HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index

Q: Who is the manufacturer of HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

Edwards Lifesciences, LLC filed the 510(k) submission for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687).

Q: What is the FDA product code for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

510(k) clearance (submission type: Traditional).

Q: Does HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index use AI or machine learning?

Yes. HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index (K203687) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: What are the predicate devices for HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

HemoSphere Advanced Monitoring Platform (K201446); HemoSphere Advanced Monitoring Platform (K180881); Acumen Hypotension Prediction Index feature (DEN160044).

Q: Who can help prepare an FDA 510(k) submission like HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Q: Can an AI/ML device like HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K203687 · Edwards Lifesciences, LLC · DQK · May 28, 2021 · Cardiovascular

Device Facts

Record ID	K203687
Device Name	HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index
Applicant	Edwards Lifesciences, LLC
Product Code	DQK · Cardiovascular
Decision Date	May 28, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight Elite sensors, and ClearSight/Acumen IQ finger cuffs.

Device Story

HemoSphere Advanced Monitoring Platform is a modular hemodynamic monitoring system used in hospital critical care settings (OR, ICU, ER) by clinicians. It processes inputs from various sensors (Swan-Ganz catheters, oximetry cables, pressure cables, tissue oximetry modules, and ClearSight finger cuffs). The system reconstructs pressure waveforms from finger cuffs to radial or brachial arterial representations to calculate hemodynamic parameters (CO, CI, SV, SVI, MAP, etc.). The Acumen HPI feature uses a predictive algorithm to alert clinicians to potential future hypotensive events. Output is visualized on the HemoSphere monitor, providing quantitative physiological data to assist clinicians in hemodynamic optimization and goal-directed therapy. The device benefits patients by enabling continuous, real-time assessment of cardiac function, fluid status, and vascular resistance, facilitating timely clinical interventions.

Clinical Evidence

Clinical performance was verified using prospective analyses of retrospective clinical data from multiple independent datasets. Data included patients >18 years undergoing surgical procedures with both minimally invasive and non-invasive monitoring. Results demonstrated that the HPI algorithm performance with non-invasive technology is safe and effective, maintaining substantial equivalence to the predicate device. Bench testing and system-level verification confirmed all performance specifications were met.

Technological Characteristics

Modular platform consisting of a monitor and external modules (Swan-Ganz, Oximetry, Pressure, Tissue Oximetry, ClearSight). Uses volume clamp method (Peñáz) and generalized transfer function (Gizdulich) for non-invasive pressure reconstruction. Connectivity includes wired sensor inputs. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 62304, 62366-1, 60601-2-34, 60601-2-57, 60601-2-49, and 80601-2-49. Software is IEC 62304 compliant.

Indications for Use

Indicated for adult and pediatric critical care patients requiring monitoring of cardiac output, hemodynamic parameters, venous oxygen saturation, or tissue oxygen saturation in hospital environments. The Acumen Hypotension Prediction Index (HPI) feature is indicated for surgical patients receiving advanced hemodynamic monitoring to provide insight into the likelihood of future hypotensive events (MAP < 65 mmHg for ≥ 1 minute).

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)
HemoSphere Advanced Monitoring Platform (K180881)
Acumen Hypotension Prediction Index feature (DEN160044)

Related Devices

K201446 — HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module · Edwards Lifesiences, LLC · Oct 1, 2020
K221833 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module · Edwards Lifesciences, LLC · Nov 7, 2022
K231248 — Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform · Edwards Lifesciencess, LLC · Sep 21, 2023
K213682 — HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote · Edwards Lifesciences, LLC · Jun 22, 2022
K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module · Edwards Lifesciences, LLC · Aug 29, 2019

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 28, 2021 Edwards Lifesciences LLC Varad Raghuwanshi Sr. Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614 Re: K203687 Trade/Device Name: HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB Dated: April 23, 2021 Received: April 26, 2021 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. 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, for LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203687 Device Name HemoSphere Advanced Monitoring Platform Indications for Use (Describe) HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module: The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediativ critical care patients requiring of venous oxygen saturation (Sv02 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. {3}------------------------------------------------ # HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module: The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor. · When used with large 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 noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The Edwards Lifesciences Acumen Hypotension 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 ClearSight finger cuff and Acumen IO finger cuff indications 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ 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." {5}------------------------------------------------ # 510(k) Summary – HemoSphere Advanced Monitoring Platform #### I. Submitter: | Sponsor: | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 2015691 | | Contact Person: | Varad Raghuwanshi Sr. Specialist, Regulatory Affairs One Edwards Way Irvine, CA 92614 Telephone: (949) 756-4502 Fax: (949) 809-2972 | | Date Prepared: | May 26, 2021 | | II. Device Information: | | | Platform Name (Name of the Device) | HemoSphere Advanced Monitoring Platform | | Trade Name: | HemoSphere Advanced Monitor HemoSphere Swan-Ganz Module HemoSphere Oximetry Cable HemoSphere Pressure Cable Acumen Hypotension Prediction Index (HPI) feature Invasive and Non-Invasive technology HemoSphere Tissue Oximetry Module HemoSphere ClearSight Module | | Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | Classification Name: | Programmable Diagnostic Computer Fiberoptic Oximeter Catheter | Adjunctive Predictive Cardiovascular Indicator 21 CFR 870.2210 Oximeter 21 CFR 870.2700 Noninvasive blood pressure measurement system 21 CFR 870.1130 Impedance plethysmograph 21 CFR 870.2770 feature for Minimally 21 CFR 870.1425 21 CFR 870.1230 {6}------------------------------------------------ | Product Code and Regulatory Class: | | |------------------------------------------|----------| | DQK | Class II | | DQE | Class II | | QAQ | Class II | | MUD | Class I | | DXN | Class II | | DSB | Class II | #### III. Predicate Device | Primary Predicate Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards Lifesciences, K201446 cleared October 1, 2020. | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Additional Predicate Devices: | HemoSphere Advanced Monitoring Platform by Edwards Lifesciences, K180881 cleared November 16, 2018, utilized for the Acumen Hypotension Prediction Index software feature. | | | Acumen Hypotension Prediction Index feature by Edwards Lifesciences DEN160044, granted March 16, 2018 utilized for the Acumen Hypotension Prediction Index software feature. | #### IV. Device Description | 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). | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The HemoSphere Advanced Monitor with HemoSphere ClearSight module is a non-invasive monitoring platform intended to continuously and noninvasively measure blood pressure and associated hemodynamic parameters. | | | The HemoSphere Advanced Monitoring Platform when used with ClearSight Module uses the same technology as the predicate device. The volume clamp method of Peñáz is the measurement method, and the pressure waveform reconstruction is based on the generalized transfer function and level of correction of Gizdulich. | {7}------------------------------------------------ The platform also includes the Acumen Hypotension Prediction Index (HPI) feature for the ClearSight (non-invasive) technology. Currently, the HemoSphere Pressure Cable enables the HPI feature when connected to an Acumen IQ sensor. This feature has been updated to also enable the HPI feature when connected to the Acumen IQ finger cuff (ClearSight finger cuff). The modified ClearSight System receives the pressure signal from the finger cuff and reconstructs it to a radial arterial pressure representation of the signal. This radial reconstructed signal is then used to calculate the previously available key hemodynamic parameters; PR, MAP, SYS, DIA, PPV and SVV. Additionally, the radial reconstructed signal is also used to calculate the parameters associated with the Hypotension Prediction Index feature (HPI, Eadyn, and dP/dt). The cardiac output (CO) and other measurements derived from cardiac output, such as stroke volume (SV), cardiac output index (CI), stroke volume index (SVI) remain unchanged and will continue to use previously cleared ClearSight algorithm to reconstruct the finger pressure waveform into a brachial arterial pressure waveform. | Model Number | Associated Accessories | |--------------|-------------------------------| | PC2 | Pressure controller | | EVHRS | Heart Reference Sensor | | CSCS | ClearSight Finger Cuff Small | | CSCM | ClearSight Finger Cuff Medium | | CSCL | ClearSight Finger Cuff Large | | CSC2S | ClearSight Finger Cuff Small | | CSC2M | ClearSight Finger Cuff Medium | | CSC2L | ClearSight Finger Cuff Large | | AIQCS | Acumen IQ Finger Cuff Small | | AIQCM | Acumen IQ Finger Cuff Medium | | AIQCL | Acumen IQ Finger Cuff Large | | HEMBAT10 | HemoSphere Battery Pack | | HEMRLSTD1000 | HemoSphere Roll Stand | The associated accessories include: {8}------------------------------------------------ #### V. Indications for Use: Note: The Indication for Use statements are identical for all the previously cleared technologies (K201446 Cleared October 1, 2020) with the exception of the addition of the indication for Acumen Hypotension Predication Index (HPI) for the non-invasive (ClearSight) technology. # HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population. ## HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric 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 {9}------------------------------------------------ #### K203687 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. # 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. {10}------------------------------------------------ # HemoSphere Advanced Monitor with HemoSphere ClearSight Module Note: There is no change to the ClearSight indication from what was cleared in K201446 October 1, 2020 with the exception of the addition of Acumen Hypotension Index (HPI) indication for non-invasive technology. The Acumen HPI indication for non-invasive technology is identical to the predicate K180881 (Cleared November 16, 2018). 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. 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 ClearSight and Acumen IQ 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 hospital setting. > The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight Elite sensors, and ClearSight/Acumen IQ finger cuffs. {11}------------------------------------------------ A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below in table 1-1. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population. | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------|-----------------------------------|------------------------|--------------------------------------------------------------------| | CO | continuous cardiac output | | Adult only | Operating Room, Intensive Care Unit, Emergency Room | | sCO | STAT cardiac output | | | | | CI | continuous cardiac index | | | | | sCI | STAT cardiac index | | | | | EDV | right ventricular end diastolic volume | | | | | sEDV | STAT right ventricular end diastolic volume | | | | | EDVI | right ventricular end diastolic volume index | | | | | sEDVI | STAT right ventricular end diastolic volume index | | | | | HRavg | averaged heart rate | | | | | LVSWI | left ventricular stroke work index | | | | | PVR | pulmonary vascular resistance | HemoSphere Swan-Ganz Module | | | | PVRI | pulmonary vascular resistance index | | | | | RVEF | right ventricular ejection fraction | | | | | sRVEF | STAT right ventricular ejection fraction | | | | | RVSWI | right ventricular stroke work index | | | | | SV | stroke volume | | | | | SVI | stroke volume index | | | | | SVR | systemic vascular resistance | | Adult and Pediatric | | | SVRI | systemic vascular resistance index | | | | | iCO | intermittent cardiac output | | | | | iCI | intermittent cardiac index | | | | | iSVR | intermittent systemic vascular resistance | | | | | iSVRI | intermittent systemic vascular resistance index | | | | A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere oximetry cable are as listed below: | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|-------------------------------------|---------------------------------|------------------------|-----------------------------------------------| | SvO2 | Mixed Venous Oxygen Saturation | HemoSphere Oximetry Cable | Adult and Pediatric | Operating Room, Intensive Care Unit, | | ScvO2 | Central Venous Oxygen Saturation | | | Emergency Room | {12}------------------------------------------------ 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 Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------| | DO2 | Oxygen Delivery | | | | | DO2I | Oxygen Delivery Indexed | | Adult and Pediatric | Operating Room, Intensive Care Unit, Emergency Room | | VO2 | Oxygen Consumption | HemoSphere Swan-Ganz Module and HemoSphere Oximetry Cable | | | | VO2e | Estimated Oxygen Consumption when ScvO2 is being monitored | | | | | VO2I | Oxygen Consumption Index | | | | | VO2Ie | Estimated Oxygen Consumption Index when ScvO2 is being 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 Module Used | Patient Population | Hospital Environment | |-------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|---------------------------------|-----------------------|--------------------------------------------------------------------| | CO/ CI | Continuous Cardiac Output1/ Continuous Cardiac Index1 | | | | | CVP | Central Venous Pressure | | | | | DIAART | Systemic arterial diastolic blood pressure | | | | | DIAPAP | pulmonary artery diastolic blood pressure | | | | | dP/dt | Systolic slope2 | | | | | Eadyn | Dynamic Arterial Elastance2 | | | Operating Room, Intensive Care Unit, Emergency Room | | MAP | Mean Arterial Pressure | HemoSphere Pressure Cable | Adult only | | | MPAP | Mean Pulmonary Arterial Pressure | | | | | PPV | pulse pressure variation1 | | | | | PRART | Pulse rate | | | | | SV/ SVI | Stroke Volume1/ Stroke Volume Index1 | | | | | SVR/ SVRI | Systemic Vascular Resistance1/ Systemic Vascular Resistance1 Index | | | | | SVV | Stroke Volume Variation1 | | | | | SYS | Systolic Blood Pressure | | | | | HPI | Acumen Hypotension Prediction Index | | | | | 1FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTrac feature is enabled. | | | | | | 2HPI parameters are available when using an Acumen IQ sensor and if the HPI feature is activated. | | | | | {13}------------------------------------------------ ### K203687 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 Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------------------------|---------------------------------------|-----------------------|--------------------------------------------------------------------| | DO2 | Oxygen Delivery | | | | | DO2I | Oxygen Delivery Indexed | | Adult only | Operating Room, Intensive Care Unit, Emergency Room | | VO2 | Oxygen Consumption | | | | | VO2e | Estimated Oxygen Consumption when ScvO2 is being monitored | HemoSphere Swan-Ganz Module and | | | | VO2I | Oxygen Consumption Index | HemoSphere Oximetry Cable | | | | VO2Ie | Estimated Oxygen Consumption Index when ScvO2 is being 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 | | 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 Operators Manual for specific information on the intended use environment and patient population. | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|--------------------------|------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------| | StO2 | Tissue oxygen saturation | HemoSphere Tissue Oximetry Module and Fore-Sight Elite Module | Adult and Pediatric | Operating Room, Intensive Care Unit, Emergency Room | {14}------------------------------------------------ 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 Module Used | Patient Population | Hospital Environment | |-------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------|-----------------------|--------------------------------------------------------------------| | CO/CI | Continuous Cardiac Output/ Continuous Cardiac Index | | | | | DIA | Noninvasive arterial diastolic blood pressure | | | | | MAP | Noninvasive Mean Arterial Pressure | | | Operating Room, Intensive Care Unit, Emergency Room | | PPV | pulse pressure variation | | | | | PR | Noninvasive Pulse rate | | | | | SV/SVI | Stroke Volume/ Stroke Volume Index | HemoSphere ClearSight Module | Adult only | | | SVR/SVRI | Systemic Vascular Resistance/ Systemic Vascular Resistance Index | | | | | SVV | Stroke Volume Variation | | | | | SYS | Systolic Blood Pressure | | | | | dP/dt | Maximal slope of the arterial pressure upstroke1 | | | | | Eadyn | Dynamic Arterial Elastance1 | | | | | HPI | Acumen Hypotension Prediction Index1 | | | Operating Room only | | 1HPI parameters are available when using an Acumen IQ cuff and if the HPI feature is activated. | | | | | | Note: CO/CI and SV/SVI are measured using a reconstructed brachial arterial waveform. All other | | | | | monitored parameters use a reconstructed radial arterial waveform. SVR/SVRI are derived from CO/CI and MAP along with an entered or monitored CVP value. 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 Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------|----------------------------------------------| | DO2 | Oxygen Delivery | | | | | DO2I | Oxygen Delivery Indexed | | | | | VO2 | Oxygen Consumption | HemoSphere ClearSight Module and HemoSphere Oximetry Cable | Adult only | Operating Room, Intensive Care Unit | | VO2e | Estimated Oxygen Consumption when ScvO2 is being monitored | | | | | VO2I | Oxygen Consumption Index | | | | | VO2Ie | Estimated Oxygen Consumption Index when ScvO2 is being monitored | | | | {15}------------------------------------------------ #### VI. Comparison of Technological Characteristics with the Predicate Devices: The existing HemoSphere Advanced Monitoring Platform which is the primary predicate for this submission consists of: - I HemoSphere Advanced Monitor - HemoSphere Swan-Ganz Module - HemoSphere Oximetry Cable - HemoSphere Pressure Cable - 트 Acumen Hypotension Prediction Index (use with Minimally invasive technology only) - HemoSphere Tissue Oximetry Module ■ - HemoSphere ClearSight Module The subject and predicate devices are based on the following same technological elements: - Platform: The subject device uses the same platform as the predicate (K201446 cleared October 1, 2020). - . Non-Invasive technology: The subject and predicate (K201446 cleared October 1, 2020) are non-invasive blood pressure measurement systems and use the same method of measurement. - . Graphical User Interface: The subject and predicate (K201446 cleared October 1, 2020) have the same Graphical User Interface (GUI) - . Predictive Algorithm: The subject and predicate (initially cleared in DEN160044 and later cleared in K180881 for HemoSphere Advanced monitoring Platform) have the same core predictive algorithm for Acumen Hypotension Predication Index. - Accessories/Components: The subject and the predicate (K201446 cleared October 1, 2020) device both use previously cleared Pressure controller, Heart Reference Sensor and ClearSight Cuffs for measurement of noninvasive parameters. The following technological differences exist between the subject and predicate devices: {16}------------------------------------------------ - I ClearSight Algorithm update: The currently cleared ClearSight algorithm (K201446) has been modified such that the non-invasive pressure signal acquired from the finger cuff is reconstructed using the subject modified algorithm to a radial arterial pressure representation of the signal instead of a brachial arterial representation as cleared in K201446 on October 1, 2020. This radial reconstructed signal is used to calculate the previously available key hemodynamic parameters; PR, MAP, SYS, DIA, PPV and SVV. Additionally, the radial reconstructed signal is also used to calculate the parameters associated with the Hypotension Prediction Index feature (HPI, Eadyn, and dP/dt). The cardiac output (CO) and other measurements derived from cardiac output, such as stroke volume (SV), cardiac output index (CI), stroke volume index (SVI) remain unchanged and will continue to use previously cleared ClearSight algorithm to reconstruct the finger pressure waveform into a brachial arterial pressure waveform The purpose of this 510(k) submission is to introduce the following modifications to the HemoSphere Advanced Monitoring Platform (K201446 on October 1, 2020): - & Modifications to existing features/algorithm of the HemoSphere Advanced Monitoring Platform (previously cleared in K201446 on October 1, 2020): - 트 Algorithm Modification: Update to the existing ClearSight™ Algorithm The existing ClearSight algorithm receives the pressure signal from the finger cuff and reconstructs it to a brachial arterial pressure representation of the signal. This reconstructed signal is then used to calculate Cardiac Output along with the other derived parameters for Cardiac Output (CO), Pulse Rate (PR), Mean Arterial Blood Pressure (MAP), Systolic Blood Pressure (SYS), Diastolic Blood Pressure (DIA) Blood Pressure, Pulse Pressure Variation (PPV) and Stroke Volume Variation (SVV) and to derive additional hemodynamic parameters (CI, SV, SVI, SVR and SVRI) from the calculated parameters. {17}------------------------------------------------ The modified ClearSight algorithm receives the pressure signal from the finger cuff and reconstructs it to a radial arterial pressure representation of the signal. This radial reconstructed signal is then used to calculate the currently available key hemodynamic parameters PR, MAP, SYS, DIA, PPV and SVV. Additionally, the radial reconstructed signal is also used to calculate the parameters associated with the Hypotension Prediction Index (HPI) feature (HPI, Eadyn, and dP/dt) as further detailed below. The cardiac output (CO) and other measurements derived from cardiac output, such as stroke volume (SV), cardiac output index (CI), stroke volume index (SVI) remain unchanged and will continue to use previously cleared ClearSight algorithm to reconstruct the finger pressure waveform into a brachial arterial pressure waveform. - 트 Acumen Hypotension Prediction Index (HPI) feature for Non-invasive technology: Currently, the HemoSphere Pressure Cable enables the Acumen Hypotension Prediction Index (HPI) feature when connected to an Acumen IQ sensor (K180881 Cleared, November 16, 2018). This feature has been modified to now recognize the Acumen IQ finger cuff for non-invasive (ClearSight) technology when using HPI. HPI cannot be used without either an Acumen IQ sensor (minimally invasive technology) or Acumen IQ finger cuff (non-invasive technology). No modifications to the core predictive HPI algorithm have been made from the granted version in DEN160044 (granted March 16, 2018). The HPI algorithm processes the non-invasive radial arterial pressure waveform identically to the previously cleared minimally invasive radial arterial pressure waveform. | Performance Data: | * Modifications to the labelling of the HemoSphere Advanced Monitoring Platform (K201446, cleared October 1, 2020): | | | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | | ■ Indication expansion and additions to accommodate the expanded functionality for non-invasive HPI and modified ClearSight algorithm: | | | | | The HemoSphere Advanced Monitoring Platform Operator's Manual is being updated to include the expanded indications for use for non-invasive (ClearSight) HPI for surgical patients. Additions are also being made to support the usage and | | | {18}------------------------------------------------ expanded functionality of the non-invasive Acumen HPI when using the non-invasive ClearSight technology. The following verification and validation activities were performed in support of a substantial equivalence determination for the modifications being made as part of this submission. # Usability Study Usability study was conducted per FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices" to investigate primary operating functions and critical tasks of the system for any usability issues regarding the HemoSphere Advanced Monitoring Platform that may lead to patient or user harm. A total of 30 participants were included. There were two user groups; a minimum of 15 participants from each user group was included in testing. The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm. #### System Verification (Non-Clinical Performance): Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device. Measured and derived parameters were tested using a bench simulation. Additionally, individual modules were tested at a system level to verify the safety of these modules. They were also integrated as a system and verified for their safety and effectiveness. All tests passed. ### Electrical Safety and Electromagnetic Compatibility (EMC) Electrical safety and EMC testing were conducted on the subject HemoSphere Advanced Monitoring Platform, consisting of the HemoSphere Monitor, the ClearSight Module, Pressure Controller, Heart Reference and finger cuff. The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8. IEC 62304, IEC 62366-1, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49 and IEC 80601-2-49. All tests passed. {19}------------------------------------------------ # Wireless Coexistence Testing Bench and simulated environment testing were performed on the entire HemoSphere Advanced Monitoring Platform, including all sub-system modules and interfacing analog inputs and outputs. All tests passed. # Software Verification Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Software on each of the individual modules was tested at a sub-system level to ensure the safety of the device. All tests passed. # Algorithm Verification (Clinical Performance Data): Algorithm performance was tested using clinical data. The results establish that the usage of the HPI algorithm with non-invasive technology did not adversely affect the safety and effectiveness of the subject device. # Clinical Performance Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from patients over the age of 18 years undergoing surgical procedures with both minimally invasive and non-invasive monitoring, were analyzed to verify the safety and performance of the subject device. #### Conclusions The clinical data demonstrate that the safety and effectiveness profile of the subject device is substantially equivalent to the predicate device. The technological characteristics of the subject and predicate devices are similar, and the differences do not raise any concerns of safety and effectiveness of the subject device. 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, clinical validation and bench studies. The testing performed demonstrates that the HemoSphere Advanced Monitoring Platform with the subject modifications and expanded indications for use of the HemoSphere ClearSight Module is substantially equivalent to the legally marketed predicates.