(134 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 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.
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).
The provided text describes the Edwards Lifesciences HemoSphere Advanced Monitor, HemoSphere Swan-ganz Module, and HemoSphere Oximetry Cable. This K163381 submission details the device, its intended use, and substantial equivalence to predicate devices, but it does not contain the specific acceptance criteria or the study that definitively "proves" the device meets acceptance criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Vigilance II Continuous Cardiac Output/Oximetry/Volumetric Monitor, K043103). The performance data section describes verification activities rather than a formal study with predefined acceptance criteria for a new AI/algorithmic performance metric.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given text. The document refers to "predetermined design and performance specifications" for the verification activities but does not list them in a table or state specific numerical targets for accuracy, sensitivity, or specificity for the parameters measured by the device.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided for a test set in the context of an AI/algorithmic performance study. The document mentions "bench simulation" for key parameters, and an "animal study involving 4 pigs." This is not a test set for assessing algorithmic performance in humans.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable/provided as no human expert-adjudicated test set for algorithmic performance is described. The "animal study involving 4 pigs and 25 clinicians" was for usability verification, not for establishing ground truth for device measurements.
4. Adjudication Method for the Test Set
This information is not applicable/provided as no human expert-adjudicated test set for algorithmic performance is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done or described. The document explicitly states an "animal study involving 4 pigs and 25 clinicians was performed to verify usability of the HemoSphere Advanced Monitoring Platform," which is not an MRMC study comparing human readers with and without AI assistance for diagnostic performance.
6. Standalone Performance Study
While the device's computational algorithms are mentioned as being the same as the predicate device, a standalone (algorithm only without human-in-the-loop) performance study with specific metrics like accuracy, sensitivity, specificity, etc., against a new set of data is not explicitly described. The "System Verification" section mentions testing key parameters using a bench simulation, which implies some form of standalone testing, but specific performance results and acceptance criteria are not detailed.
- Key Cardiac Output parameters (ICO, CCO, RVEF, Blood Temperature and Injectate Temperature) and Oximetry parameters (SvO2 and ScvO2) were tested using a bench simulation. However, the detailed results or acceptance criteria for these tests are not present.
7. Type of Ground Truth Used
For the bench simulation of cardiac output and oximetry parameters, the ground truth would likely be established by the known inputs or reference measurements from the simulation system. For the "usability animal study," the ground truth was related to the device's interaction and functionality as observed by clinicians, not a medical ground truth for diagnosis/measurement accuracy.
8. Sample Size for the Training Set
This information is not provided. The device uses "the same computational algorithms for hemodynamic monitoring" as its predicate device (Vigilance II, K043103). This implies the algorithms were developed and "trained" (if applicable to this type of algorithm) prior to this submission, likely based on data relevant to the predicate device's development. No new training set or training process is described for the HemoSphere platform, as it primarily represents a modernization and feature addition rather than a new core algorithm.
9. How Ground Truth for the Training Set Was Established
This information is not provided, as no new training set is described. For the original algorithms from the predicate device, the ground truth would have been established through methods appropriate for physiological parameter measurement, such as direct measurement using established invasive techniques, reference devices, or controlled experimental conditions in labs or animal studies.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2017
Edwards Lifesciences, LLC Chirag Shah Associate Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K163381
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-ganz Module, HemoSphere Oximetry Cable Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE Dated: March 15, 2017 Received: March 16, 2017
Dear Chirag Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Fernando Aguel -
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163381
Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatic critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Type of Use (Select one or both, as applicable)
| ☑ 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)
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Section 5 – 510(k) Summary
| Sponsor: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614 |
|---|---|
| EstablishmentRegistration Number: | 2015691 |
| Contact Person: | Chirag ShahAssociate Manager, Regulatory AffairsOne Edwards WayIrvine, CA 92614Telephone: (949) 250-1580Fax: (949) 809-2972 |
| Date: | November 30, 2016 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry Cable |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification Name: | Programmable Diagnostic Computer21 CFR 870.1425Fiberoptic Oximeter Catheter21 CFR 870.1230 |
| Product Code: | DQK, Class IIDQE, Class II |
| Primary PredicateDevice: | Vigilance II Continuous Cardiac Output/Oximetry/Volumetric(CCO/SvO2/CEDV) Monitor manufactured by EdwardsLifesciences, K043103, cleared December 9, 2004. |
| Secondary PredicateDevice: | EV1000 Clinical Platform manufactured by Edwards Lifesciences,K160552, cleared June 01, 2016. |
| Device Description: | The HemoSphere Advanced Monitoring Platform is a modularsystem which uses the same monitoring technology (CCO, ICO,Oximetry), the same associated devices (Swan-Ganz and OximetryCatheters), the same analog inputs from external vital sign monitors,the same computational algorithms for hemodynamic monitoringand the same default alarm limits as the Vigilance II System |
| (K043103, cleared December 9, 2004). Updates made to theHemoSphere Advanced Monitoring Platform include a modernizedlook (updated Graphical User Interface (GUI) and touchscreenmonitor), wireless capability, a modular architecture for scalabilityand two new derived oximetry parameters. The updated GUI issimilar to the GUI utilized in the EV1000 Clinical Platform(K160552, cleared June 01, 2016). The two new derived oximetryparameters (Estimated Oxygen Consumption (VO2e) and EstimatedOxygen Consumption Index (VO2Ie)) are derived parameters thatare currently available on the EV1000 Clinical Platform (K160552,cleared June 01, 2016). | |
| The HemoSphere Advanced Monitoring Platform consists of theHemoSphere Advanced Monitor that provides a means to interactwith and visualize hemodynamic and volumetric data on a screenand two optional external modules: the HemoSphere Swan-GanzModule and the HemoSphere Oximetry Cable. | |
| These optional modules provide an interface to connect withcurrently cleared and commercially available Edwards LifesciencesSwan-Ganz and Oximetry catheters (K803058, K822350, K905458,K924650, K934742, K940795, K053609 and K110167 andK160884). The modules provide the software technology tocompute hemodynamic monitoring data that is then sent to themonitor for visualization and storage. | |
| The HemoSphere Advanced Monitor has an input that can beconnected to an external vital sign patient monitor for the purpose ofslaving in an analog ECG signal. The HemoSphere Platform usesthis analog ECG input signal to calculate a heart rate that is used bythe HemoSphere Swan-Ganz Module to calculate certain derivedparameters (e.g. HRavg, SV, RVEF and EDV). |
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Indications for Uses fonitor with Hemosp రువ్ Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
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HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
The HemoSphere Advanced Monitoring Platform is intended to be Intended Use: used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.
The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters.
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed in the table below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population
| Parameters | Description | Patient Population |
|---|---|---|
| CO | continuous cardiac output | Adult only |
| sCO | STAT cardiac output | |
| CI | continuous cardiac index | |
| sCI | STAT cardiac index | |
| EDV | right ventricular end diastolic volume | |
| sEDV | STAT right ventricular end diastolic volume | |
| EDVI | right ventricular end diastolic volume index | |
| sEDVI | STAT right ventricular end diastolic volume index | |
| HRavg | averaged heart rate | |
| LVSWI | left ventricular stroke work index | |
| PVR | pulmonary vascular resistance | |
| PVRI | pulmonary vascular resistance index | |
| RVEF | right ventricular ejection fraction |
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| sRVEF | STAT right ventricular ejectionfraction | |
|---|---|---|
| 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 andPediatric |
| 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:
| Parameters | Description | PatientPopulation |
|---|---|---|
| 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 | PatientPopulation |
|---|---|---|
| DO2 | Oxygen Delivery | Adult andPediatric |
| 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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| Comparison toPredicate Device: | The HemoSphere Advanced Monitoring Platform is a modularplatform which uses the same monitoring technology (CCO, ICO,Oximetry), the same associated catheters (Swan-Ganz and OximetryCatheters), the same analog inputs from external vital sign monitors,the same computational algorithms for hemodynamic monitoringand the same default alarm limits as Vigilance II System (K043103,cleared December 9, 2014).Updates made to the HemoSphere Advanced Monitoring Platforminclude a modernized look (updated Graphical User Interface (GUI)and touchscreen monitor), wireless capability, a modulararchitecture designed for scalability, and two additional derivedoximetry parameters (Estimated Oxygen Consumption (VO2e) andEstimated Oxygen Consumption Index (VO2Ie)). The updated GUIis similar to the GUI utilized in the EV1000 Clinical Platform(K160552, cleared June 01, 2016). Wireless capabilities for theHemoSphere Advanced Monitoring Platform are limited toconnecting and sending data to external Medical Device DataSystems. The two additional derived oximetry parameters (VO2eand VO2Ie) are derived parameters that are currently available onthe EV1000 Clinical Platform.The HemoSphere Advanced Monitor has an HDMI display outputport to connect to an external monitor as opposed to a VGA port onthe Vigilance II System. All other input and output ports remain thesame.The HemoSphere Advanced Monitor is built on a Windows 7Operating System whereas the Vigilance II System used a NucleusReal Time Operating System (RTOS).Verification and validation testing was performed to compare theperformance and functionality of the HemoSphere AdvancedMonitoring Platform and the Vigilance II System. Testing includeda side-by-side comparison of the output parameters using a benchtest. |
|---|---|
| Performance Data(Bench and/orClinical): | The following verification activities were performed in support of asubstantial equivalence determination.System VerificationKey Cardiac Output parameters (ICO, CCO, RVEF, BloodTemperature and Injectate Temperature) and Oximetry parameters(SvO2 and ScvO2) were tested using a bench simulation. Powerswitching and shutoff verification for the Swan-Ganz module wasperformed. Additionally, individual modules were tested at asystem level to verify the safety of these modules. They were alsointegrated as a system and verified for their safety and effectiveness. |
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Electrical Safety and Electromagnetic Compatibility (EMC)
The HemoSphere Advanced Monitor, The HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable were tested to the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8. IEC 62304. IEC 62366 and IEC 60601-2-49.
Wireless Coexistence Testing
Bench and simulated environment testing was performed on the HemoSphere Advanced Monitoring Platform.
Software Verification
The HemoSphere Advanced Monitor and the HemoSphere Oximetry Cable were both considered as software of Moderate Level of Concern. The HemoSphere Swan-Ganz Module was considered as software of Major Level of Concern.
Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software on each of the individual modules was tested at a sub-system level to ensure the safety of the device.
Animal Study
An animal study involving 4 pigs and 25 clinicians was performed to verify usability of the HemoSphere Advanced Monitoring Platform.
Clinical Performance
Clinical data was not required for this device.
Non-Clinical Performance Conclusions: Conclusions
Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device.
Clinical Performance Conclusions: Clinical data was not required for this device.
Overall Conclusion:
The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitoring Platform (the HemoSphere Advanced Monitor, the HemoSphere Swan-Ganz Module and the HemoSphere Oximetry Cable ) is substantially equivalent to the legally marketed predicate Vigilance II System.
§ 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).