FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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).