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.

Device Description

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.

AI/ML Overview

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.

Feature	Predicate Device (K131497)	Subject Device (K230881)	Performance/Comparison
Indications for Use	Complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, analytical assessment, patient/procedural data management.	Identical. Intended for use in cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.	Identical. The indications are unchanged, including the indicated environment for use and associated procedures.
Vital Signs Acquisition Unit (Hardware)	Schiller AG's Argus PB-1000 (K012226)	Schiller AG's Argus PB-3000 (K221056)	Substantially Equivalent. Verification testing shows the new PB-3000 is substantially equivalent to the predicate device's component.
Monitored Parameters, Waveforms, & Patient Connections	ECG, SpO2, IBP, NIBP, Temperature, TDCO, CO2 (capnogram), Resp, FFR via same connections.	Identical.	Identical. Provides the same display of waveforms and clinical parameter monitoring via the same connections to the patient.
Calculations and Clinical Formulas	Standard clinical formulas (Peak-to-Peak and Mean Gradient measurements).	Standard clinical formulas plus added functionality of Peak Instantaneous Gradient measurement.	Substantially Equivalent. Clinical formulas are identical and calculations are substantially equivalent as they rely on the same measurements. Verification of the added Peak Instantaneous Gradient measurement shows substantial equivalence.
Operating System and Database Engines	Older versions (not specified explicitly but implied by "newer versions...implemented").	Newer versions implemented.	Substantially Equivalent. Newer versions add robustness and reliability.
Communication with External Systems	Image, Document and Data Export file formats, Communication protocol, Network infrastructure.	Identical.	Identical.
Alarms	Visual/audio alarm systems (physiological alarms).	Visual/audio alarm systems (physiological alarms) plus technical alarms.	Substantially Equivalent. Updates for alarm functionality (addition of Technical Alarms) comply with IEC 60601-1-8 standard, demonstrating substantial equivalence.
Other Software Updates	Not specified, but implied by "software updates improve robustness and security".	Updates to improve robustness and security.	Substantially Equivalent. Software verification demonstrates substantial equivalence.
Electrical Safety, EMC, and Additional Standards Testing	(Presumed compliant as predicate)	Successfully tested against AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012, IEC 60601-1-2 Ed 4.1, IEC 60601-1-6 Ed 3.1, IEC 60601-1-8:2006 Amd 1:2012, IEC 60601-2-27:2011, IEC 80601-2-30:2018, IEC 60601-2-34:2011, ISO 80601-2-55:2018, ISO 80601-2-56:2017, ISO 80601-2-61:2017.	Complies with FDA recognized consensus standards, demonstrating safety and effectiveness.
Software Verification and Validation Testing	(Presumed compliant as predicate)	Performed at unit, integration, and system levels per IEC 62304:2015. Usability testing performed where applicable.	Functioned as intended in all instances, demonstrating substantial equivalence with the predicate device.

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.

Summary

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September 11, 2023

Change Healthcare Israel Ltd. Alona Golik Sr. Director, Regulatory Affairs 26 Harokmim St. Holon, 5885849 Israel

Re: K230881

Trade/Device Name: Change Healthcare Cardiology HemodynamicsTM Regulation Number: 21 CFR 870.2300 and 21 CFR 870.1425 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI, DOK Dated: August 14, 2023 Received: August 14, 2023

Dear Alona Golik:

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

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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 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,

Robert T. Kazmierski -S

for

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices 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) K230881/S002

Device Name Change Healthcare Cardiology HemodynamicsTM

Indications for Use (Describe)

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.

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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Image /page/3/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in a bold, 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.

510(k) SUMMARY K230881

Change Healthcare Canada Company

1. SUBMITTER

Change Healthcare Israel Ltd. 26 HAROKMIM ST., AZRIELI CENTER,

BUILDING A, HOLON Central, IL 5885849

Contact Person:	Alona Golik,
	VP Quality Assurance and Regulatory Affairs
	Change Healthcare Israel Ltd.
	26 HAROKMIM ST., AZRIELI CENTER, BUILDING A
	HOLON, Central IL 5885849
	Telephone: 972-52-4084942
	Email: regulatory@changehealthcare.com

Date Prepared: August 13th, 2023

2. DEVICE

Name of the device:	Change Healthcare Cardiology Hemodynamics™
Common or Usual Name:	Cardiac Monitor
Classification Name:	Monitor, Physiological, Patient, Without Arrhythmia, Detection orAlarms
Classification Regulation	21 C.F.R. § 870.2300 and 21 C.F.R. § 870.1425
Regulatory Class	II
Classification Product code:	MWI
Subsequent Product code:	DQK

K230881 Page 1 of 7

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3. PREDICATE DEVICE

Name of the device:	Change Healthcare / McKesson Cardiology Hemo ™
510(k) number	K131497
Classification Name:	Monitor, Physiological, Patient, Without Arrhythmia, Detection orAlarms
Classification Regulation	21 C.F.R. § 870.2300
Regulatory Class	II
Classification Product code:	MWI
Subsequent Product code:	DQK

No reference devices were used in this submission.

4. DEVICE DESCRIPTION

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)

K230881 Page 2 of 7

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Image /page/5/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in a bold, 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.

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.

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Image /page/6/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in dark blue, except for the "A", which is a red triangle. Below the word "CHANGE" is the word "HEALTHCARE" in red.

5. INDICATIONS FOR USE/ INTENDED USE

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, 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.

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.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A comparison of the features and functionalities in the Change Healthcare Cardiology Hemodynamics™ compared to the predicate are as follows in the table below:

Feature	Comparison Between Subject Device K230881 andPredicate Device K131497
Indications for Use	Identical. The indications are unchanged, which includes the indicatedenvironment for use and associated procedures.
Vital Signs AcquisitionUnit (Hardware)	Substantially Equivalent. The front-end unit for patient parametersacquisition (vital data signs) hardware has been changed from the SchillerAG's Argus PB-1000 (K012226) to the PB-3000 (K221056). The verificationtesting in the subject 510(k) shows that the new PB-3000 is substantiallyequivalent to the predicate device.
MonitoredParameters,Waveforms andPatient Connections	Identical. The subject device provides the same display of waveformsand clinical parameter monitoring (ECG, SpO2, IBP, NIBP, Temperature,TDCO, CO2 (capnogram), Resp, FFR), via the same connections to thepatient (ECG, IBP, SpO2, NIBP, TDCO, Temp, CO2), as the predicatedevice.

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Calculations andClinical Formulas	Substantially Equivalent. The clinical formulas provided by the predicateand subject device are identical and the calculations are substantiallyequivalent, as they rely on the same measurements. The subjectHemodynamics device incorporates an added functionality of PeakInstantaneous Gradient measurement, in addition to the existing Peak-to-Peak and Mean Gradient measurements. The the verification of thiscalculation shows substantial equivalence to the predicate device.
Operating System anddatabase engines	Substantially Equivalent. Newer versions were implemented in theChange Healthcare Cardiology Hemodynamics™ device that addrobustness and reliability to the platforms.
Communication withExternal Systems	Identical. The Image, Document and Data Export file formats,Communication protocol, Network infrastructure remain identicalbetween the subject and predicate devices.
Alarms	Substantially Equivalent. Both the subject and predicate devices havealarm systems (visual/audio). The subject Hemodynamics device hastechnical alarms, in addition to physiological alarms that are part of boththe predicate and subject devices. The updates for the Alarmfunctionality (addition of Technical Alarms) are done in compliance withthe current IEC 60601-1-8 standard, and therefore demonstratessubstantial equivalence to the predicate. .
Other SoftwareUpdates	Substantially Equivalent. Software updates improve robustness andsecurity of the device, and the software verification demonstratessubstantial equivalence to the predicate device. .

7. NON-CLINICAL PERFORMANCE DATA

7.1. Electrical Safety, Electromagnetic Compatibility (EMC), and additional Standards Testing

The system has been tested and proved to comply with the FDA recognized consensus standards listed below:

Title of the Consensus Standard	FDARecognition #
AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012, Medical ElectricalEquipment - Part 1: General Requirements For Basic Safety And Essential Performance	19-4
IEC 60601-1-2 Edition 4.1 2020-09, Medical Electrical Equipment - Part 1-2:	19-36

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Image /page/8/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is in large, bold, dark blue letters, except for the "A" which is a red triangle. Below the word "CHANGE" is the word "HEALTHCARE" in smaller, red letters.

General Requirements For Basic Safety And Essential Performance - Collateral Standard:Electromagnetic Disturbances - Requirements and Tests	5-89
IEC 60601-1-6 Edition 3.1 2013-10, Medical Electrical Equipment - Part 1-6:General Requirements For Basic Safety And Essential Performance - Collateral Standard:Usability
IEC 60601-1-8:2006 Amd 1:2012, Medical electrical equipment- Part 1-8:General requirements for basic safety and essential performance- CollateralStandard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems	5-76
IEC 60601-2-27:2011, Medical Electrical Equipment - Part 2-27: ParticularRequirements For The Basic Safety And Essential Performance Of ElectrocardiographicMonitoring Equipment	3-126
IEC 80601-2-30:2018, Medical electrical equipment - Part 2-30: Particularrequirements for the basic safety and essential performance of automated non-invasivesphygmomanometers (NIBP automated)	3-123
IEC 60601-2-34:2011, Medical electrical equipment - Part 2-34: Particularrequirements for the basic safety and essential performance of invasive blood pressuremonitoring equipment	3-115
ISO 80601-2-55:2018, Medical electrical equipment Part 2: Particular requirements forthe basic safety and essential performance of respiratory gas monitors	1-140
ISO 80601-2-56:2017, Particular requirements for basic safety and essentialperformance of clinical thermometers for body temperature measurement(Temperature)	6-421
ISO 80601-2-61:2017, Medical electrical equipment -- Part 2-61: Particularrequirements for basic safety and essential performance of pulse oximeter equipment(SpO2)	1-139

7.2. Software Verification and Validation Testing

Title of the Consensus Standard	FDARecognition #
IEC 62304:2015, medical device software - software life cycle processes	13-79

Software Verification and Validation testing was performed at the unit, integration and system levels for the Change Healthcare Cardiology Hemodynamics™ software to ensure it meets all specifications. Usability testing was performed where applicable. In all instances, Change Healthcare Cardiology Hemodynamics™ functioned as intended and the observed results demonstrate substantial equivalence with the predicate device.

7.3. Clinical Testing

No clinical testing was necessary to support substantial equivalence.

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Image /page/9/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in large, bold, dark blue letters, with a red triangle in place of the letter "A". Below the word "CHANGE", the word "HEALTHCARE" is written in smaller, red letters. The logo is simple and modern, and the colors are eye-catching.

8. CONCLUSION

Change Healthcare Cardiology Hemodynamics™, the subject of this submission, is substantially equivalent to the previously cleared Change Healthcare/McKesson Cardiology Hemo (K131497). Change Healthcare Cardiology Hemodynamics™ has the same intended uses and indications, technological characteristics, and principles of operation as the predicate device and as demonstrated by the performance data in the submission.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).