(165 days)
No
The summary describes a hemodynamic monitoring system focused on data acquisition, processing, management, and display. It mentions standard vital sign monitoring, calculations, documentation, and interfacing with other systems. There is no mention of AI, ML, or any advanced analytical techniques that would typically involve these technologies. The "analytical assessment" mentioned in the intended use appears to refer to standard clinical calculations and data review, not AI/ML-driven analysis.
No
The device is described as a hemodynamic monitoring system for data acquisition, processing, and management. Its functions are related to monitoring and data handling, not direct therapeutic action. The text explicitly states, "Use of the system is not intended patient monitoring or in situations where arrhythmia detection is required." but the full intent is for monitoring, clinical data acquisition, medical image and data processing and analytical assessment. This is a monitoring and data management device, not a therapeutic one.
Yes
The first paragraph under "Intended Use / Indications for Use" states that the device is intended for "complete physiological/hemodynamic monitoring," "clinical data acquisition," and "analytical assessment," which are all functions of a diagnostic device.
No
The device description explicitly states that the system incorporates the Argus PB-3000 vital signs monitoring device, which is a hardware component with various sensors and probes. While the system includes software for data processing and management, it is not solely software.
Based on the provided text, the Change Healthcare Cardiology Hemodynamics™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the Change Healthcare Cardiology Hemodynamics™ system is a hemodynamic monitoring system. It acquires physiological data directly from the patient (ECG, blood pressure, SpO2, temperature, CO2) and manages patient and procedural data.
- Lack of Specimen Analysis: There is no mention of the device collecting or analyzing specimens from the human body. Its function is focused on real-time physiological monitoring and data management.
Therefore, the device falls under the category of a physiological monitoring system and data management system, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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, 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.
Product codes
MWI, DOK
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.
Mentions image processing
Yes, "medical image and data processing"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where patient/procedural data management is needed.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was necessary to support substantial equivalence. Non-clinical performance data included Electrical Safety, Electromagnetic Compatibility (EMC), and additional Standards Testing, as well as Software Verification and Validation Testing. The system was tested to comply with listed FDA recognized consensus standards. Software V&V testing was performed at unit, integration, and system levels, and usability testing was performed where applicable. The device functioned as intended and demonstrated substantial equivalence with the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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
2
Indications for Use
510(k) Number (if known) K230881/S002
Device Name Change Healthcare Cardiology HemodynamicsTM
Indications for Use (Describe)
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.
| 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 or |
| Alarms | |
| 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 or |
| Alarms | |
| 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
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)
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.
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.
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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.
Change Healthcare Cardiology Hemodynamics™ is intended for use in the areas of: cardiology, cardiac catheterization, electrophysiology, radiology, invasive radiology, and other areas where 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.
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 and
Predicate Device K131497 |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Identical. The indications are unchanged, which includes the indicated
environment for use and associated procedures. |
| Vital Signs Acquisition
Unit (Hardware) | Substantially Equivalent. The front-end unit for patient parameters
acquisition (vital data signs) hardware has been changed from the Schiller
AG's Argus PB-1000 (K012226) to the PB-3000 (K221056). The verification
testing in the subject 510(k) shows that the new PB-3000 is substantially
equivalent to the predicate device. |
| Monitored
Parameters,
Waveforms and
Patient Connections | Identical. The subject device provides the same display of waveforms
and clinical parameter monitoring (ECG, SpO2, IBP, NIBP, Temperature,
TDCO, CO2 (capnogram), Resp, FFR), via the same connections to the
patient (ECG, IBP, SpO2, NIBP, TDCO, Temp, CO2), as the predicate
device. |
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Image /page/7/Picture/0 description: The image shows the logo for Change Healthcare. The word "CHANGE" is written in large, bold letters, with the "A" replaced by a red triangle. Below the word "CHANGE" is the word "HEALTHCARE" in smaller, red letters.
| Calculations and
Clinical Formulas | Substantially Equivalent. The clinical formulas provided by the predicate
and subject device are identical and the calculations are substantially
equivalent, as they rely on the same measurements. The subject
Hemodynamics device incorporates an added functionality of Peak
Instantaneous Gradient measurement, in addition to the existing Peak-to-
Peak and Mean Gradient measurements. The the verification of this
calculation shows substantial equivalence to the predicate device. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operating System and
database engines | Substantially Equivalent. Newer versions were implemented in the
Change Healthcare Cardiology Hemodynamics™ device that add
robustness and reliability to the platforms. |
| Communication with
External Systems | Identical. The Image, Document and Data Export file formats,
Communication protocol, Network infrastructure remain identical
between the subject and predicate devices. |
| Alarms | Substantially Equivalent. Both the subject and predicate devices have
alarm systems (visual/audio). The subject Hemodynamics device has
technical alarms, in addition to physiological alarms that are part of both
the predicate and subject devices. The updates for the Alarm
functionality (addition of Technical Alarms) are done in compliance with
the current IEC 60601-1-8 standard, and therefore demonstrates
substantial equivalence to the predicate. . |
| Other Software
Updates | Substantially Equivalent. Software updates improve robustness and
security of the device, and the software verification demonstrates
substantial 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 | FDA
Recognition # |
|-------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| AAMI ANSI ES60601-1:2005/(R)2012 + A1:2012, Medical Electrical
Equipment - 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- Collateral | |
| Standard: General requirements, tests and guidance for alarm systems in | |
| medical electrical equipment and medical electrical systems | 5-76 |
| IEC 60601-2-27:2011, Medical Electrical Equipment - Part 2-27: Particular | |
| Requirements For The Basic Safety And Essential Performance Of Electrocardiographic | |
| Monitoring Equipment | 3-126 |
| IEC 80601-2-30:2018, Medical electrical equipment - Part 2-30: Particular | |
| requirements for the basic safety and essential performance of automated non-invasive | |
| sphygmomanometers (NIBP automated) | 3-123 |
| IEC 60601-2-34:2011, Medical electrical equipment - Part 2-34: Particular | |
| requirements for the basic safety and essential performance of invasive blood pressure | |
| monitoring equipment | 3-115 |
| ISO 80601-2-55:2018, Medical electrical equipment Part 2: Particular requirements for | |
| the basic safety and essential performance of respiratory gas monitors | 1-140 |
| ISO 80601-2-56:2017, Particular requirements for basic safety and essential | |
| performance of clinical thermometers for body temperature measurement | |
| (Temperature) | 6-421 |
| ISO 80601-2-61:2017, Medical electrical equipment -- Part 2-61: Particular | |
| requirements 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 | FDA
Recognition # |
|-------------------------------------------------------------------------|----------------------|
| 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.