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:

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

Device Description

HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).

AI/ML Overview

Acceptance Criteria and Device Performance for Edwards HemoSphere ClearSight Module

Based on the provided text, the Edwards HemoSphere ClearSight Module has undergone a modification to its existing APCO algorithm. The acceptance criteria and performance evaluation are related to ensuring this modification did not adversely affect the safety and effectiveness of the device, particularly concerning Cardiac Output accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Predicate Device Specifications: The modified algorithm's performance (specifically Cardiac Output accuracy) should meet the specifications cleared for the predicate device (Edwards HemoSphere Advanced Monitoring Platform, K201446).	"All testing passed without exception." The retrospective analysis of clinical data demonstrated that the modification did not adversely affect the safety and effectiveness of the subject device, and "All tests passed."
No Adverse Effect on Safety and Effectiveness: The modification should not negatively impact other aspects of the device's safety and effectiveness.	"System verification activities confirmed that the modification to the device did not adversely affect the safety and effectiveness of the subject device."
Software Verification: The software modification should comply with FDA guidance for software in medical devices, including design, development, and traceability.	"Software verification was performed per FDA's Guidance for Industry and FDA Staff... All tests passed."
System Verification: The algorithm change should be integrated without issues.	"the change in the algorithm was integrated without any concern and all integration passed with no exceptions."
Unchanged Design, Materials, Energy Source, User Interface, Measurement Principle, and Performance Specifications: These aspects of the HemoSphere ClearSight Module should remain the same.	"Design, materials, energy source, user interface, measurement principle, and all performance specifications of the modified HemoSphere ClearSight Module remain unchanged."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The text states that "retrospective analysis of clinical data from multiple independent datasets, comprised of data from patients over the age of 18 years" was used. However, a specific numerical sample size (e.g., number of patients or data points) is not provided in the document.
Data Provenance: The data was "retrospective analysis of clinical data from multiple independent datasets." The country of origin of the data is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The text does not describe how the "ground truth" for the clinical data used in the retrospective analysis was established, nor does it mention the use of experts for this purpose.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned or described in the document. This study focuses on an algorithm modification for a medical device (HemoSphere ClearSight Module) measuring physiological parameters, not on human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation of the algorithm was done. The "Algorithm Verification (Clinical Performance Data)" section specifically states: "Algorithm performance was tested using clinical data." This indicates an evaluation of the algorithm's performance independent of real-time human interaction.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The document refers to the evaluation of "Cardiac Output accuracy." For a device that measures physiological parameters like Cardiac Output, the "ground truth" would typically refer to a gold standard measurement technique for that parameter. However, the exact gold standard method used to establish the ground truth for Cardiac Output in the clinical data is not explicitly stated in the provided text. It implies the use of "clinical data" which would have reference measurements for comparison but does not detail the nature of these reference measurements.

8. The Sample Size for the Training Set

The document only mentions "retrospective analysis of clinical data" for testing the algorithm modification. It does not provide any information regarding a "training set" or its sample size. This suggests that the modification might have been made to an existing algorithm, and the focus of this submission is on verifying the impact of that modification using a test set, rather than developing a new algorithm from scratch requiring a separate training set.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned, this information is not provided in the document.

Summary

{0}------------------------------------------------

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

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.

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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:

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:

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:

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:

{3}------------------------------------------------

· 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:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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 LLCOne Edwards WayIrvine, CA 92614
EstablishmentRegistrationNumber:	2015691
Contact Person:	Varad RaghuwanshiManager, Regulatory AffairsOne Edwards WayIrvine, CA 92614Telephone: (949) 756-4502Fax: (949) 809-2972
Date Prepared:	October 8, 2022
II. Device Information:
Platform Name(Name of the Device)	HemoSphere Advanced Monitoring Platform
Trade Name:	HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableHemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE TissueOximeter ModuleHemoSphere ClearSight Module
Common Name:	Cardiac Output/Oximetry/Ejection Fraction Computer
ClassificationName:	Programmable Diagnostic ComputerFiberoptic Oximeter CatheterAdjunctive Predictive Cardiovascular IndicatorOximeter	21 CFR 870.142521 CFR 870.123021 CFR 870.221021 CFR 870.2700

Impedance plethysmograph

Noninvasive blood pressure measurement system 21 CFR 870.1130

21 CFR 870.2770

{5}------------------------------------------------

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.

{6}------------------------------------------------

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 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.

{7}------------------------------------------------

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

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

{8}------------------------------------------------

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-SystemModuleUsed	PatientPopulation	HospitalEnvironment
CO	continuous cardiac output	HemoSphereSwan-GanzModule	Adult only	OperatingRoom,IntensiveCare Unit,EmergencyRoom
sCO	STAT cardiac output
CI	continuous cardiac index
sCI	STAT cardiac index
EDV	right ventricular end diastolicvolume
sEDV	STAT right ventricular enddiastolic volume
EDVI	right ventricular end diastolicvolume index
sEDVI	STAT right ventricular enddiastolic volume index
HRavg	averaged heart rate
LVSWI	left ventricular stroke work index
PVR	pulmonary vascular resistance
PVRI	pulmonary vascular resistanceindex
RVEF	right ventricular ejection fraction
sRVEF	STAT right ventricular ejectionfraction
RVSWI	right ventricular stroke work index
SV	stroke volume
SVI	stroke volume index
SVR	systemic vascular resistance		Adult andPediatric
SVRI	systemic vascular resistance index
iCO	intermittent cardiac output
iCI	intermittent cardiac index
iSVR	intermittent systemic vascularresistance
iSVRI	intermittent systemic vascularresistance index

{9}------------------------------------------------

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-SystemModuleUsed	PatientPopulation	HospitalEnvironment
SvO2	Mixed Venous Oxygen Saturation	HemoSphereOximetryCable	Adult andPediatric	OperatingRoom,IntensiveCare Unit,EmergencyRoom
ScvO2	Central Venous OxygenSaturation

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-SystemModuleUsed	PatientPopulation	HospitalEnvironment
DO2	Oxygen Delivery	HemoSphereSwan-GanzModule andHemoSphereOximetryCable	Adult andPediatric	OperatingRoom,IntensiveCare Unit,EmergencyRoom
DO2I	Oxygen Delivery Indexed
VO2	Oxygen Consumption
VO2e	Estimated Oxygen Consumptionwhen ScvO2 is being monitored
VO2I	Oxygen Consumption Index
VO2Ie	Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored

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

Parameter	Description	Sub-SystemModuleUsed	PatientPopulation	HospitalEnvironment
CO/CI	Continuous Cardiac Output¹/Continuous Cardiac Index¹
CVP	Central Venous Pressure
DIAART	Systemic arterial diastolic bloodpressure
DIAPAP	pulmonary artery diastolic bloodpressure			OperatingRoom,IntensiveCare Unit,EmergencyRoom
dP/dt	Systolic slope²	HemoSpherePressureCable	Adult only
Eadyn	Dynamic Arterial Elastance²
MAP	Mean Arterial Pressure
MPAP	Mean Pulmonary Arterial Pressure
PPV	pulse pressure variation¹
PRART	Pulse rate
SV/SVI	Stroke Volume¹/Stroke Volume Index¹

{10}------------------------------------------------

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/SVRI	Systemic Vascular Resistance1/Systemic Vascular Resistance1Index
SVV	Stroke Volume Variation1
SYS	Systolic Blood Pressure
HPI	Acumen Hypotension PredictionIndex
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-SystemModuleUsed	PatientPopulation	HospitalEnvironment
DO2	Oxygen Delivery
DO2I	Oxygen Delivery Indexed		Adult only
VO2	Oxygen Consumption	HemoSphereSwan-GanzModule and		OperatingRoom,IntensiveCare Unit,EmergencyRoom
VO2e	Estimated Oxygen Consumptionwhen ScvO2 is being monitored
VO2I	Oxygen Consumption Index	HemoSphereOximetryCable
VO2Ie	Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored

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

{11}------------------------------------------------

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-SystemModule Used	PatientPopulation	HospitalEnvironment
StO2	Tissue oxygen saturation	HemoSphere TissueOximetry Moduleand Fore-Sight EliteModule	Adult andPediatric	OperatingRoom,Intensive CareUnit,EmergencyRoom

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-SystemModuleUsed	PatientPopulationn	HospitalEnvironment
CO/CI	Continuous Cardiac Output/Continuous Cardiac Index
DIA	Noninvasive arterial diastolic bloodpressure
MAP	Noninvasive Mean Arterial Pressure
PPV	pulse pressure variation	HemoSphereClearSightModule	Adult only	OperatingRoom,IntensiveCare Unit,EmergencyRoom
PR	Noninvasive Pulse rate
SV/SVI	Stroke Volume/Stroke Volume Index
SVR/SVRI	Systemic Vascular ResistanceSystemic 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-SystemModuleUsed	PatientPopulation	HospitalEnvironment
DO2	Oxygen Delivery
DO2I	Oxygen Delivery Indexed
VO2	Oxygen Consumption	HemoSphereClearSightModule andHemoSphereOximetryCable	Adult only	OperatingRoom,IntensiveCare Unit
VO2e	Estimated Oxygen Consumptionwhen ScvO2 is being monitored
VO2I	Oxygen Consumption Index
VO2Ie	Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the word "Edwards" in a serif font below a gray square. Inside the square is a large letter "E" in white. The letter "E" is overlaid with a circular grid pattern.

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,

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

Image /page/13/Picture/0 description: The image shows the 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 within it. Below the square grid, the word 'Edwards' is written in a serif font.

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.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
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.(b)
Classification. Class II (performance standards).