(206 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. 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in opeating room (OR) only 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.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on adults and transitional adolescents >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 < 8 kg and non-cerebral use on pediatric subjects <5kg.
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 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.
The provided text is a 510(k) Summary for the "HemoSphere Advanced Monitoring Platform" and its associated modules and features. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing performance through various verification and validation activities.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the information provided:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested (e.g., specific thresholds for accuracy, sensitivity, specificity for the Hypotension Prediction Index or other parameters). Instead, it states that "All tests passed" for various verification activities.
However, based on the description of the testing performed, the implicit acceptance criterion for each test was that the device met its predetermined design and performance specifications.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| System Verification | Measured and derived parameters were tested using a bench simulation. Individual modules and integrated system were verified for safety and effectiveness. All tests passed. |
| Electrical Safety & EMC | The HemoSphere Advanced Monitor and HemoSphere Pressure Cable were 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 standards. All tests passed. |
| Wireless Coexistence | 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 | 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 individual module was tested at a sub-system level. All tests passed. |
| Usability Study | A usability study was performed in accordance with FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices." Test Passed. |
| Clinical Performance | Clinical data was not required for this device. (This implies the acceptance criterion for clinical performance was that existing predicate data and non-clinical testing were sufficient to demonstrate substantial equivalence, and no new clinical study was deemed necessary by the FDA for this submission.) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document mentions "bench simulation" for system verification and "bench and simulated environment testing" for wireless coexistence. For the usability study, "32 users" were involved.
- Test Set Sample Size:
- System Verification: Not explicitly stated beyond "bench simulation."
- Wireless Coexistence: Not explicitly stated beyond "bench and simulated environment."
- Usability Study: 32 users.
- Data Provenance: The document does not specify the country of origin for the testing data or whether it was retrospective or prospective. Given the nature of "bench simulation" and "simulated environment," these are inherently prospective tests conducted in a controlled lab setting rather than on patient data from a real clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not describe the establishment of a ground truth by experts in a clinical context. The testing primarily involved performance verification against design specifications and relevant standards in laboratory settings.
For the usability study, "32 users with a mix of clinicians and nurses" were involved, but their role was in usability testing (evaluating the human-device interface) rather than establishing ground truth for a diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
No adjudication method is mentioned. This is consistent with the type of testing performed (bench/simulated verification and usability testing) which typically does not involve adjudication of clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The document explicitly states: "Clinical data was not required for this device." Therefore, there is no information on improvement of human readers with or without AI assistance. The Acumen Hypotension Prediction Index (HPI) feature is described as providing "physiological insight" and "additional quantitative information" for reference, with the caveat that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates that it's an informational tool, not a diagnostic aid requiring human-in-the-loop performance evaluation in the described submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Acumen Hypotension Prediction Index feature" is an algorithm. While its standalone performance is not detailed with specific metrics (e.g., accuracy, sensitivity, specificity of hypotension prediction), its inclusion as part of the overall system verification implies that its computational function was tested. The statement "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" suggests that the HPI's output, like other parameters, was verified against expected values or predicate device outputs in a simulated environment. However, specific performance metrics for the HPI algorithm itself are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not detail the use of expert consensus, pathology, or outcomes data to establish ground truth.
- For system verification, the implied ground truth would be the device's own predetermined design and performance specifications, likely established through engineering and scientific principles. "Bench simulation" typically involves comparing device outputs to known inputs or established reference values.
- For electrical safety, EMC, wireless coexistence, and software verification, the ground truth is defined by the compliance requirements of the cited industry and FDA standards (e.g., IEC 60601 series, FDA Guidance for software).
- For the usability study, the "ground truth" equates to the successful completion of tasks by users, and compliance with usability engineering principles, rather than a clinical truth.
8. The sample size for the training set
The document describes verification and validation activities conducted on the device, but it does not mention a training set sample size. This is consistent with the type of submission which focuses on substantial equivalence for hardware, integrated software functions, and an analytical feature (HPI) where the underlying algorithms might have been developed and "trained" prior to this specific submission, and this submission focuses on their integration and verification in the new platform. If the HPI algorithm itself had undergone a new, extensive development and training phase relevant to this submission, more details would typically be provided.
9. How the ground truth for the training set was established
Since no training set is mentioned, there is no information on how its ground truth was established. For algorithms like HPI, ground truth during development would typically involve physiological data labeled with actual hypotensive events from a large pool of patients, but this information is not part of this 510(k) summary.
{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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in opeating room (OR) only 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.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on adults and
{3}------------------------------------------------
transitional adolescents >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 < 8 kg and non-cerebral use on pediatric subjects <5kg.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
K190205 Page 1 of 10
510(k) Summary – HemoSphere Advanced Monitoring Platform
| 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: | August 26, 2019 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableHemoSphere Tissue Oximetry ModuleAcumen 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 870.2210Oximeter21 CFR 870.2700 |
| Product Code: | DQK, Class IIDQE, Class IIQAQ, Class IIMUD, Class II |
| PrimaryPredicate Device: | HemoSphere Advanced Monitoring Platform manufactured by EdwardsLifesciences, K180881, cleared on November 16, 2018. |
| AdditionalPredicateDevices: | CAS Medical System Inc.'s FORE-SIGHT ELITE Absolute TissueOximeter Monitor (K143675 cleared April 10, 2015) utilized for the tissueoximetry parameter and graphical user interface.Cheetah NICOM/Starling SV (K101487, cleared on July 2, 2010) utilizedfor the fluid responsiveness test feature (passive leg raise and fluid bolus) |
| 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 fouroptional external modules: the HemoSphere Swan-Ganz Module(existing), the HemoSphere Oximetry Cable (existing), the HemoSpherePressure Cable (existing) and the HemoSphere Tissue Oximetry Module(subject of this submission). The platform also includes the AcumenHypotension Prediction Index feature.The existing optional HemoSphere Swan-Ganz Module and HemoSphereOximetry Cable provide an interface to connect with currently cleared andcommercially available Edwards Lifesciences Swan-Ganz catheters andOximetry catheters (K803058, K822350, K905458, K924650, K934742,K940795, K053609 and K110167 and K160884).The HemoSphere Pressure Cable provides an interface to connect withcurrently cleared and commercially available Edwards LifesciencesFloTrac (K152980), FloTrac IQ (K152980) and TruWave DPT sensors(K142749).The HemoSphere Pressure Cable also enables the Acumen HypotensionPrediction Index (HPI) feature when connected to an Acumen IQ sensor.The HemoSphere Tissue Oximetry Module is an interface moduleintended to be used with the Fore-Sight Elite Tissue Oximeter Module(K180003, cleared May 10, 2018) to display continuous monitoring ofblood oxygen saturation in the tissue (StO2). |
| Additionally, the HemoSphere Advanced Monitoring Platform includesthe Fluid Responsiveness Test feature (fluid bolus and passive leg raise). | |
| The HemoSphere Advanced Monitor has an input that can be connected toan external vital sign patient monitor for slaving in an analog ECG andpressure signals. The HemoSphere Platform uses this analog ECG inputsignal to calculate a heart rate that is used by the HemoSphere Swan-GanzModule to calculate certain derived parameters (e.g. HRavg, SV, RVEFand EDV). | |
| The HemoSphere Pressure-Out cable enables output of analog pressuresignals (AP, CVP or PAP) for display on an external patient monitor. | |
| Indications forUse: | HemoSphere Advanced Monitor with HemoSphere Swan-GanzModule |
| HemoSphere Advanced Monitor with HemoSphere Swan-Ganz ModuleThe 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. It may be used for monitoring hemodynamicparameters in conjunction with a perioperative goal directed therapyprotocol in a hospital environment. Refer to the Edwards Swan-Ganzcatheter indications for use statement for information on target patientpopulation specific to the catheter being used. | |
| Refer to the Intended Use statement below for a complete list of measuredand derived 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 hemodynamicparameters in a hospital environment. Refer to the Edwards oximetrycatheter indications for use statement for information on target patientpopulation specific to the catheter being used. | |
| Refer to the Intended Use statement for a complete list of measured andderived parameters available for each patient population. | |
| HemoSphere Advanced Monitor with HemoSphere Pressure CableThe HemoSphere Advanced Monitor when used with the HemoSpherePressure Cable is indicated for use in critical care patients in which thebalance 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 < 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.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
- When used with large sensorsis indicated for use on adults and transitional adolescents >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 < 8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
{8}------------------------------------------------
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.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO | continuous cardiac output | |||
| sCO | STAT cardiac output | |||
| CI | continuous cardiac index | |||
| sCI | STAT cardiac index | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom | |
| 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 | |||
| 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:
{9}------------------------------------------------
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphere | Adult and | OperatingRoom,Intensive |
| ScvO2 | Central Venous OxygenSaturation | OximetryCable | Pediatric | Care Unit,EmergencyRoom |
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-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 | |
| 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 | OperatingRoom,IntensiveCare Unit,EmergencyRoom | ||
| 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
{10}------------------------------------------------
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | |||
| VO2 | Oxygen Consumption | HemoSphereSwan-GanzModule andHemoSphereOximetry | Adult only | OperatingRoom,IntensiveCare Unit,Emergency |
| VO2e | Estimated Oxygen Consumptionwhen 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 toPredicate Device: | The existing HemoSphere Advanced Monitoring Platform (K180881cleared 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.
§ 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).