(58 days)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and SevO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function. fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
The non-invasive Fore-Sight Elite tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The Fore-Sight Elite tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with medium sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on pediatric subjects >3 kg.
· When used with small sensors, the Fore-Sight Elite tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Intended use - Viewfinder Remote:
Viewfinder Remote is a mobile application which provides supplemental remote near real-time display of non-invasive hemodynamic parameters measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.
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 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), HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 cleared October 1, 2020).
The HemoSphere Advanced Monitor (K201446 most recently cleared October 1, 2020), subject of this submission, is being modified to enable connectivity to a Viewfinder Remote mobile application via a software-based Viewfinder Hub and Viewfinder Cloud.
The Viewfinder Remote mobile application provides clinicians with a supplemental near-real time display of the patient hemodynamic data from the connected HemoSphere Advanced Monitoring Platform. The Viewfinder Remote application is part of the Edwards Viewfinder network, which includes Viewfinder Hub and Viewfinder Cloud. The Viewfinder Remote mobile application functions as a supportive visual aid for patient status communication between clinicians and allows them to view multiple patient monitoring sessions at once from their mobile device. The near-real time updates to patient monitoring sessions includes non-invasive hemodynamic parameter data and the associated physiological alarm notifications, historical trend data and parameter waveform data.
The provided text describes modifications to an existing device, the HemoSphere Advanced Monitoring Platform, to include a new feature: the Viewfinder Remote mobile application. The primary predicate device is the HemoSphere Advanced Monitoring Platform itself (K201446). The submission focuses on the addition of the Viewfinder Remote and changes to the HemoSphere Advanced Monitor to support this remote viewing functionality.
The acceptance criteria and study information provided are primarily related to the safety and functionality of the new remote viewing feature and the integrated system, rather than the clinical performance of the underlying hemodynamic monitoring parameters. No clinical performance data is deemed necessary for the modifications.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for parameters like accuracy, sensitivity, or specificity for the Viewfinder Remote mobile application. Instead, it states that "All tests passed" for various verification activities, implying that the device met internal performance specifications for these tests. The focus is on ensuring data integrity, safety, and usability of the remote viewing function.
| Acceptance Criteria Category | Specific Test/Description | Reported Device Performance |
|---|---|---|
| System Verification | End-to-end system verification for data integrity and accuracy (Monitor to Remote View mobile application) | All tests passed. |
| Electrical Safety & EMC | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49 standards | All tests passed. |
| Wireless Coexistence | ANSI C63.27/D1.0, bench and simulated environment testing on the entire platform, including modules and the Viewfinder Remote | All tests passed. |
| Software Verification | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | All tests passed. (HemoSphere Advanced Monitor: Major Level of Concern; Viewfinder Remote: Moderate Level of Concern) |
| Usability Study | FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices" | All tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for any of the verification tests (system, wireless, software, usability). It does not mention clinical data proving the device meets the acceptance criteria, as clinical data was not required for the modifications. The tests appear to be non-clinical (bench and simulated environment).
- Test Set Sample Size: Not specified.
- Data Provenance: Non-clinical (bench and simulated environment testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The verification activities mentioned are technical and regulatory compliance tests, not typically requiring expert ground truth in the way a diagnostic algorithm's performance would. For the usability study, "clinicians" are mentioned as users, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was mentioned. The device (Viewfinder Remote) is a "supportive visual aid" for remote display of parameters, not an AI-assisted diagnostic tool that would improve human reader performance in interpreting complex medical images or data.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Viewfinder Remote itself is a standalone application in the sense that it displays data from the HemoSphere monitor, but its "performance" is based on accurately reflecting the data generated by the primary monitoring platform. The verification activities focus on the integrity and accuracy of this data transfer and display, not on the Viewfinder Remote generating independent algorithmic outputs. The "Acumen Hypotension Prediction Index Feature" is mentioned as a component of the HemoSphere system, providing "additional quantitative information," but the document doesn't detail standalone performance studies for this specific AI feature outside of its integration with the HemoSphere platform and the context of the Viewfinder Remote submission.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the HemoSphere Advanced Monitoring Platform itself, the ground truth for its core hemodynamic parameters would typically be established through validation against gold-standard invasive measurements or other well-established methods. However, for the modifications related to the Viewfinder Remote, the "ground truth" for the verification tests involved comparing the displayed data on the remote application against the data displayed on the primary HemoSphere monitor, and ensuring it passed technical and regulatory standards.
- For the Viewfinder Remote modifications: The ground truth for data integrity and accuracy would be the parameters and alarms generated and displayed on the HemoSphere Advanced Monitor itself.
- For the overall HemoSphere Advanced Monitor (implied from its existing clearance K201446 and general device type): Ground truth for hemodynamic parameters like cardiac output, pressure, and oxygen saturation would typically rely on established clinical measurement techniques (e.g., thermodilution for CO, direct arterial line measurement for BP, co-oximetry for SvO2).
8. The Sample Size for the Training Set
This information is not provided. Given that clinical data was not required for these specific modifications, and the focus is on a remote display application rather than a new diagnostic algorithm requiring extensive training data, a training set as typically understood for AI models is not explicitly mentioned. If the Acumen HPI feature involves AI, its training data details are not provided in this document.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. (See point 8).
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 8, 2021
Edwards Lfesciences Chirag Shah Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K211465
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module, HemoSphere ForeSight Module, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index Feature, Viewfinder Remote Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB Dated: May 10, 2021 Received: May 11, 2021
Dear Chirag Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{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}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module, HemoSphere ClearSight Module, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index, Viewfinder Remote
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and SevO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function. fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
{3}------------------------------------------------
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
The non-invasive Fore-Sight Elite tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The Fore-Sight Elite tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on adults and transitional adolescents ≥40 kg.
· When used with medium sensors, the Fore-Sight Elite tissue oximeter module is indicated for use on pediatric subjects >3 kg.
· When used with small sensors, the Fore-Sight Elite tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the non-invasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
| Sponsor: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614 |
|---|---|
| EstablishmentRegistrationNumber: | 2015691 |
| Contact Person: | Chirag ShahManager, Regulatory AffairsOne Edwards WayIrvine, CA 92614Telephone: (949) 250-1580Fax: (949) 809-2972 |
| Date: | July 1, 2021 |
| Platform Name | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableHemoSphere Tissue Oximetry ModuleHemoSphere ForeSight ModuleHemoSphere ClearSight ModuleAcumen Hypotension Prediction Index featureViewfinder Remote |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| ClassificationName: | Programmable Diagnostic Computer21 CFR 870.1425Fiberoptic Oximeter Catheter21 CFR 870.1230Adjunctive Predictive Cardiovascular Indicator21 CFR 870.2210Oximeter21 CFR 870.2700Oximeter, Tissue Saturation21 CFR 870.1130System, Measurement, Blood-Pressure, Non-Invasive21 CFR 870.2770Plethysmograph, Impedance |
510(k) Summary – HemoSphere Advanced Monitoring Platform
{5}------------------------------------------------
| Product Code: | DQK, Class IIDQE, Class IIQAQ, Class IIMUD, Class IIDSB, Class IIDXN, Class II |
|---|---|
| PrimaryPredicateDevice: | HemoSphere Advanced Monitoring Platform manufactured by EdwardsLifesciences, K201446, cleared October 1, 2020. |
| DeviceDescription: | The HemoSphere Advanced Monitoring platform was designed to simplifythe customer experience by providing one platform with modular solutionsfor their hemodynamic monitoring needs. The user can choose from theavailable optional sub-system modules or use multiple sub-system modulesat the same time. This modular approach provides the customer with thechoice of purchasing and/or using specific monitoring applications based ontheir needs. Users are not required to have all of the modules installed at thesame time for the platform to function.HemoSphere Advanced Monitoring Platform consists of the HemoSphereAdvanced Monitor that provides a means to interact with and visualizehemodynamic and volumetric data on a screen and five (5) optional externalmodules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April14, 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),HemoSphere ForeSight Module (K180003, May 10, 2018), and theHemoSphere ClearSight Module (K201446 cleared October 1, 2020).The HemoSphere Advanced Monitor (K201446 most recently clearedOctober 1, 2020), subject of this submission, is being modified to enableconnectivity to a Viewfinder Remote mobile application via a software-based Viewfinder Hub and Viewfinder Cloud.The Viewfinder Remote mobile application provides clinicians with asupplemental near-real time display of the patient hemodynamic data fromthe connected HemoSphere Advanced Monitoring Platform. TheViewfinder Remote application is part of the Edwards Viewfinder network,which includes Viewfinder Hub and Viewfinder Cloud. The ViewfinderRemote mobile application functions as a supportive visual aid for patientstatus communication between clinicians and allows them to view multiplepatient monitoring sessions at once from their mobile device. The near-realtime updates to patient monitoring sessions includes non-invasivehemodynamic parameter data and the associated physiological alarmnotifications, historical trend data and parameter waveform data. |
{6}------------------------------------------------
Indications for HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module The HemoSphere Advanced Monitor when used with the HemoSphere Use: Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. When used in conjunction with a HemoSphere Pressure Cable, CO20s, CI20s, SV20s and SVI20s can be monitored. Use of HemoSphere Swan-Ganz Module in conjunction with HemoSphere Pressure Cable is restricted to adult patients only. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment.
Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the
balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac. Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions
{7}------------------------------------------------
should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ForeSight Module and HemoSphere Tissue Oximetry Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reduced-flow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
- . When used with large sensor is indicated for use on adults and transitional adolescents >40 kg.
- When used with Medium Sensors, the FORE-SIGHT ELITE tissue ● oximeter module is indicated for use on pediatric subjects >3 kg.
- . When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module The HemoSphere Advanced Monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Intended Use: The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a
{8}------------------------------------------------
hospital setting. The HemoSphere Advanced Monitoring Platform can be used with the Viewfinder Remote mobile application for supplemental near real-time remote display of tissue oximetry and non-invasive hemodynamic parameter data monitored with a FORE-SIGHT ELITE oximeter module and HemoSphere ClearSight Module, respectively.
The HemoSphere Advanced Monitoring Platform is intended for use with the Edwards Swan-Ganz and Oximetry Catheters and FloTrac, Acumen IQ, TruWave DPT sensors and ClearSight cuffs.
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz Module are listed in the table below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO | continuous cardiac output | |||
| sCO | STAT cardiac output | |||
| CI | continuous cardiac index | |||
| sCI | STAT cardiac index | |||
| EDV | right ventricular end diastolicvolume | |||
| sEDV | STAT right ventricular enddiastolic volume | |||
| EDVI | right ventricular end diastolicvolume index | |||
| sEDVI | STAT right ventricular enddiastolic volume index | |||
| HRavg | averaged heart rate | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom | |
| LVSWI | left ventricular stroke work index | |||
| PVR | pulmonary vascular resistance | HemoSphere | ||
| PVRI | pulmonary vascular resistanceindex | Swan-GanzModule | ||
| RVEF | right ventricular ejection fraction | |||
| sRVEF | STAT right ventricular ejectionfraction | |||
| RVSWI | right ventricular stroke work index | |||
| SV | stroke volume | |||
| SVI | stroke volume index | |||
| SVR | systemic vascular resistance | |||
| SVRI | systemic vascular resistance index | |||
| iCO | intermittent cardiac output | Adult andPediatric | ||
| iCI | intermittent cardiac index | |||
| iSVR | intermittent systemic vascularresistance | |||
| iSVRI | intermittent systemic vascularresistance 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:
{9}------------------------------------------------
| 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-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | |||
| VO2 | Oxygen Consumption | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Adult andPediatric | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous Cardiac Output¹/Continuous Cardiac Index¹ | |||
| CVP | Central Venous Pressure | |||
| DIA | Systemic arterial diastolic bloodpressure | |||
| DIAPAP | pulmonary artery diastolic bloodpressure | |||
| dP/dt | Systolic slope² | |||
| Eadyn | Dynamic Arterial Elastance² | OperatingRoom,Intensive | ||
| MAP | Mean Arterial Pressure | |||
| MPAP | Mean Pulmonary Arterial¹ Pressure | HemoSpherePressureCable | Adult only | |
| PPV | pulse pressure variation¹ | Care Unit,EmergencyRoom | ||
| PRART | Pulse rate | |||
| SV/SVI | Stroke Volume¹/Stroke Volume Index¹ | |||
| SVR/SVRI | Systemic Vascular Resistance¹/Systemic Vascular Resistance¹Index | |||
| SVV | Stroke Volume Variation¹ | |||
| SYS | Systolic Blood Pressure | |||
| HPI | Acumen Hypotension PredictionIndex | |||
| ¹FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTracfeature is enabled. | ||||
| ²HPI parameters are available when using an Acumen IQ sensor and if the HPI feature is activated. |
{10}------------------------------------------------
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable and a connected HemoSphere oximetry cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz Module and pressure cable are listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO20s | 20-second cardiac output | HemoSphere | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| CI20s | 20-second cardiac index | Swan-Ganz | ||
| SV20s | 20-second stroke volume | Module andHemoSphere | ||
| SVI20s | 20-second stroke volume index | OximetryCable |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Tissue Oximetry Module, and HemoSphere ForeSight Module are listed below.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| StO2 | Absolute regional hemoglobinoxygen saturation of blood underthe sensors | HemoSphereForeSightModule andHemoSphereTissueOximetryModule | Adult andPediatric | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight module are listed below.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous Cardiac Output/Continuous Cardiac Index | OperatingRoom, | ||
| DIA | noninvasive arterial diastolic bloodpressure | HemoSphereClearSightModule | Adultonly | Intensive CareUnit, |
| MAP | Noninvasive Mean Arterial Pressure | EmergencyRoom | ||
| PPV | pulse pressure variation |
{11}------------------------------------------------
| PR | Noninvasive Pulse rate |
|---|---|
| SV/ | Stroke Volume/ |
| SVI | Stroke Volume Index |
| SVR/ | Systemic Vascular Resistance |
| SVRI | Systemic Vascular Resistance Index |
| SVV | Stroke Volume Variation |
| SYS | Systolic Blood Pressure |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere ClearSight module and oximetry cable are listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphereClearSightModule andHemoSphereOximetryCable | Adult only | OperatingRoom,IntensiveCare Unit |
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
Intended use - Viewfinder Remote:
Viewfinder Remote is a mobile application which provides supplemental remote near real-time display of non-invasive hemodynamic parameters measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.
| Comparison toPredicateDevice: | The existing HemoSphere Advanced Monitoring Platform (K201446,cleared October 1, 2020) consists of: |
|---|---|
| • | HemoSphere Advanced Monitor |
| • | HemoSphere Swan-Ganz Module |
| • | HemoSphere Oximetry Cable |
| • | HemoSphere Pressure Cable |
| • | HemoSphere Tissue Oximetry Module |
- HemoSphere ForeSight Module ● ● HemoSphere ClearSight Module
- Acumen Hypotension Prediction Index feature (when used with Acumen IQ sensor only)
{12}------------------------------------------------
As part of its connectivity development program, Edwards has modified the HemoSphere Advanced Monitor (subject of this 510(k)) to allow it to wirelessly stream continuously monitored non-invasive hemodynamic parameter data to the Viewfinder Remote (subject of this 510(k)), a mobile device-based application, for remote viewing of the information.
As a connected device, cybersecurity modifications have been implemented on the HemoSphere Advanced Monitor. Additionally, workflow-based updates to support the functionality of remote viewing, including the ability to end a session, provide additional metadata support, as well as multiple setup wizards for initial configuration have been made. The following predicate is used to establish substantial equivalence:
- Primary Predicate: HemoSphere Advanced Monitor (K201446, cleared October 1, 2020) utilized for substantial equivalence to the HemoSphere Advanced Monitor in terms of the graphical user interface (GUI) used, wireless module incorporated, device modularity and basic device functionality. Modifications are being made to the HemoSphere Advanced Monitor to add the capability for it to remotely connect to the Viewfinder Remote mobile application.
Per FDA's guidance, "Medical Device Accessories – Describing Accessories and Classification Pathways" the remote view application (Viewfinder Remote) is considered an accessory to the HemoSphere Advanced Monitor since it augments the performance of the HemoSphere Advanced Monitor by allowing convenience of use (remote display of noninvasive hemodynamic parameters, alarms and alerts) of the device. Hence, the primary predicate for this application is the HemoSphere Advanced Monitor (K201446, cleared October 1, 2020).
Verification and validation testing were performed to compare the performance and functionality of the HemoSphere Advanced Monitoring Platform to its predicate device. Testing included a side-by-side comparison of the output parameters using a bench test.
| PerformanceData (Benchand/or Clinical): | The following verification activities were performed in support of asubstantial equivalence determination for the modifications being made aspart of this submission. |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
System Verification
End-to-end system verification was performed to ensure data integrity and accuracy from the Monitor to the Remote View mobile application. All tests passed.
{13}------------------------------------------------
Electrical Safety and Electromagnetic Compatibility (EMC)
The HemoSphere Advanced Monitor and all its connected modules/cables were tested to the following standards: IEC 60601-1. IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34 and IEC 60601-2-49. All tests passed.
Wireless Coexistence Testing
ANSI C63.27/D1.0, bench and simulated environment testing were performed on the entire HemoSphere Advanced Monitoring Platform. including all sub-system modules and its interfacing analog inputs and outputs and the wirelessly connected Viewfinder Remote mobile application running on a mobile device. All tests passed.
Software Verification
The HemoSphere Advanced Monitor is considered as software of Major Level of Concern. The Viewfinder Remote mobile application is considered as software of Moderate Level of Concern.
Software verification was performed per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed.
Usability Study
A usability study was performed for the HemoSphere Advanced Monitoring Platform and Viewfinder Remote in accordance with FDA's guidance, "Applying Human Factors and Usability Engineering to Medical Devices". All tests Passed.
Clinical Performance
Clinical data was not required for this device or the modifications being made to the device.
Non-Clinical Performance Conclusions:
Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device.
Conclusions Overall Conclusion:
The nonclinical and clinical tests demonstrate that the HemoSphere Advanced Monitor and the Viewfinder Remote mobile application are substantially equivalent to their legally marketed predicates.
§ 870.1425 Programmable diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).