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

Q: Who is the manufacturer of 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 filed the 510(k) submission for 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 (K213682).

Q: What is the FDA product code for 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?

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 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?

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

Q: Does 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 use AI or machine learning?

Yes. 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 (K213682) 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 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?

HemoSphere Advanced Monitoring Platform (K203687); FORE-SIGHT ELITE Tissue Oximeter Module (K190270); Acumen Assisted Fluid Management (AFM) feature on EV1000A Clinical Platform (DEN190029); HemoSphere Advanced Monitoring Platform (K211465).

Q: Who can help prepare an FDA 510(k) submission like 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?

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 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 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.

K213682 · Edwards Lifesciences, LLC · DQK · Jun 22, 2022 · Cardiovascular

Device Facts

Record ID	K213682
Device Name	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
Applicant	Edwards Lifesciences, LLC
Product Code	DQK · Cardiovascular
Decision Date	Jun 22, 2022
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 Advanced Viewfinder Remote mobile application can be used for supplemental near real-time remote display of monitored hemodynamic parameter data as well as Faults, Alerts and Notifications generated by the HemoSphere Advanced Monitoring Platform. The HemoSphere Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPT sensors, ForeSight 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, finger cuffs, ForeSight sensors) to calculate and display hemodynamic parameters (CO, CI, SV, SVR, SvO2, ScvO2, StO2, blood pressure). The system includes software features: Acumen Hypotension Prediction Index (HPI) for predicting hypotensive events (MAP < 65 mmHg) and Acumen Assisted Fluid Management (AFM) for fluid responsiveness suggestions. Data is visualized on the monitor and can be streamed to the Viewfinder Remote mobile application for remote viewing. The device provides quantitative physiological data to assist clinicians in hemodynamic optimization and goal-directed therapy. It does not make therapeutic decisions; clinicians review data to guide fluid administration or other interventions. Benefits include continuous assessment of cardiac function, fluid status, and tissue oxygenation, potentially improving patient management in ischemic or hemodynamic instability states.

Clinical Evidence

No clinical testing was performed. Evidence consists of bench testing, system-level verification, software verification, and a usability study. Bench simulations verified measured and derived parameters. Electrical safety and EMC testing confirmed compliance with IEC 60601-1, 60601-1-2, 60601-2-34, 60601-2-57, 60601-2-49, and 80601-2-49. Wireless coexistence testing followed ANSI C63.27/D1.0. Usability studies confirmed that intended users could perform critical tasks without usability issues leading to harm.

Technological Characteristics

Modular hemodynamic monitor with external sub-system modules. Connectivity via wired/wireless interfaces to Hospital Information Systems and mobile devices (Viewfinder Remote). Software includes HPI and AFM algorithms. Complies with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-8, 62304, 62366, 60601-2-34, 60601-2-57, 60601-2-49, and 80601-2-49. Cybersecurity includes Windows 10 IoT, OS/App hardening, and security logs.

Indications for Use

Indicated for adult and pediatric critical care patients requiring hemodynamic monitoring (cardiac output, venous oxygen saturation, blood pressure, vascular resistance, fluid responsiveness, and tissue hemoglobin oxygenation) in hospital environments (OR, ICU, ER). Specific indications vary by module (Swan-Ganz, Oximetry, Pressure, Technology/ForeSight, ClearSight). Acumen HPI is indicated for surgical/non-surgical patients receiving advanced hemodynamic monitoring. Acumen AFM is indicated for surgical patients ≥18 years. ForeSight sensors are indicated for regional hemoglobin oxygen saturation monitoring based on weight/age (Adults/adolescents >40kg; Pediatrics >3kg; Cerebral <8kg/Non-cerebral <5kg).

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 (K203687)
FORE-SIGHT ELITE Tissue Oximeter Module (K190270)
Acumen Assisted Fluid Management (AFM) feature on EV1000A Clinical Platform (DEN190029)
HemoSphere Advanced Monitoring Platform (K211465)

Related Devices

K223127 — HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable · Edwards Lifeciences, LLC · Nov 7, 2022
K243781 — HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Smart Pressure Controller (PC1Q); Acumen IQ Plus Finger Cuff (AIQCA2); HemoSphere Pressure Cable (HEMPSC100); HemoSphere Vita Monitor (HEMVITA1); HemoSphere Vita Technology Module (HEMVTOM1); HemoSphere VitaWave module (HEMVWM1); VitaWave Plus finger cuff (VWCA2) · Edwards Lifesciences · Jul 23, 2025
K223865 — HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor · Edwards Lifesciences, LLC · Jun 9, 2023
K190205 — HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module · Edwards Lifesciences, LLC · Aug 29, 2019
K201446 — HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module · Edwards Lifesiences, LLC · Oct 1, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 22, 2022 Edwards Lifesciences, LLC Manthan Damani Manager, Regulatory Affairs One Edwards Way Irvine, California 92614 Re: K213682 Trade/Device Name: 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 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB, QMS, FLL Dated: November 19, 2021 Received: November 22, 2021 Dear Manthan Damani: 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. 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}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use #### 510(k) Number (if known) #### K213682 #### Device Name HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, 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. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Oximetry Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere Pressure Cable: The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Acumen Hypotension 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 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. {3}------------------------------------------------ HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the paysiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable: The non-invasive ForeSight Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 on the HemoSphere advanced monitor. - When used with large sensor, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >40 kg. · When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects 23 kg. · When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. HemoSphere Advanced Monitor with HemoSphere ClearSight Module: The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. The Edwards Lifesciences Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quanitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter. Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. {4}------------------------------------------------ Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) #### 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." {5}------------------------------------------------ # K213682 | Sponsor: | Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 | | | |-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------| | Establishment Registration Number: | 2015691 | | | | Contact Person: | Manthan Damani Senior Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614 manthan_damani@edwards.com Telephone: (949) 250-7853 | | | | Date: | June 22, 2022 | | | | Platform Name | HemoSphere Advanced Monitoring Platform | | | | Trade Name: | HemoSphere Advanced Monitor HemoSphere Swan-Ganz Module HemoSphere Oximetry Cable HemoSphere Pressure Cable HemoSphere Technology Module ( subject ) HemoSphere ForeSight Oximeter Cable ( subject ) HemoSphere ClearSight Module Acumen Hypotension Prediction Index software feature ( subject ) Acumen Assisted Fluid Management software feature ( subject ) Viewfinder Remote ( subject ) | | | | Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | | | Classification Name for HemoSphere Monitor and Accessories: | Programmable Diagnostic Computer Fiberoptic Oximeter Catheter Adjunctive Predictive Cardiovascular Indicator Oximeter, Tissue Saturation (Non-Invasive) System, Measurement, Blood-Pressure, Non-Invasive Plethysmograph, Impedance Adjunctive Open Loop Fluid Therapy Recommender Thermometer, Electronic, Clinical | 21 CFR 870.1425 | 21 CFR 870.1230 | | | | 21 CFR 870.2210 | 21 CFR 870.2700 | | | | 21 CFR 870.1130 | 21 CFR 870.2770 | | | | 21 CFR 870.5600 | 21 CFR 880.2910 | # 510(k) Summary – HemoSphere Advanced Monitoring Platform {6}------------------------------------------------ | Product Code for HemoSphere Monitor and Accessories: | DQK, Class II DQE, Class II QAQ, Class II MUD, Class II DXN, Class II DSB, Class II QMS, Class II FLL, Class II | |------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Predicate Device for HemoSphere Monitor and Accessories: | HemoSphere Advanced Monitoring Platform, manufactured by Edwards Lifesciences, K203687 cleared May 28, 2021, is being utilized for substantial equivalence to the device modularity, basic device functionality, graphical user interface (GUI) used, core predictive algorithm for the Acumen Hypotension Prediction Index (HPI) feature, and cybersecurity features. The indications for use are also similar to the subject device. | | Secondary Predicate Devices for HemoSphere Monitor and Accessories: | FORE-SIGHT ELITE Tissue Oximeter Module (K190270, cleared October 21, 2019), manufactured by Edwards Lifesciences, is being utilized for substantial equivalence to the tissue hemoglobin feature and indications for use. | | | Acumen Assisted Fluid Management (AFM) feature on EV1000A Clinical Platform (DEN190029, granted November 13, 2020), manufactured by Edwards Lifesciences, is being utilized for substantial equivalence to the Acumen Assisted Fluid Management (AFM) software feature and indications for use. | | | HemoSphere Advanced Monitoring Platform (K211465, cleared July 08, 2021), manufactured by Edwards Lifesciences, is being utilized for substantial equivalence to the connectivity features of the HemoSphere Advanced monitor to allow it to connect to the Viewfinder Remote mobile application as well as for the Viewfinder Remote application itself. | | Device Description: | The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function. | | | HemoSphere Advanced Monitoring Platform, subject of this submission, consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on the monitor screen and its 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 Technology Module (previously referred to as "Tissue Oximetry Module"; K190305 cleared, August 29, 2019), | {7}------------------------------------------------ HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). The HemoSphere Advanced Monitor also has wired and wireless capabilities which was originally used only for connecting to a Hospital Information System (HIS) for data charting purposes. This capability is now used to allow it to stream continuously monitored data to the Viewfinder Remote, a mobile device-based application, for remote viewing the information (K211465 cleared July 8, 2021). The remotely transmitted data from the patient monitoring sessions include all hemodynamic parameter data and the associated physiological alarm notifications, historical trend data, and parameter waveform data. A high-level overview of the new features and modifications that have been implemented as part of this subject submission are listed below: #### -Addition of new features, algorithm, and/or technology to the HemoSphere Platform: - o Tissue Hemoglobin - The updated ForeSight Oximeter Cable (previously referred to as "FORE-SIGHT ELITE Oximeter Module/FSM") with the Tissue Hemoglobin algorithm (K190270 cleared October 21, 2019) has been incorporated into the HemoSphere Monitoring Platform. The tissue hemoglobin parameter includes relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum total hemoglobin concentration, under the sensor when used with a compatible host monitor. As such, the indications for use and intended use of the existing HemoSphere Advanced Monitor have been expanded to include the ability to measure relative change in total hemoglobin. Additionally, since the HemoSphere Advanced Monitor will act as the host monitor, the graphical user interface (GUI) of the Monitor is being updated to allow display of the hemoglobin parameter. - Assisted Fluid Management software feature: O - The Edwards' Acumen™ Assisted Fluid Management (AFM) ■ software feature (DEN190029 granted on November 13, 2020) has been incorporated into the HemoSphere Advanced Monitoring Platform to recognize patterns of fluid responsiveness (i.e., hemodynamic data and past responses to fluid) and recommend when fluid administration is expected to improve the patient's hemodynamic state. This AFM software feature (AFM algorithm + AFM GUI) is now being incorporated as part of the HemoSphere Advanced Monitor. No modifications have been made to the previously granted AFM algorithm. {8}------------------------------------------------ - Updates to existing features, algorithm, and/or technology to the HemoSphere Platform: - HPI Smart Alerts and Smart Trends o . The Acumen Hypotension Prediction Index (HPI) algorithm defines hypotensive events as mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. The software triggers an alert screen whenever the HPI parameter value is greater than 85 for two consecutive readings. From the alert screen, the user has the option to go to a secondary screen, where additional data related to alert can be viewed. Modifications have been made to the HPI alert popup and HPI secondary screen. The appearance and behavior of the HPI alert popup (referred to as a Smart Alert popup) has been modified to display the physiological mechanisms of preload, contractility, and afterload that may have changed in accordance with user-defined settings. The HPI secondary screen options also now include a new Smart Trends screen that displays values and trends for user-defined parameters associated with preload, contractility, and afterload when they have reached the user-defined targets. The Smart Settings menu allows clinician to select parameters to be monitored for each physiological mechanism (preload, contractility, afterload), and customize when the mechanism is triggered based on the percent change threshold over a pre-set time interval. There are no changes to the core HPI algorithm, the behavior of the HPI parameter display, nor the indications for use and intended use of the HPI parameter due to this Smart Trends/ Smart Alerts modification. - Connectivity feature O - As part of its connectivity development program, Edwards had . modified the HemoSphere Advanced Monitor (K211465 cleared July 8,2021) to allow it to stream (wired or wireless) continuously monitored non-invasive hemodynamic data to the Viewfinder Remote, a mobile device-based application, for remote viewing the information. Modifications have been made to the connectivity feature on HemoSphere Advanced Monitoring Platform to also allow the remote display of minimally invasive and invasive hemodynamic data on the physicians/clinicians mobile/handheld devices such as cell phone using Viewfinder Remote application. Additional connectivity feature modifications include workflow-based updates to the HemoSphere monitor to support the functionality of remote viewing, including the ability to end a session, additional metadata support, multiple setup wizards for initial configuration, as well as remote software and cybersecurity patch updates. {9}------------------------------------------------ - Cybersecurity updates O - Cybersecurity updates on HemoSphere Monitor include Windows 10 IoT and cybersecurity tools, OS and App level hardening, and dedicated security logs. - Miscellaneous Updates: о - ForeSight Sensor surface temperature detection ■ - Non-Pulsatile Mode - CASMED IFMOut/EMR protocol integration - Status Screen Updates - I Default CVP Values - I Nomenclature changes due to rebranding - Viewfinder Remote Application updates O - 트 The intended use of the Viewfinder Remote mobile application, which is an accessory to the HemoSphere Monitor (K211465, cleared July 08, 2021), has been expanded to allow for remote display of all existing hemodynamic data from the HemoSphere monitor including minimally invasive and invasive parameters on the physicians/clinicians mobile/handheld devices such as cell phone when using Viewfinder Remote application (previously only allowed display of the non-invasive parameters). Please Note: The AFM feature is not offered or displayed on Viewfinder Remote. #### HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module Indications for Use: The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population. ## HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and 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. {10}------------------------------------------------ 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 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 Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients >18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions. ## HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable The noninvasive ForeSight Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor. {11}------------------------------------------------ - . When used with large sensors, the ForeSight Oximeter Cable is indicated for use on adults and transitional adolescents >40 kg. - . When used with medium sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects >3 kg. - When used with small sensors, the ForeSight Oximeter Cable is indicated for ● cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg. Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population. ## HemoSphere Advanced Monitor with HemoSphere ClearSight Module The HemoSphere Advanced Monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with comorbidities 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 IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used. 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- HemoSphere Advanced Monitoring Platform: Intended Use of the The HemoSphere Advanced Monitoring Platform is intended to be used by qualified HemoSphere personnel or trained clinicians in a critical care environment in a hospital setting. The Advanced Viewfinder Remote mobile application can be used for supplemental near real-time remote Monitor: display of monitored hemodynamic parameter data as well as Faults, Alerts and Notifications generated by the HemoSphere Advanced Monitoring Platform. {12}------------------------------------------------ The HemoSphere Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs. A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz Module are listed in the table below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population. | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|---------------------------------------------------------|-----------------------------------|------------------------|--------------------------------------------------------------------| | CO | continuous cardiac output | | | | | 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 | | Adult only | Operating Room, Intensive Care Unit, Emergency Room | | LVSWI | left ventricular stroke work index | HemoSphere Swan-Ganz Module | | | | PVR | pulmonary vascular resistance | | | | | 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 | | | | | SVRI | systemic vascular resistance index | | | | | BT | pulmonary artery blood temperature | | | | | iCO | intermittent cardiac output | | | | | iCI | intermittent cardiac index | | | | | iSVR | intermittent systemic vascular resistance | | Adult and Pediatric | | | 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: {13}------------------------------------------------ | 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 Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------| | DO2 | Oxygen Delivery | HemoSphere Swan-Ganz Module and HemoSphere Oximetry Cable | Adult and Pediatric | | | DO2I | Oxygen Delivery Indexed | | | Operating Room, Intensive Care Unit, Emergency Room | | VO2 | Oxygen Consumption | | | | | 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 | | | Operating Room, Intensive Care Unit, Emergency Room | | CVP | Central Venous Pressure | | | | | DIA | Systemic arterial diastolic blood pressure | | | | | DIAPAP | pulmonary artery diastolic blood pressure | | | | | dP/dt | Systolic slope² | | | | | Eadyn | Dynamic Arterial Elastance² | | | | | MAP | Mean Arterial Pressure | | | | | MPAP | Mean Pulmonary Arteria¹ Pressure | HemoSphere Pressure Cable | Adult only | | | 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 | | | | | SYSART | Systemic Arterial Systolic Blood Pressure | | | | | SYSPAP | Pulmonary Artery Systolic Blood Pressure | | | | | HPI | Acumen Hypotension Prediction Index² | | | | | 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. | | | | | {14}------------------------------------------------ A list of Acumen Assisted Fluid Management (AFM) outputs available for surgical patients ≥18 years of age while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below: | AFM outputs | Sub-System Module Used | Patient Population | Hospital Environment | |-----------------------------------------------------------------------------------------------|---------------------------------|--------------------------|-------------------------| | Fluid Bolus Suggested | | | | | Test Bolus Suggested | | ≥18 years of age only | Operating Room | | Fluid Not Suggested | | | | | Suggestions Suspended | HemoSphere Pressure Cable | | | | Bolus in Progress... | | | | | Bolus Complete | | | | | Bolus Complete; Analyzing Hemodynamic Response | | | | | Tracked Case Vol. | | | | | AFM outputs are available when using an Acumen IQ sensor and if the AFM feature is activated. | | | | A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable and a connected HemoSphere oximetry cable are as listed below: | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|------------------------------------------------------------------------|--------------------------------------------------------------------------|-----------------------|--------------------------------------------------------------------| | DO2 | Oxygen Delivery | | | | | DO2I | Oxygen Delivery Indexed | HemoSphere Swan-Ganz Module and HemoSphere Oximetry Cable | Adult only | Operating Room, Intensive Care Unit, Emergency Room | | VO2 | Oxygen Consumption | | | | | 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 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 Module Used | Patient Population | Hospital Environment | |-----------|-------------------------------|-----------------------------------------------|-----------------------|--------------------------------------------------------------------| | CO20s | 20-second cardiac output | HemoSphere | Adult only | Operating Room, Intensive Care Unit, Emergency Room | | CI20s | 20-second cardiac index | Swan-Ganz | | | | SV20s | 20-second stroke volume | Module and HemoSphere Pressure Cable | | | | SVI20s | 20-second stroke volume index | | | | A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Technology Module, and ForeSight Oximeter Cable are listed below. {15}------------------------------------------------ | Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment | |-----------|---------------------------------------------------------------------------------|------------------------------------|------------------------|-----------------------------------------------| | StO2 | Absolute regional hemoglobin oxygen saturation of blood under the sensors | ForeSight Oximeter Cable and | Adult and Pediatric | Operating Room, Intensive Care Unit, | | ΔctHb | Relative change in Total Hemoglobin | HemoSphere Technology Module | | Emergency 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 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 | | | | | PPV | pulse pressure variation | | | Operating Room, | | PR | Noninvasive Pulse rate | | | Intensive Care Unit, | | SV/ | Stroke Volume/ Stroke | HemoSphere ClearSight Module | Adult only | Emergency Room | | SVI | Volume Index | | | | | SVR/ | Systemic Vascular Resistance Systemic | | | | | SVRI | 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 | HemoSphere ClearSight Module and HemoSphere Oximetry Cable | | Operating Room, Intensive Care Unit | | DO2I | Oxygen Delivery Indexed | | | | | VO2 | Oxygen Consumption | | Adult only | | | VO2e | Estimated Oxygen Consumption when ScvO2 is being monitored | | | | | VO2I | Oxygen Consumption Index | | | | | VO2Ie | Estimated Oxygen Consumption Index when ScvO2 is being monitored | | | | {16}------------------------------------------------ ## Intended Use of Viewfinder Remote: Viewfinder Remote is a mobile application, which provides supplemental remote near realtime display of hemodynamic data 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 of The existing HemoSphere Advanced Monitoring Platform, K203687 (cleared May 28, Technological 2021) consists of: Characteristics with Predicate Devices: - HemoSphere Advanced Monitor - HemoSphere Swan-Ganz Module - HemoSphere Oximetry Cable ● - HemoSphere Pressure Cable - HemoSphere Technology Module (previously known as "Tissue Oximetry ● Module") - . HemoSphere ForeSight Oximeter Cable (previously known as "FORE-SIGHT ELITE Tissue Oximeter Module") - HemoSphere ClearSight Module ● - Acumen Hypotension Prediction Index (HPI) for Minimally Invasive and Non-. Invasive technology - . Viewfinder Remote Mobile Application (for non-invasive parameters) Per the FDA Guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device (October 25, 2017), the modifications made to the HemoSphere Advanced Monitoring Platform as part of this submission are considered as technology, engineering, and performance changes. A summary of the new and modified technological characteristics of the subject device along with a reference to the predicate device(s) for those characteristics are provided below: | New/Modified Feature or Technology | Predicate Device Chosen with Justification | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | HemoSphere Advanced Monitoring Platform | HemoSphere Advanced Monitoring Platform (K203687, cleared May 28, 2021) This is the base platform to which the new features, technology additions or modifications (inclusive of miscellaneous GUI/ functionality modifications) are being made and has similar intended use and indications and hence is the Primary Predicate. | | Tissue Hemoglobin Software Feature and Parameters | FORE-SIGHT ELITE Tissue Oximeter Module (K190270 cleared October 21, 2019) This device (smart cable) was chosen as a secondary predicate for the new indication on the HemoSphere platform related to the hemoglobin parameters (oxygenated hemoglobin, deoxygenated hemoglobin, and their summation total hemoglobin, of blood under the sensors). The algorithm for this parameter is directly being ported over from what was cleared for the FORE-SIGHT ELITE Tissue Oximeter Module (also now referred to as HemoSphere ForeSight Oximeter Cable (FSOC) as part of rebranding that is occurring). There are GUI modifications being made to integrate it with the HemoSphere Advanced Monitoring Platform. | | Assisted Fluid Management and Acumen AFM Cable | Acumen Assisted Fluid Management (AFM) Software Feature (DEN190029 granted November 13, 2020) This software feature was chosen as the secondary predicate since the Assisted Fluid Management algorithm and feature, as granted in this DeNovo will be used on the HemoSphere Advanced Monitor. | | HPI Smart Trends and Alerts | HemoSphere Advanced Monitoring Platform (K203687 cleared May 28, 2021) This device was chosen as the predicate since it is the base HemoSphere platform for the HPI feature to which modifications are being made. There are no changes to the core HPI algorithm, the behavior of the HPI parameter display, nor the indications for use and intended use of the HPI parameter due to this Smart Trends/ Smart Alerts modification. | | Connectivity Solutions | HemoSphere Advanced Monitoring Platform (K211465 cleared July 8, 2021) This device was chosen as the predicate for the connectivity features that allow the HemoSphere Advanced Monitor to connect to the Viewfinder Remote mobile application. Modifications have been made to the connectivity feature on HemoSphere Advanced Monitor to enable remote software and cybersecurity patch updates and also allow the remote display of minimally invasive and invasive hemodynamic<…