Change Healthcare Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images and information from other data sources.

Change Healthcare Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and distributed locations and may be part of a larger PACS configuration.

Change Healthcare Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Change Healthcare Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

Device Description

Change Healthcare Cardiology™ is a software application intended to run on a client/server array in a physical or virtual hosting environment to allow:

Importation of images in DICOM format, final reports, and various discrete data elements
Review, editing, management and synchronization of patient information and procedure data
Storage and management of data elements (images, reports, discrete data, and so on) for long term archive and disaster recovery purposes
Review, performance and editing of measurements
Creation, editing and confirmation of procedure reports
Distribution of procedure reports and results to other systems in file or discrete data element formats
Integration with 3rd party software components to provide additional image review, measurement tools, reporting and/or data import/export capabilities
Departmental administrative tasks such as managing charges and billing, departmental stock inventory levels, and so on.

New additional features and functionalities in this version and subject of this submission include:

Reporting module was redesigned on web based technology improving former reporting version capabilities:
- New Change Healthcare Cardiology Vascular Ultrasound Report:
  - Step-by-step design to accommodate the user's workflow
  - Enhanced Vascular Diagrams
  - Enhanced efficiency of filling in clinical findings
  - Predefined content ease data insertion
- New Change Healthcare Cardiology Adult Echo Report:
  - Step-by-step design to accommodate the user's workflow
  - Improved data display
  - Enhanced efficiency of filling in clinical findings
Change Healthcare Cardiology Reference Viewer was renewed and is now fully zero footprint
Change Healthcare Cardiology Web was aligned with Change Healthcare Cardiology™ client capabilities:
- Added functionalities to the procedure list
- Improved viewer display and functionalities
- Enhanced measurements in the viewer
- Added DICOM protocol transfer capabilities
- Launch of additional viewing third parties
Report Editor has been enhanced to allow administrators to perform a broader range of customizations. They can customize:
- The new Change Healthcare Cardiology Vascular Ultrasound Report
- The new Change Healthcare Cardiology Adult Echo Report
Adaptive Archiving and IOCM (Imaging Object Change Management) were built for VNA (Vendor Neutral Archive) interoperability as the DICOM Archive
Added security, privacy and cybersecurity enhancements

AI/ML Overview

The provided text describes the Change Healthcare Cardiology™ system, a medical image management and processing system. The submission (K212528) focuses on demonstrating substantial equivalence to a predicate device (McKesson Cardiology™ K181080) rather than a standalone clinical study evaluating diagnostic performance against specific acceptance criteria. Therefore, several of the requested sections (e.g., specific acceptance criteria for diagnostic performance, details of a study proving those criteria, expert qualifications, adjudication methods, MRMC studies) are not directly addressed in this document.

However, based on the provided text, here's what can be extracted and inferred regarding performance data:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Compliance with design specifications	"Verification and validation testing was performed on Change Healthcare Cardiology™ to ensure it met all specifications."
Usability	"usability testing was performed where applicable."
Intended Functionality	"The device was further validated to ensure that it performs as intended."
Compliance with IEC 62304:2015 (Medical software life cycle processes)	"Performance testing was conducted to verify compliance with specified design requirements under IEC 62304:2015"
Compliance with IEC 62366-1:2015 (Usability engineering for medical devices)	"Performance testing was conducted to verify compliance with specified design requirements under... IEC 62366-1:2015"
Compliance with ISO 14971:2007 (Medical devices – Application of risk management)	"Performance testing was conducted to verify compliance with specified design requirements under... and ISO 14971:2007"
Compliance with FDA Guidelines for Cybersecurity and Interoperability	"Performance testing was conducted to verify compliance with specified design requirements under... which are FDA Guidelines for Cybersecurity and Interoperability."
DICOM Conformance (NEMA 3.1-3.20 (2016) standards)	"Furthermore, DICOM conformance testing was performed to verify compliance with NEMA 3.1-3.20 (2016) standards."
Substantial Equivalence to predicate device (McKesson Cardiology™ K181080)	"In all instances, Change Healthcare Cardiology™ functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices." "Change Healthcare Cardiology™ has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate device."
Absence of new issues of safety or effectiveness compared to the predicate device	"The minor technological differences between Change Healthcare Cardiology™ and its predicate device raise no new issues of safety or effectiveness."

Sample size used for the test set and the data provenance:
The document does not specify a distinct "test set" sample size in the context of diagnostic performance. The validation was primarily technical and functional. No clinical studies were necessary to support substantial equivalence. The document does not provide details on data provenance (e.g., country of origin, retrospective/prospective) for any specific performance testing datasets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The submission states "No clinical studies were necessary," which implies there wasn't a separate clinical ground truth establishment process involving external experts for diagnostic accuracy.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no specific test set requiring expert adjudication for diagnostic ground truth is mentioned.
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 comparative effectiveness study is mentioned. The device is described as an image and information system intended to "assist trained professionals in the viewing and diagnostic interpretation." It does not claim to be an AI-assisted diagnostic tool that augments human reader performance in a measurable way described by an effect size.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is an image and information management system, not a standalone diagnostic algorithm. It "is intended to assist trained professionals."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the technical and functional validation, the "ground truth" was defined by the specified design requirements, industry standards (IEC, ISO, NEMA), and the intended functionalities the system was designed to fulfill. There is no mention of clinical ground truth (e.g., pathology, outcomes data, expert consensus) being established for diagnostic performance.
The sample size for the training set:
Not applicable. The Change Healthcare Cardiology™ system is described as a software application for image and information management, not a machine learning model that requires a training set in the conventional sense. The "training" for the system would involve software development and testing rather than data-driven model training.
How the ground truth for the training set was established:
Not applicable, as there is no mention of a training set for a machine learning model. The ground truth for the software's development and verification would be its design specifications and compliance with relevant standards.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

October 18. 2021

Change Healthcare Israel Ltd. % Chester Mccoy VP, Quality Assurance & Regulatory Affairs and Chief Quality Officer Change Healthcare Canada Company 10711 Cambie Road Richmond, British Columbia V6X3G5 CANADA

Re: K212528

Trade/Device Name: Change Healthcare Cardiology™ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: August 5, 2021 Received: August 11, 2021

Dear Chester Mccoy:

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

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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/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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212528

Device Name Change Healthcare Cardiology™

Indications for Use (Describe)

Change Healthcare Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Type of Use ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/0 description: The image shows the logo for Change Healthcare. The logo consists of the word "CHANGE" in dark blue, with a red triangle replacing the "A". Below the word "CHANGE" is the word "HEALTHCARE" in red. The logo is simple and modern, and the colors are eye-catching.

510(k) SUMMARY

K212528

Change Healthcare Canada Company

Change Healthcare Canada Company 10711 Cambie Road Richmond, British Columbia, V6X 3G5 Canada

Contact Person:	Chester McCoy,Vice President, Quality Assurance and Regulatory Affairs, and ChiefQuality OfficerChange Healthcare Canada Company10711 Cambie RoadRichmond, British Columbia, V6X 3G5, CanadaTelephone: (574) 302-5855Email: Chester.McCoy@changehealthcare.com
Date Prepared:	September 27, 2021
Name of the device:	Change Healthcare Cardiology™
Common or Usual Name:	System, Image processing, Radiological
Classification Name:	Medical image management and processing system.
Classification Regulation:	21 C.F.R. § 892.2050
Product code:	LLZ
Device Class:	Class II
Predicate Device:	McKesson Cardiology™ (K181080)

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Image /page/4/Picture/1 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in a sans-serif font, with the letters in navy blue except for the "A" which is a red triangle. Below the word "CHANGE" is the word "HEALTHCARE" in red sans-serif font.

Intended Use and Indications for Use

Change Healthcare Cardiology™ offers support for third party plug-ins to enable the use of commercially available tools for analysis, quantification, and reporting. Change Healthcare Cardiology™ is intended to assist trained professionals in the viewing and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease.

Technological Characteristics

Change Healthcare Cardiology™ is a software application intended to run on a client/server array in a physical or virtual hosting environment to allow:

Importation of images in DICOM format, final reports, and various discrete data elements
Review, editing, management and synchronization of patient information and procedure data
Storage and management of data elements (images, reports, discrete data, and so on) for long term archive and disaster recovery purposes
Review, performance and editing of measurements
Creation, editing and confirmation of procedure reports
Distribution of procedure reports and results to other systems in file or discrete data element formats
Integration with 3rd party software components to provide additional image review, measurement tools, reporting and/or data import/export capabilities
Departmental administrative tasks such as managing charges and billing, departmental stock inventory levels, and so on.

New additional features and functionalities in this version and subject of this submission include:

Reporting module was redesigned on web based technology improving former reporting version capabilities:
- o New Change Healthcare Cardiology Vascular Ultrasound Report:
  - l Step-by-step design to accommodate the user's workflow
  - Enhanced Vascular Diagrams
  - l Enhanced efficiency of filling in clinical findings
  - Predefined content ease data insertion
- o New Change Healthcare Cardiology Adult Echo Report:
  - Step-by-step design to accommodate the user's workflow
  - . Improved data display
  - . Enhanced efficiency of filling in clinical findings
Change Healthcare Cardiology Reference Viewer was renewed and is now fully zero footprint ●

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Image /page/5/Picture/1 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in a sans-serif font, with the "A" replaced by a red triangle with a white outline. Below the word "CHANGE" is the word "HEALTHCARE" in a smaller, red sans-serif font. The logo is simple and modern, and the use of color is eye-catching.

Change Healthcare Cardiology Web was aligned with Change Healthcare Cardiology™ client capabilities:
- Added functionalities to the procedure list O
- Improved viewer display and functionalities O
- Enhanced measurements in the viewer O
- O Added DICOM protocol transfer capabilities
- O Launch of additional viewing third parties
Report Editor has been enhanced to allow administrators to perform a broader range of customizations. They can customize:
- The new Change Healthcare Cardiology Vascular Ultrasound Report O
- о The new Change Healthcare Cardiology Adult Echo Report
Adaptive Archiving and IOCM (Imaging Object Change Management) were built for VNA (Vendor Neutral Archive) interoperability as the DICOM Archive
Added security, privacy and cybersecurity enhancements

Performance Data

Verification and validation testing was performed on Change Healthcare Cardiology™ to ensure it met all specifications. In addition, usability testing was performed where applicable. The device was further validated to ensure that it performs as intended. Performance testing was conducted to verify compliance with specified design requirements under IEC 62304:2015, IEC 62366-1:2015, and ISO 14971:2007, which are FDA Guidelines for Cybersecurity and Interoperability.

Furthermore, DICOM conformance testing was performed to verify compliance with NEMA 3.1-3.20 (2016) standards. No clinical studies were necessary to support substantial equivalence. In all instances, Change Healthcare Cardiology™ functioned as intended and the observed results demonstrate substantial equivalence with the predicate devices.

Substantial Equivalence

Change Healthcare Cardiology™, the subject of this submission, is substantially equivalent to the previously cleared McKesson Cardiology™ (K181080). Change Healthcare Cardiology™ has the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate device.

The minor technological differences between Change Healthcare Cardiology™ and its predicate device raise no new issues of safety or effectiveness. Thus, Change Healthcare Cardiology™ is substantially equivalent to the previously cleared predicate device.

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).