(134 days)
No
The description focuses on traditional hemodynamic monitoring technology, computational algorithms, and hardware updates, with no mention of AI or ML.
No.
The device is indicated for monitoring and providing data, not for treating or preventing a disease.
Yes
The device is indicated for monitoring cardiac output, derived hemodynamic parameters, and venous oxygen saturation in critical care patients, which are all diagnostic functions.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform is a "modular system" consisting of the "HemoSphere Advanced Monitor" and "two optional external modules: the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable." It also mentions connections to external vital sign monitors and catheters, indicating hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The HemoSphere Advanced Monitoring Platform, when used with the specified modules and catheters, is described as a system for monitoring cardiac output, derived hemodynamic parameters, and venous oxygen saturation in critical care patients. It measures these parameters directly within the patient's circulatory system using invasive catheters.
- Lack of Specimen Examination: The device does not examine specimens in vitro (outside the body). It is directly connected to the patient's body via catheters to obtain real-time physiological measurements.
Therefore, the HemoSphere Advanced Monitoring Platform falls under the category of a patient monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
The HemoSphere Advanced Monitoring Platform is intended to be 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.
Product codes (comma separated list FDA assigned to the subject device)
DQK, DQE
Device Description
The HemoSphere Advanced Monitoring Platform is a modular system which uses the same monitoring technology (CCO, ICO, Oximetry), the same associated devices (Swan-Ganz and Oximetry Catheters), the same analog inputs from external vital sign monitors, the same computational algorithms for hemodynamic monitoring and the same default alarm limits as the Vigilance II System (K043103, cleared December 9, 2004). Updates made to the HemoSphere Advanced Monitoring Platform include a modernized look (updated Graphical User Interface (GUI) and touchscreen monitor), wireless capability, a modular architecture for scalability and two new derived oximetry parameters. The updated GUI is similar to the GUI utilized in the EV1000 Clinical Platform (K160552, cleared June 01, 2016). The two new derived oximetry parameters (Estimated Oxygen Consumption (VO2e) and Estimated Oxygen Consumption Index (VO2Ie)) are derived parameters that are currently available on the EV1000 Clinical Platform (K160552, cleared June 01, 2016).
The HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and two optional external modules: the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable.
These optional modules provide an interface to connect with currently cleared and commercially available Edwards Lifesciences Swan-Ganz and Oximetry catheters (K803058, K822350, K905458, K924650, K934742, K940795, K053609 and K110167 and K160884). The modules provide the software technology to compute hemodynamic monitoring data that is then sent to the monitor for visualization and storage.
The HemoSphere Advanced Monitor has an input that can be connected to an external vital sign patient monitor for the purpose of slaving in an analog ECG signal. The HemoSphere Platform uses this analog ECG input signal to calculate a heart rate that is used by the HemoSphere Swan-Ganz Module to calculate certain derived parameters (e.g. HRavg, SV, RVEF and EDV).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
qualified personnel or trained clinicians in a critical care environment in a hospital setting.
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)
System Verification: Key Cardiac Output parameters (ICO, CCO, RVEF, Blood Temperature and Injectate Temperature) and Oximetry parameters (SvO2 and ScvO2) were tested using a bench simulation. Power switching and shutoff verification for the Swan-Ganz module was performed. Additionally, individual modules were tested at a system level to verify the safety of these modules. They were also integrated as a system and verified for their safety and effectiveness.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K803058, K822350, K905458, K924650, K934742, K940795, K053609, K110167, K160884
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, featuring three human profiles facing right.
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
1
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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over The Counter Use (21 CFR 801 Subpart C) |
| × Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5 – 510(k) Summary
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration Number: | 2015691 |
| Contact Person: | Chirag Shah
Associate Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 250-1580
Fax: (949) 809-2972 |
| Date: | November 30, 2016 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification Name: | Programmable Diagnostic Computer
21 CFR 870.1425
Fiberoptic Oximeter Catheter
21 CFR 870.1230 |
| Product Code: | DQK, Class II
DQE, Class II |
| Primary Predicate
Device: | Vigilance II Continuous Cardiac Output/Oximetry/Volumetric
(CCO/SvO2/CEDV) Monitor manufactured by Edwards
Lifesciences, K043103, cleared December 9, 2004. |
| Secondary Predicate
Device: | EV1000 Clinical Platform manufactured by Edwards Lifesciences,
K160552, cleared June 01, 2016. |
| Device Description: | The HemoSphere Advanced Monitoring Platform is a modular
system which uses the same monitoring technology (CCO, ICO,
Oximetry), the same associated devices (Swan-Ganz and Oximetry
Catheters), the same analog inputs from external vital sign monitors,
the same computational algorithms for hemodynamic monitoring
and the same default alarm limits as the Vigilance II System |
| | (K043103, cleared December 9, 2004). Updates made to the
HemoSphere Advanced Monitoring Platform include a modernized
look (updated Graphical User Interface (GUI) and touchscreen
monitor), wireless capability, a modular architecture for scalability
and two new derived oximetry parameters. The updated GUI is
similar to the GUI utilized in the EV1000 Clinical Platform
(K160552, cleared June 01, 2016). The two new derived oximetry
parameters (Estimated Oxygen Consumption (VO2e) and Estimated
Oxygen Consumption Index (VO2Ie)) are derived parameters that
are currently available on the EV1000 Clinical Platform (K160552,
cleared June 01, 2016). |
| | The HemoSphere Advanced Monitoring Platform consists of the
HemoSphere Advanced Monitor that provides a means to interact
with and visualize hemodynamic and volumetric data on a screen
and two optional external modules: the HemoSphere Swan-Ganz
Module and the HemoSphere Oximetry Cable. |
| | These optional modules provide an interface to connect with
currently cleared and commercially available Edwards Lifesciences
Swan-Ganz and Oximetry catheters (K803058, K822350, K905458,
K924650, K934742, K940795, K053609 and K110167 and
K160884). The modules provide the software technology to
compute hemodynamic monitoring data that is then sent to the
monitor for visualization and storage. |
| | The HemoSphere Advanced Monitor has an input that can be
connected to an external vital sign patient monitor for the purpose of
slaving in an analog ECG signal. The HemoSphere Platform uses
this analog ECG input signal to calculate a heart rate that is used by
the HemoSphere Swan-Ganz Module to calculate certain derived
parameters (e.g. HRavg, SV, RVEF and EDV). |
4
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.
5
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 |
6
| sRVEF | STAT right ventricular ejection
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
Pediatric |
| iCI | intermittent cardiac index | |
| iSVR | intermittent systemic vascular
resistance | |
| iSVRI | intermittent systemic vascular
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
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
Population |
|------------|------------------------------------------------------------------------|------------------------|
| DO2 | Oxygen Delivery | Adult and
Pediatric |
| DO2I | Oxygen Delivery Indexed | |
| VO2 | Oxygen Consumption | |
| VO2e | Estimated Oxygen Consumption
when ScvO2 is being monitored | |
| VO2I | Oxygen Consumption Index | |
| VO2Ie | Estimated Oxygen Consumption
Index when ScvO2 is being
monitored | |
7
| Comparison to
Predicate Device: | The HemoSphere Advanced Monitoring Platform is a modular
platform which uses the same monitoring technology (CCO, ICO,
Oximetry), the same associated catheters (Swan-Ganz and Oximetry
Catheters), the same analog inputs from external vital sign monitors,
the same computational algorithms for hemodynamic monitoring
and the same default alarm limits as Vigilance II System (K043103,
cleared December 9, 2014).
Updates made to the HemoSphere Advanced Monitoring Platform
include a modernized look (updated Graphical User Interface (GUI)
and touchscreen monitor), wireless capability, a modular
architecture designed for scalability, and two additional derived
oximetry parameters (Estimated Oxygen Consumption (VO2e) and
Estimated Oxygen Consumption Index (VO2Ie)). The updated GUI
is similar to the GUI utilized in the EV1000 Clinical Platform
(K160552, cleared June 01, 2016). Wireless capabilities for the
HemoSphere Advanced Monitoring Platform are limited to
connecting and sending data to external Medical Device Data
Systems. The two additional derived oximetry parameters (VO2e
and VO2Ie) are derived parameters that are currently available on
the EV1000 Clinical Platform.
The HemoSphere Advanced Monitor has an HDMI display output
port to connect to an external monitor as opposed to a VGA port on
the Vigilance II System. All other input and output ports remain the
same.
The HemoSphere Advanced Monitor is built on a Windows 7
Operating System whereas the Vigilance II System used a Nucleus
Real Time Operating System (RTOS).
Verification and validation testing was performed to compare the
performance and functionality of the HemoSphere Advanced
Monitoring Platform and the Vigilance II System. Testing included
a side-by-side comparison of the output parameters using a bench
test. |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data
(Bench and/or
Clinical): | The following verification activities were performed in support of a
substantial equivalence determination.
System Verification
Key Cardiac Output parameters (ICO, CCO, RVEF, Blood
Temperature and Injectate Temperature) and Oximetry parameters
(SvO2 and ScvO2) were tested using a bench simulation. Power
switching and shutoff verification for the Swan-Ganz module was
performed. Additionally, individual modules were tested at a
system level to verify the safety of these modules. They were also
integrated as a system and verified for their safety and effectiveness. |
8
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.