HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor

K223865 · Edwards Lifesciences, LLC · DQK · Jun 9, 2023 · Cardiovascular

Device Facts

• Record ID: K223865
• Device Name: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQK · Cardiovascular
• Decision Date: Jun 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: 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 Viewfinder Remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as Faults, Alerts and Notifications generated by the HemoSphere Advanced Monitoring Platform. The HemoSphere Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, Acumen IQ sensors, Acumen IQ fluid meter, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.

Device Story

HemoSphere Advanced Monitoring Platform is a modular hemodynamic monitor; processes inputs from various sensors (Swan-Ganz catheters, oximetry cables, pressure cables, ClearSight finger cuffs, Acumen IQ fluid meters). Transforms physiological signals (pressure waveforms, thermodilution, oximetry) into hemodynamic parameters (CO, CI, SV, SVR, SvO2, StO2, etc.). Features include Acumen Hypotension Prediction Index (HPI) and Assisted Fluid Management (AFM). AFM now supports automated fluid tracking via Acumen AFM Cable and Acumen IQ fluid meter. Heart Reference Sensor (HRS) now features automatic zeroing via firmware model. Used in OR, ICU, ER by clinicians. Output displayed on monitor; remote viewing via Viewfinder Remote app. Provides quantitative physiological data to assist clinicians in goal-directed therapy and fluid management decisions. Benefits include continuous hemodynamic assessment and early warning of hypotensive events.

Clinical Evidence

No clinical data. Evidence consists of bench testing, software verification/validation, usability studies, electrical safety (IEC 60601 series), and biocompatibility (ISO 10993-1).

Technological Characteristics

Modular platform; wired/wireless connectivity. Materials: sterile single-use Acumen IQ fluid meter, reusable Acumen AFM cable. Sensing: thermodilution, oximetry, pressure waveform analysis, plethysmography. Software: firmware-based signal processing and predictive algorithms (HPI, AFM). Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1, ISO 11607-1.

Indications for Use

Indicated for adult and pediatric critical care patients requiring hemodynamic monitoring (cardiac output, venous oxygen saturation, blood pressure, fluid status, vascular resistance) in hospital environments (OR, ICU, ER). Acumen AFM feature indicated for surgical patients ≥18 years. ForeSight Oximeter indicated for patients at risk of ischemia (weight-based sensor selection). ClearSight module indicated for patients >18 years requiring continuous hemodynamic assessment where invasive monitoring is difficult.

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 (K213682)

Submission Summary (Full Text)

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June 9, 2023

Edwards Lifesciences, LLC Sara Pesian Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K223865

Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, QAQ, MUD, DXN, DSB Dated: May 9, 2023 Received: May 10, 2023

Dear Sara Pesian:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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,

# Robert T. Kazmierski -S

for

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) K223865

#### Device Name

HemoSphere Advanced Monitoring Platform, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter

#### 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. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. 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 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 catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.

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

HemoSphere Advanced Monitor with HemoSphere Pressure Cable:

The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards 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 or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen 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 Acumen 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 Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.

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Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.

The Acumen Assisted Fluid management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.

HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight Oximeter Cable 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 ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 on the HemoSphere advanced monitor. • When used with large sensor, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents

>40 kg.

- · When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
· When used with Small Sensors, the ForeSight Oximeter Cable 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.

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) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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| 510(k) Summary – HemoSphere Advanced Monitoring Platform | |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 |
| Establishment<br>Registration<br>Number: | 2015691 |
| Contact<br>Person: | Sara Pesian<br>Manager, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>[e-mail]<br>Telephone: [phone] |
| Date: | June 08, 2023 |
| Platform<br>Name: | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor (subject device)<br>HemoSphere ClearSight Module (subject device)<br>Heart Reference Sensor (subject device)<br>Pressure Controller (subject device)<br>HemoSphere Swan-Ganz Module<br>HemoSphere Oximetry Cable<br>HemoSphere Pressure Cable<br>HemoSphere Technology Module<br>HemoSphere ForeSight Oximeter Cable<br>Acumen Hypotension Prediction Index software feature<br>Acumen Assisted Fluid Management software feature with Acumen AFM Cable<br>and Acumen IQ fluid meter (subject device)<br>Viewfinder Remote |
| Common<br>Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification<br>Name for<br>HemoSphere<br>Monitor and<br>Accessories: | Programmable Diagnostic Computer 21 CFR 870.1425<br>Fiberoptic Oximeter Catheter 21 CFR 870.1230<br>Adjunctive Predictive Cardiovascular Indicator 21 CFR 870.2210<br>Oximeter, Tissue Saturation (Non-Invasive) 21 CFR 870.2700<br>System, Measurement, Blood-Pressure, Non-Invasive 21 CFR 870.1130<br>Plethysmograph, Impedance 21 CFR 870.2770<br>Adjunctive Open Loop Fluid Therapy Recommender 21 CFR 870.5600<br>Thermometer, Electronic, Clinical 21 CFR 880.2910 |
| 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>FLL, Class II |
| Primary<br>Predicate<br>Device | The HemoSphere Advanced Monitoring Platform, manufactured by Edwards<br>Lifesciences, K213682 cleared June 22, 2022, is being utilized for substantial<br>equivalence to the device modularity, basic device functionality, graphical user<br>interface (GUI) used, core predictive algorithm for the Assisted Fluid<br>Management software feature, and cybersecurity features. The indications for use<br>are also similar to the subject device. |
| Device<br>Description: | The HemoSphere Advanced Monitoring platform was designed to simplify the<br>customer experience by providing one platform with modular solutions for their<br>hemodynamic monitoring needs. The user can choose from the available optional<br>sub-system modules or use multiple sub-system modules at the same time. This<br>modular approach provides the customer with the choice of purchasing and/or<br>using specific monitoring applications based on their needs. Users are not<br>required to have all of the modules installed at the same time for the platform to<br>function.<br>HemoSphere Advanced Monitoring Platform, subject of this submission, consists<br>of the HemoSphere Advanced Monitor that provides a means to interact with and<br>visualize hemodynamic and volumetric data on the monitor screen and its five (5)<br>optional external modules: the HemoSphere Swan-Ganz Module (K163381<br>cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 cleared,<br>April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16,<br>2018), HemoSphere Technology Module (K213682 cleared, June 22, 2022),<br>HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphere<br>ClearSight Module (K203687 cleared, May 28, 2021). Additionally, the<br>HemoSphere Advanced Monitoring Platform includes the Acumen Hypotension<br>Prediction Index software feature (DEN160044 granted March 16, 2018) and the<br>Acumen Assisted Fluid Management software feature (DEN190029 granted<br>November 13, 2020). The HemoSphere Advanced Monitor also has wired and<br>wireless capabilities, which was originally used only for connecting to a Hospital<br>Information System (HIS) for data charting purposes. This capability is now used<br>to allow it to stream continuously monitored data to the Viewfinder Remote, a<br>mobile device-based application, for remote viewing the information (K211465,<br>cleared July 8, 2021). The remotely transmitted data from the patient monitoring<br>sessions include all hemodynamic parameter data and the associated physiological<br>alarm notifications, historical trend data, and parameter waveform data. |

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

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HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:

- 1) Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.

The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.

The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.

When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens.

#### 2) Automatic Zeroing of the Heart Reference Sensor (HRS)

The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.

The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is

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designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.

In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.

For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.

The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information.

3) Patient Query

As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor.

#### 4) Miscellaneous Updates

Miscellaneous updates include:

- Bug fixes -
- Cybersecurity updates -
- Operator's manual updates -
- Heart Reference Sensor Instructions for Use update -

#### Indications HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module

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

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(CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. 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 critical care patients requiring monitoring 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 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 or 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.

HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor:

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The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.

The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IO fluid meter.

#### HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable

The noninvasive ForeSight Oximeter Cable 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 ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.

- When used with large sensors, the ForeSight Oximeter Cable is indicated ● for use on adults and transitional adolescents ≥40 kg.
- When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects ≥3 kg.
- When used with small sensors, the ForeSight Oximeter Cable 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.

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| | The Edwards Lifesciences Acumen Hypotension Prediction Index feature<br>provides the clinician with physiological insight into a patient's likelihood of<br>future hypotensive events (defined as mean arterial pressure < 65 mmHg for at<br>least one minute in duration) and the associated hemodynamics. The Acumen HPI<br>feature is intended for use in surgical patients receiving advanced hemodynamic<br>monitoring. The Acumen HPI feature is considered to be additional quantitative<br>information regarding the patient's physiological condition for reference only and<br>no therapeutic decisions should be made based solely on the Hypotension<br>Prediction Index (HPI) parameter. |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use<br>statements for information on target patient population specific to the finger cuff<br>being used. |
| | Indications for Use for the Acumen IQ Fluid Meter<br>The Acumen IQ fluid meter is indicated for surgical patients over 18 years of age<br>to track the fluid being administered to the patient, when used with a compatible<br>hemodynamic monitoring platform. |
| Intended Use<br>of the<br>HemoSphere<br>Advanced<br>Monitor: | Intended Use- HemoSphere Advanced Monitoring Platform:<br>The HemoSphere Advanced Monitoring Platform is intended to be used by<br>qualified personnel or trained clinicians in a critical care environment in a<br>hospital setting. The Viewfinder Remote mobile application can be used for<br>supplemental near real-time remote display of monitored hemodynamic parameter<br>data as well as Faults, Alerts and Notifications generated by the HemoSphere<br>Advanced Monitoring Platform. |
| | The HemoSphere Advanced Monitoring Platform is intended for use with<br>compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, |

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 in the table below. Only iCO, iCI, iSVR, and iSVRI are

available to the pediatric patient population.

Acumen IQ sensors, Acumen IQ fluid meter, TruWave DPT sensors, ForeSight

Edwards Lifesciences

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| 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 | | | |
| sEDV | STAT right ventricular end<br>diastolic volume | | | |
| EDVI | right ventricular end diastolic<br>volume index | | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| sEDVI | STAT right ventricular end<br>diastolic volume index | | | |
| HRavg | averaged heart rate | | | |
| LVSWI | left ventricular stroke work index | HemoSphere<br>Swan-Ganz<br>Module | | |
| PVR | pulmonary vascular resistance | | | |
| PVRI | pulmonary vascular resistance<br>index | | | |
| RVEF | right ventricular ejection fraction | | | |
| sRVEF | STAT right ventricular ejection<br>fraction | | | |
| RVSWI | right ventricular stroke work index | | | |
| SV | stroke volume | | | |
| SVI | stroke volume index | | | |
| SVR | systemic vascular resistance | | | |
| SVRI | systemic vascular resistance index | | | |
| BT | pulmonary artery blood<br>temperature | | | |
| iCO | intermittent cardiac output | | | |
| iCI | intermittent cardiac index | | | |
| iSVR | intermittent systemic vascular<br>resistance | | Adult and<br>Pediatric | |
| iSVRI | intermittent systemic vascular<br>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<br>Pediatric | Operating Room,<br>Intensive Care<br>Unit, Emergency<br>Room |
| ScvO2 | Central Venous Oxygen Saturation | HemoSphere<br>Oximetry<br>Cable | | |

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:

{13}------------------------------------------------

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|--------------------------------------------------------------|
| DO2 | Oxygen Delivery | HemoSphere<br>Swan-Ganz<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | | Operating Room,<br>Intensive Care<br>Unit, Emergency<br>Room |
| DO2I | Oxygen Delivery Indexed | | | |
| VO2 | Oxygen Consumption | | Adult and<br>Pediatric | |
| 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:

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|---------------------------------|-----------------------|--------------------------------------------------------------|
| CO/<br>CI | Continuous Cardiac Output¹/<br>Continuous Cardiac Index¹ | | | |
| CVP | Central Venous Pressure | | Adult only | Operating Room,<br>Intensive Care<br>Unit, Emergency<br>Room |
| DIA | 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 | | |
| MAP | Mean Arterial Pressure | | | |
| MPAP | Mean Pulmonary Arteria¹ Pressure | | | |
| PPV | pulse pressure variation¹ | | | |
| PRART | Pulse rate | | | |
| SV/<br>SVI | Stroke Volume¹/<br>Stroke Volume Index¹ | | | |
| SVR/<br>SVRI | Systemic Vascular Resistance¹/<br>Systemic Vascular Resistance¹ Index | | | |
| SVV | Stroke Volume Variation¹ | | | |
| SYSART | Systemic Arterial Systolic Blood<br>Pressure | | | |
| SYSPAP | Pulmonary Artery Systolic Blood<br>Pressure | | | |
| HPI | Acumen Hypotension Prediction Index² | | | |
| ¹FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTrac feature is enabled.<br>²HPI parameters are available when using an Acumen IQ sensor and if the HPI feature is activated | | | | |

A list of Acumen Assisted Fluid Management (AFM) outputs available for surgical patients ≥18 years of age while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below:

{14}------------------------------------------------

| AFM outputs | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|--------------------------|-------------------------|
| Fluid Bolus Suggested | | | |
| Test Bolus Suggested | | | |
| Fluid Not Suggested | | ≥18 years of age<br>only | Operating Room |
| Suggestions Suspended | HemoSphere<br>Pressure Cable | | |
| Bolus in Progress... | | | |
| Bolus Complete | and Acumen<br>AFM Cable | | |
| Bolus Complete; Analyzing Hemodynamic Response | | | |
| Tracked Case Vol. | | | |
| Flow Rate | | | |
| Bolus Volume | | | |
| AFM outputs are available when using an Acumen IQ sensor and if the AFM feature is activated. Flow rate and<br>Bolus Volume are visible when using automatic fluid tracking mode. | | | |

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<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------|
| DO2 | Oxygen Delivery | HemoSphere<br>Swan-Ganz<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | | Operating Room,<br>Intensive Care<br>Unit, Emergency<br>Room |
| DO2I | Oxygen Delivery Indexed |…