HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform

K211465 · Edwards Lfesciences · DQK · Jul 8, 2021 · Cardiovascular

Device Facts

• Record ID: K211465
• Device Name: HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform
• Applicant: Edwards Lfesciences
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 8, 2021
• 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 HemoSphere Advanced Monitoring Platform can be used with the Viewfinder Remote mobile application for supplemental near real-time remote display of tissue oximetry and non-invasive hemodynamic parameter data monitored with a FORE-SIGHT ELITE oximeter module and HemoSphere ClearSight Module, respectively. The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters and FloTrac, Acumen IQ, TruWave DPT sensors and ClearSight cuffs.

Device Story

HemoSphere Advanced Monitoring Platform processes hemodynamic and volumetric data from connected modules (Swan-Ganz, Oximetry, Pressure, Tissue Oximetry, ClearSight). System transforms sensor inputs into real-time hemodynamic parameters, waveforms, and physiological alarms. Viewfinder Remote mobile application enables supplemental near-real-time remote display of non-invasive data and alarms via Viewfinder Hub and Cloud. Used in hospital settings (OR, ICU, ER) by clinicians; provides supportive visual aid for patient status communication. Output allows clinicians to monitor multiple patients simultaneously; assists in hemodynamic optimization and goal-directed therapy protocols. Benefits include improved situational awareness and remote access to patient status.

Clinical Evidence

No clinical data was required for this submission. Performance was established through bench testing, system verification, electrical safety/EMC testing (IEC 60601 series), wireless coexistence testing (ANSI C63.27), and usability studies.

Technological Characteristics

Modular hemodynamic monitoring platform. Components: HemoSphere Advanced Monitor, Swan-Ganz/Oximetry/Pressure/Tissue Oximetry/ClearSight modules. Connectivity: Wireless streaming to mobile application via Viewfinder Hub/Cloud. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34, IEC 60601-2-49. Software: Major level of concern for monitor, moderate for mobile app.

Indications for Use

Indicated for adult and pediatric critical care patients requiring monitoring of cardiac output, hemodynamic parameters, venous oxygen saturation, or regional hemoglobin oxygen saturation. Used in hospital environments (OR, ICU, ER) for continuous assessment of cardiac function, fluid status, vascular resistance, and pressure. Acumen HPI feature indicated for surgical or non-surgical patients receiving advanced hemodynamic monitoring to provide insight into likelihood of future hypotensive events (MAP < 65 mmHg). Fore-Sight Elite module indicated for individuals at risk for reduced-flow or no-flow ischemic states.

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 (K201446)

Reference Devices

• HemoSphere Swan-Ganz Module (K163381)
• HemoSphere Oximetry Cable (K163381)
• HemoSphere Pressure Cable (K180881)
• HemoSphere Tissue Oximetry Module (K190205)
• HemoSphere ForeSight Module (K180003)
• HemoSphere ClearSight Module (K201446)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 8, 2021

Edwards Lfesciences Chirag Shah Manager, Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K211465

Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module, HemoSphere ForeSight Module, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index Feature, Viewfinder Remote Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB Dated: May 10, 2021 Received: May 11, 2021

Dear Chirag Shah:

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

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

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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.

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)

K211465

#### Device Name

HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module, HemoSphere ClearSight Module, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index, Viewfinder Remote

#### 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 is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and SevO2) 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 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 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.

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HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter 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, the Fore-Sight Elite tissue oximeter module is indicated for use on adults and transitional adolescents ≥40 kg.

· When used with medium sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on pediatric subjects >3 kg.

· When used with small sensors, the Fore-Sight Elite tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.

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

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.

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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| Sponsor: | Edwards Lifesciences LLC<br>One Edwards Way<br>Irvine, CA 92614 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration<br>Number: | 2015691 |
| Contact Person: | Chirag Shah<br>Manager, Regulatory Affairs<br>One Edwards Way<br>Irvine, CA 92614<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 1, 2021 |
| Platform Name | 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<br>HemoSphere ForeSight Module<br>HemoSphere ClearSight Module<br>Acumen Hypotension Prediction Index feature<br>Viewfinder Remote |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification<br>Name: | Programmable Diagnostic Computer<br>21 CFR 870.1425<br>Fiberoptic Oximeter Catheter<br>21 CFR 870.1230<br>Adjunctive Predictive Cardiovascular Indicator<br>21 CFR 870.2210<br>Oximeter<br>21 CFR 870.2700<br>Oximeter, Tissue Saturation<br>21 CFR 870.1130<br>System, Measurement, Blood-Pressure, Non-Invasive<br>21 CFR 870.2770<br>Plethysmograph, Impedance |

# 510(k) Summary – HemoSphere Advanced Monitoring Platform

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| Product Code: | DQK, Class II<br>DQE, Class II<br>QAQ, Class II<br>MUD, Class II<br>DSB, Class II<br>DXN, Class II |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary<br>Predicate<br>Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards<br>Lifesciences, K201446, cleared October 1, 2020. |
| Device<br>Description: | The HemoSphere Advanced Monitoring platform was designed to simplify<br>the customer experience by providing one platform with modular solutions<br>for their hemodynamic monitoring needs. The user can choose from the<br>available optional sub-system modules or use multiple sub-system modules<br>at the same time. This modular approach provides the customer with the<br>choice of purchasing and/or using specific monitoring applications based on<br>their needs. Users are not required to have all of the modules installed at the<br>same time for the platform to function.<br><br>HemoSphere Advanced Monitoring Platform consists of the HemoSphere<br>Advanced Monitor that provides a means to interact with and visualize<br>hemodynamic and volumetric data on a screen and five (5) optional external<br>modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April<br>14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14,<br>2017), HemoSphere Pressure Cable (K180881 Cleared, November 16,<br>2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019),<br>HemoSphere ForeSight Module (K180003, May 10, 2018), and the<br>HemoSphere ClearSight Module (K201446 cleared October 1, 2020).<br><br>The HemoSphere Advanced Monitor (K201446 most recently cleared<br>October 1, 2020), subject of this submission, is being modified to enable<br>connectivity to a Viewfinder Remote mobile application via a software-<br>based Viewfinder Hub and Viewfinder Cloud.<br><br>The Viewfinder Remote mobile application provides clinicians with a<br>supplemental near-real time display of the patient hemodynamic data from<br>the connected HemoSphere Advanced Monitoring Platform. The<br>Viewfinder Remote application is part of the Edwards Viewfinder network,<br>which includes Viewfinder Hub and Viewfinder Cloud. The Viewfinder<br>Remote mobile application functions as a supportive visual aid for patient<br>status communication between clinicians and allows them to view multiple<br>patient monitoring sessions at once from their mobile device. The near-real<br>time updates to patient monitoring sessions includes non-invasive<br>hemodynamic parameter data and the associated physiological alarm<br>notifications, historical trend data and parameter waveform data. |

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#### Indications for HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module The HemoSphere Advanced Monitor when used with the HemoSphere Use: 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. When used in conjunction with a HemoSphere Pressure Cable, CO20s, CI20s, SV20s and SVI20s can be monitored. Use of HemoSphere Swan-Ganz Module in conjunction with HemoSphere Pressure Cable is restricted to adult patients only. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.

Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.

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 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

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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 ForeSight Module and 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 sensor 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.

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: The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a

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hospital setting. The HemoSphere Advanced Monitoring Platform can be used with the Viewfinder Remote mobile application for supplemental near real-time remote display of tissue oximetry and non-invasive hemodynamic parameter data monitored with a FORE-SIGHT ELITE oximeter module and HemoSphere ClearSight Module, respectively.

The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters and FloTrac, Acumen IQ, TruWave DPT sensors and ClearSight 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.

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

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

A comprehensive list of additional parameters that are available for adult and pediatric patient populations on the HemoSphere Advanced Monitor and a connected HemoSphere Swan-Ganz Module and a connected HemoSphere Oximetry Cable are as listed below:

| Parameter | Description | Sub-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:

| 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 | | | |
| DIA | Systemic arterial diastolic blood<br>pressure | | | |
| DIAPAP | pulmonary artery diastolic blood<br>pressure | | | |
| dP/dt | Systolic slope² | | | |
| Eadyn | Dynamic Arterial Elastance² | | | Operating<br>Room,<br>Intensive |
| MAP | Mean Arterial Pressure | | | |
| MPAP | Mean Pulmonary Arterial¹ Pressure | HemoSphere<br>Pressure<br>Cable | Adult only | |
| PPV | pulse pressure variation¹ | | | Care Unit,<br>Emergency<br>Room |
| PRART | Pulse rate | | | |
| SV/<br>SVI | Stroke Volume¹/<br>Stroke Volume Index¹ | | | |
| 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<br>feature is enabled. | | | | |
| ²HPI parameters are available when using an Acumen IQ sensor and if the HPI feature is activated. | | | | |

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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 | HemoSphere<br>Swan-Ganz<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| 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 while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz Module and pressure cable are listed below:

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|-------------------------------|------------------------------|-----------------------|--------------------------------------------------------------------|
| CO20s | 20-second cardiac output | HemoSphere | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit,<br>Emergency<br>Room |
| CI20s | 20-second cardiac index | Swan-Ganz | | |
| SV20s | 20-second stroke volume | Module and<br>HemoSphere | | |
| SVI20s | 20-second stroke volume index | Oximetry<br>Cable | | |

A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Tissue Oximetry Module, and HemoSphere ForeSight Module are listed below.

| Parameter | Description | Sub-System<br>Module<br>Used | Patient<br>Population | Hospital<br>Environment |
|-----------|---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------|
| StO2 | Absolute regional hemoglobin<br>oxygen saturation of blood under<br>the sensors | HemoSphere<br>ForeSight<br>Module and<br>HemoSphere<br>Tissue<br>Oximetry<br>Module | Adult and<br>Pediatric | Operating<br>Room,<br>Intensive<br>Care 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 | Hospital<br>Environment |
|-----------|--------------------------------------------------------|------------------------------------|-----------------------|-------------------------|
| CO/CI | Continuous Cardiac Output/<br>Continuous Cardiac Index | | | Operating<br>Room, |
| DIA | noninvasive arterial diastolic blood<br>pressure | HemoSphere<br>ClearSight<br>Module | Adult<br>only | Intensive Care<br>Unit, |
| MAP | Noninvasive Mean Arterial Pressure | | | Emergency<br>Room |
| PPV | pulse pressure variation | | | |

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| PR | Noninvasive Pulse rate |
|------|------------------------------------|
| SV/ | Stroke Volume/ |
| SVI | Stroke Volume Index |
| SVR/ | Systemic Vascular Resistance |
| SVRI | 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 | HemoSphere<br>ClearSight<br>Module and<br>HemoSphere<br>Oximetry<br>Cable | Adult only | Operating<br>Room,<br>Intensive<br>Care Unit |
| 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 | | | |

#### Intended use - Viewfinder Remote:

Viewfinder Remote is a mobile application which provides supplemental remote near real-time display of non-invasive hemodynamic parameters measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.

| Comparison to<br>Predicate<br>Device: | The existing HemoSphere Advanced Monitoring Platform (K201446,<br>cleared October 1, 2020) consists of: |
|---------------------------------------|---------------------------------------------------------------------------------------------------------|
| • | HemoSphere Advanced Monitor |
| • | HemoSphere Swan-Ganz Module |
| • | HemoSphere Oximetry Cable |
| • | HemoSphere Pressure Cable |
| • | HemoSphere Tissue Oximetry Module |

- HemoSphere ForeSight Module ● ● HemoSphere ClearSight Module
- Acumen Hypotension Prediction Index feature (when used with Acumen IQ sensor only)

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As part of its connectivity development program, Edwards has modified the HemoSphere Advanced Monitor (subject of this 510(k)) to allow it to wirelessly stream continuously monitored non-invasive hemodynamic parameter data to the Viewfinder Remote (subject of this 510(k)), a mobile device-based application, for remote viewing of the information.

As a connected device, cybersecurity modifications have been implemented on the HemoSphere Advanced Monitor. Additionally, workflow-based updates to support the functionality of remote viewing, including the ability to end a session, provide additional metadata support, as well as multiple setup wizards for initial configuration have been made. The following predicate is used to establish substantial equivalence:

- Primary Predicate: HemoSphere Advanced Monitor (K201446, cleared October 1, 2020) utilized for substantial equivalence to the HemoSphere Advanced Monitor in terms of the graphical user interface (GUI) used, wireless module incorporated, device modularity and basic device functionality. Modifications are being made to the HemoSphere Advanced Monitor to add the capability for it to remotely connect to the Viewfinder Remote mobile application.
Per FDA's guidance, "Medical Device Accessories – Describing Accessories and Classification Pathways" the remote view application (Viewfinder Remote) is considered an accessory to the HemoSphere Advanced Monitor since it augments the performance of the HemoSphere Advanced Monitor by allowing convenience of use (remote display of noninvasive hemodynamic parameters, alarms and alerts) of the device. Hence, the primary predicate for this application is the HemoSphere Advanced Monitor (K201446, cleared October 1, 2020).

Verification and validation testing were performed to compare the performance and functionality of the HemoSphere Advanced Monitoring Platform to its predicate device. Testing included a side-by-side comparison of the output parameters using a bench test.

| Performance<br>Data (Bench<br>and/or Clinical): | The following verification activities were performed in support of a<br>substantial equivalence determination for the modifications being made as<br>part of this submission. |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

## System Verification

End-to-end system verification was performed to ensure data integrity and accuracy from the Monitor to the Remote View mobile application. All tests passed.

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## Electrical Safety and Electromagnetic Compatibility (EMC)

The HemoSphere Advanced Monitor and all its connected modules/cables were tested to the following standards: IEC 60601-1. IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49. All tests passed.

## Wireless Coexistence Testing

ANSI C63.27/D1.0, bench and simulated environment testing were performed on the entire HemoSphere Advanced Monitoring Platform. including all sub-system modules and its interfacing analog inputs and outputs and the wirelessly connected Viewfinder Remote mobile application running on a mobile device. All tests passed.

## Software Verification

The HemoSphere Advanced Monitor is considered as software of Major Level of Concern. The Viewfinder Remote mobile application is considered as software of Moderate Level of Concern.

Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed.

## Usability Study

A usability study was performed for the HemoSphere Advanced Monitoring Platform and Viewfinder Remote in accordance with FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices". All tests Passed.

## Clinical Performance

Clinical data was not required for this device or the modifications being made to the device.

#### Non-Clinical Performance Conclusions:

Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device.

#### Conclusions Overall Conclusion:

The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitor and the Viewfinder Remote mobile application are substantially equivalent to their legally marketed predicates.