HemoSphere Advanced Monitor, HemoSphere ClearSight Module

K221833 · Edwards Lifesciences, LLC · DXN · Nov 7, 2022 · Cardiovascular

Device Facts

• Record ID: K221833
• Device Name: HemoSphere Advanced Monitor, HemoSphere ClearSight Module
• Applicant: Edwards Lifesciences, LLC
• Product Code: DXN · Cardiovascular
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• 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 finger cuffs.

Device Story

HemoSphere Advanced Monitoring Platform provides visualization of hemodynamic/volumetric data; utilizes external modules (Swan-Ganz, Oximetry, Pressure, Tissue Oximetry, ClearSight) to process signals from catheters, sensors, and finger cuffs; displays measured/derived parameters (CO, CI, SvO2, ScvO2, StO2, BP, etc.). Used in hospital critical care (OR, ICU, ER) by clinicians. Includes Acumen Hypotension Prediction Index (HPI) feature providing physiological insight into likelihood of future hypotensive events. Output assists clinicians in hemodynamic optimization and goal-directed therapy. Modification to ClearSight APCO algorithm improves bias in cardiac output calculation. System integrates data for continuous assessment of cardiac function, fluid status, and vascular resistance.

Clinical Evidence

Retrospective analysis of clinical data from multiple independent datasets (patients >18 years) used to verify Cardiac Output accuracy of the modified APCO algorithm. Results demonstrated the modification did not adversely affect safety or effectiveness. All testing passed.

Technological Characteristics

Hemodynamic monitoring platform with external modules. Measurement principles include arterial pressure-based cardiac output (APCO), oximetry, and tissue oximetry. Connectivity via proprietary cables/modules. Software-based processing. No changes to materials, energy source, or user interface compared to predicate.

Indications for Use

Indicated for adult and pediatric critical care patients requiring hemodynamic monitoring (cardiac output, oxygen saturation, pressure, tissue oximetry) in hospital environments (OR, ICU, ER). Specific modules are indicated for: Swan-Ganz catheters (adult/pediatric); Oximetry cables (adult/pediatric); Pressure cables (adult/pediatric); FORE-SIGHT ELITE tissue oximetry (adults/adolescents ≥40kg; pediatric ≥3kg; cerebral pediatric <8kg; non-cerebral pediatric <5kg); ClearSight module (adults >18 years).

Regulatory Classification

Identification

A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.

Predicate Devices

• HemoSphere Advanced Monitoring Platform (K201446)
• HemoSphere Swan-Ganz Module (K163381)
• HemoSphere Oximetry Cable (K163381)
• HemoSphere Pressure Cable (K180881)
• HemoSphere Tissue Oximetry Module (K190205)
• HemoSphere ClearSight Module (K201446)

Submission Summary (Full Text)

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November 7, 2022

Edwards Life Sciences LLC Varad Raghuwanshi Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K221833

Trade/Device Name: HemoSphere Advanced Monitor. HemoSphere SwanGanz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module, HemoSphere ClearSight Module Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, DQK, DQE, MUD Dated: June 21, 2022 Received: June 23, 2022

Dear Varad Raghuwanshi:

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.

# 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K221833

### Device Name

HemoSphere Advanced Monitor. HemoSphere SwanGanz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module, HemoSphere ClearSight 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 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 is indicated for use in adult and pediatric crtical care patients requring 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 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 surgical and nonsurgical 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:

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The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor for 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.

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 non-invasive 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.

Refer to the ClearSight 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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Image /page/4/Picture/0 description: The image shows a logo with a large letter 'E' in white, set against a gray square background. The 'E' is stylized with a grid pattern and circular lines intersecting it. Below the square, the word 'Edwards' is written in a simple, sans-serif font.

# 510(k) Summary – HemoSphere Advanced Monitoring Platform

#### I. Submitter:

| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|
| Establishment<br>Registration<br>Number: | 2015691 | | |
| Contact Person: | Varad Raghuwanshi<br>Manager, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>Telephone: [phone]<br>Fax: [phone] | | |
| Date Prepared: | October 8, 2022 | | |
| II. Device Information: | | | |
| Platform Name<br>(Name of the Device) | HemoSphere Advanced Monitoring Platform | | |
| Trade Name: | HemoSphere Advanced Monitor<br>HemoSphere Swan-Ganz Module<br>HemoSphere Oximetry Cable<br>HemoSphere Pressure Cable<br>HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue<br>Oximeter Module<br>HemoSphere ClearSight Module | | |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| Classification<br>Name: | Programmable Diagnostic Computer<br>Fiberoptic Oximeter Catheter<br>Adjunctive Predictive Cardiovascular Indicator<br>Oximeter | 21 CFR 870.1425<br>21 CFR 870.1230<br>21 CFR 870.2210<br>21 CFR 870.2700 | |

Impedance plethysmograph

Noninvasive blood pressure measurement system 21 CFR 870.1130

21 CFR 870.2770

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Image /page/5/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in a gray color, set against a square background that is also gray. The letter 'E' is overlaid with a circular design, giving it a modern and sophisticated look. Below the square logo, the word 'Edwards' is written in a simple, sans-serif font.

| Product Code | DQK, Class II |
|----------------|---------------|
| and Regulatory | DQE, Class II |
| Class: | QAQ, Class II |
| | MUD, Class II |
| | DXN, Class II |
| | DSB, Class II |

#### III. Predicate Device

Primary HemoSphere Advanced Monitoring Platform manufactured by Edwards Predicate Device: Lifesciences, K201446 cleared October 1, 2020.

#### IV. Device Description

Device HemoSphere Advanced Monitoring Platform consists of the HemoSphere Description: 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 Tissue Oximetry Module (K190205 August 29, 2019), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

#### V. Indications for Use:

Note: There is no change to the Indication for Use statements from what was cleared in K201446 on October 1, 2020.

### 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.

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Image /page/6/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in white, set against a gray background divided into a grid of squares. The letter 'E' is partially overlaid with a circular design composed of thin white lines. Below the grid, the word 'Edwards' is written in a simple, sans-serif font.

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 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 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.

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Image /page/7/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in a gray square grid. The letter 'E' is white and has a circular design element overlaid on it. Below the grid, the name 'Edwards' is written in a simple, sans-serif font.

## 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 non-invasive 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.

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

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Image /page/8/Picture/0 description: The image shows a logo for Edwards. The logo features a large, white letter 'E' set against a gray, grid-like background. Below the letter, the name 'Edwards' is written in a simple, sans-serif font.

### Intended Use: Note: There is no change to the Intended use from what was cleared in K201446 on October 1, 2020.

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 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. 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 | HemoSphere<br>Swan-Ganz<br>Module | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| 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 | | | |
| sEDVI | STAT right ventricular end<br>diastolic volume index | | | |
| HRavg | averaged heart rate | | | |
| LVSWI | left ventricular stroke work index | | | |
| 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 | | Adult and<br>Pediatric | |
| SVRI | systemic vascular resistance index | | | |
| iCO | intermittent cardiac output | | | |
| iCI | intermittent cardiac index | | | |
| iSVR | intermittent systemic vascular<br>resistance | | | |
| iSVRI | intermittent systemic vascular<br>resistance index | | | |

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Image /page/9/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in white, set against a gray square background with a grid pattern. The letter 'E' is partially overlaid with a circular design, giving it a modern and corporate look. Below the square, the name 'Edwards' is written in a simple, sans-serif font.

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<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| ScvO2 | Central Venous Oxygen<br>Saturation | | | |

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 | 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 |
| DO2I | Oxygen Delivery Indexed | | | |
| VO2 | Oxygen Consumption | | | |
| 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 | | | |
| DIAART | Systemic arterial diastolic blood<br>pressure | | | |
| DIAPAP | pulmonary artery diastolic blood<br>pressure | | | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| dP/dt | Systolic slope² | HemoSphere<br>Pressure<br>Cable | Adult only | |
| Eadyn | Dynamic Arterial Elastance² | | | |
| MAP | Mean Arterial Pressure | | | |
| MPAP | Mean Pulmonary Arterial Pressure | | | |
| PPV | pulse pressure variation¹ | | | |
| PRART | Pulse rate | | | |
| SV/<br>SVI | Stroke Volume¹/<br>Stroke Volume Index¹ | | | |

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Image /page/10/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in white, overlaid on a gray square with a grid pattern. The word "Edwards" is written in a simple, sans-serif font below the square.

| SVR/<br>SVRI | Systemic Vascular Resistance1/<br>Systemic Vascular Resistance1<br>Index | | |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|--|
| SVV | Stroke Volume Variation1 | | |
| SYS | Systolic Blood Pressure | | |
| HPI | Acumen Hypotension Prediction<br>Index | | |
| 1FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTrac feature is | | | |

enabled.

2 HPI 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<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|------------------------------------------------------------------------|---------------------------------------|-----------------------|--------------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | | Adult only | |
| VO2 | Oxygen Consumption | HemoSphere<br>Swan-Ganz<br>Module and | | 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 | HemoSphere<br>Oximetry<br>Cable | | |
| VO2Ie | Estimated Oxygen Consumption<br>Index when ScvO2 is being<br>monitored | | | |

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.

| Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment |
|-----------|-------------------------------|-----------------------------------------------------------|--------------------|-----------------------------------------------------|
| CO20s | 20-second cardiac output | HemoSphere Swan-Ganz module and HemoSphere pressure cable | | Operating room, intensive care unit, emergency room |
| CI20s | 20-second cardiac index | HemoSphere pressure cable | Adult only | |
| SV20s | 20-second stroke volume | | | |
| SVI20s | 20-second stroke volume index | | | |

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

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Image /page/11/Picture/0 description: The image shows the logo for Edwards. The logo consists of a large, stylized letter 'E' in white, set against a gray, grid-like background. Below the logo, the word 'Edwards' is written in a simple, sans-serif font.

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

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population<br>n | 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 | HemoSphere<br>ClearSight<br>Module | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| PR | Noninvasive Pulse rate | | | |
| SV/SVI | Stroke Volume/<br>Stroke Volume Index | | | |
| SVR/SVRI | Systemic Vascular Resistance<br>Systemic Vascular Resistance Index | | | |
| SVV | Stroke Volume Variation | | | |
| SYS | Systolic Blood Pressure | | | |

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 | | | |
| VO2 | Oxygen Consumption | HemoSphere<br>ClearSight<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit |
| 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 | | | |

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#### Comparison of Technological Characteristics with the Predicate Devices: VI.

| | The intended use, indications for use, instructions and technological characteristics of the modified device remain unchanged. The following section provides a summary of the modification. |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The purpose of this 510(k) submission is to introduce the following modification to the HemoSphere Advanced Monitoring Platform (Cleared in K201446 on October 1, 2020): |
| | Modification to the existing APCO algorithm of the HemoSphere ClearSight™ Module |
| | The existing HemoSphere ClearSight Module includes the APCO algorithm (Arterial pressure-based Cardiac Output) to calculate Cardiac Output and derived parameters. As a part of Edwards's continuous improvement efforts, a modification has been made to improve the existing bias in the currently cleared APCO algorithm. |
| Performance Data: | The following verification activities were performed to evaluate the modification being made as part of this submission. Pass/Fail criteria were based on the specifications cleared for the predicate devices, and test results showed substantial equivalence. |
| | There is no change in the electromagnetic compatibility, electrical safety, environmental (including Mechanical stress testing and Package Testing), and usability compared to the predicate. |
| | Algorithm Verification (Clinical Performance Data): |
| | Algorithm performance was tested using clinical data. The Cardiac Output accuracy of the modified algorithm testing was performed via retrospective analysis of clinical data from multiple independent datasets, comprised of data from patients over the age of 18 years. The results establish that the modification did not adversely affect the safety and effectiveness of the subject device. All testing passed without exception. |
| | 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". This verification included software design, development, and traceability. There were no changes to function, operation, or parameters monitored. Same methods, protocols, |

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and acceptance criteria as the predicate device (K201446) were used to evaluate the modification. All tests passed.

### System Verification (Non-clinical Performance):

System verification activities confirmed that the modification to the device did not adversely affect the safety and effectiveness of the subject device. and the change in the algorithm was integrated without any concern and all integration passed with no exceptions. The same methods, protocols, and acceptance criteria as the predicate device (K201446) were used to evaluate the modification. All tests passed.

Design, materials, energy source, user interface, measurement principle, and all performance specifications of the modified HemoSphere ClearSight Module remain unchanged.

### The clinical data demonstrate that the safety and effectiveness profile of Conclusions the subject device is substantially equivalent to the predicate device. The technological characteristics of the subject and predicate devices are identical. The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitoring Platform has successfully passed functional and performance testing, including software verification and validation, algorithm, validation and bench studies. The testing performed demonstrates that the HemoSphere Advanced Monitoring Platform with the subject modification of the HemoSphere ClearSight Module is substantially equivalent to the legally marketed predicate device.