(226 days)
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 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 pediative 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.
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 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
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 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 three optional external modules: the HemoSphere Swan-Ganz Module (existing), the HemoSphere Oximetry Cable (existing) and the HemoSphere Pressure Cable (new to the platform). This version of the platform also includes the Acumen Hypotension Prediction Index feature.
The existing optional modules 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 new 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).
All the sub-system modules provide the hardware and software technology to compute hemodynamic monitoring data that is then sent to the HemoSphere Advanced Monitor for visualization and storage.
As cleared under K163381 on April 14, 2017, 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 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 Advanced Monitor when used with the HemoSphere Pressure Cable (new to the HemoSphere platform) uses the same monitoring technology (pressure and pressure based Cardiac Output), the same computational algorithms and the same default alarm limits as the EV1000A Clinical Platform (K160552, cleared June 1, 2016).
The HemoSphere Pressure Cable also enables the Acumen Hypotension Prediction Index (HPI) feature when connected to a FloTrac IQ sensor similar to the EV1000A Clinical Platform (DEN160044, granted March 16, 2018).
The HemoSphere Pressure Cable when connected to a TruWave DPT sensor and a compatible Edwards Advanced Swan-Ganz catheter allows monitoring of a new parameter; Mean Pulmonary Arterial Pressure (MPAP).
Additionally, a HemoSphere Pressure-Out cable has been developed for the HemoSphere Advanced Monitor. This cable enables output of analog pressure signals (MAP, CVP or PAP) for display on an external patient monitor.
The provided text is a 510(k) summary for the Edwards Lifesciences HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, and Acumen Hypotension Prediction Index feature.
Based on the provided document, here's a breakdown of the acceptance criteria and the study proving the device meets them:
No clinical performance data (multi-reader multi-case study, standalone performance) for the Acumen Hypotension Prediction Index (HPI) feature is provided in this 510(k) summary. The document explicitly states: "Clinical data was not required for this device." The review of the Acumen HPI feature is described as "similar to that granted in DEN160044 on March 2018." Therefore, information regarding acceptance criteria and performance studies for the Acumen HPI feature would likely be found in the DEN160044 submission, not in this document.
The provided document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing (bench and simulated environment testing) for the new or modified components of the HemoSphere Advanced Monitoring Platform, particularly the HemoSphere Pressure Cable and the integration of the Acumen HPI feature (which itself was previously cleared).
Therefore, the following answers are based on the information provided for the HemoSphere system components and the integration of the HPI feature, not the HPI algorithm's performance itself.
1. Table of Acceptance Criteria and Reported Device Performance
Since this submission focuses on non-clinical testing for substantial equivalence, the "acceptance criteria" are not detailed as specific performance metrics with target values for accuracy, sensitivity, or specificity in a clinical context. Instead, the acceptance criteria are implicitly that the device performs functionally as intended and meets relevant safety and electromagnetic compatibility (EMC) standards. The "reported device performance" is that all tests passed, demonstrating functional equivalence to predicate devices and adherence to safety standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| System Verification | Measured parameters (pressure, pressure-based cardiac output) were tested using a bench simulation. Individual modules and integrated system tested for safety and effectiveness. All tests passed. |
| Electrical Safety and EMC | Tested to 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 | Bench and simulated environment testing performed on the entire platform, including all sub-system modules and interfaces. All tests passed. |
| Software Verification | Performed per FDA guidance for software in medical devices. Software tested at sub-system level for safety. All tests passed. |
| Usability Study | Conducted in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Test Passed. |
| Overall Non-Clinical Performance | All verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Differences in design and materials did not adversely affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI performance. The testing described is non-clinical (bench and simulated environment).
- Data Provenance: Not applicable for a clinical test set. The data originates from bench testing, simulated environments, and usability studies. No specific country of origin for clinical data is mentioned as none was gathered. The provenance is internal company testing. The studies were non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable for the type of testing described. Ground truth for the non-clinical tests (e.g., pressure measurements, electrical safety) would be established by reference standards, calibrated equipment, or engineering specifications, not by human experts interpreting data.
- For the usability study, "32 users with a mix of clinicians and nurses" were involved. Their qualifications are listed as "clinicians and nurses" but no further detail on their experience level is provided for establishing "ground truth" (as their role was to evaluate usability, not establish a clinical gold standard).
4. Adjudication Method for the Test Set
- Not applicable for the type of testing described (non-clinical verification). Adjudication is typically used in clinical studies where multiple human readers interpret data that may have ambiguity, which is not the case for electrical safety or bench performance verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical data was not required for this device."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone clinical performance study of the Acumen HPI algorithm was not presented in this submission. The submission states that the HPI feature is "similar to that granted in DEN160044 on March 2018." This implies that the standalone performance of the HPI algorithm was evaluated as part of the DEN160044 submission, not this K180881 submission.
- The tests performed were non-clinical, verifying the integration and function of the HPI feature within the new HemoSphere platform, rather than re-evaluating the core HPI algorithm's performance.
7. The Type of Ground Truth Used
- For the non-clinical performance and verification testing:
- Bench Testing: Ground truth established through calibrated measurement devices, comparison to reference standards, and predetermined design specifications.
- Electrical Safety/EMC: Defined by international standards (e.g., IEC 60601 series).
- Software Verification: Defined by software requirements specifications and testing protocols.
- Usability Study: User feedback against usability goals and metrics.
- For the Acumen HPI feature itself, the previous submission (DEN160044) would have defined its ground truth (e.g., actual hypotensive events observed in clinical data), but this information is not in this document. The current submission relies on the prior clearance.
8. The Sample Size for the Training Set
- Not applicable for this submission. This document describes the 510(k) clearance for a device (HemoSphere monitor and cables) and the integration of a previously cleared feature (Acumen HPI). It does not describe the training or development of the Acumen HPI algorithm itself. Training set information would reside with the data used to develop the Acumen HPI algorithm, likely part of the DEN160044 submission.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for this submission, as it does not detail the training set for the Acumen HPI algorithm. This information would be found in the documentation for the original DEN160044 submission for the Acumen HPI feature.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below that.
November 16, 2018
Edwards Lifesciences, LLC Chirag Shah Program Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Received: October 17, 2018
Re: K180881
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, Acumen Hypotension Prediction Index feature Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DOE, OAO Dated: October 16, 2018
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 C. Browning -S5
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) K180881
Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable and Acumen Hypotension Prediction Index feature
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 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 pediative 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.
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 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Section 5 – 510(k) Summary
| Sponsor: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614 |
|---|---|
| EstablishmentRegistrationNumber: | 2015691 |
| Contact Person: | Chirag ShahProgram Manager, Regulatory AffairsOne Edwards WayIrvine, CA 92614Telephone: (949) 250-1580Fax: (949) 809-2972 |
| Date: | November 13, 2018 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableAcumen Hypotension Prediction Index feature |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| ClassificationName: | Programmable Diagnostic Computer21 CFR 870.1425Fiberoptic Oximeter Catheter21 CFR 870.1230Adjunctive Predictive Cardiovascular Indicator21 CFR 870.2210 |
| Product Code: | DQK, Class IIDQE, Class IIQAQ, Class II |
| PrimaryPredicate Device: | HemoSphere Advanced Monitoring Platform manufactured by EdwardsLifesciences, K163381, cleared on April 14, 2017. |
| AdditionalPredicateDevices: | EV1000A Clinical Platform manufactured by Edwards Lifesciences,K160552, cleared June 01, 2016. |
| Acumen Hypotension Prediction Index (HPI) feature on EV1000AClinical Platform manufactured by Edwards Lifesciences, DEN160044,granted on March 16, 2018. | |
| Philips IntelliVue MP50 manufactured by Philips Medizin SystemeBoeblingen GmbH, K053522, cleared on January 10, 2006 utilized for theparameter; Mean Pulmonary Arterial Pressure (MPAP). | |
| Philips IntelliVue Patient Monitor MP50 manufactured by PhilipsMedizin Systeme Boeblingen GmbH, K062283, cleared on September 20,2006 utilized for the parameter; Pulse Pressure Variation (PPV). | |
| DeviceDescription: | The HemoSphere Advanced Monitoring platform was designed tosimplify the customer experience by providing one platform with modularsolutions for their hemodynamic monitoring needs. The user can choosefrom the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides thecustomer with the choice of purchasing and/or using specific monitoringapplications based on their needs. Users are not required to have all of themodules installed at the same time for the platform to function. |
| The HemoSphere Advanced Monitoring Platform consists of theHemoSphere Advanced Monitor that provides a means to interact withand visualize hemodynamic and volumetric data on a screen and threeoptional external modules: the HemoSphere Swan-Ganz Module(existing), the HemoSphere Oximetry Cable (existing) and theHemoSphere Pressure Cable (new to the platform). This version of theplatform also includes the Acumen Hypotension Prediction Index feature. | |
| The existing optional modules provide an interface to connect withcurrently cleared and commercially available Edwards Lifesciences Swan-Ganz catheters and Oximetry catheters (K803058, K822350, K905458,K924650, K934742, K940795, K053609 and K110167 and K160884). | |
| The new HemoSphere Pressure Cable provides an interface to connectwith currently cleared and commercially available Edwards LifesciencesFloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors(K142749). | |
| All the sub-system modules provide the hardware and softwaretechnology to compute hemodynamic monitoring data that is then sent tothe HemoSphere Advanced Monitor for visualization and storage. | |
| As cleared under K163381 on April 14, 2017, the HemoSphere AdvancedMonitor has an input that can be connected to an external vital sign patientmonitor for the purpose of slaving in an analog ECG and pressure signals.The HemoSphere Platform uses this analog ECG input signal to calculate | |
| K180881Page 3 of 10 | |
| a heart rate that is used by the HemoSphere Swan-Ganz Module tocalculate certain derived parameters (e.g. HRavg, SV, RVEF and EDV). | |
| The HemoSphere Advanced Monitor when used with the HemoSpherePressure Cable (new to the HemoSphere platform) uses the samemonitoring technology (pressure and pressure based Cardiac Output), thesame computational algorithms and the same default alarm limits as theEV1000A Clinical Platform (K160552, cleared June 1, 2016). | |
| The HemoSphere Pressure Cable also enables the Acumen HypotensionPrediction Index (HPI) feature when connected to a FloTrac IQ sensorsimilar to the EV1000A Clinical Platform (DEN160044, granted March16, 2018). | |
| The HemoSphere Pressure Cable when connected to a TruWave DPTsensor and a compatible Edwards Advanced Swan-Ganz catheter allowsmonitoring of a new parameter; Mean Pulmonary Arterial Pressure(MPAP). | |
| Additionally, a HemoSphere Pressure-Out cable has been developed forthe HemoSphere Advanced Monitor. This cable enables output of analogpressure signals (MAP, CVP or PAP) for display on an external patientmonitor. | |
| Indications forUse: | HemoSphere Advanced Monitor with HemoSphere Swan-GanzModuleThe HemoSphere Advanced Monitor when used with the HemoSphereSwan-Ganz Module and Edwards Swan-Ganz Catheters is indicated foruse in adult and pediatric critical care patients requiring monitoring ofcardiac output [continuous (CO) and intermittent (iCO)] and derivedhemodynamic parameters in a hospital environment. Refer to theEdwards Swan-Ganz catheter indications for use statement forinformation on target patient population specific to the catheter beingused. |
| Refer to the Intended Use statement for a complete list of measured andderived parameters available for each patient population. | |
| HemoSphere Advanced Monitor with HemoSphere Oximetry CableThe HemoSphere Advanced Monitor when used with the HemoSphereOximetry Cable and Edwards oximetry catheters is indicated for use inadult and pediatric critical care patients requiring monitoring of venousoxygen saturation (SvO2 and ScvO2) and derived hemodynamic |
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{6}------------------------------------------------
oxygen saturation (SVO2 and SCVO2) and derived nemodynamic
parameters in a hospital environment. Refer to the Edwards oximetry
{7}------------------------------------------------
K180881 Page 4 of 10
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, FloTrac 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
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 Intended Use: 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 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.
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K180881 Page 5 of 10
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO | continuous cardiac output | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom | |
| sCO | STAT cardiac output | |||
| CI | continuous cardiac index | |||
| sCI | STAT cardiac index | |||
| EDV | right ventricular end diastolicvolume | HemoSphereSwan-GanzModule | ||
| sEDV | STAT right ventricular enddiastolic volume | |||
| EDVI | right ventricular end diastolicvolume index | |||
| sEDVI | STAT right ventricular enddiastolic volume index | |||
| HRavg | averaged heart rate | |||
| LVSWI | left ventricular stroke work index | |||
| PVR | pulmonary vascular resistance | |||
| PVRI | pulmonary vascular resistanceindex | |||
| RVEF | right ventricular ejection fraction | |||
| sRVEF | STAT right ventricular ejectionfraction | |||
| RVSWI | right ventricular stroke work index | |||
| SV | stroke volume | |||
| SVI | stroke volume index | |||
| SVR | systemic vascular resistance | Adult andPediatric | ||
| SVRI | systemic vascular resistance index | |||
| iCO | intermittent cardiac output | |||
| iCI | intermittent cardiac index | |||
| iSVR | intermittent systemic vascularresistance | |||
| iSVRI | intermittent systemic vascularresistance 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:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphereOximetryCable | Adult andPediatric | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| ScvO2 | Central Venous OxygenSaturation |
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:
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K180881 Page 6 of 10
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Adult andPediatric | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
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-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous Cardiac Output/Continuous Cardiac Index | HemoSpherePressureCable | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| CVP | Central Venous Pressure | |||
| DIA | Diastolic Blood Pressure | |||
| dP/dt | Maximal slope of the arterialpressure upstroke | |||
| Eadyn | Dynamic Arterial Elastance | |||
| MAP | Mean Arterial Pressure | |||
| MPAP | Mean Pulmonary Arterial Pressure | |||
| SV/SVI | Stroke Volume/Stroke VolumeIndex | |||
| SVR/SVRI | Systemic Vascular Resistance/Systemic Vascular ResistanceIndex | |||
| SVV | Stroke Volume Variation | |||
| SYS | Systolic Blood Pressure | |||
| HPI | Acumen Hypotension PredictionIndex | OperatingRoom Only |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable and a connected HemoSphere oximetry cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| DO2I | Oxygen Delivery Indexed | |||
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
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K180881 Page 7 of 10
Comparison to Predicate Device:
The existing HemoSphere Advanced Monitoring Platform (K163381, cleared April 14, 2017) consists of:
- HemoSphere Advanced Monitor
- . HemoSphere Swan-Ganz Module
- HemoSphere Oximetry Cable
This 510(k) submission adds the following to the HemoSphere Advanced Monitoring Platform:
- . HemoSphere Pressure Cable
- Acumen Hypotension Prediction Index feature ●
- HemoSphere Pressure-Out Cable (a new accessory) ●
- . New key parameter; Mean Pulmonary Arterial Pressure (MPAP)
Modifications to existing elements include:
- Graphical User Interface updates to the Sentinel Host Module of . the HemoSphere Advanced Monitor
- . Software modifications to the Data Bridge Module of the HemoSphere Advanced Monitor
- . Algorithm updates for the Acumen Hypotension Prediction Index parameters (display only); Stroke Volume Variation (SVV), Dynamic Elastance (Eaayn) and Left Ventricular Contractility (dP/dt)
The following predicates are used to establish substantial equivalence:
- Primary Predicate: HemoSphere Advanced Monitor (K163381, . cleared April 14, 2017) 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: EV1000A Clinical Platform (K160552, cleared June 1, 2016) utilized for substantial equivalence to the HemoSphere Pressure Cable in terms of key parameters (pressure and arterial pressure based cardiac output) and derived hemodynamic parameters when connected to previously cleared Edwards FloTrac (K152980), FloTrac IQ (LTF to K152980) and TruWave DPT sensors (K142749)Additional Predicate: Acumen Hypotension Prediction Index feature (DEN160044, granted March 16, 2018) utilized for substantial equivalence to the Acumen Hypotension Prediction Index feature, including all its parameters and secondary screens
- . Additional Predicate: Philips IntelliVue Patient Monitor MP50 manufactured by Philips Medizin Systeme Boeblingen GmbH. K053522, cleared on January 10, 2006 utilized for the parameter; Mean Pulmonary Arterial Pressure (MPAP)
- Additional Predicate: Philips IntelliVue Patient Monitor MP50 ● manufactured by Philips Medizin Systeme Boeblingen GmbH,
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K062283, cleared on September 20, 2006 utilized for the parameter; Pulse Pressure Variation (PPV)
The HemoSphere Advanced Monitoring Platform 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 as cleared in K163381 on April 14. 2017.
A new sub-system module; the HemoSphere Pressure Cable is being added to allow for monitoring of pressure and arterial pressure based cardiac output along with Acumen Hypotension Prediction Index (HPI) feature. The HemoSphere Pressure Cable also calculates additional derived parameters based on the key monitored parameters. The HemoSphere Pressure Cable when used with the HemoSphere Advanced Monitor uses the same associated sensors (FloTrac, FloTrac IO and TruWave), the same analog inputs from external vital sign monitors, the same computational algorithms for hemodynamic monitoring and the same default alarm limits as the EV1000A Clinical Platform (K160552 cleared on June 1, 2016). The HPI feature is similar to that granted in DEN160044 on March 2018.
The HemoSphere Pressure Cable uses the HPI feature as granted in DEN160044, including the algorithms, secondary screens and graphical user interface with some waveform smoothing modifications made to the Pulse Pressure Variation (PPV) and Left Ventricular Contractility (dP/dt) algorithms for display purposes only.
Additional modifications were made to the Graphical User Interface of the HemoSphere Advanced Monitor (K163381, cleared April 14, 2017) to support two different modes: Invasive and Minimally-Invasive modes based on the sub-system module being used. Clinical Data Logging feature was added to collect sub-system module data for internal technical analysis.
The HemoSphere Pressure Cable when connected to a TruWave DPT sensor and a compatible Edwards Advanced Swan-Ganz catheter allows monitoring of a new parameter that is not available on the EV1000A Clinical Platform (K160552, cleared June 1, 2016); Mean Pulmonary Arterial Pressure (MPAP).
In addition, a HemoSphere Pressure-Out Cable has been developed to output Mean Arterial Pressure (MAP), Central Venous Pressure (CVP) or Pulmonary Arterial Pressure (PAP) signals to an external patient monitor.
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Verification and validation testing was performed to compare the performance and functionality of the HemoSphere Advanced Monitor when used with a HemoSphere Pressure Cable and the EV1000 Clinical Platform. 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 Data (Bench substantial equivalence determination for the modifications being made as and/or Clinical): part of this submission.
System Verification
Measured parameters (pressure and pressure based cardiac output) 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 and HemoSphere Pressure Cable 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, including software changes and changes to the Acumen Hypotension Prediction Index feature in accordance with FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices". Testing involved 32 users with a mix of clinicians and nurses. Test Passed.
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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.
Overall Conclusion: Conclusions
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 and the Acumen Hypotension Prediction Index feature) are substantially equivalent to the legally marketed predicates.
§ 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).