HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Device Facts
| Record ID | K163381 |
|---|---|
| Device Name | HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable |
| Applicant | Edwards Lifesciences, LLC |
| Product Code | DQK · Cardiovascular |
| Decision Date | Apr 14, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatic critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Device Story
Modular hemodynamic monitoring platform; consists of HemoSphere Advanced Monitor, Swan-Ganz Module, and Oximetry Cable. Inputs: data from Swan-Ganz/oximetry catheters; analog ECG signals from external vital sign monitors. Transforms inputs via computational algorithms (same as Vigilance II) to calculate hemodynamic/volumetric parameters (e.g., CO, CI, EDV, RVEF, SvO2, ScvO2, VO2e). Used in hospital critical care environments by clinicians. Output: visual display of parameters on touchscreen monitor; HDMI output for external display. Benefits: provides real-time hemodynamic data to assist clinical decision-making in critical care. Features modernized GUI, wireless data transmission to MDDS, and modular architecture.
Clinical Evidence
No clinical data required. Evidence consists of bench simulation testing for cardiac output (iCO, CCO, RVEF, blood/injectate temperature) and oximetry (SvO2, ScvO2) parameters, system-level safety verification, and usability testing involving 4 pigs and 25 clinicians.
Technological Characteristics
Modular system; Windows 7 OS; touchscreen interface. Connectivity: wireless (to MDDS), HDMI display output, analog ECG input. Standards: IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 62304, 62366, 60601-2-49. Software: Moderate (Monitor, Oximetry Cable) and Major (Swan-Ganz Module) level of concern.
Indications for Use
Indicated for adult and pediatric critical care patients in hospital settings requiring monitoring of cardiac output (CO, iCO), venous oxygen saturation (SvO2, ScvO2), and derived hemodynamic parameters via compatible Edwards catheters.
Regulatory Classification
Identification
A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.
Predicate Devices
- Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor (K043103)
- EV1000 Clinical Platform (K160552)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Edwards Lifesciences, LLC Chirag Shah Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K163381
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-ganz Module, HemoSphere Oximetry Cable Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE Dated: March 15, 2017 Received: March 16, 2017
Dear Chirag Shah:
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. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel -
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
### 510(k) Number (if known) K163381
### Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatic critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Type of Use (Select one or both, as applicable)
| <span style="font-family: sans-serif;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|---------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> ☐ Over The Counter Use (21 CFR 801 Subpart C) </span> |
| × Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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K163381
# Section 5 – 510(k) Summary
| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 2015691 |
| Contact Person: | Chirag Shah<br>Associate Manager, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>Telephone: (949) 250-1580<br>Fax: (949) 809-2972 |
| Date: | November 30, 2016 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor<br>HemoSphere Swan-Ganz Module<br>HemoSphere Oximetry Cable |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification Name: | Programmable Diagnostic Computer<br>21 CFR 870.1425<br>Fiberoptic Oximeter Catheter<br>21 CFR 870.1230 |
| Product Code: | DQK, Class II<br>DQE, Class II |
| Primary Predicate<br>Device: | Vigilance II Continuous Cardiac Output/Oximetry/Volumetric<br>(CCO/SvO2/CEDV) Monitor manufactured by Edwards<br>Lifesciences, K043103, cleared December 9, 2004. |
| Secondary Predicate<br>Device: | EV1000 Clinical Platform manufactured by Edwards Lifesciences,<br>K160552, cleared June 01, 2016. |
| Device Description: | The HemoSphere Advanced Monitoring Platform is a modular<br>system which uses the same monitoring technology (CCO, ICO,<br>Oximetry), the same associated devices (Swan-Ganz and Oximetry<br>Catheters), the same analog inputs from external vital sign monitors,<br>the same computational algorithms for hemodynamic monitoring<br>and the same default alarm limits as the Vigilance II System |
| | (K043103, cleared December 9, 2004). Updates made to the<br>HemoSphere Advanced Monitoring Platform include a modernized<br>look (updated Graphical User Interface (GUI) and touchscreen<br>monitor), wireless capability, a modular architecture for scalability<br>and two new derived oximetry parameters. The updated GUI is<br>similar to the GUI utilized in the EV1000 Clinical Platform<br>(K160552, cleared June 01, 2016). The two new derived oximetry<br>parameters (Estimated Oxygen Consumption (VO2e) and Estimated<br>Oxygen Consumption Index (VO2Ie)) are derived parameters that<br>are currently available on the EV1000 Clinical Platform (K160552,<br>cleared June 01, 2016). |
| | The HemoSphere Advanced Monitoring Platform consists of the<br>HemoSphere Advanced Monitor that provides a means to interact<br>with and visualize hemodynamic and volumetric data on a screen<br>and two optional external modules: the HemoSphere Swan-Ganz<br>Module and the HemoSphere Oximetry Cable. |
| | These optional modules provide an interface to connect with<br>currently cleared and commercially available Edwards Lifesciences<br>Swan-Ganz and Oximetry catheters (K803058, K822350, K905458,<br>K924650, K934742, K940795, K053609 and K110167 and<br>K160884). The modules provide the software technology to<br>compute hemodynamic monitoring data that is then sent to the<br>monitor for visualization and storage. |
| | The HemoSphere Advanced Monitor has an input that can be<br>connected to an external vital sign patient monitor for the purpose of<br>slaving in an analog ECG signal. The HemoSphere Platform uses<br>this analog ECG input signal to calculate a heart rate that is used by<br>the HemoSphere Swan-Ganz Module to calculate certain derived<br>parameters (e.g. HRavg, SV, RVEF and EDV). |
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#### Indications for Uses fonitor with Hemosp రువ్ Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
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## HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
#### The HemoSphere Advanced Monitoring Platform is intended to be Intended Use: used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.
The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters.
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed in the table below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population
| Parameters | Description | Patient Population |
|------------|---------------------------------------------------|--------------------|
| CO | continuous cardiac output | Adult only |
| sCO | STAT cardiac output | |
| CI | continuous cardiac index | |
| sCI | STAT cardiac index | |
| EDV | right ventricular end diastolic volume | |
| sEDV | STAT right ventricular end diastolic volume | |
| EDVI | right ventricular end diastolic volume index | |
| sEDVI | STAT right ventricular end diastolic volume index | |
| HRavg | averaged heart rate | |
| LVSWI | left ventricular stroke work index | |
| PVR | pulmonary vascular resistance | |
| PVRI | pulmonary vascular resistance index | |
| RVEF | right ventricular ejection fraction | |
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| sRVEF | STAT right ventricular ejection<br>fraction | |
|-------|----------------------------------------------------|------------------------|
| RVSWI | right ventricular stroke work index | |
| SV | stroke volume | |
| SVI | stroke volume index | |
| SVR | systemic vascular resistance | |
| SVRI | systemic vascular resistance index | |
| iCO | intermittent cardiac output | Adult and<br>Pediatric |
| iCI | intermittent cardiac index | |
| iSVR | intermittent systemic vascular<br>resistance | |
| iSVRI | intermittent systemic vascular<br>resistance index | |
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere oximetry cable are as listed below:
| Parameters | Description | Patient<br>Population |
|------------|----------------------------------|-----------------------|
| SvO2 | Mixed Venous Oxygen Saturation | Adult and |
| ScvO2 | Central Venous Oxygen Saturation | Pediatric |
A comprehensive list of additional parameters that are available for adult and pediatric patient populations on the HemoSphere Advanced Monitor when connected with the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable are as listed below:
| Parameters | Description | Patient<br>Population |
|------------|------------------------------------------------------------------------|------------------------|
| DO2 | Oxygen Delivery | Adult and<br>Pediatric |
| DO2I | Oxygen Delivery Indexed | |
| VO2 | Oxygen Consumption | |
| VO2e | Estimated Oxygen Consumption<br>when ScvO2 is being monitored | |
| VO2I | Oxygen Consumption Index | |
| VO2Ie | Estimated Oxygen Consumption<br>Index when ScvO2 is being<br>monitored | |
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| Comparison to<br>Predicate Device: | The HemoSphere Advanced Monitoring Platform is a modular<br>platform which uses the same monitoring technology (CCO, ICO,<br>Oximetry), the same associated catheters (Swan-Ganz and Oximetry<br>Catheters), the same analog inputs from external vital sign monitors,<br>the same computational algorithms for hemodynamic monitoring<br>and the same default alarm limits as Vigilance II System (K043103,<br>cleared December 9, 2014).<br><br>Updates made to the HemoSphere Advanced Monitoring Platform<br>include a modernized look (updated Graphical User Interface (GUI)<br>and touchscreen monitor), wireless capability, a modular<br>architecture designed for scalability, and two additional derived<br>oximetry parameters (Estimated Oxygen Consumption (VO2e) and<br>Estimated Oxygen Consumption Index (VO2Ie)). The updated GUI<br>is similar to the GUI utilized in the EV1000 Clinical Platform<br>(K160552, cleared June 01, 2016). Wireless capabilities for the<br>HemoSphere Advanced Monitoring Platform are limited to<br>connecting and sending data to external Medical Device Data<br>Systems. The two additional derived oximetry parameters (VO2e<br>and VO2Ie) are derived parameters that are currently available on<br>the EV1000 Clinical Platform.<br><br>The HemoSphere Advanced Monitor has an HDMI display output<br>port to connect to an external monitor as opposed to a VGA port on<br>the Vigilance II System. All other input and output ports remain the<br>same.<br><br>The HemoSphere Advanced Monitor is built on a Windows 7<br>Operating System whereas the Vigilance II System used a Nucleus<br>Real Time Operating System (RTOS).<br><br>Verification and validation testing was performed to compare the<br>performance and functionality of the HemoSphere Advanced<br>Monitoring Platform and the Vigilance II System. Testing included<br>a side-by-side comparison of the output parameters using a bench<br>test. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data<br>(Bench and/or<br>Clinical): | The following verification activities were performed in support of a<br>substantial equivalence determination.<br><br><b>System Verification</b><br>Key Cardiac Output parameters (ICO, CCO, RVEF, Blood<br>Temperature and Injectate Temperature) and Oximetry parameters<br>(SvO2 and ScvO2) were tested using a bench simulation. Power<br>switching and shutoff verification for the Swan-Ganz module was<br>performed. Additionally, individual modules were tested at a<br>system level to verify the safety of these modules. They were also<br>integrated as a system and verified for their safety and effectiveness. |
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### Electrical Safety and Electromagnetic Compatibility (EMC)
The HemoSphere Advanced Monitor, The HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable were tested to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8. IEC 62304. IEC 62366 and IEC 60601-2-49.
### Wireless Coexistence Testing
Bench and simulated environment testing was performed on the HemoSphere Advanced Monitoring Platform.
### Software Verification
The HemoSphere Advanced Monitor and the HemoSphere Oximetry Cable were both considered as software of Moderate Level of Concern. The HemoSphere Swan-Ganz Module was considered as software of Major Level of Concern.
Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software on each of the individual modules was tested at a sub-system level to ensure the safety of the device.
### Animal Study
An animal study involving 4 pigs and 25 clinicians was performed to verify usability of the HemoSphere Advanced Monitoring Platform.
### Clinical Performance
Clinical data was not required for this device.
#### Non-Clinical Performance Conclusions: Conclusions
Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device.
Clinical Performance Conclusions: Clinical data was not required for this device.
### Overall Conclusion:
The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitoring Platform (the HemoSphere Advanced Monitor, the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable ) is substantially equivalent to the legally marketed predicate Vigilance II System.
