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.

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.

AI/ML Overview

This 510(k) premarket notification describes the IBM iConnect Access (v8.0), a Picture Archiving and Communication System (PACS), which is substantially equivalent to a previously cleared version (IBM iConnect Access v7.0, K182290).

The primary focus of this submission revolves around the addition of new features related to 3D model manipulation and export for 3D printing. Because it is a PACS system and the changes are primarily functional enhancements to existing capabilities (e.g., image manipulation, 3D reconstruction, and data export), the submission states that clinical studies are not required to demonstrate safety and effectiveness.

Therefore, the following information, which would typically be found in a study demonstrating clinical performance, is not available in this document:

A table of acceptance criteria and reported device performance (for clinical endpoints)
Sample sizes for test sets and data provenance
Number of experts and their qualifications for establishing ground truth
Adjudication method
MRMC comparative effectiveness study results
Standalone algorithm performance
Type of ground truth used (for clinical validation)
Sample size for the training set
Ground truth establishment for the training set

The document does, however, provide information regarding non-clinical testing for the new features.

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

The document does not provide a formal table with acceptance criteria and reported device performance metrics in the way one would typically see for a diagnostic AI device. Instead, it describes compliance with voluntary standards and in-house testing for the new features.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "in-house testing of de-identified CT and MRI DICOM images" but does not specify the sample size or the data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as clinical ground truth establishment by experts for specific diagnostic performance metrics was not part of this submission. The testing focused on technical functionality.

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

Not applicable, as no clinical adjudication of diagnostic findings from a test set is described.

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

No MRMC study was conducted or reported. The device is a PACS system with added image manipulation and export features, not an AI-assisted diagnostic tool in the sense of providing specific interpretations.

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

The device's functionality is to provide tools for healthcare professionals; it does not operate in a standalone diagnostic manner. The document does not describe standalone algorithm performance.

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

For the non-clinical testing described, the "ground truth" was likely the expected technical output for the interactive segmentation and mesh generation features, rather than clinical ground truth (e.g., pathology confirmed disease presence). The document states: "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." This implies a verification against pre-defined technical specifications for the output.

8. The sample size for the training set

Not applicable. The description does not involve a training set for an AI model that performs diagnostic interpretation. The software's new features are based on algorithms for image manipulation and geometric processing, not typically requiring a distinct "training set" in the context of deep learning for image classification or detection.

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

Not applicable, as there is no mention of a training set for an AI model.

Summary

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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

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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)

· 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.

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.

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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 Incorporated900 Walnut Ridge DriveHartland, Wisconsin 53209 USA
510(k) Number:	K203104
Date Prepared:	October 9, 2020
Contact Person:	Carol NakagawaSr. Manager of Regulatory AffairsPhone: (905) 316-2579Email: carol.nakagawa@ca.ibm.com ormed.reg.contact@ca.ibm.com
Secondary Contact:	Tracey FoxRAQA Executive, Regulatory AffairsPhone: (262) 369-3156Email: 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 System21 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

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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.

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.

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.

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. 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.

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	InformationOnly
510(k) Applicant	Merge Healthcare Incorporated	Merge Healthcare Incorporated	InformationOnly
Common Nameof Device/Classification/Product Code	Picture Archiving andCommunications System (PACS)21 CFR 892.2050LLZ - Radiological Image ProcessingSystem	Picture Archiving andCommunications System (PACS)21 CFR 892.2050LLZ - Radiological Image ProcessingSystem	InformationOnly
IntendedUse/Indicationsfor Use	The IBM iConnect Access applicationprovides internet access to multi-modality softcopy medical images,	The IBM iConnect Access applicationprovides internet access to multi-modality softcopy medical images,	SubstantiallyEquivalent:

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 beinterpreted using an FDA approvedmonitor that offers at least 5 MPresolution and meets other technicalspecifications reviewed and acceptedby FDA.Display monitors used for readingmedical images for diagnosticpurposes must comply withapplicable regulatory approvals andwith quality control requirements fortheir use and maintenance.Use of IBM iConnect Accessapplication on mobile devices such asiPhones and iPads is not intended fordiagnostic use.	Display monitors used for readingmedical images for diagnosticpurposes must comply withapplicable regulatory approvals andwith quality control requirements fortheir use and maintenance.Use of IBM iConnect Accessapplication on mobile devices such asiPhones and iPads is not intended fordiagnostic use.
ImageManipulation	CineFilters:Edge Enhancement for X-ray images RGB channel filter color/ monochrome transformations Image RotateImage FlipMagnifyInvert ImageMirrorTools for SegmentationAuto Draw CenterlinePath Definition and Boundary detectionRotate - Click CenterRotate - Image CenterSculpting - polygonSculpting - freehandStraightening the display of curved structuresCross-sections perpendicular to and rotation around curved anatomyCropControl of slice thicknessFreehand scalpel to remove unwanted tissue from 3D modelInteractive cylindrical eraser toolCircular eraser tool for 3D model refinementCircular paint tool to augment 3D segmentation in MPR viewports	CineFilters:Edge Enhancement for X-ray images RGB channel filter color/ monochrome transformations Image RotateImage FlipMagnifyInvert ImageMirrorTools for SegmentationAuto Draw CenterlinePath Definition and Boundary detectionRotate - Click CenterRotate - Image CenterSculpting - polygonSculpting - freehandStraightening the display of curved structuresCross-sections perpendicular to and rotation around curved anatomyCropControl 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 toolThere 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 equivalentAdded the ability to enable a patient viewing role.There is no impact on safety or effectiveness.
ImageRendering	HTML4 Enterprise Viewer: Server side rendering via web browser as JPEG for lossy data and PNG for lossless dataHTML5 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 dataHTML5 Universal Viewer: Client side rendering via web browser as JPEG for lossy data and PNG for lossless data	Identical
Measurementand 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 XDScompliant archivesImage import: HTML5 web uploader,Exam Importer (Windows MSI), Javaweb uploaderImage export: transfer feature toroute DICOM, download image tolocal, de-identified DICOM tags.Generate and export STL files to 3Dprinting service. Physical/3D printedmodels generated from the digitaloutput files are not for diagnostic use.	Interfaces with DICOM or XDScompliant archivesImage import: HTML5 web uploader,Exam Importer (Windows MSI), Javaweb uploaderImage export: transfer feature toroute DICOM, download image tolocal, de-identified DICOM tags.	Substantiallyequivalent:Added theability toexport STLfiles.There is noimpact onsafety oreffectiveness.
3D ImageReformatting	3D Reconstructions of 2D multi-sliceDICOM exams:Reformatting images,including creation of MPRs,MIPS, MinIPs,color/monochrome 3Dvolume rendered images Planar Reconstructions(MPRs): orthogonal,oblique, curved/cross-curved, slab Color Slab 3D volume review Tomographic colonography Endoscopic Review Extract and display surfacemesh for 3D model Enable user to control thelevel of smoothing applied tothe surface mesh Output the surface mesh toan STL file	3D Reconstructions of 2D multi-sliceDICOM exams:Reformatting images,including creation of MPRs,MIPS, MinIPs,color/monochrome 3Dvolume rendered images Planar Reconstructions(MPRs): orthogonal,oblique, curved/cross-curved, slab Color Slab 3D volume review Tomographic colonography Endoscopic Review	Substantiallyequivalent:Added theability tocreate adigitalsurface meshfrom asegmenteddigital 3Dmodel tooutput asSTL files.There is noimpact tosafety oreffectiveness.
Image View andNotation	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.

Image /page/11/Picture/8 description: The image shows the logo for Watson Health. The logo consists of a stylized image of a sun or starburst to the left of the text "Watson Health". The text is in a bold, sans-serif font. There is a green bar at the top of the image.

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).