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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the IBM iConnect Access device. It does not contain specific acceptance criteria or details of a study that proves the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of features and stating that internal verification and validation testing confirmed product specifications.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics cannot be extracted from this document.

However, I can provide what information is available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in terms of specific metrics (e.g., sensitivity, specificity, accuracy). It generally asserts that "product specifications have been met" based on internal verification and validation. The table in the "Comparison with Predicate" section outlines features and capabilities, and the rationale column often states "Substantially Equivalent."

Acceptance Criteria Category	Reported Device Performance (Summary from text)
Overall Performance	"product specifications have been met" (through internal verification and validation testing)
Intended Use/Indications	"Substantially Equivalent" to predicate devices, with expanded indications and minor modifications for clarification. Mobile use not for diagnostic viewing.
Image Manipulation	"Substantially Equivalent" to predicate devices; RGB channel filter added, Edge enhancement and Cine evaluated as non-significant change.
Server Compatibility	"Substantially Equivalent" - compatible with more recent versions of Windows Server and SQL Server.
User Access	"Substantially Equivalent" - compatible with more recent browser versions and includes HTML5 Universal viewer support.
Image Rendering	"Substantially Equivalent" - provides client-side rendering for HTML5 in addition to server-side rendering.
Images Displayed	"Substantially Equivalent" - includes the ability to display non-DICOM images in addition to DICOM.
Collaboration	"Substantially Equivalent" - real-time collaboration builds upon current email connection and image rendering engine.
Measurement & Analysis	"Substantially Equivalent" - additional lines and Pixel Value evaluated as non-significant change in previous releases.
Storage & Image Transfer	"Substantially Equivalent" - addition of de-identified DICOM tags/Data Masking; XDS compliance and image transfer evaluated as non-significant change in previous releases.
Printing	"Substantially Equivalent" - includes the ability to print to PDF.
Workflow & Navigation	"Substantially Equivalent" - user can choose between old and new UI navigation; additional workflow features evaluated as non-significant change in previous releases.
Reports & Document Viewing	"Substantially Equivalent" - additional document viewing types evaluated as non-significant change in previous releases.

2. Sample size used for the test set and the data provenance

This information is not provided in the document. The document states "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." It does not specify the sample size, type of data used (e.g., patient cases, synthetic data), or its provenance for these internal tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document does not describe the establishment of a "ground truth" using experts for the purpose of validating the device's performance against clinical outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No details on adjudication methods for a test set are mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the document. The IBM iConnect Access device is described as a Picture Archiving and Communication System (PACS) with advanced imaging capabilities, not an AI-assisted diagnostic tool that would typically undergo such a study to evaluate human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not detail a standalone performance study in the way it might for an AI algorithm. It describes the device as providing "healthcare professional tools to aid in interpreting medical images," and 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's not a standalone diagnostic algorithm. The cardiac calcium scoring feature is described as "using tomographic medical image data and clinically accepted calcium scoring algorithms," suggesting it integrates existing, accepted algorithms rather than presenting a novel standalone algorithm for independent validation in this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The document does not specify the type of ground truth used, as it does not detail a clinical study with a defined ground truth for device performance evaluation. The "ground truth" for the verification and validation largely refers to the device meeting its own design specifications and intended functionality, and demonstrating substantial equivalence to predicate devices.

8. The sample size for the training set

The document does not provide information about a training set since it focuses on a PACS system and its comparison to predicate devices, not on a machine learning model that would require a distinct training set.

9. How the ground truth for the training set was established

As there is no mention of a training set, this information is not applicable/provided.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K182290

Device Name IBM iConnect Access

Indications for Use (Describe)

o Displaying DICOM compliant medical images and non-DICOM content using XDS

o Creating individually captured DICOM images that can be displayed and stored in a PACS

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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510(k) Summary

Submitter:	Merge Healthcare Incorporated900 Walnut Ridge DriveHartland, Wisconsin 53209 USA
Date Prepared:	August 22, 2018
Contact Person:	Tracey FoxGlobal Regulatory Affairs Program ManagerPhone: (262) 369-3156Email: tracey.fox@ibm.com or med.reg.contact@ca.ibm.com
Secondary Contact:	Meg MuchaSr. RA/QA LeaderPhone: (262) 912-3514Email: meg.mucha@ibm.com
Trade Name:	IBM iConnect Access
Common Name:	Picture Archiving and Communication System (PACS)
Classification Name:	Radiological Image Processing System21 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.

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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.

Intended Use/ Indications for Use

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.

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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 DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
510(K) Number	TBD	K092915	K143318	InformationOnly
510(K)Applicant	Merge HealthcareIncorporated	Cedara SoftwareCompany	DR Systems, Inc.	InformationOnly
CommonName ofDevice/Classification/Product Code	Picture Archiving andCommunications System(PACS)21 CRF 892.2050LLZ - Radiological ImageProcessing System	Picture ArchivingandCommunicationsSystem (PACS)21 CRF 892.2050LLZ - RadiologicalImage ProcessingSystem	Digital Image Processing21 CRF 892.2050LLZ – Radiological ImageProcessing System	InformationOnly
IntendedUse/Indicationsfor Use	The IBM iConnect Accessapplication providesinternet access to multi-modality softcopy medicalimages, reports, and otherpatient-related informationto conduct diagnosticreview, planning andreporting through theinteractive display and	CedaraWebAccess 2.4 isa softwareapplication thatprovides internetaccess to multi-modality softcopymedical images,reports and otherpatient related	DR Systems Z3D isintended to provide readingphysicians, referringphysicians, and otherappropriate healthcareprofessionals' tools to aidin interpreting medicalimages, including:	SubstantiallyEquivalent -Proposeddevicecombinesbothpredicateindicationsfor use withminor
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
	manipulation of medicaldata. IBM iConnect Accessprovides healthcareprofessional tools to aid ininterpreting medical imagesincluding:Displaying DICOMcompliant medicalimages and non-DICOM content usingXDS Reformatting images,including creation ofMPRS, MIPS, MinIPs,color/monochrome 3Dvolume renderedimages Manipulating displayedimages via control ofslice thickness, sliceinterval, obliquity,perspective, rotation,window/ level, crop,zoom,color/monochrometransformations,segmentation,sculpting, straighteningthe display of curvedstructures, andcreating imagesperpendicular to acurvilinear path. Creating individuallycaptured DICOMimages that can bedisplayed and storedin a PACS Measuring coronarycalcium, which isintended for non-invasive identificationand quantification ofcalcifiedatheroscleroticplaques in thecoronary arteries usingtomographic medicalimage data andclinically acceptedcalcium scoringalgorithms. The IBM iConnect Accessapplication can beconfigured to provide eitherlossless or lossycompressed images for	information forconductingdiagnostic review,planning, andreporting throughthe interactivedisplay andmanipulation ofmedical data.CedaraWebAccess 2.4 iscapable of beingconfigured to	Displaying DICOMcompliant medicalimage volumes,such as CT, MRI,and PET Reformattingimages, includingcreation of MPRs,MIPS, MinIPs,color/monochrome3D volumerendered images Manipulatingdisplayed imagesvia control of slicethickness, sliceinterval, obliquity,perspective,rotation,window/level,crop, zoom,color/monochrometransformations,segmentation,sculpting,straightening thedisplay of curvedstructures, andcreating imagesperpendicular to acurvilinear path. Creating series ofDICOM imagesand individuallycaptured imagesthat can bedisplayed andstored in a PACS. Measuringcoronary calcium,which is intendedfor non- invasiveidentification andquantification ofcalcifiedatheroscleroticplaques in thecoronary arteriesusing tomographicmedical imagedata and clinicallyaccepted calcium	modificationsforclarification.Addition ofstatementthat mobileuse is not fordiagnosticviewing.
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
	display. The medicalprofessional user mustdetermine the appropriatelevel of image datacompression that issuitable for their purpose.Lossy compressedmammographic imagesand digitized film screenimages must not bereviewed for primary imageinterpretations.Mammographic imagesmay only be interpretedusing an FDA approvedmonitor that offers at least5 MP resolution and meetsother technicalspecifications reviewed andaccepted by FDA.Display monitors used forreading medical images fordiagnostic purposes mustcomply with applicableregulatory approvals andwith quality controlrequirements for their useand maintenance.Use of IBM iConnectAccess application onmobile devices such asiPhones and iPads is notintended for diagnostic use.	provide eitherlossless or lossycompressedimages for display.The medicalprofessional usermust determinethe appropriatelevel of image datacompression thatis suitable for theirpurpose.Display monitorsused for readingmedical images fordiagnosticpurposes mustcomply withapplicableregulatoryapprovals and withquality controlrequirements fortheir use andmaintenance.Lossy compressedmammographicimages anddigitized filmscreen imagesmust not bereviewed forprimary imageinterpretations.Mammographicimages may onlybe interpretedusing an FDAapproved monitorthat offers at least5 MP resolutionand meets othertechnicalspecificationsreviewed andaccepted by FDA.	scoringalgorithms.
ImageManipulation	Cine Filters: Edge Enhancement forX-ray images RGB channel filter	Image Rotate Image Flip Magnify Invert Image Mirror	Color/Monochrometransformations Tools for Segmentation Auto Draw Centerline Path Definition andBoundary detection	SubstantiallyEquivalent -RGB channelfilter addedwith thisrelease.Edge
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
	color/monochrometransformations Image Rotate Image Flip Magnify Invert Image Mirror Tools for Segmentation Auto Draw Centerline Path Definition andBoundary detection Rotate - Click Center Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening thedisplay of curvedstructures Cross-sectionsperpendicular to androtation around curvedanatomy Crop Control of slicethickness		Rotate - Image Center Sculpting - polygon Sculpting - freehand Straightening thedisplay of curvedstructures Cross-sectionsperpendicular to androtation around curvedanatomy Crop Control of slicethickness	ment andCineevaluated inpreviousrelease asnon-significantchange.
Server	Windows Server 2012R2 Windows Server 2016 SQL Server 2012 SQL Server 2014 SQL Server 2016 Hyper-V WindowsServer 2012 R2 and2016 VMware ESX andVsphere 5.x and 6.x	Windows Server2008 R2Windows Server2003 R2SQL Server 2003SQL Server 2005	Windows Server 2008 R2	SubstantiallyEquivalent -compatiblewith morerecentversions.
User Access	Internet Browservia desktop and mobile(iPad and iPhone) Browsers supported:Microsoft InternetExplorer 11, MicrosoftEdge, Mozilla Firefox,Google Chrome, andApple Safari HTML4 Enterpriseviewer support HTML5 Universalviewer support	Internet Browservia desktopand mobile(iPad, IPhone,iPod Touch,Blackberry)Browserssupported:MicrosoftInternetExplorer,MozillaFirefox,Google	Desktop Windows PC& Apple MacIntoshwith MicrosoftSilverlight 4 or above Browsers supported:Microsoft InternetExplorer, MozillaFirefox, GoogleChrome, and AppleSafari HTML4 viewer support	SubstantiallyEquivalent -compatiblewith morerecentversions.
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
		Chrome, andApple SafariHTML4 viewer support
ImageRendering	HTML4 Enterprise Viewer:Server side rendering viaweb browser as JPEG forlossy data and PNG forlossless dataHTML5 Universal Viewer:Client side rendering viaweb browser as JPEG forlossy data and PNG forlossless data	Server siderendering via webbrowser as JPEGfor lossy data andPNG for losslessdata	Server side rendering viaweb browser as JPEG forlossy data and PNG forlossless data	SubstantiallyEquivalent –providesclient siderendering forHTML5
ImagesDisplayed	DICOM compliant medicalimage volumes (DICOMconformance statementavailable on-line)Non-DICOM images (JPG,GIF)	DICOM compliantmedical imagevolumes (DICOMconformancestatement availableon-line)	DICOM compliant medicalimage volumes (DICOMconformance statementavailable on-line)	SubstantiallyEquivalent –IBM iConnectAccessincludes theability todisplay non-DICOMimages.
Collaboration	Real-time collaborationscreen viewing	Image Sharing viaemail	None	SubstantiallyEquivalent –real timecollaborationbuilds uponthe currentemailconnectionand imagerenderingengine toallowsimultaneousviewing
Measurementand Analysis	Plumb lines Joint lines (angles formetatarsalosteotomies) Transischialmeasurement Calibration lines Pixel Value OCT cross referenceline Line measurement Rectangle Ellipse ROI Angle Cobb Angle	Linemeasurement Rectangle Ellipse ROI Angle Cobb Angle	Line measurement Cardiac CalciumScoring PET imagery analysis Undo-Segmentation Redo- Segmentation Reset Tissue selection tool	SubstantiallyEquivalent –Additionallines andPixel Valueevaluated inpreviousreleases asnon-significantchange.
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara WebAccess 2.4	Reference PredicateZero Download 3D Viewer	Rationale
	Cardiac CalciumScoringPET imagery analysisUndo-SegmentationRedo- SegmentationResetTissue selection tool
Storage &Image Transfer(Import/Export)	Interfaces with DICOM orXDS compliant archivesImage import: HTML5 webuploader, Exam Importer(Windows MSI), Java webuploaderImage export: transferfeature to route DICOM,download image to local,de-identified DICOM tags	Interfaces withDICOM archives	Interfaces with DICOMarchivesDownload Image	Substantiallyequivalent -Addition ofde-identifiedDICOMtags/DataMasking.XDScomplianceand imagetransferevaluated inpreviousrelease asnon-significantchange.
Printing	Print to PDF or printerat local or networkedprinter	Print to local ornetworked printer	None	Substantiallyequivalent -IBM iConnectAccessincludes theability to printto pdf
Workflow andNavigationFunctions	User Preference of UIBriefcase / teachingworklist (TWL)Patient History TabViewing OrderRequisitionsViewing AttachmentsSharing Studies toRecipients andConference FoldersConsultation NotesArchiving / suggestingarchivingComparing RelatedStudiesViewing Study ReportsNavigating Studies byThumbnailsViewing/searchingPatient Records	ComparingRelatedStudiesViewing StudyReportsNavigatingStudies byThumbnailsViewing/searchingPatientRecords	Navigating Studies byThumbnails	SubstantiallyEquivalent -user able tochoosebetween oldand new UInavigation;additionalworkflowfeaturesevaluated inpreviousreleases asnon-significantchange.
Category	Proposed DeviceIBM iConnect Access	Primary PredicateCedara Web Access 2.4	Reference PredicateZero 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".

Regulation Number and Section

§ 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).

Indications for Use

Indications for Use (Describe)

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510(k) Summary

Device Description

Intended Use/ Indications for Use

Comparison with Predicate

Performance Data

Conclusion

§ 892.2050 Medical image management and processing system.

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