HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)

K221704 · Edwards Lifesciences, LLC · DQK · Nov 22, 2022 · Cardiovascular

Device Facts

• Record ID: K221704
• Device Name: HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI)
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 22, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

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 compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight Elite sensors, and ClearSight/Acumen IQ finger cuffs.

Device Story

HemoSphere Advanced Monitoring Platform is a modular hemodynamic monitor for hospital critical care (OR, ICU, ER). It processes inputs from various Edwards sensors/catheters (Swan-Ganz, oximetry, pressure, tissue oximetry, ClearSight finger cuffs). The platform displays measured and derived hemodynamic parameters (e.g., CO, CI, SvO2, blood pressure, RVP). The new Right Ventricular Pressure (RVP) algorithm provides physiological insight into right ventricular status. Clinicians use the platform to assess cardiac function, fluid status, and vascular resistance, often within goal-directed therapy protocols. The system provides quantitative data for reference; therapeutic decisions must not rely solely on HPI or RVP parameters. The modular design allows clinicians to select specific monitoring applications based on patient needs.

Clinical Evidence

No new clinical trials were performed. Evidence consists of bench testing, system-level verification, software verification, and a usability study. Clinical waveforms were collected to support the design and validation of the RVP algorithm. All verification and validation activities met predetermined specifications.

Technological Characteristics

Modular hemodynamic monitoring platform. Components: HemoSphere monitor, Swan-Ganz module, oximetry cable, pressure cable, tissue oximetry module, ClearSight module. Connectivity: Networked/hospital environment. Software: Embedded firmware with integrated RVP algorithm. Sterilization: Not applicable (monitor/modules are capital equipment).

Indications for Use

Indicated for adult and pediatric critical care patients requiring hemodynamic monitoring (cardiac output, venous oxygen saturation, pressure, and derived parameters) in hospital environments (OR, ICU, ER). Specific modules are indicated for patients >18 years (RVP, ClearSight), adults and adolescents ≥40 kg (large tissue oximetry sensors), pediatric subjects ≥3 kg (medium sensors), and pediatric subjects <8 kg (cerebral) or <5 kg (non-cerebral) (small sensors). Contraindications: None explicitly stated, but RVP and HPI are for reference only and not for sole therapeutic decision-making.

Regulatory Classification

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.

Predicate Devices

• HemoSphere Advanced Monitoring Platform (K203687)
• Philips IntelliVue (K161531)

Submission Summary (Full Text)

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November 22, 2022

Edwards Lifesciences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine. California 92614

Re: K221704

Trade/Device Name: HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK, QDE, QAQ, MUD, DXN, DSB, QMS, QNL Dated: October 19, 2022 Received: October 20, 2022

Dear Michelle Ducca:

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

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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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Stephen C. Browning -S

LCDR 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

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### Indications for Use

510(k) Number (if known) K221704

Device Name HemoSphere Advanced Monitoring Platform

#### 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 also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:

The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requiring of venous 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 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 surgical 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.

When used in combination with the Swan-Ganz Module connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18

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years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm 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 Right Ventricular Pressure (RVP) parameters.

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 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.

HemoSphere Advanced Monitor with HemoSphere ClearSight Module:

The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The Edwards Lifesciences Acumen Hypotension 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 surgical 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 ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

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)

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# K221704

| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 | | |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------|
| Establishment<br>Registration<br>Number: | 2015691 | | |
| Contact<br>Person: | Michelle Ducca<br>Manager, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>[e-mail]<br>Telephone: [phone] | | |
| Date: | November 11, 2022 | | |
| Platform<br>Name | HemoSphere Advanced Monitoring Platform | | |
| Trade Name: | HemoSphere Advanced Monitor (subject)<br>HemoSphere Swan-Ganz Module<br>HemoSphere Oximetry Cable<br>HemoSphere Pressure Cable (subject)<br>Acumen Hypotension Prediction Index (HPI) for Minimally Invasive and Non-<br>invasive technologies<br>HemoSphere Tissue Oximetry Module<br>HemoSphere FORE-SIGHT ELITE Tissue Oximetry Module<br>HemoSphere ClearSight Module<br>Right Ventricular Pressure Feature (subject) | | |
| Common<br>Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| Classification<br>Name for<br>HemoSphere<br>Monitor and<br>Accessories: | Programmable Diagnostic Computer<br>Fiberoptic Oximeter Catheter<br>Adjunctive Predictive Cardiovascular Indicator<br>Oximeter, Tissue Saturation (Non-Invasive)<br>System, Measurement, Blood-Pressure, Non-Invasive<br>Plethysmograph, Impedance | 21 CFR 870.1425<br>21 CFR 870.1230<br>21 CFR 870.2210<br>21 CFR 870.2700<br>21 CFR 870.1130 | 21 CFR 870.2770 |

## 510(k) Summary – HemoSphere Advanced Monitoring Platform

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| Product Code<br>for<br>HemoSphere<br>Monitor and<br>Accessories: | DQK, Class II<br>DQE, Class II<br>QAQ, Class II<br>MUD, Class II<br>DXN, Class II<br>DSB, Class II<br>QMS, Class II<br>QNL, Class II |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|

- HemoSphere Advanced Monitoring Platform, manufactured by Edwards Primarv Predicate: Lifesciences, K203687 cleared May 28, 2021, is being utilized for substantial equivalence to the device modularity, basic device functionality, graphical user interface (GUI) used, similar existing algorithm for the Right Ventricular Pressure (RVP) feature. The indications for use are also similar to the subject device.
- Philips IntelliVue (K161531, cleared July 1, 2016) manufactured by Philips Additional Predicates: Medizin Systeme Boeblingen GmbH, is being utilized for substantial equivalence to the Right Ventricular Pressure (RVP) feature in terms of technology and similar indications/intended use.
- Device The HemoSphere Advanced Monitoring platform was designed to simplify the Description: 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.

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 five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module Indications for Use: 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

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parameters. It mav also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of yenous 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. 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 mmHz for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical and non-surgical 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.

When used in combination with the Swan-Ganz Module connected to a compatible Swan-Ganz catheter, the Edward Lifesciences Right Ventricular

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Pressure (RVP) algorithm provides the clinician with physiological insight into the hemodynamic status of the right ventricle of the heart. The RVP algorithm is indicated for critically ill patients over 18 years of age receiving advanced hemodynamic monitoring in the operating room (OR) and intensive care unit (ICU). The RVP algorithm 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 Right Ventricular Pressure (RVP) parameters.

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 non-invasive 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, 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.

#### HemoSphere Advanced Monitor with HemoSphere ClearSight Module

The HemoSphere Advanced Monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with comorbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards' finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.

The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of

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future hypotensive events (defined as mean arterial pressure < 65 mmHz for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical 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 ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

#### Intended Use: Intended Use- HemoSphere Advanced Monitoring Platform:

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 compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight Elite sensors, and ClearSight/Acumen IQ finger cuffs.

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below in table 1-1. Only iCO. iCI. iSVR, and iSVRI are available to the pediatric patient population.

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------|-----------------------------------|-----------------------|-------------------------|
| CO | continuous cardiac output | | | |
| sCO | STAT cardiac output | | | |
| CI | continuous cardiac index | | | |
| sCI | STAT cardiac index | | | |
| EDV | right ventricular end diastolic<br>volume | | | Operating<br>Room, |
| sEDV | STAT right ventricular end<br>diastolic volume | HemoSphere<br>Swan-Ganz<br>Module | Adult only | Intensive<br>Care Unit, |
| EDVI | right ventricular end diastolic<br>volume index | | | Emergency<br>Room |
| sEDVI | STAT right ventricular end<br>diastolic volume index | | | |
| HRavg | averaged heart rate | | | |
| LVSWI | left ventricular stroke work index | | | |
| PVR | pulmonary vascular resistance | | | |

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| PVRI | pulmonary vascular resistance index |
|-------|-------------------------------------------------|
| RVEF | right ventricular ejection fraction |
| sRVEF | STAT right ventricular ejection fraction |
| RVSWI | right ventricular stroke work index |
| SV | stroke volume |
| SVI | stroke volume index |
| SVR | systemic vascular resistance |
| SVRI | systemic vascular resistance index |
| iCO | intermittent cardiac output |
| iCI | intermittent cardiac index |
| iSVR | intermittent systemic vascular resistance |
| iSVRI | intermittent systemic vascular resistance index |

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere oximetry cable are as listed below:

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|-------------------------------------|---------------------------------|-----------------------|---------------------------------|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphere<br>Oximetry<br>Cable | Adult and | Operating<br>Room,<br>Intensive |
| ScvO2 | Central Venous Oxygen<br>Saturation | | Pediatric | Care Unit,<br>Emergency<br>Room |

A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz module and oximetry cable are listed below:

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | | | |
| VO2 | Oxygen Consumption | HemoSphere<br>Swan-Ganz<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | Adult and<br>Pediatric | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| VO2e | Estimated Oxygen Consumption<br>when ScvO2 is being monitored | | | |
| VO2I | Oxygen Consumption Index | | | |
| VO2Ie | Estimated Oxygen Consumption<br>Index when ScvO2 is being<br>monitored | | | |

A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below:

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| Parameter | Description | Sub-System<br>ModuleUsed | Patient<br>Population | Hospital<br>Environment |
|-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------|-----------------------|--------------------------------------------------------------------|
| CO/<br>CI | Continuous Cardiac Output1/<br>Continuous Cardiac Index1 | | | |
| CVP | Central Venous Pressure | | | |
| DIAART | Systemic arterial diastolic blood<br>pressure | | | |
| DIAPAP | pulmonary artery diastolic blood<br>pressure | | | |
| dP/dt | Systolic slope2 | | | |
| Eadyn | Dynamic Arterial Elastance2 | HemoSphere<br>Pressure<br>Cable | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| MAP | Mean Arterial Pressure | | | |
| MPAP | Mean Pulmonary Arterial Pressure | | | |
| PPV | pulse pressure variation1 | | | |
| PRART | Pulse rate | | | |
| SV/<br>SVI | Stroke Volume1/ Stroke<br>Volume Index1 | | | |
| SVR/<br>SVRI | Systemic Vascular Resistance1/<br>Systemic Vascular Resistance1<br>Index | | | |
| SVV | Stroke Volume Variation1 | | | |
| SYSART | Systemic Arterial Systolic Blood<br>Pressure | | | |
| SYSPAP | Pulmonary Artery Systolic Blood<br>Pressure | | | |
| HPI | Acumen Hypotension Prediction<br>Index2 | | | |
| 1FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTrac feature is<br>enabled. | | | | |
| 2HPI parameters are available when using an Acumen IQ sensor and if the HPI feature is activated. | | | | |

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-System<br>Module Used | Patient<br>Population | Hospital<br>Environment |
|-----------|---------------------------------------------------------------------|---------------------------|-----------------------|--------------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | HemoSphere<br>Pressure | Adult only | Operating<br>Room,<br>Intensive Care<br>Unit,<br>Emergency<br>Room |
| VO2 | Oxygen Consumption | | | |
| VO2e | Estimated Oxygen Consumption<br>when ScvO2 is being monitored | Cable and<br>HemoSphere | | |
| VO2I | Oxygen Consumption Index | Oximetry<br>Cable | | |
| VO2Ie | Estimated Oxygen Consumption<br>Index when ScvO2 is being monitored | Cable | | |

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz Module and a connected HemoSphere pressure cable are as listed below.

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| Parameter | Description | Sub-System<br>Module Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------|------------------------------------------------------------------------|-----------------------|-----------------------------------------------------------------|
| CO20s | 20-second<br>cardiac<br>output | | | |
| CI20s | 20-second<br>cardiac<br>index | | | |
| SV20s | 20-second stroke<br>volume | | | |
| SVI20s | 20-second stroke<br>volume index | | | |
| RVEDP | Right Ventricular<br>End Diastolic<br>Pressure | HemoSphere<br>Swan-<br>Ganz module and<br>HemoSphere<br>pressure cable | Adult only | Operating<br>room, intensive<br>care unit,<br>emergency<br>room |
| RV dP/dt | Maximal right<br>ventricular<br>systolic slope | | | |
| SYSRVP | Systolic Right<br>Ventricular<br>Pressure | | | |
| DIARVP | Right Ventricular<br>Diastolic<br>Pressure | | | |
| MRVP | Mean Right<br>Ventricular<br>Pressure | | | |
| PRRVP | Right Ventricular<br>Pulse Rate | | | |

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 HemoSphere Advanced Monitoring Platform Operators Manual for specific information on the intended use environment and patient population.

| Parameter | Description | Sub-System<br>Module Used | Patient<br>Populatio<br>n | Hospital<br>Environment |
|-----------|--------------------------|------------------------------------------------------------------------|---------------------------|--------------------------------------------------------------------|
| StO2 | Tissue oxygen saturation | HemoSphere Tissue<br>Oximetry Module<br>and Fore-Sight Elite<br>Module | Adult and<br>Pediatric | Operating<br>Room,<br>Intensive Care<br>Unit,<br>Emergency<br>Room |

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight module are listed below

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| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------|-----------------------|--------------------------------------------------------------------|
| CO/CI | Continuous Cardiac Output/<br>Continuous Cardiac Index | | | |
| DIA | Noninvasive arterial diastolic blood<br>pressure | | | |
| MAP | Noninvasive Mean Arterial Pressure | | | |
| PPV | pulse pressure variation | | | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| PR | Noninvasive Pulse rate | | | |
| SV/SVI | Stroke Volume/<br>Stroke Volume Index | HemoSphere<br>ClearSight<br>Module | Adult only | |
| SVR/SVRI | Systemic Vascular Resistance/<br>Systemic Vascular Resistance Index | | | |
| SVV | Stroke Volume Variation | | | |
| SYS | Systolic Blood Pressure | | | |
| dP/dt | Maximal slope of the arterial<br>pressure upstroke1 | | | |
| Eadyn | Dynamic Arterial Elastance1 | | | |
| HPI | Acumen Hypotension Prediction<br>Index1 | | | Operating<br>Room only |
| 1HPI parameters are available when using an Acumen IQ cuff and if the HPI feature is activated | | | | |

A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere ClearSight module and oximetry cable are listed below

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------|----------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit |
| VO2 | Oxygen Consumption | HemoSphere<br>ClearSight<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | | |
| VO2e | Estimated Oxygen Consumption<br>when ScvO2 is being monitored | | | |
| VO2I | Oxygen Consumption Index | | | |
| VO2Ie | Estimated Oxygen Consumption<br>Index when ScvO2 is being<br>monitored | | | |

Comparison The existing HemoSphere Advanced Monitoring Platform, K203687 (cleared May 28, 2021) consists of: to Predicate Device:

- HemoSphere Advanced Monitor .
- HemoSphere Swan-Ganz Module ●
- HemoSphere Oximetry Cable ●
- HemoSphere Pressure Cable
- Acumen Hypotension Prediction Index (HPI)
- HemoSphere Tissue Oximetry Module
- HemoSphere FORE-SIGHT ELITE Tissue Oximetry Module ●
- . HemoSphere ClearSight Module

The subject and predicate devices are based on the following same technological elements:

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- Platform: the subject device uses the same platform as the Primary . Predicate (K203687, cleared May 28, 2021)
- . Graphical User Interface: The subject and Primary Predicate (K203687, cleared May 28, 2021) and Secondary Predicate (K161531, cleared July 1, 2016) have the same or similar Graphical User Interface (GUI).
- Accessories/Components: The subject and the Primary Predicate . (K203687, cleared May 28, 2021) device both use previously cleared Swan-Ganz Module,= and Pressure Cable for measurement.
- Intended Use/Indications for Use: The subject and the Primary Predicate (K203687, cleared May 28, 2021) and Secondary predicates (K161531, cleared July 1, 2016.

The following technological differences exist between the subject and predicate devices (There is no new hardware for the subject of this 510(k)):

- . Algorithm update: The currently cleared platform has been modified to integrate the Right Ventricular Pressure (RVP) algorithm, which uses the same Swan-Ganz Module and Pressure Cable already available in the predicate (K203687, cleared May 28, 2021).
The purpose of the is 510(k) submission is to introduce the following modifications to the HemoSphere Advanced Monitoring Platform (K203687, Mav 28, 2021):

- * Modifications to existing features/algorithm of the HemoSphere Advanced Monitoring Platform (previously cleared in K203687 on May 28, 2021):
- . Algorithm modification: Addition of the Right Ventricular Pressure (RVP) algorithm

The Right Ventricular Pressure (RVP) algorithm has been incorporated into the HemoSphere Advanced Monitoring Platform. This algorithm provides the option to monitor the right ventricular pressure waveform and its associated derived parameters (SYSRVP, DIARVP, MRVP, PRRVP, RV dp/dt and RVEDP). The new algorithm uses the same Swan-Ganz Module and Pressure Cable already available in the predicate K203687, cleared May 28, 2021.

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#### * Modifications to the labeling of the HemoSphere Advanced Monitoring Platform (K203687 cleared on May 28, 2021):

- 트 Indication/Intended Use expansion and addition to accommodate the expanded functionality for Right Ventricular Pressure (RVP) algorithm on the HemoSphere Advanced Monitoring platform:
The HemoSphere Advanced Monitoring Platform Operator's Manual is being updated to include the expanded indications for use for the Right Ventricular Pressure (RVP) feature. The Intended Use for Swan-Ganz Module when used with Pressure Cable is being expanded to include the addition of the RVP.

The following verification activities were performed in support of a substantial Performance equivalence determination for the modifications being made as part of this Data: submission.

#### System Verification (Non-clinical performance)

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 features did not adversely affect the safety and effectiveness of the subject device. 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.

#### 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 (issued May 11, 2005). Software on each of the updated module and algorithm were tested at a sub-system level to ensure the safety of the device. All tests passed.

#### Usabilitv Study

Usability study was conducted per FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 2016), to investigate primary operating functions and critical tasks of the system for any usability issues regarding HemoSphere Advanced Monitoring Platform that may lead to patient or user harm. The usability study demonstrated that the intended users could perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm.

#### Clinical Performance

No new clinical testing was performed in support of the subject 510(k). However, clinical data (waveforms) were collected in support of the design and validation of the RVP algorithm.

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#### Conclusions Overall Conclusion:

The HemoSphere Advanced Monitoring Platform with the subject modifications has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies. Completion of all performance 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 features did not adversely affect the safety and effectiveness of the subject device. The testing performed demonstrates that the HemoSphere Advanced Monitoring Platform with the subject modifications and expanded indications for use is substantially equivalent to its legally marketed predicates.