Search Results

Change Healthcare Cardiology Hemodynamics™ is intended for complete physiological/hemodynamic monitoring. clinical data acquisition, medical image and data processing, and analytical assessment. Change Healthcare Cardiology Hemodynamics™ is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data. Data may also be acquired from and/or sent to other devices, such as physiological monitoring systems, information management systems, image acquisition/storage devices, and other medical devices.

Change Healthcare Cardiology Hemodynamics™ is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other patient/procedural data management is needed.

User-adjustable alarms (both visual and audible) available in the system alert the operator to anomalous occurrences and facilitate timely responses.

Use of the system is not intended patient monitoring or in situations where arrhythmia detection is required.

The Change Healthcare Cardiology Hemodynamics™ device is a hemodynamic monitoring system for monitoring vital signs, performing measurements and calculations, documenting procedure and patient data and interfacing to other systems and devices during and after procedures in the area of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.

Change Healthcare Cardiology Hemodynamics™ also acquires patient information from other hospital information systems and makes hemodynamic information available to them. It facilitates interfacing with hospital information systems and cardiac image management, archiving and reporting systems.

Change Healthcare Cardiology Hemodynamics™ incorporates the Argus PB-3000 vital signs monitoring device (K221056), manufactured by Schiller AG, which provides patient monitoring via:

• ECG leads
• Invasive Blood Pressure (connected to non-Change Healthcare transducers)
• SpO2 finger clip
• Non-invasive blood pressure (NIBP) cuff
• Temperature probe
• Thermal Dilution Cardiac output temperature probe (connected to non-Change Healthcare Cardiac Output catheter)
• CO2 (connected to non-Change Healthcare cannulas or intubation tubes)
  Argus PB-3000 monitoring device is provided with compatible accessories (cables, sensors, cuffs, probes, etc). Appendix L of the Change Healthcare Cardiology Hemodynamics User Guide includes a List of qualified PB-3000 accessories.

Change Healthcare Cardiology Hemodynamics™ is composed of:

• A control and documentation unit (Information System) that is used for administration, performing measurements, recording full disclosure, taking samples and entering procedure notes and overall data input and management of the patient and procedure data.
• A Clinical System that incorporates the RT Monitor and the Front-end (which incorporates the Schiller Argus PB-3000 device). The clinical system is responsible for acquiring, analyzing, and displaying patient vitals and other pertinent clinical data. The data is displayed on monitors.

Change Healthcare Cardiology Hemodynamics™ uses an interface that displays patient data, procedure data, waveforms, and numeric values. The performing physician views the monitor, and conveys instructions and procedure notes to the technician, who operates the application using a touch screen, keyboard and mouse, for maximum convenience.

The control and documentation unit (Information System) can function independently from the Clinical unit and therefore can be setup without the clinical unit for instances where only patient/procedure documentation is required.

In addition, the Change Healthcare Cardiology Hemodynamics™ system can receive and/or export data from 3rd party devices and systems. One such utilization is the ability to import monitored parameter data from 3rd party bedside monitors for documentation purposes as part of the patient's log (part of the Holding Area Charting configuration). This import is performed via the utilization of FDA cleared Capsule's SmartLinx software (K200856) that is intended for clinical information management through networks with independent devices.

Physicians can instruct the technician to configure the appearance, content and layout of the display on the monitors that display the patient's vitals and other pertinent clinical data (real-time monitors) and to perform real-time functions and measurements using the tools that exist in the control and documentation unit. This pane can be shown or hidden at any time by clicking Procedure Control in the display control bar. Each pane in the real-time controls area can be expanded to show more content and contracted to save space when that content is not needed. Changes should be made only upon request or instruction of the physician.

The clinical system resides on a dedicated computer to ensure that it is not vulnerable to failure of the network or the backend computer on which the application resides. In case of application failure, the system knows how to restart itself and restore a stable OS environment on the computer. Watchdogs are in place to prevent failure.

This document is a 510(k) Pre-market Notification from the FDA, asserting that the Change Healthcare Cardiology Hemodynamics™ device is substantially equivalent to a previously cleared predicate device. Therefore, a full clinical study to prove the device meets acceptance criteria was not performed or required as part of this submission.

Here's a breakdown based on the provided document, addressing the points where information is available or explicitly stated as not applicable:

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

The document does not provide a table of acceptance criteria and reported device performance in the typical sense of a clinical trial for a new device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Change Healthcare / McKesson Cardiology Hemo™, K131497) through non-clinical testing and comparison of technological characteristics.

The "acceptance criteria" here are implicitly the successful completion of the listed non-clinical tests and the demonstration that the new device's changes (e.g., updated vital signs acquisition unit, software, alarms) preserve its safety and effectiveness and do not raise new questions of safety or effectiveness compared to the predicate.

The reported "performance" is the device functioning as intended in the non-clinical tests and demonstrating identical or substantially equivalent features to the predicate.

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

This document describes a 510(k) submission, relying primarily on non-clinical performance data and comparison to a predicate device. Therefore, the concept of a "test set" with "data provenance" (like in a clinical study) as commonly understood for AI/ML device validation is not directly applicable here.

• Test Set Sample Size: Not applicable in the context of an AI/ML clinical study test set. The validation was against engineering specifications, simulated data (where applicable for non-clinical testing of the vital signs unit or software functionality), and comparison to the predicate.
• Data Provenance: Not applicable. The testing described (electrical safety, EMC, software V&V) is typically done in laboratory or simulated environments, not with patient data.

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

Not applicable. The submission did not involve clinical image interpretation or data labeling by experts for a test set to establish ground truth because it is not an AI/ML diagnostic or prognostic device that relies on such interpretation. The "ground truth" for non-clinical tests would be the established engineering specifications and performance standards.

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

Not applicable, as there was no clinical image interpretation test set requiring adjudication.

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 done. The document explicitly states: "No clinical testing was necessary to support substantial equivalence." This device is a hemodynamic monitoring system, not an AI-assisted diagnostic imaging device that would typically undergo MRMC studies.

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

This is not an AI/ML algorithm with "standalone" performance. The device is a physiological/hemodynamic monitoring system incorporating hardware and software, designed to be operated by a human technician and used under the direction of a physician. Its performance is inherent in its operation and data acquisition, not as an algorithm generating a diagnostic output on its own.

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

For a device like this, the "ground truth" generally refers to:

• Engineering specifications and regulatory standards: The device's components (e.g., vital signs acquisition unit, software modules) are expected to perform according to predefined technical specifications and comply with relevant international standards (e.g., IEC 60601 series for electrical safety, ISO standards for specific physiological measurements, IEC 62304 for software lifecycle processes).
• Predicate device performance: The performance of the new device relative to the legally marketed predicate device is the primary "ground truth" for demonstrating substantial equivalence.

No clinical expert consensus, pathology, or outcomes data were used to establish ground truth for this 510(k) submission as no clinical study was performed.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model trained on a "training set" of data.

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

Not applicable for the same reason as above.

Ask a specific question about this device

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.

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

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:

1. 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."

2. 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.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. 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.

4. 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.

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 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.

6. 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."

7. 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.

8. 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.

9. 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.

Ask a specific question about this device