(104 days)
IBM iConnect Access 7.0 (K182290)
Not Found
No
The document describes standard medical image processing and viewing functionalities, including MPR, MIP, 3D rendering, and calcium scoring using "clinically accepted calcium scoring algorithms." There is no mention of AI, ML, deep learning, or any related terms or concepts in the intended use, device description, or performance studies sections. The focus is on image manipulation, display, and measurement using established techniques.
No.
The device is for viewing, manipulating, and analyzing medical images and patient data for diagnostic review, planning, and reporting, but it explicitly states it "does not interpret or provide a diagnosis" and that "Medical diagnosis is the responsibility of the user." It lacks any therapeutic function.
No
The device provides tools for interpreting medical images and displaying patient data for diagnostic review, but 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." Additionally, its use on mobile devices is "not intended for diagnostic use."
Yes
The device is described as an "application" and "software system" that provides access to and manipulation of medical images and data. While it interacts with hardware (monitors, computers, mobile devices), the core functionality and the device being regulated is the software itself. The description focuses on software features and capabilities, not hardware components.
Based on the provided information, the IBM iConnect Access application is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description of IBM iConnect Access clearly state that it provides access to and manipulation of medical images and patient-related information. It works with imaging data (DICOM, non-DICOM) and reports, not biological specimens.
- The core function is image viewing, manipulation, and access. While it includes tools like coronary calcium scoring and 3D model creation, these are based on analyzing existing medical images, not on testing biological samples.
- The device description explicitly states it "does not interpret or provide a diagnosis." This is a key characteristic that differentiates it from many IVD devices which are designed to provide diagnostic information based on specimen analysis.
Therefore, the IBM iConnect Access application falls under the category of medical image management and viewing software, not 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:
- · 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 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.
- · Creating individually captured DICOM images that can be displayed and stored in a PACS
- · 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.
- · Creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.
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 download or application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view exams and patient information including but not limited to the following content: Diagnostic Reports. Kev 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.
When configured by an Administrator, patients can view their radiological information via portals that launch IBM iConnect Access and provide the ability to view clinical results, modality imaging, key images, scope/surgery videos, and associated clinical documentation. The role for patient access is limited to zooming the image, panning the image, and scrolling through a series of images.
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 and can employ advanced image processing and display from local or remote locations.
IBM iConnect Access provides advanced image segmentation and editing tools for the purpose of creating digital 3D anatomical models. These models can be exported as STL files for the purpose of fabricating physical replicas, such as 3D printing. Physical/3D printed models generated from the digital output files are not for diagnostic use.
IBM iConnect Access can be used to query and 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 Suite is an offering that combines the image storage capability of IBM iConnect Enterprise Archive with the diagnostic viewer capability of IBM iConnect Access.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-modality softcopy medical images, tomographic medical image data
DICOM compliant medical images
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, Qualified system administrators, patients (limited viewing role).
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)
Comparison of the Intended Uses/Indications for Use, the technological characteristics, and performance specifications demonstrate the equivalence of the subject device to the predicate device. Verification and validation test results established that the device meets its design requirements and intended uses and that no new issues relative to safety and effectiveness were raised. Watson Health Imaging considers the IBM iConnect Access device to be as safe and as effective as the predicate device.
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.
IBM iConnect Access 7.0 (K182290)
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.
Not Found
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
January 26, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Merge Healthcare Incorporated % Ms. Carol Nakagawa Sr. Manager of Regulatory Affairs 900 Walnut Ridge Drive HARTLAND WI 53029
Re: K203104
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: December 17, 2020 Received: December 17, 2020
Dear Ms. Nakagawa:
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 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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203104
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:
- · 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 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.
- · Creating individually captured DICOM images that can be displayed and stored in a PACS
• 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.
· Creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Submitter Information | |
|---|---|
| Submitter: | Merge Healthcare Incorporated |
| 900 Walnut Ridge Drive | |
| Hartland, Wisconsin 53209 USA | |
| 510(k) Number: | K203104 |
| Date Prepared: | October 9, 2020 |
| Contact Person: | Carol Nakagawa |
| Sr. Manager of Regulatory Affairs | |
| Phone: (905) 316-2579 | |
| Email: carol.nakagawa@ca.ibm.com or | |
| med.reg.contact@ca.ibm.com | |
| Secondary Contact: | Tracey Fox |
| RAQA Executive, Regulatory Affairs | |
| Phone: (262) 369-3156 | |
| Email: tracey.fox@ibm.com | |
| Identification of the Device | |
| 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 Device | |
| Predicate Device: | IBM iConnect Access 7.0 (K182290) |
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 download or application-specific installation required on the user's computer, healthcare professionals can use IBM iConnect Access with a standard internet browser to view exams and
5
patient information including but not limited to the following content: Diagnostic Reports. Kev 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.
When configured by an Administrator, patients can view their radiological information via portals that launch IBM iConnect Access and provide the ability to view clinical results, modality imaging, key images, scope/surgery videos, and associated clinical documentation. The role for patient access is limited to zooming the image, panning the image, and scrolling through a series of images.
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 and can employ advanced image processing and display from local or remote locations.
IBM iConnect Access provides advanced image segmentation and editing tools for the purpose of creating digital 3D anatomical models. These models can be exported as STL files for the purpose of fabricating physical replicas, such as 3D printing. Physical/3D printed models generated from the digital output files are not for diagnostic use.
IBM iConnect Access can be used to query and 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 Suite is an offering that combines the image storage capability of IBM iConnect Enterprise Archive with the diagnostic viewer capability of IBM iConnect Access.
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 includina:
- . 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
Image /page/5/Picture/14 description: The image contains the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outwards, resembling a sun. To the right of the image is the text "Watson Health." The text is in a bold, sans-serif font.
6
- . 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.
- . Creating and outputting digital files suitable for the fabrication of physical replicas, such as 3D printing, using DICOM files as inputs. Physical/3D printed models generated from the digital output files are not for diagnostic use.
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 requlatory 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.
Technological Characteristics
IBM iConnect Access is a zero-client universal viewer and image sharing/exchange platform that has multiple modules and scalable architectures.
Determination of Substantial Equivalence
The modification to IBM iConnect Access includes updates to the software and labeling. A summary of the key changes in the subject device compared to the predicate device IBM iConnect Access that was cleared in 510(k) K182290 is provided below. Additional nonsignificant changes to non-clinical workflow and performance speed were made, and software bugs were fixed.
| | Proposed Device:
IBM iConnect Access (v8.0) | Predicate Device:
IBM iConnect Access (v7.0)
K182290 | Rationale |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | TBD | K182290 | Information
Only |
| 510(k) Applicant | Merge Healthcare Incorporated | Merge Healthcare Incorporated | Information
Only |
| Common Name
of Device/
Classification/
Product Code | Picture Archiving and
Communications System (PACS)
21 CFR 892.2050
LLZ - Radiological Image Processing
System | Picture Archiving and
Communications System (PACS)
21 CFR 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, | The IBM iConnect Access application
provides internet access to multi-
modality softcopy medical images, | Substantially
Equivalent: |
Image /page/6/Picture/10 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outwards, suggesting light or energy. To the right of the image is the text "Watson Health" in bold, black letters. The logo is set against a white background with a green bar at the top.
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Image /page/7/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized symbol to the left of the text "Watson Health." The text is in a bold, sans-serif font, and there is a trademark symbol after the word "Health."
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| | Proposed Device:
IBM iConnect Access (v8.0) | Predicate Device:
IBM iConnect Access (v7.0)
K182290 | Rationale |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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. | 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. | |
| Image
Manipulation | Cine
Filters:
Edge Enhancement for X-ray images RGB channel filter 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
Freehand scalpel to remove unwanted tissue from 3D model
Interactive cylindrical eraser tool
Circular eraser tool for 3D model refinement
Circular paint tool to augment 3D segmentation in MPR viewports | Cine
Filters:
Edge Enhancement for X-ray images RGB channel filter 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 | Substantially equivalent:
Added tools for users to interactively modify and refine the digital 3D model:
- Freehand scalpel
- Cylindrical eraser
- Circular eraser
- Circular paint tool
- Adjustable cut plane
- Hold filling and noise reduction
- Freehand and polygon scalpel
- Freehand and polygon brush tool
There is no impact to safety and effectiveness. |
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| | Proposed Device:
IBM iConnect Access (v8.0) | Predicate Device:
IBM iConnect Access (v7.0)
K182290 | Rationale |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | Adjustable cut plane extending through entire data volume Hole filling and noise reduction Freehand and polygon scalpel tool on MPR views for 3D model refinement Freehand and polygon brush tool on MPR views for 3D model refinement | | |
| 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 Administrators can configure a user role for patient access to limited image viewing and report viewing features. | 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 | Substantially equivalent
Added the ability to enable a patient viewing role.
There is no impact on safety or effectiveness. |
| 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 | 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 | Identical |
| 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 Cardiac Calcium Scoring PET imagery analysis Undo-Segmentation Redo- Segmentation Reset Tissue selection tool | 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 Cardiac Calcium Scoring PET imagery analysis Undo-Segmentation Redo- Segmentation Reset Tissue selection tool | Identical |
Image /page/9/Picture/1 description: The image shows the logo for Watson Health. The logo consists of a stylized sun-like graphic on the left, followed by the text "Watson Health" in a bold, sans-serif font. The word "Health" is followed by the trademark symbol.
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| | Proposed Device:
IBM iConnect Access (v8.0) | Predicate Device:
IBM iConnect Access (v7.0)
K182290 | Rationale |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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.
Generate and export STL files to 3D
printing service. Physical/3D printed
models generated from the digital
output files are not for diagnostic use. | 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. | Substantially
equivalent:
Added the
ability to
export STL
files.
There is no
impact on
safety or
effectiveness. |
| 3D Image
Reformatting | 3D Reconstructions of 2D multi-slice
DICOM exams:
Reformatting images,
including creation of MPRs,
MIPS, MinIPs,
color/monochrome 3D
volume rendered images Planar Reconstructions
(MPRs): orthogonal,
oblique, curved/cross-
curved, slab Color Slab 3D volume review Tomographic colonography Endoscopic Review Extract and display surface
mesh for 3D model Enable user to control the
level of smoothing applied to
the surface mesh Output the surface mesh to
an STL file | 3D Reconstructions of 2D multi-slice
DICOM exams:
Reformatting images,
including creation of MPRs,
MIPS, MinIPs,
color/monochrome 3D
volume rendered images Planar Reconstructions
(MPRs): orthogonal,
oblique, curved/cross-
curved, slab Color Slab 3D volume review Tomographic colonography Endoscopic Review | Substantially
equivalent:
Added the
ability to
create a
digital
surface mesh
from a
segmented
digital 3D
model to
output as
STL files.
There is no
impact to
safety or
effectiveness. |
| Image View and
Notation | Navigation: zoom, pan Window Level Auto Window Level Reset Scout/localizer Lines Annotate Oblique Scrolling Tool Available volumes Perspective Slice interval | Navigation: zoom, pan Window Level Auto Window Level Reset Scout/localizer Lines Annotate Oblique Scrolling Tool Available volumes Perspective Slice interval | Identical |
Summary of Non-Clinical Tests
Image /page/10/Picture/2 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a globe with lines radiating outward, resembling a sun. To the right of the image is the text "Watson Health" in a bold, sans-serif font. There is a trademark symbol after the word "Health".
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IBM iConnect Access complies with voluntary standards as detailed in this premarket notification.
In-house testing of de-identified CT and MRI DICOM images confirmed that interactive segmentation of digital 3D models and mesh generation for STL file creation was acceptable.
Verification and validation testing of qualified datasets was performed to ensure that the software design outputs meet its design inputs.
The subject of this submission, IBM iConnect Access, is a software device and does not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.
Summary of Clinical Tests
Clinical studies are not required to demonstrate the safety and effectiveness of IBM iConnect Access.
Conclusion
Comparison of the Intended Uses/Indications for Use, the technological characteristics, and performance specifications demonstrate the equivalence of the subject device to the predicate device. Verification and validation test results established that the device meets its design requirements and intended uses and that no new issues relative to safety and effectiveness were raised. Watson Health Imaging considers the IBM iConnect Access device to be as safe and as effective as the predicate device.
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