Merge PACS™ is a Picture Archiving and Communication System (PACS) for multi-modality (CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, secondary capture (SC), and other DICOM-compliant modalities) image processing and display, diagnostic reading and reporting, communication, printing, and storage of medical imaging studies and other patient data. Intended clinical users include radiologists, orthopedic and other surgeons, referring physicians, and other qualified medical professionals.

Device Description

Merge PACS, a software medical device, is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining clinicians' worklists and retrieving and managing studies for reading, reporting, communication, and storage.

Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) via DICOM protocol, for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.) via HL7.

Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes.

The focus of this premarket notification is on the addition of the Region Analysis Area and Region Analysis Volume tools, which allows for additional clinical analysis of images, including volumetric Standard Uptake Value (SUV) calculation. There has been a minor change in the indications for use statement from the previous Merge PACS device, with the removal of the optional Reach component which is no longer offered. Additional non-significant changes since the previous submission will be discussed.

AI/ML Overview

This document (K192455) is a 510(k) summary for a Picture Archiving and Communication System (PACS) called "Merge PACS." It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

Acceptance Criteria and Device Performance (Based on provided text):

The document does not explicitly present a table of quantitative acceptance criteria for the Merge PACS device's performance, as it focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance metrics. The primary "performance" discussed is the addition of new features and the continued meeting of existing specifications.

However, based on the narrative and the comparison table, we can infer some "acceptance criteria" and "performance" in terms of functionality and safety equivalence to the predicate. The key "significant change" introduced is related to SUV (Standardized Uptake Value) Calculation for PET images.

Here's an interpretation based on the information provided, framed as acceptance criteria and performance:

1. Table of Implied Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Implied)	Reported Device Performance
General Functionality	Device functions as a Picture Archiving and Communication System (PACS) for multi-modality image processing, display, diagnostic reading/reporting, communication, printing, and storage.	Device performs as described for multi-modality images, including CT, MR, PT, US, MG, BTO, CR, DR/DX, NM, XA, RF, SC, and other DICOM-compliant modalities.
User Interface/Experience	Provides image manipulation tools (linking, MPR, MIP, 3D fusion/registration, CVR, measurements, annotations).	Provides the listed image manipulation tools.
Workflow Management	Supports Real Time Worklist (RTWL) and customizable workflow management. Facilitates and documents critical results communication.	RTWL displays real-time radiology activity and provides workflow management. Critical results communication functionality is facilitated and documented.
Patient Data View	Offers a composite view of patient data, including imaging and non-imaging, with multi-tier identity matching.	Provides a composite view of patient data and supports multi-tier identity matching.
HIS/RIS Integration	Receives and displays order and report information via HL7 messaging from HIS/RIS.	Receives and displays HIS/RIS information via HL7 messaging.
Image Compression Support	Supports lossless and lossy image compression for viewing, storage, and communication.	Supports both lossless and lossy image compression.
Mammography Interpretation	Displays full fidelity DICOM images for diagnostic interpretation of mammography (MG or BTO). Lossy compressed images/digitized screen film not used for primary diagnosis. Only regulatory-cleared display monitors used for interpretation.	Meets these requirements for mammography images, explicitly stating restrictions on lossy images and monitor use.
SUV Calculation (PET) - Significant Change	New Capability: Accurately performs 2D and 3D SUV calculations for PET images using Probe, ROI, Region Area Analysis, and Region Volume Analysis tools. (Implicit: calculations are clinically appropriate and consistent with predicate's capabilities for 2D and Xelis Fusion's 3D capabilities).	The device includes Probe Tool, ROI Tool, Region Area Analysis, and Region Volume Analysis, which perform 2D and 3D SUV calculations. The documentation claims "Applicable verification and validation testing has been performed to justify the safety and efficacy of this difference from the primary predicate." and that the reference predicate (Xelis Fusion) supports 3D ROI SUV analysis.
System Compatibility	Compatible with Windows 10, Internet Explorer 11, Edge, Chrome, Windows 2016 64-bit, and Windows 2012 R2 server OS.	Compatible with the specified operating systems and browsers. (Considered "not a clinically significant difference" but important for functionality).
Integration (Terarecon, Blackford, Patient Synopsis)	Seamless integration with Terarecon, Blackford for auto-registration, and Watson Imaging Patient Synopsis.	Integration is present and provides user convenience. (Considered "not a clinically significant difference" by the submission).
Security & User Accounts	Enhanced security and flexible DICOM user account options.	Security enhancements and customizable user account controls are implemented. (Considered "not a clinically significant difference").
Safety & Effectiveness	As safe and effective as predicate devices.	"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 Merge PACS to be as safe and as effective as its predicate devices."

2. Sample Size and Data Provenance:

Test Set Sample Size: The document does not specify a separate "test set" sample size in the context of clinical performance evaluation (e.g., for diagnostic accuracy). The non-clinical testing performed includes "Testing on unit level," "Integration testing," and "Performance testing." These tests would have used various forms of data, but the specific volume or type of imaging data is not detailed.
Data Provenance: The document does not provide details on the country of origin of data or whether it was retrospective or prospective. Given that no new clinical studies were required, any data used for internal verification and validation would likely be existing, retrospective data.

3. Number of Experts and Qualifications for Ground Truth:

The document states: "The subject of this premarket submission, Merge PACS, did not require clinical studies to support substantial equivalence." Therefore, there is no information provided on the number or qualifications of experts used to establish ground truth for a clinical test set in the context of diagnostic performance. The ground truth for the functional verification and validation would be against product specifications and established DICOM standards.

4. Adjudication Method for the Test Set:

Since no clinical studies were performed requiring human interpretation and ground truth establishment for diagnostic performance, no adjudication method (e.g., 2+1, 3+1) is mentioned or implied.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done or mentioned. The submission explicitly states, "The subject of this premarket submission, Merge PACS, did not require clinical studies to support substantial equivalence." The device is a PACS system, and the focus is on its basic functionality, image display, and measurement tools, rather than a direct diagnostic aid that would typically undergo such a study.

6. Standalone (Algorithm Only) Performance:

This device is a PACS system, which is a tool for clinicians to view and manipulate medical images. It is not an AI diagnostic algorithm or an "algorithm only" device in the sense of providing automated diagnoses or confidence scores. Its "performance" is in its ability to correctly acquire, store, display, and process images and data. Therefore, the concept of a "standalone" (algorithm-only) performance is not directly applicable in the way it would be for a CADx or AI detection algorithm.
The document implies that the device's measurement capabilities (e.g., SUV calculation) are part of the overall system and are validated through non-clinical means against expected mathematical outputs or standard benchmarks.

7. Type of Ground Truth Used:

For the significant change (3D SUV calculation), the "ground truth" would likely be derived from:
- Physics-based or Phantom Data: Verified calculations on known phantom images with defined SUV values.
- Reference Standard Implementations: Comparison of calculated SUVs against established, validated algorithms (e.g., from the reference predicate Xelis Fusion or other industry-standard software).
- Mathematical/Computational Verification: Demonstrating that the algorithms correctly implement the SUV calculation formulas.
For the PACS functionalities in general, the ground truth for "acceptance" is often:
- DICOM Conformance: Data transmission, storage, and display adhere to DICOM standards.
- Software Requirements Specifications: The software performs as intended according to detailed design documents.
- User Interface/Experience Expectations: The tools function as designed for user interaction.

8. Sample Size for the Training Set:

As this is primarily a PACS system with new measurement tools, and not an AI/ML algorithm that requires a "training set" in the traditional sense, no information on a training set sample size is provided. The development process involved "Design Reviews," "Testing on unit level," "Integration testing," and "Performance testing," which are typical for software validation but do not typically involve a separate "training set."

9. How Ground Truth for Training Set Was Established:

Given that there is no "training set" for an AI/ML algorithm, the question of how its ground truth was established is not applicable to this submission. The "ground truth" for the development and verification of the PACS system's features would be based on:
- Medical standards and protocols (e.g., DICOM).
- Mathematical accuracy for measurements (e.g., SUV calculation).
- Functional requirements and specifications.
- Comparison to the performance of predicate devices.

Summary

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October 17, 2019

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Merge Healthcare Incorporated % Ms. Amy Tannenbaum Regulatory Affairs Specialist 900 Walnut Ridge Drive HARTLAND WA 53209

Re: K192455

Trade/Device Name: Merge PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: September 16, 2019 Received: September 17, 2019

Dear Ms. Tannenbaum:

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/cfpmp/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

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Section 4

Indications for Use Statement (Form 3881)

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Indications for Use

510(k) Number (if known) K192455

Device Name Merge PACS

Indications for Use (Describe)

Data can be received directly from acquisities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.

Merge PACS provides image manipulation tools to enable users to view and compare images such as: linking, MPR, MIP, 3D image fusion/registration of CT, MR, and PET; as well as CVR (Color Volume Rendering), measurements (linear distances, angles, areas, SUV, etc.), and annotations (for example, outline and label regions of interest, label spinal vertebrae).

The Real Time Worklist (RTWL) displays the real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, configurable components.

The Patient Dashboard provides a composite view of patient data, both imaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities.

Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging.

Lossless (reversible) and lossy (irreversible) image compression are supported for viewing, storage and communication. Merge PACS displays full fidelity DICOM images for use in the diagnostic interpretation of mammography using MG or BTO images. Thick slab MIP presentation can be applied to BTO images.

Lossy compressed images and digitized screen film images must not be used for primary diagnosis of mammography studies, and only display monitors that have regulatory clearance for mammography interpretation should be used for the interpretation of mammography studies.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary - Merge PACS K192455

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:	K192455
Date Prepared:	September 6, 2019
Contact Person:	Amy TannenbaumRegulatory Affairs SpecialistPhone: 617-528-3087Email: amy.tannenbaum@ibm.com
Secondary Contact:	Tracey FoxGlobal Regulatory Affairs, ManagerPhone: 1-262-369-3156Email: tracey.fox@ibm.com
Identification of the Device
Trade Name:	Merge PACS
Common Name:	Picture Archiving and Communication System (PACS)
Classification Name:	Radiological Image Processing System21 CFR 892 2050

Product Code:

Device Class:

Predicate Device(s) Primary Predicate: Merge PACS (K173475) Reference Predicate: Xelis Fusion (K111613)

LLZ

Class II

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Device Description

Merge PACS can be accessed from within the hospital or enterprise, or from remote locations via web-based access. Images viewed on mobile devices should not be used for diagnostic purposes.

Intended Use/ Indications for Use

Data can be received directly from acquisition modalities, CAD systems, and other image processing systems, or indirectly via importing. Data that is not DICOM-compliant, such as photos, can be converted to DICOM format by Merge PACS.

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The Patient Dashboard provides a composite view of patient data, both imaging and nonimaging. Multi-tier patient identity matching provides a comprehensive view even when dealing with multiple disparate patient identities.

Order and report information generated by the HIS/RIS and report creation systems are received and displayed via the transmission of HL7 messaging.

Technological Characteristics

Merge PACS and its predicate device(s) have the same fundamental scientific technology. The primary predicate is the previous Merge PACS (K173475) for which the subject device is a modification of, with reference predicate Xelis Fusion (K111613).

The subject device has the same basic intended use as the predicates and near identical indications for use as Merge PACS (K173475). The devices have essentially the same basic image processing, display, storage, and communication features, based on the same or similar technology. Availability and bundling and naming of additional features and toolsets may vary between the devices, but the technology behind each feature is essentially the same regardless of how it is catered to a specific user.

It is our opinion that the subject Merge PACS device is substantially equivalent to the previous Merge PACS (K173475) as it is an earlier version of the device that contains the same technology and functionality. The subject device is also substantially equivalent to the reference predicate, Xelis Fusion (K111613), sharing essentially the same basic image processing, display. storage and communication features as well as the new capability of volumetric SUV measurements.

Determination of Substantial Equivalence

The modifications to Merge PACS include updates to the software and labeling from the previous Merge PACS K173475. A summary of the key changes in the subject Merge PACS

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device are summarized below with comparison to its predicates. Additional non-significant changes and bug fixes have been made to improve workflow and security, and do not have an impact on clinical functionality of the device.

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Table 1: Comparison to predicates

Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
General	Common Nameof Device/ClassificationProduct code	Picture Archiving andCommunications System(PACS)21 CFR 892.2050LLZ- Radiological ImageProcessing System	Picture Archiving andCommunications System(PACS)21 CFR 892.2050LLZ- Radiological ImageProcessing System	Picture ArchivingandCommunicationsSystem (PACS)21 CFR 892.2050LLZ- RadiologicalImage ProcessingSystem	No changes
	OperatingSystem	Windows 10	Windows 7/8.1/10	Unknown	Not a clinically significantdifference - support forlatest Windows OS.
	BrowserSupport	Internet Explorer 11,Edge, Chrome	Internet Explorer 7, 8, 9,10, 11	Unknown	Not a clinically significantdifference - support for newbrowser only
	Server OSSupport	Windows 2016 64-bit,Windows 2012 R2	Windows 2012 R2	Windows 32 and 64-bit	Not a clinically significantdifference - support forlatest server OS
	Indication forUse Statement	Merge PACS™ is a PictureArchiving andCommunication System(PACS) for multi-modality(CT, MR, PT, US, MG,BTO, CR, DB/DX, NM, XA	Merge PACS™ is a PictureArchiving andCommunication System(PACS) for multi-modality(CT, MR, PT, US, MG, BTO,CR, DB/DX, NM, XA, RF	The Xelis Fusion is asoftware device thatreceives digitalimages and datafrom varioussources (e.g. CT	There is only a minor changein the indications for usestatement from theprevious Merge PACSdevice, with the removal ofthe optional Reach
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
		RF, secondary capture(SC), and other DICOM-compliant modalities)image processing anddisplay, diagnosticreading and reporting,communication, printing,and storage of medicalimaging studies andother patient data.Intended clinical usersinclude radiologists,orthopedic and othersurgeons, referringphysicians, technologists,and other qualifiedmedical professionals.	secondary capture (SC),and other DICOM-compliant modalities)image processing anddisplay, diagnostic readingand reporting,communication, printing,and storage of medicalimaging studies and otherpatient data. Intendedclinical users includeradiologists, orthopedicand other surgeons,referring physicians,technologists, and otherqualified medicalprofessionals.	scanners, MRultrasound systems,R/F Units, computed& directradiographicdevices, secondarycapture devices,scanners, imaginggateways or otherimage sources).Diagnosis orcomputer aideddiagnosis is notperformed by thesoftware but byRadiologists.	component which is nolonger offered. Similarindications to referencepredicate. There is noclinically significantdifference as Reach was notused by radiologists fordiagnosis.
		Data can be receiveddirectly from acquisitionmodalities, CAD systems,and other imageprocessing systems, orindirectly via importing.Data that is not DICOM-compliant, such asphotos, can be converted	Data can be receiveddirectly from acquisitionmodalities, CAD systems,and other imageprocessing systems, orindirectly via importing.Data that is not DICOM-compliant, such as photos,can be converted to	Images (includingmammographic)and data can bestored,communicated,processed anddisplayed within thesystem and oracross computernetworks at
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
		to DICOM format byMerge PACS.Merge PACS providesimage manipulation toolsto enable users to viewand compare imagessuch as: linking, MPR,MIP, 3D imagefusion/registration of CT,MR, and PET; as well asCVR (Color VolumeRendering),measurements (lineardistances, angles, areas,SUV, etc.), andannotations (forexample, outline andlabel regions of interest,label spinal vertebrae).The Real Time Worklist(RTWL) displays the real-time status of radiologyactivity and providescustomizable workflowmanagement capabilities.	DICOM format by MergePACS.Merge PACS providesimage manipulation toolsto enable users to viewand compare images suchas: linking, MPR, MIP, 3Dimage fusion/registrationof CT, MR, and PET; aswell as CVR (Color VolumeRendering),measurements (lineardistances, angles, areas,SUV, etc.), andannotations (for example,outline and label regionsof interest, label spinalvertebrae).The Real Time Worklist(RTWL) displays the real-time status of radiologyactivity and providescustomizable workflowmanagement capabilities.Communication of critical	distributedlocations. Inaddition, XelisFusion can beintegrated with aninstitution's HIS orRIS for an integratedand electronicpatient record.Lossy compressedmammographicimages and digitizedfilm screen imagesmust not bereviewed forprimary imageinterpretation.Mammographicimages may only beinterpreted usingand FDA approvedmonitor that offersat least 5 Mega-pixel resolution andmeets othertechnicalspecifications
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
		Communication of criticalresults is facilitated anddocumented throughoptional, configurablecomponents.The Patient Dashboardprovides a compositeview of patient data,both imaging and non-imaging. Multi-tierpatient identity matchingprovides acomprehensive vieweven when dealing withmultiple disparatepatient identities.Order and reportinformation generated bythe HIS/RIS and reportcreation systems arereceived and displayedvia the transmission ofHL7 messaging.	results is facilitated anddocumented throughoptional, configurablecomponents.The Patient Dashboardprovides a composite viewof patient data, bothimaging and non-imaging.The optional Reachcomponent providesclinicians with secure,proactive communicationand access to clinicalreports and images. Multi-tier patient identitymatching provides acomprehensive view evenwhen dealing withmultiple disparate patientidentities.Order and reportinformation generated bythe HIS/RIS and reportcreation systems arereceived and displayed via	reviewed andaccepted by FDA.
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
		Lossless (reversible) andlossy (irreversible) imagecompression aresupported for viewing,storage andcommunication. MergePACS displays full fidelityDICOM images for use inthe diagnosticinterpretation ofmammography using MGor BTO images. Thick slabMIP presentation can beapplied to BTO images.Lossy compressed imagesand digitized screen filmimages must not be usedfor primary diagnosis ofmammography studies,and only display monitorsthat have regulatoryclearance formammographyinterpretation should beused for the	the transmission of HL7messaging.Lossless (reversible) andlossy (irreversible) imagecompression aresupported for viewing,storage andcommunication. MergePACS displays full fidelityDICOM images for use inthe diagnosticinterpretation ofmammography using MGor BTO images. Thick slabMIP presentation can beapplied to BTO images.Lossy compressed imagesand digitized screen filmimages must not be usedfor primary diagnosis ofmammography studies,and only display monitorsthat have regulatoryclearance formammography
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
		interpretation ofmammography studies.	interpretation should beused for theinterpretation ofmammography studies.
Significant change(s) introduced in subject device Merge PACS:
Measurement	SUV Calculation(PET)	Probe Tool, ROI ToolRegional Area Analysisand Regional VolumeAnalysis2D and 3D SUVcalculations	Probe Tool and ROI Tool2D SUV calculations only	Supports 3D regionof interest (ROI) SUVanalysis	Addition of Region Area andVolume Analysis tools allowsfor additional clinicalanalysis of PET images forpatient treatment, including3D SUV calculations. Thereference predicate deviceshares this new feature withthe subject Merge PACS.Applicable verification andvalidation testing has beenperformed to justify thesafety and efficacy of thisdifference from the primarypredicate.
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
Non-significant changes(s) introduced in subject device Merge PACS:
Viewer	TerareconIntegration	Yes - Terareconembedded in MergePACS, opens in samewindow	Yes - Terarecon opens inseparate window	Unknown	Not a clinically significantdifference. End functionalityowned by Terarecon.Smoother integration withMerge PACS for userconvenience, but no clinicalimpact to the patient.
	AutomaticRegistration forseries that donot share acommon frameof reference	Yes	No - Automatic linking ofseries with same frame ofreference UID andmanually linking of seriesthat do not share acommon frame ofreference only	Yes	Not a clinically significantdifference for Merge PACS.Automatic registration isthrough the functionality ofBlackford to deliver DICOMobjects to Merge PACS forautomatic registration ofseries that do not share acommon frame ofreference. No impact tosafety or effectiveness.
	Patient Synopsisinformationwithin PatientRecord	Yes	No	Similar functionality- can Integrate withpatient record	Not a clinically significantdifferent, Watson ImagingPatient Synopsis provides anew option for clinicians toview patient information.
Category	Feature/Information	Subject Merge PACS(K192455)	Primary Predicate: MergePACS (K173475)	ReferencePredicate: XelisFusion (K111613)	Clinically SignificantChange?
					No clinical impact to thepatient.
Viewer — MammoSupport	2D/3D Mammotoggle tool	Yes	No – user must performadditional key clicks to gobetween 2D and 3Dimages	Unknown	Not a clinically significantdifference. Provides a userconvenience only to morequickly toggle betweenviews. No clinical impact tothe patient.
DICOM useraccounts	Allow flexibilityin choosing thedesired local,network (e.gLDAP), or MergePACS accountsof various userservices	Yes	No	Unknown	Security enhancements onlyand allows for morecustomizable controls. Noimpact to safety oreffectiveness.
Other changes	Securityenhancements,and updates tographics inAbout Screen	Yes	No	Unknown	Not a clinically significantdifference. About Screenprovides information onlyand security enhancementshave no impact to safety oreffectiveness.

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Summary of Non-Clinical Tests

The following quality assurance measures were applied to the Merge PACS product:

Risk Analysis
Requirements Review
Design Reviews
Testing on unit level
Integration testing
Performance testing

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".

No performance standards for PACS system or components have been issued under the authority of Section 514. Non-clinical testing has been performed on Merge PACS and demonstrates compliance with international and FDA-recognized consensus standards and FDA guidance documents. This Traditional 510(k) has been written in accordance with the applicable FDA Guidance Document for the Submission of Premarket Notifications for Medical Image Management Devices (July 2000), and meets the following voluntary standard(s):

DICOM - Digital Imaging and Communications in Medicine, for the format of medical images and data, NEMA PS 3.1 - 3.20 Set (2016)
Results from internal verification and validation testing performed in accordance with Watson Health Imaging design control processes confirm that Merge PACS 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. Cybersecurity is also addressed in this submission.

The subject of this submission, Merge PACS, did not require animal testing, biological testing, sterility testing, electrical safety testing or electromagnetic compatibility testing.

Summary of Clinical Tests

The subject of this premarket submission, Merge PACS, did not require clinical studies to support substantial equivalence.

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 device. Verification and validation test results established that the device meets its

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design requirements and intended uses and that no new issues relative to safety and effectiveness were raised. Watson Health Imaging considers the Merge PACS to be as safe and as effective as its predicate devices.

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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).