA. | scoring
algorithms. | |
| Image
Manipulation | Cine Filters: Edge Enhancement for
X-ray images RGB channel filter | Image Rotate Image Flip Magnify Invert Image Mirror | Color/Monochrome
transformations Tools for Segmentation Auto Draw Centerline Path Definition and
Boundary detection | Substantially
Equivalent -
RGB channel
filter added
with this
release.
Edge |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| | color/
monochrome
transformations Image Rotate Image Flip Magnify Invert Image Mirror Tools for Segmentation Auto Draw Centerline Path Definition and
Boundary detection Rotate - Click Center Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening the
display of curved
structures Cross-sections
perpendicular to and
rotation around curved
anatomy Crop Control of slice
thickness | | Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening the
display of curved
structures Cross-sections
perpendicular to and
rotation around curved
anatomy Crop Control of slice
thickness | ment and
Cine
evaluated in
previous
release as
non-
significant
change. |
| Server | Windows Server 2012
R2 Windows Server 2016 SQL Server 2012 SQL Server 2014 SQL Server 2016 Hyper-V Windows
Server 2012 R2 and
2016 VMware ESX and
Vsphere 5.x and 6.x | Windows Server
2008 R2
Windows Server
2003 R2
SQL Server 2003
SQL Server 2005 | Windows Server 2008 R2 | Substantially
Equivalent -
compatible
with more
recent
versions. |
| User Access | Internet Browser
via desktop and mobile
(iPad and iPhone) Browsers supported:
Microsoft Internet
Explorer 11, Microsoft
Edge, Mozilla Firefox,
Google Chrome, and
Apple Safari HTML4 Enterprise
viewer support HTML5 Universal
viewer support | Internet Browser
via desktop
and mobile
(iPad, IPhone,
iPod Touch,
Blackberry)
Browsers
supported:
Microsoft
Internet
Explorer,
Mozilla
Firefox,
Google | Desktop Windows PC
& Apple MacIntosh
with Microsoft
Silverlight 4 or above Browsers supported:
Microsoft Internet
Explorer, Mozilla
Firefox, Google
Chrome, and Apple
Safari HTML4 viewer support | Substantially
Equivalent -
compatible
with more
recent
versions. |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| | | Chrome, and
Apple Safari
HTML4 viewer support | | |
| Image
Rendering | HTML4 Enterprise Viewer:
Server side rendering via
web browser as JPEG for
lossy data and PNG for
lossless data
HTML5 Universal Viewer:
Client side rendering via
web browser as JPEG for
lossy data and PNG for
lossless data | Server side
rendering via web
browser as JPEG
for lossy data and
PNG for lossless
data | Server side rendering via
web browser as JPEG for
lossy data and PNG for
lossless data | Substantially
Equivalent –
provides
client side
rendering for
HTML5 |
| Images
Displayed | DICOM compliant medical
image volumes (DICOM
conformance statement
available on-line)
Non-DICOM images (JPG,
GIF) | DICOM compliant
medical image
volumes (DICOM
conformance
statement available
on-line) | DICOM compliant medical
image volumes (DICOM
conformance statement
available on-line) | Substantially
Equivalent –
IBM iConnect
Access
includes the
ability to
display non-
DICOM
images. |
| Collaboration | Real-time collaboration
screen viewing | Image Sharing via
email | None | Substantially
Equivalent –
real time
collaboration
builds upon
the current
email
connection
and image
rendering
engine to
allow
simultaneous
viewing |
| Measurement
and Analysis | Plumb lines Joint lines (angles for
metatarsal
osteotomies) Transischial
measurement Calibration lines Pixel Value OCT cross reference
line Line measurement Rectangle Ellipse ROI Angle Cobb Angle | Line
measurement Rectangle Ellipse ROI Angle Cobb Angle | Line measurement Cardiac Calcium
Scoring PET imagery analysis Undo-Segmentation Redo- Segmentation Reset Tissue selection tool | Substantially
Equivalent –
Additional
lines and
Pixel Value
evaluated in
previous
releases as
non-
significant
change. |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web
Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| | Cardiac Calcium
ScoringPET imagery analysisUndo-SegmentationRedo- SegmentationResetTissue selection tool | | | |
| Storage &
Image Transfer
(Import/Export) | Interfaces with DICOM or
XDS compliant archives
Image import: HTML5 web
uploader, Exam Importer
(Windows MSI), Java web
uploader
Image export: transfer
feature to route DICOM,
download image to local,
de-identified DICOM tags | Interfaces with
DICOM archives | Interfaces with DICOM
archives
Download Image | Substantially
equivalent -
Addition of
de-identified
DICOM
tags/Data
Masking.
XDS
compliance
and image
transfer
evaluated in
previous
release as
non-
significant
change. |
| Printing | Print to PDF or printer
at local or networked
printer | Print to local or
networked printer | None | Substantially
equivalent -
IBM iConnect
Access
includes the
ability to print
to pdf |
| Workflow and
Navigation
Functions | User Preference of UIBriefcase / teaching
worklist (TWL)Patient History TabViewing Order
RequisitionsViewing AttachmentsSharing Studies to
Recipients and
Conference FoldersConsultation NotesArchiving / suggesting
archivingComparing Related
StudiesViewing Study ReportsNavigating Studies by
ThumbnailsViewing/searching
Patient Records | Comparing
Related
StudiesViewing Study
ReportsNavigating
Studies by
ThumbnailsViewing/
searching
Patient
Records | Navigating Studies by
Thumbnails | Substantially
Equivalent -
user able to
choose
between old
and new UI
navigation;
additional
workflow
features
evaluated in
previous
releases as
non-
significant
change. |
| Category | Proposed Device
IBM iConnect Access | Primary Predicate
Cedara Web Access 2.4 | Reference Predicate
Zero Download 3D Viewer | Rationale |
| Reports & Document Viewing | DICOM structured reports | DICOM structured reports | None | Substantially Equivalent – additional document viewing evaluated in previous releases as non-significant change |
| | Document viewing available:
Adobe Portable Document Format (PDF) documents Microsoft Office documents (such as Microsoft Word, Microsoft PowerPoint, Microsoft Excel) HTML reports Clinical Document Architecture (CDA) files Videos (such as AVI and MPG files) Audio (such as WAV and MP3 files) Visible Light (such as JPEG, PNG, and TIFF) | | | |
Image /page/5/Picture/6 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun with rays emanating from it, followed by the words "Watson Health" in bold, black font. There is a green line above the logo.
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Image /page/6/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outward, followed by the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health".
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Image /page/7/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun with rays emanating from a central circle, followed by the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health".
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Image /page/8/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outward, followed by the text "Watson Health" in a bold, sans-serif font. The letters "TM" are in superscript after the word "Health".
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Image /page/9/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a green line at the top, followed by a stylized image of a sun or globe with intersecting lines. To the right of the image is the text "Watson Health" in a bold, sans-serif font.
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Image /page/10/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or atom to the left of the text "Watson Health." The text is in a bold, sans-serif font. There is a green line above the logo.
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IBM iConnect Access employs the same fundamental scientific technology as its predicate devices and does not pose any new issues of safety and effectiveness.
Performance Data
The software documentation was provided at a moderate level of concern following the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". IBM iConnect Access complies with voluntary standards as detailed in this premarket notification submission.
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that IBM iConnect Access product specifications have been met. Supporting documentation is included in this 510(k) Premarket Notification and supports the claims of substantial equivalence to the predicate device.
The subject of this submission, IBM iConnect Access, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
Clinical studies were not required to demonstrate the safety and effectiveness of IBM iConnect Access.
Image /page/11/Picture/7 description: The image shows the logo for Watson Health. The logo consists of a stylized atom symbol to the left of the words "Watson Health". The word "Health" has a trademark symbol next to it. There is a green bar above the logo.
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Conclusion
Comparison of the Intended Uses /Indications for Use, the technological characteristics, and performance specifications demonstrate the functional equivalence of the subject device to the predicate devices.
Verification and validation test results established that the device meets its design requirements and intended use, and that it is as safe, as effective, and performs as well as the predicate devices and that no new issues of safety and effectiveness were raised.
Image /page/12/Picture/3 description: The image shows the logo for Watson Health. The logo consists of a green line at the top, followed by a stylized image of a globe with lines radiating outward. To the right of the globe is the text "Watson Health" in a bold, sans-serif font. The letters are black, and there is a trademark symbol after the word "Health".