(168 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. 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 catheters 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 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 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 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.
The Acumen Assisted Fluid management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.
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 ≥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 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 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 Intended Use statement for a complete list of measured and derived parameters available for each patient population.
Indications for Use for the Acumen IQ Fluid Meter
The Acumen IQ fluid meter is indicated for surgical patients over 18 years of age to track the fluid being administered to the patient, when used with a compatible hemodynamic monitoring platform.
Intended Use- HemoSphere Advanced Monitoring Platform:
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 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, Acumen IQ fluid meter, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.
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 (K213682 cleared, June 22, 2022), HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). Additionally, the HemoSphere Advanced Monitoring Platform includes the Acumen Hypotension Prediction Index software feature (DEN160044 granted March 16, 2018) and the Acumen Assisted Fluid Management software feature (DEN190029 granted November 13, 2020). 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.
HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:
-
Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.
The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.
The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.
When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens. -
Automatic Zeroing of the Heart Reference Sensor (HRS)
The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.
The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.
In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.
For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.
The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information. -
Patient Query
As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor. -
Miscellaneous Updates
Miscellaneous updates include:
- Bug fixes -
- Cybersecurity updates -
- Operator's manual updates -
- Heart Reference Sensor Instructions for Use update -
Based on the provided text, the document is a 510(k) Premarket Notification from the FDA to Edwards Lifesciences, LLC, regarding the HemoSphere Advanced Monitor and related components. It does not contain the detailed acceptance criteria and study proving device performance in the way typically required for AI/ML-driven diagnostic devices. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new clinical claim with a standalone performance study.
Therefore, many of the requested details about acceptance criteria, human expert involvement, ground truth, and training set information are not available in this specific regulatory document, as they are not typically required for a 510(k) submission for device modifications like those described here. The "Acumen Assisted Fluid Management software feature" is mentioned, and an "AFM algorithm" is referenced, but detailed studies on its performance metrics are not included in this summary.
Here's a breakdown of what can be extracted and what information is missing:
Acceptance Criteria and Device Performance Study (Partial Information)
This 510(k) notification describes modifications to an existing device (HemoSphere Advanced Monitoring Platform) and new components (Acumen AFM Cable, Acumen IQ fluid meter). The primary goal is to demonstrate substantial equivalence to a previously cleared predicate device (K213682). As such, the performance data presented is focused on verifying that the modifications do not adversely affect safety and effectiveness, rather than establishing new clinical performance metrics or comparing AI performance against human readers.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of predetermined acceptance criteria for AI performance in the way one would for a new AI diagnostic claim (e.g., sensitivity, specificity, AUC). Instead, it lists various verification and validation activities performed to ensure the modified device functions as intended and remains safe and effective.
Summary of Performance Data Presented:
| Criteria/Test Category | Description and Reported Outcome |
|---|---|
| System Verification | Demonstrated that subject devices and software meet predetermined design and performance specifications. Modifications did not adversely affect safety and effectiveness. Acumen AFM Cable and Acumen IQ fluid meter tested at system level for safety. AFM outputs with fluid meter mode were "tested using a bench simulation." All tests passed. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49, and ISO 81060-2. Electrical testing of disposable board and reusable board performed. All tests passed. |
| Software Verification | Performed per FDA's guidance (May 11, 2005). New AFM fluid meter mode tested at sub-system level. Acumen AFM Cable and HemoSphere ClearSight Module firmware tested. All tests passed. |
| Usability Study | Conducted per FDA's guidance (February 3, 2016) to investigate primary operating functions and critical tasks related to AFM fluid meter mode. Demonstrated intended users could perform tasks without usability issues leading to patient or user harm. |
| Mechanical Testing | Performed on Acumen IQ fluid meter and Acumen AFM Cable. All tests passed. |
| Sterilization Validation | Performed for the sterile Acumen IQ fluid meter (disposable) in accordance with Edwards Quality System and applicable standards. |
| Packaging Testing | Validated Acumen IQ fluid meter packaging per ISO 11607-1: 2009/A1: 2014, including shipping simulation and conditioning tests. Also performed on Acumen AFM Cable. All tests passed. |
| Biocompatibility Testing | Performed for Acumen IQ fluid meter (indirect patient contact) per ISO 10993-1: 2009 and FDA guidance (June 16, 2016). All tests passed. |
| Clinical Performance | "No new clinical testing was performed in support of the subject 510(k)." This explicitly states that no clinical trial was conducted for the modifications, relying on substantial equivalence to the predicate. Therefore, there are no reported clinical performance metrics for the AI/AFM features from this submission. The AFM algorithm itself was "previously cleared" (DEN190029 granted November 13, 2020), so any clinical performance data for the algorithm would have been part of that earlier submission, not this one. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not specified for any quantitative testing that would typically involve a "test set" in the context of AI model validation (e.g., number of patient cases, number of images). The performance data cited are primarily bench simulations and system-level verification, not a clinical study with a patient test set.
- Data Provenance: Not specified, as no new clinical data or specific patient test sets are described. The reference to "bench simulation" suggests data generated in a lab environment.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable/Not Provided: Since "No new clinical testing was performed" for this 510(k), there is no mention of expert involvement for establishing ground truth on a clinical test set. The original AFM algorithm clearance (DEN190029) might contain this information, but it's not in this document.
4. Adjudication Method for Test Set
- Not Applicable/Not Provided: No clinical test set described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No: The document explicitly states, "No new clinical testing was performed." Therefore, no MRMC study was conducted or reported in this submission.
6. Standalone (Algorithm Only) Performance Study
- Partial/Limited: While the document mentions "AFM outputs when the fluid meter mode was unlocked... were tested using a bench simulation," it does not provide quantitative results (e.g., accuracy, precision) for the algorithm's performance in a standalone setting. The focus is on the functionality and safety of the hardware additions (cable, meter) and the automation of fluid tracking for an existing algorithm. The "core predictive algorithm for the Assisted Fluid Management software feature" is stated to be from the predicate device (K213682), which itself refers back to DEN190029.
7. Type of Ground Truth Used
- Not explicitly stated for AI performance: For the "bench simulation" of AFM outputs, the "ground truth" would likely be the known, controlled fluid flow rates programmed into the simulation. No external clinical ground truth (e.g., pathology, long-term outcomes) is described in relation to the AI/AFM performance in this document.
8. Sample Size for Training Set
- Not Provided: The document focuses on demonstrating substantial equivalence of modifications. Information about the training set size for the AI algorithm (Acumen Assisted Fluid Management software feature) would have been part of its original clearance (DEN190029), not this subsequent 510(k) for modifications and new hardware. It mentions: "No modifications have been made to the previously cleared AFM algorithm."
9. How Ground Truth for Training Set Was Established
- Not Provided: Similar to point 8, this information would pertain to the original clearance of the AFM algorithm (DEN190029) and is not detailed in this document.
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June 9, 2023
Edwards Lifesciences, LLC Sara Pesian Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K223865
Trade/Device Name: 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 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, QAQ, MUD, DXN, DSB Dated: May 9, 2023 Received: May 10, 2023
Dear Sara Pesian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223865
Device Name
HemoSphere Advanced Monitoring Platform, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter
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 catheters 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 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 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 patient's physiological condition and estimated response to fluid therapy.
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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.
The Acumen Assisted Fluid management software feature may be used with the Acumen AFM Cable and Acumen IQ fluid meter.
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 ≥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 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 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 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Summary – HemoSphere Advanced Monitoring Platform | |
|---|---|
| Sponsor: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614 |
| EstablishmentRegistrationNumber: | 2015691 |
| ContactPerson: | Sara PesianManager, Regulatory AffairsOne Edwards WayIrvine, CA 92614sara_pesian@edwards.comTelephone: (949) 250-4657 |
| Date: | June 08, 2023 |
| PlatformName: | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor (subject device)HemoSphere ClearSight Module (subject device)Heart Reference Sensor (subject device)Pressure Controller (subject device)HemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableHemoSphere Technology ModuleHemoSphere ForeSight Oximeter CableAcumen Hypotension Prediction Index software featureAcumen Assisted Fluid Management software feature with Acumen AFM Cableand Acumen IQ fluid meter (subject device)Viewfinder Remote |
| CommonName: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| ClassificationName forHemoSphereMonitor andAccessories: | Programmable Diagnostic Computer 21 CFR 870.1425Fiberoptic Oximeter Catheter 21 CFR 870.1230Adjunctive Predictive Cardiovascular Indicator 21 CFR 870.2210Oximeter, Tissue Saturation (Non-Invasive) 21 CFR 870.2700System, Measurement, Blood-Pressure, Non-Invasive 21 CFR 870.1130Plethysmograph, Impedance 21 CFR 870.2770Adjunctive Open Loop Fluid Therapy Recommender 21 CFR 870.5600Thermometer, Electronic, Clinical 21 CFR 880.2910 |
| Product CodeforHemoSphereMonitor andAccessories: | DQK, Class IIDQE, Class IIQAQ, Class IIMUD, Class IIDXN, Class IIDSB, Class IIQMS, Class IIFLL, Class II |
| PrimaryPredicateDevice | The HemoSphere Advanced Monitoring Platform, manufactured by EdwardsLifesciences, K213682 cleared June 22, 2022, is being utilized for substantialequivalence to the device modularity, basic device functionality, graphical userinterface (GUI) used, core predictive algorithm for the Assisted FluidManagement software feature, and cybersecurity features. The indications for useare also similar to the subject device. |
| DeviceDescription: | The HemoSphere Advanced Monitoring platform was designed to simplify thecustomer experience by providing one platform with modular solutions for theirhemodynamic monitoring needs. The user can choose from the available optionalsub-system modules or use multiple sub-system modules at the same time. Thismodular approach provides the customer with the choice of purchasing and/orusing specific monitoring applications based on their needs. Users are notrequired to have all of the modules installed at the same time for the platform tofunction.HemoSphere Advanced Monitoring Platform, subject of this submission, consistsof the HemoSphere Advanced Monitor that provides a means to interact with andvisualize hemodynamic and volumetric data on the monitor screen and its five (5)optional external modules: the HemoSphere Swan-Ganz Module (K163381cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 cleared,April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16,2018), HemoSphere Technology Module (K213682 cleared, June 22, 2022),HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphereClearSight Module (K203687 cleared, May 28, 2021). Additionally, theHemoSphere Advanced Monitoring Platform includes the Acumen HypotensionPrediction Index software feature (DEN160044 granted March 16, 2018) and theAcumen Assisted Fluid Management software feature (DEN190029 grantedNovember 13, 2020). The HemoSphere Advanced Monitor also has wired andwireless capabilities, which was originally used only for connecting to a HospitalInformation System (HIS) for data charting purposes. This capability is now usedto allow it to stream continuously monitored data to the Viewfinder Remote, amobile device-based application, for remote viewing the information (K211465,cleared July 8, 2021). The remotely transmitted data from the patient monitoringsessions include all hemodynamic parameter data and the associated physiologicalalarm notifications, historical trend data, and parameter waveform data. |
510(k) Summary - HemoSphere Advanced Monitoring Platform
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HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:
-
- Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.
- Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.
The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.
When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens.
2) Automatic Zeroing of the Heart Reference Sensor (HRS)
The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.
The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is
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designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.
In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.
For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.
The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information.
- Patient Query
As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor.
4) Miscellaneous Updates
Miscellaneous updates include:
- Bug fixes -
- Cybersecurity updates -
- Operator's manual updates -
- Heart Reference Sensor Instructions for Use update -
Indications HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
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
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(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 Scv02) 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 mmHz 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 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:
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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.
The Acumen Assisted Fluid Management software feature may be used with the Acumen AFM Cable and Acumen IO fluid meter.
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.
- 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 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.
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| The Edwards Lifesciences Acumen Hypotension Prediction Index featureprovides the clinician with physiological insight into a patient's likelihood offuture hypotensive events (defined as mean arterial pressure < 65 mmHg for atleast one minute in duration) and the associated hemodynamics. The Acumen HPIfeature is intended for use in surgical patients receiving advanced hemodynamicmonitoring. The Acumen HPI feature is considered to be additional quantitativeinformation regarding the patient's physiological condition for reference only andno therapeutic decisions should be made based solely on the HypotensionPrediction Index (HPI) parameter. | |
|---|---|
| Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for usestatements for information on target patient population specific to the finger cuffbeing used. | |
| Indications for Use for the Acumen IQ Fluid MeterThe Acumen IQ fluid meter is indicated for surgical patients over 18 years of ageto track the fluid being administered to the patient, when used with a compatiblehemodynamic monitoring platform. | |
| Intended Useof theHemoSphereAdvancedMonitor: | Intended Use- HemoSphere Advanced Monitoring Platform:The HemoSphere Advanced Monitoring Platform is intended to be used byqualified personnel or trained clinicians in a critical care environment in ahospital setting. The Viewfinder Remote mobile application can be used forsupplemental near real-time remote display of monitored hemodynamic parameterdata as well as Faults, Alerts and Notifications generated by the HemoSphereAdvanced Monitoring Platform. |
| The HemoSphere Advanced Monitoring Platform is intended for use withcompatible Edwards Swan-Ganz and Oximetry Catheters, FloTrac sensors, |
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.
Acumen IQ sensors, Acumen IQ fluid meter, TruWave DPT sensors, ForeSight
Edwards Lifesciences
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| 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 | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom | |
| sEDVI | STAT right ventricular enddiastolic volume index | |||
| HRavg | averaged heart rate | |||
| LVSWI | left ventricular stroke work index | HemoSphereSwan-GanzModule | ||
| PVR | pulmonary vascular resistance | |||
| PVRI | pulmonary vascular resistanceindex | |||
| RVEF | right ventricular ejection fraction | |||
| sRVEF | STAT right ventricular ejectionfraction | |||
| RVSWI | right ventricular stroke work index | |||
| SV | stroke volume | |||
| SVI | stroke volume index | |||
| SVR | systemic vascular resistance | |||
| SVRI | systemic vascular resistance index | |||
| BT | pulmonary artery bloodtemperature | |||
| iCO | intermittent cardiac output | |||
| iCI | intermittent cardiac index | |||
| iSVR | intermittent systemic vascularresistance | Adult andPediatric | ||
| 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:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphereOximetryCable | Adult andPediatric | Operating Room,Intensive CareUnit, EmergencyRoom |
| ScvO2 | Central Venous Oxygen Saturation | HemoSphereOximetryCable |
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:
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| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Operating Room,Intensive CareUnit, EmergencyRoom | |
| DO2I | Oxygen Delivery Indexed | |||
| VO2 | Oxygen Consumption | Adult andPediatric | ||
| 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 | Adult only | Operating Room,Intensive CareUnit, EmergencyRoom | |
| DIA | Systemic arterial diastolic bloodpressure | |||
| DIAPAP | pulmonary artery diastolic bloodpressure | |||
| dP/dt | Systolic slope² | |||
| Eadyn | Dynamic Arterial Elastance² | HemoSpherePressureCable | ||
| MAP | Mean Arterial Pressure | |||
| MPAP | Mean Pulmonary Arteria¹ Pressure | |||
| PPV | pulse pressure variation¹ | |||
| PRART | Pulse rate | |||
| SV/SVI | Stroke Volume¹/Stroke Volume Index¹ | |||
| SVR/SVRI | Systemic Vascular Resistance¹/Systemic Vascular Resistance¹ Index | |||
| SVV | Stroke Volume Variation¹ | |||
| SYSART | Systemic Arterial Systolic BloodPressure | |||
| SYSPAP | Pulmonary Artery Systolic BloodPressure | |||
| 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 |
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:
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| AFM outputs | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|
| Fluid Bolus Suggested | |||
| Test Bolus Suggested | |||
| Fluid Not Suggested | ≥18 years of ageonly | Operating Room | |
| Suggestions Suspended | HemoSpherePressure Cable | ||
| Bolus in Progress... | |||
| Bolus Complete | and AcumenAFM Cable | ||
| Bolus Complete; Analyzing Hemodynamic Response | |||
| Tracked Case Vol. | |||
| Flow Rate | |||
| Bolus Volume | |||
| AFM outputs are available when using an Acumen IQ sensor and if the AFM feature is activated. Flow rate andBolus Volume are visible when using automatic fluid tracking mode. |
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 | HemoSphereSwan-GanzModule andHemoSphereOximetryCable | Operating Room,Intensive CareUnit, EmergencyRoom | |
| DO2I | Oxygen Delivery Indexed | |||
| VO2 | Oxygen Consumption | Adult only | ||
| 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 | Operating Room,Intensive CareUnit, EmergencyRoom |
| CI20s | 20-second cardiac index | Swan-Ganz | ||
| SV20s | 20-second stroke volume | Module andHemoSpherePressureCable | ||
| 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.
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| Parameter | Description | Sub-SystemModule Used | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| StO2 | Absolute regional hemoglobin oxygensaturation of blood under the sensors | ForeSightOximeter | OperatingRoom, | |
| ΔctHb | Relative change in Total Hemoglobin | Cable andHemoSphereTechnologyModule | Adult andPediatric | Intensive CareUnit,EmergencyRoom |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight Module are listed below.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous Cardiac Output/Continuous Cardiac Index | |||
| DIA | Noninvasive arterial diastolic bloodpressure | |||
| MAP | Noninvasive Mean Arterial Pressure | |||
| PPV | pulse pressure variation | |||
| PR | Noninvasive Pulse rate | OperatingRoom,IntensiveCare Unit,EmergencyRoom | ||
| SV/SVI | Stroke Volume/ StrokeVolume Index | HemoSphereClearSight Module | Adult only | |
| SVR/SVRI | Systemic Vascular Resistance SystemicVascular Resistance Index | |||
| SVV | Stroke Volume Variation | |||
| SYS | Systolic Blood Pressure | |||
| dP/dt | Maximal slope of the arterialpressure upstroke1 | |||
| Eadyn | Dynamic Arterial Elastance1 | |||
| HPI | Acumen Hypotension PredictionIndex1 | OperatingRoom 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 parametersuse 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-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | HemoSphere | ||
| DO2I | Oxygen Delivery Indexed | ClearSight | OperatingRoom,IntensiveCare Unit | |
| VO2 | Oxygen Consumption | Module andHemoSphere | Adult only | |
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | Oximetry | ||
| VO2I | Oxygen Consumption Index | Cable |
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| VO2Ie | Estimated Oxygen Consumption Index when ScvO2 is being monitored | ||||
|---|---|---|---|---|---|
| ------- | ------------------------------------------------------------------ | -- | -- | -- | -- |
Intended Use – Acumen IQ Fluid Meter
The Acumen IQ fluid meter is a sterile single use device that is intended to be used with the Acumen AFM Cable and AFM software feature to inform the user of the rate of flow. The device is intended to be used by qualified personnel or clinicians in a clinical setting for up to 24 hours.
A summary comparison of the subject to predicate device is provided below:
Comparison to Predicate
| Device: |
|---|
| SubjectFeature/Technology | Predicate Device Chosen with Justification |
|---|---|
| HemoSphere AdvancedMonitoring Platform | HemoSphere Advanced Monitoring Platform (K213682 cleared June 22, 2022)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 . |
| Acumen Assisted FluidManagement feature onHemoSphere monitorwith automatedtracking via AcumenAFM cable andAcumen IQ fluid meter | HemoSphere advanced monitor with Acumen Assisted FluidManagement software feature with manual fluid tracking mode(K213682 cleared June 22, 2022).This software feature was chosen as the primary predicate since the Assisted Fluid Management algorithm and feature, as cleared in this submission will be used on the HemoSphere Advanced Monitor. An additional option is being added to the HemoSphere Advanced Monitor that allows the user to automatically track amount of fluid administered via two components, namely, the Acumen AFM Cable and Acumen IQ fluid meter. |
| Automatic Zero ofHeart Reference Sensor | HemoSphere advanced monitor with HemoSphere ClearSight Module(K213682 cleared May 22, 2022)This device was chosen as the predicate since it allows zeroing of the Heart Reference Sensor prior to monitoring and is now being modified to automatically zero the HRS. |
| Patient Query | HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022)This device was chosen as the predicate since it is the base platform with the patient query feature to which modifications are being made. There are no changes to the fundamental technology. |
| Miscellaneous Updates(bug fixes,cybersecurity, labeling) | HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022)This device was chosen as the predicate since it is the base platform to which modifications (bug fixes and cybersecurity updates) are being made. There are no changes to the fundamental technology. |
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The following verification activities were performed in support of a substantial Performance Data (Bench equivalence determination for the modifications made to the HemoSphere Advanced Monitoring Platform due to the modifications to the Acumen Assisted and/or Clinical): Fluid Management software feature, Automatic Zeroing of the Heart Reference Sensor. Patient Ouery, and Bug and cybersecurity updates and to ensure the safety and effectiveness of the new Acumen AFM Cable and Acumen IQ fluid meter components.
System Verification (Non-clinical performance)
Completion of all verification and validation activities demonstrated that the subject devices and software meet their predetermined design and performance specifications. Verification activities performed confirmed that the modifications made to the HemoSphere Advanced Monitoring Platform did not adversely affect the safety and effectiveness of the subject device. The Acumen AFM Cable when connected to Acumen IQ fluid meter were tested at a system level to verify the safety of these components. AFM outputs when the fluid meter mode was unlocked using the Acumen AFM Cable and the Acumen IO fluid meter were tested using a bench simulation. All tests passed.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject HemoSphere Advanced Monitoring Platform, consisting of the HemoSphere Monitor, the Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen AFM Cable with Acumen IQ fluid meter. The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49, and ISO 81060-2. All tests passed.
Additionally, Electrical testing was performed on the Acumen IO fluid meter's disposable board and the Acumen AFM Cable's reusable board to ensure they meet all their electrical requirements specification
Software Verification
Software verification was performed per FDA's Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005). The new advanced feature (AFM fluid meter mode) added to HemoSphere AFM Software was tested at a sub-system level to ensure the safety of the device. The Acumen AFM Cable and HemoSphere ClearSight Module firmware was tested to ensure the safety of the device. All tests passed.
Usability Study
Usability study was conducted per FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 3016), to investigate primary operating functions and critical tasks of the system for any usability issues regarding AFM fluid meter mode on HemoSphere Advanced
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Monitoring Platform that may lead to patient or user harm. The usability study demonstrated that the intended users could perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm.
Mechanical Testing
Mechanical testing was performed on the Acumen IO fluid meter and the Acumen AFM Cable to ensure they meet all their mechanical requirements specification. All tests passed.
Sterilization Validation
The Acumen IQ fluid meter is provided sterile. As such, sterilization validation and shelf life of the device was performed in accordance with the Edwards Quality System and the applicable standards.
Packaging Testing
Acumen IQ fluid meter packaging configurations were validated in accordance with the requirements of ISO 11607-1: 2009/A1: 2014. Shipping simulation and conditioning tests were completed to demonstrate the sterile barrier produced under the worst-case parameters and distribution conditions maintain sterile barrier integrity. Packaging testing was also performed on the Acumen AFM Cable. All test passed.
Biocompatibility Testing
Since the Acumen IQ fluid meter is considered to have indirect contact with the patient, biocompatibility testing was performed in accordance with the requirements of ISO 10993-1: 2009 - Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process and FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (June 16, 2016). All tests passed.
Clinical Performance
No new clinical testing was performed in support of the subject 510(k).
Overall Conclusion: Conclusions
The Acumen AFM Software Feature on HemoSphere Advanced Monitoring Platform with the subject modifications has successfully passed functional and performance testing, including software verification and validation ,bench, and usability studies. Completion of all performance 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 features and design did not adverselv affect the safety and effectiveness of the subject device. The testing performed demonstrates that the
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HemoSphere Advanced Monitoring Platform with subject modifications to the Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Automatic Zeroing of the Heart Reference Sensor, Patient Query, bug fixes and cybersecurity updates is substantially equivalent to its legally marketed predicate device.
§ 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).