(206 days)
Yes
The text explicitly mentions the "Acumen Hypotension Prediction Index feature" which provides "physiological insight into a patient's likelihood of future hypotensive events". This type of predictive analysis based on physiological data is a strong indicator of AI/ML technology being employed.
No.
The device is a monitor designed to provide physiological insight and information for clinical decision-making, not to deliver therapy itself.
Yes
The device is indicated for monitoring various physiological parameters (e.g., cardiac output, venous oxygen saturation, pressure, tissue oxygen saturation) and derived hemodynamic parameters, and for providing insight into the likelihood of hypotensive events. These functions involve obtaining and interpreting data about a patient's health status, which falls under the definition of a diagnostic device.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform consists of a "HemoSphere Advanced Monitor" which is a physical device with a screen for interaction and visualization, and several optional external hardware modules (Swan-Ganz Module, Oximetry Cable, Pressure Cable, Tissue Oximetry Module). While software is a component, the device is fundamentally a hardware platform with integrated software.
Based on the provided text, the HemoSphere Advanced Monitor with its various modules is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- HemoSphere Function: The HemoSphere system, as described, is a monitoring platform that connects to catheters and sensors inserted into the patient's body (Swan-Ganz catheters, oximetry catheters, pressure sensors, tissue oximeter sensors). It measures and derives physiological parameters directly from the patient's circulatory system and tissues.
- Lack of Specimen Analysis: There is no mention of the HemoSphere system analyzing samples or specimens taken from the patient. Its function is to acquire and display real-time physiological data from within the body.
Therefore, the HemoSphere Advanced Monitor and its modules fall under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostic devices.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
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. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol 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 below 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 yenous oxygen saturation (SvO2 and Scv02) 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.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
- When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects >=3 kg.
- When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects 40 kg, pediatric subjects >=3 kg, pediatric subjects
§ 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/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
August 29, 2019
Edwards Lifesciences, LLC Chirag Shah Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K190205
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, Acumen Hypotension Prediction Index feature and HemoSphere Tissue Oximetry Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DOE, OAO, MUD Dated: July 18, 2019 Received: July 22, 2019
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. 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 mediation-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,
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) K190205
Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, Acumen Hypotension Prediction Index feature and HemoSphere Tissue Oximetry Module
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. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol 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 below 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 yenous oxygen saturation (SvO2 and Scv02) 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.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
· When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects Prescription Use (Part 21 CFR 801 Subpart D)
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K190205 Page 1 of 10
510(k) Summary – HemoSphere Advanced Monitoring Platform
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact Person: | Chirag Shah
Program Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 250-1580
Fax: (949) 809-2972 |
| Date: | August 26, 2019 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable
HemoSphere Pressure Cable
HemoSphere Tissue Oximetry Module
Acumen Hypotension Prediction Index feature |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification
Name: | Programmable Diagnostic Computer
21 CFR 870.1425
Fiberoptic Oximeter Catheter
21 CFR 870.1230
Adjunctive Predictive Cardiovascular Indicator
21 CFR 870.2210
Oximeter
21 CFR 870.2700 |
| Product Code: | DQK, Class II
DQE, Class II
QAQ, Class II
MUD, Class II |
| Primary
Predicate Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards
Lifesciences, K180881, cleared on November 16, 2018. |
| Additional
Predicate
Devices: | CAS Medical System Inc.'s FORE-SIGHT ELITE Absolute Tissue
Oximeter Monitor (K143675 cleared April 10, 2015) utilized for the tissue
oximetry parameter and graphical user interface.
Cheetah NICOM/Starling SV (K101487, cleared on July 2, 2010) utilized
for the fluid responsiveness test feature (passive leg raise and fluid bolus) |
| Device
Description: | The HemoSphere Advanced Monitoring platform was designed to
simplify the customer experience by providing one platform with modular
solutions for their hemodynamic monitoring needs. The user can choose
from the available optional sub-system modules or use multiple sub-
system modules at the same time. This modular approach provides the
customer with the choice of purchasing and/or using specific monitoring
applications based on their needs. Users are not required to have all of the
modules installed at the same time for the platform to function.
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 four
optional external modules: the HemoSphere Swan-Ganz Module
(existing), the HemoSphere Oximetry Cable (existing), the HemoSphere
Pressure Cable (existing) and the HemoSphere Tissue Oximetry Module
(subject of this submission). The platform also includes the Acumen
Hypotension Prediction Index feature.
The existing optional HemoSphere Swan-Ganz Module and HemoSphere
Oximetry Cable provide an interface to connect with currently cleared and
commercially available Edwards Lifesciences Swan-Ganz catheters and
Oximetry catheters (K803058, K822350, K905458, K924650, K934742,
K940795, K053609 and K110167 and K160884).
The HemoSphere Pressure Cable provides an interface to connect with
currently cleared and commercially available Edwards Lifesciences
FloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors
(K142749).
The HemoSphere Pressure Cable also enables the Acumen Hypotension
Prediction Index (HPI) feature when connected to an Acumen IQ sensor.
The HemoSphere Tissue Oximetry Module is an interface module
intended to be used with the Fore-Sight Elite Tissue Oximeter Module
(K180003, cleared May 10, 2018) to display continuous monitoring of
blood oxygen saturation in the tissue (StO2). |
| | Additionally, the HemoSphere Advanced Monitoring Platform includes
the Fluid Responsiveness Test feature (fluid bolus and passive leg raise). |
| | The HemoSphere Advanced Monitor has an input that can be connected to
an external vital sign patient monitor for slaving in an analog ECG and
pressure signals. 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). |
| | The HemoSphere Pressure-Out cable enables output of analog pressure
signals (AP, CVP or PAP) for display on an external patient monitor. |
| Indications for
Use: | HemoSphere Advanced Monitor with HemoSphere Swan-Ganz
Module |
| | 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. It may be used for monitoring hemodynamic
parameters in conjunction with a perioperative goal directed therapy
protocol 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 below 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 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. |
| | HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere
Pressure Cable is indicated for use in critical care patients in which the
balance between cardiac function, fluid status, vascular resistance and |
5
6
7
pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
• When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects >3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters and FloTrac, FloTrac IQ and TruWave DPT sensors.
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.
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|------------------------------------------------------|-----------------------------------|------------------------|--------------------------------------------------------------------|
| CO | continuous cardiac output | | | |
| sCO | STAT cardiac output | | | |
| CI | continuous cardiac index | | | |
| sCI | STAT cardiac index | | Adult only | Operating
Room,
Intensive
Care Unit,
Emergency
Room |
| EDV | right ventricular end diastolic
volume | HemoSphere
Swan-Ganz
Module | | |
| 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 | | | |
| 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:
9
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|-------------------------------------|------------------------------|-----------------------|---------------------------------|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphere | Adult and | Operating
Room,
Intensive |
| ScvO2 | Central Venous Oxygen
Saturation | Oximetry
Cable | Pediatric | Care Unit,
Emergency
Room |
A comprehensive list of additional parameters that are available for adult and pediatric patient populations on the HemoSphere Advanced Monitor and a connected HemoSphere Swan-Ganz Module and a connected HemoSphere Oximetry Cable are as listed below:
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | HemoSphere
Swan-Ganz
Module and
HemoSphere
Oximetry
Cable | Adult and
Pediatric | Operating
Room,
Intensive
Care Unit,
Emergency
Room |
| 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 | | | |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below:
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|------------------------------------------------------------------------|---------------------------------|-----------------------|--------------------------------------------------------------------|
| CO/CI | Continuous Cardiac Output/
Continuous Cardiac Index | HemoSphere
Pressure
Cable | Adult only | |
| CVP | Central Venous Pressure | | | |
| DIA | Diastolic Blood Pressure | | | |
| dP/dt | Maximal slope of the arterial
pressure upstroke | | | |
| Eadyn | Dynamic Arterial Elastance | | | |
| MAP | Mean Arterial Pressure | | | |
| MPAP | Mean Pulmonary Arterial Pressure | | | |
| SV/SVI | Stroke Volume/Stroke Volume
Index | | | |
| SVR/SVRI | Systemic Vascular Resistance/
Systemic Vascular Resistance
Index | | | |
| SVV | Stroke Volume Variation | | | |
| SYS | Systolic Blood Pressure | | | Operating
Room,
Intensive
Care Unit,
Emergency
Room |
| HPI | Acumen Hypotension Prediction
Index | | | Operating
Room only |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a
10
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|---------------------------------------------------------------|-----------------------------------------------------------------|-----------------------|------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | | | |
| VO2 | Oxygen Consumption | HemoSphere
Swan-Ganz
Module and
HemoSphere
Oximetry | Adult only | Operating
Room,
Intensive
Care Unit,
Emergency |
| VO2e | Estimated Oxygen Consumption
when ScvO2 is being monitored | | | |
| VO2I | Oxygen Consumption Index | | | |
Cable
Room
Tissue oxygen saturation. StO2, can be monitored with the HemoSphere Advanced Monitor, a connected HemoSphere Tissue Oximetry Module, and the FORE-SIGHT ELITE Tissue Oximeter Module. Refer to the FORE-SIGHT ELITE module instructions for use for specific information on the intended use environment and patient population.
| Comparison to
Predicate Device: | The existing HemoSphere Advanced Monitoring Platform (K180881
cleared November 16, 2018) consists of: |
|------------------------------------|----------------------------------------------------------------------------------------------------------|
| | • HemoSphere Advanced Monitor |
Estimated Oxygen Consumption
Index when ScvO2 is being
monitored
- HemoSphere Swan-Ganz Module ●
- HemoSphere Oximetry Cable
VO2Ie
- HemoSphere Pressure Cable ●
- . Acumen Hypotension Prediction Index
The purpose of this 510(k) submission is to add the following to the HemoSphere Advanced Monitoring Platform (K180881, cleared November 16, 2018):
- HemoSphere Tissue Oximetry Module a new sub-system ● technology module that interfaces with the Fore-Sight Elite Module Tissue Oximeter (cleared in K180003 on May 10, 2018) to display absolute levels of blood oxygenation saturation in the tissue (StO2)
- Additional new features added to the HemoSphere Advanced Monitor include:
- O
- Fluid Responsiveness Test (fluid bolus and passive leg O raise) feature
- Focused Screens o
- Modifications to existing elements of the HemoSphere Advanced ● Monitor include:
connected HemoSphere pressure cable and a connected HemoSphere oximetry cable are as listed below:
11
- Graphical User Interface updates to the HemoSphere o Advanced Monitor for a more modernized look to make more optimal use of screen space including addition of screens for the new HemoSphere Tissue Oximetry Module
- Acumen Hypotension Prediction Index feature Graphical User o Interface modifications (no algorithm changes)
- Modification to allow the use of dual pressure channels о simultaneously
- Modification of existing time and target screens to allow inputs O from invasive Swan-Ganz mode and associated indications for use update
- Cybersecurity enhancements о
The following predicates are used to establish substantial equivalence:
- Primary Predicate: HemoSphere Advanced Monitor (K180881, cleared November 16, 2018) utilized for substantial equivalence to the HemoSphere Advanced Monitor in terms of the graphical user interface (GUI) used. wireless module incorporated. device modularity and basic device functionality
- . Additional Predicate: CAS Medical System Inc.'s Fore-Sight Elite Absolute Tissue Oximeter Monitor (K143675 cleared April 10, 2015) is being used a predicate device since it displays the tissue oximetry parameter and provides the Graphical User Interface (GUI) for the subject device.
- Additional Predicate: Cheetah Nicom/Starling SV cleared in K101487, on July 2, 2010 was chosen to show equivalency to for the fluid responsiveness test (patient leg raise and fluid bolus) feature being added to the HemoSphere Advanced Monitoring Platform. The Cheetah Nicom/Starling SV medical device is being used as an additional predicate since it also has capabilities to perform a fluid responsiveness test. The intended use for both the subject and predicate devices is similar and hence can be used as a predicate.
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable allows for monitoring of hemodynamic parameters, including continuous and intermittent cardiac output, right ventricular ejection fraction, end diastolic volume and mixed or central venous oxygen saturation along with additional calculated parameters.
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable allows for monitoring of pressure and arterial pressure based cardiac output along with Acumen Hypotension Prediction Index
12
(HPI). The HemoSphere Pressure Cable also calculates additional derived parameters based on the key monitored parameters. Verification and validation testing was performed to compare the performance and functionality of the HemoSphere Advanced Monitoring Platform to its predicate devices. Testing included a side-by-side comparison of the output parameters using a bench test. Performance The following verification activities were performed in support of a substantial equivalence determination for the modifications being made as Data (Bench and/or Clinical): part of this submission. System Verification Measured and derived parameters were tested using a bench simulation. 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. All tests passed.
Electrical Safety and Electromagnetic Compatibility (EMC)
The HemoSphere Advanced Monitor and the HemoSphere Pressure 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, IEC 60601-2-34 and IEC 60601-2-49. All tests passed.
Wireless Coexistence Testing
Bench and simulated environment testing was performed on the entire HemoSphere Advanced Monitoring Platform, including all sub-system modules and interfacing analog inputs and outputs. All tests passed.
Software Verification
The HemoSphere Advanced Monitor and HemoSphere Swan-Ganz Module are considered as software of Major Level of Concern. The HemoSphere Oximetry Cable, HemoSphere Pressure Cable and HemoSphere Tissue Oximetry Module are considered as software of Moderate 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. All tests passed.
Usabilitv Study
A usability study was performed for the HemoSphere Advanced Monitoring Platform in accordance with FDA's guidance, "Applying
13
Human Factors and Usability Engineering to Medical Devices". Testing involved 32 users with a mix of clinicians and nurses. Test Passed.
Clinical Performance
Clinical data was not required for this device.
Non-Clinical Performance 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.
Conclusions Overall Conclusion:
The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitoring Platform (the HemoSphere Advanced Monitor, the HemoSphere Swan-Ganz Module, the HemoSphere Oximetry Cable, the HemoSphere Pressure Cable, the HemoSphere Tissue Oximetry Module and the Acumen Hypotension Prediction Index feature) are substantially equivalent to the legally marketed predicates.