(35 days)
Indications for Use: 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-Gatheter 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 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 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.
Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.
HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable The noninvasive ForeSight Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
• 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.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the ClearSight finger cuff indications for information on target patient population specific to the finger cuff being used.
Intended Use of HemoSphere Advanced Monitor: 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, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.
Intended Use of Viewfinder Remote: Viewfinder Remote is a mobile application, which provides supplemental remote near real-time display of hemodynamic data measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.
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 Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).
The regulatory submission K223127 for the HemoSphere Advanced Monitoring Platform indicates a modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable. The submission claims substantial equivalence to a predicate device (K213682 cleared June 22, 2022) and an additional predicate (Fore-Sight Elite Module Tissue Oximeter, K143675 cleared April 10, 2015) for the StO2 algorithm.
Here's an analysis based on the provided text, fulfilling the requested information points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that "All testing passed without exception" and the "modification did not adversely affect the safety and effectiveness of the subject device." However, specific numerical acceptance criteria (e.g., accuracy +/- X%, bias Y, precision Z) and the corresponding reported performance values for the StO2 algorithm are not explicitly provided in the given text.
The text vaguely indicates that:
- "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
- "The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification."
- "Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged."
Without the actual specific criteria and reported values from the predicate device's clearance, a detailed table with numerical data cannot be generated from this document.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It mentions "Algorithm Verification" and "System Verification" without detailing the number of cases or patients included in these tests. The data provenance (e.g., country of origin, retrospective or prospective) is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set. Given that the modified device measures "absolute regional hemoglobin oxygen saturation (StO2)," the ground truth would typically be established through a reference method (e.g., co-oximetry of arterial and venous blood samples, or another validated oximetry technique) rather than expert consensus on images.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that an MRMC comparative effectiveness study was performed. The device is a monitoring platform providing quantitative physiological parameters, not an imaging device requiring human reader interpretation in the same way.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone performance study of the algorithm was done. The submission explicitly states:
- "Algorithm performance was tested using the same method and criteria as previously used in the predicate device."
- "The results establish that the modification did not adversely affect the safety and effectiveness of the subject device."
This "Algorithm Verification" section refers to directly testing the algorithm's performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used but implies it would be a comparison to existing specifications from the predicate devices. For a tissue oximeter measuring StO2, the ground truth would typically involve comparison to a validated reference method for oxygen saturation, possibly through in-vivo or in-vitro testing. It is not expert consensus on images or pathology in this context.
8. Sample Size for the Training Set
The document does not provide the sample size for the training set. This is a modification to an existing algorithm, so the original algorithm would have been developed and trained, but details about that original training are not in this submission.
9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set (of the original algorithm) was established. It only refers to the modification of an "existing StO2 algorithm."
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November 7, 2022
Edwards Lifeciences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614
Re: K223127
Trade/Device Name: HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB, QMS, FLL Dated: September 30, 2022 Received: October 3, 2022
Dear Michelle Ducca:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Special 510(k) - HemoSphere Advanced Monitoring Platform
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K22XXXXX
Device Name
HemoSphere Advanced Monitoring Platform
Indications for Use (Describe)
Indications for Use: 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-Gatheter 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 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 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with Acumen Assisted Fluid Management Feature and Acumen IQ Sensor: The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy.
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Special 510(k) - HemoSphere Advanced Monitoring Platform
Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.
HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable The noninvasive ForeSight Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
• 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.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the ClearSight finger cuff indications for information on target patient population specific to the finger cuff being used.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K223127 K22XXXX
510(k) Summary – HemoSphere Advanced Monitoring Platform
I. Submitter:
Sponsor: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Establishment 2015691 Registration Number:
- Contact Person: Michelle Ducca Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614 michelle ducca@edwards.com Telephone: (949) 250-4113
Date Prepared: September 30, 2022
Device Information: II.
Platform Name HemoSphere Advanced Monitoring Platform
| Trade Name: | HemoSphere Advanced Monitor | |
|---|---|---|
| HemoSphere Swan-Ganz Module | ||
| HemoSphere Oximetry Cable | ||
| HemoSphere Pressure Cable | ||
| HemoSphere Technology Module | ||
| HemoSphere ForeSight Oximeter Cable (Subject) | ||
| HemoSphere ClearSight Module | ||
| Acumen Hypotension Prediction Index (HPI) for Minimally Invasive andNon-Invasive technology | ||
| Viewfinder Remote (for non-invasive parameters) | ||
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | |
| Classification Name forHemoSphere Monitor andAccessories: | Programmable Diagnostic Computer | 21 CFR 870.1425 |
| Fiberoptic Oximeter Catheter | 21 CFR 870.1230 | |
| Adjunctive Predictive Cardiovascular Indicator | 21 CFR 870.2210 | |
| Oximeter, Tissue Saturation (Non-Invasive) | 21 CFR 870.2700 | |
| System, Measurement, Blood-Pressure, Non-Invasive | 21 CFR 870.1130 | |
| Plethysmograph, Impedance | 21 CFR 870.2770 |
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| Product Code | DQK, Class II |
|---|---|
| for | DQE, Class II |
| HemoSphere | QAQ, Class II |
| Monitor andAccessories: | MUD, Class II |
| DXN, Class II | |
| DSB, Class II |
III. Predicate Device
HemoSphere Advanced Monitoring Platform, manufactured by Edwards Primarv Predicate: Lifesciences, K213682 cleared June 22, 2022, is being utilized for substantial equivalence to the device modularity, basic device functionality, graphical user interface (GUI), and same existing StO2 algorithm specifications. The subject device contains the same indications and intended use as the predicate device.
Fore-Sight Elite Module Tissue Oximeter, manufactured by Casmed Inc. (now Additional part of Edwards Lifesciences), K143675 cleared April 10, 2015, is being Predicate: utilized for substantial equivalence to the StO2 algorithm. This predicate contains the original StO2 algorithm for cerebral and somatic locations using all sensor sizes. It has the same principle of operation and similar intended and indications for use and performance as the subject device.
IV. Device Description:
Device The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for Description: 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 Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).
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V. Indications for Use:
Indications for Note: There is no change to the Indication for Use statements from what was Use: previously cleared in K213682 on June 22, 2022
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 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 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
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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 Fluid Management Feature and Acumen IQ Sensor:
The Acumen Assisted Fluid Management (AFM) software feature provides the clinician with physiological insight into a patient's estimated response to fluid therapy and the associated hemodynamics. The Acumen AFM software feature is intended for use in surgical patients ≥18 years of age, that require advanced hemodynamic monitoring. The Acumen AFM software feature offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy. Acumen AFM fluid administration suggestions are offered to the clinician; the decision to administer a fluid bolus is made by the clinician, based upon review of the patient's hemodynamics. No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions.
HemoSphere Advanced Monitor with HemoSphere Technology Module and ForeSight Oximeter Cable
The noninvasive ForeSight Oximeter Cable is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the sensors in individuals at risk for reduced-flow or no-flow ischemic states. The ForeSight Oximeter Cable is also intended to monitor relative changes of total hemoglobin of blood under the sensors. The ForeSight Oximeter Cable is intended to allow for the display of StO2 and relative change in total hemoglobin on the HemoSphere advanced monitor.
- o 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
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The HemoSphere Advanced Monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards' finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Intended Use of Note: There is no change to the Intended Use from what was cleared in the K213682 on June 22, 2022 HemoSphere Intended Use- HemoSphere Advanced Monitoring Platform: Advanced The HemoSphere Advanced Monitoring Platform is intended to be used by Monitor: 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, TruWave DPT sensors, ForeSight sensors, and ClearSight/Acumen IQ finger cuffs.
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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 | HemoSphereSwan-GanzModule | Adult only | OperatingRoom,Intensive CareUnit,EmergencyRoom |
| sCO | STAT cardiac output | |||
| CI | continuous cardiac index | |||
| sCI | STAT cardiac index | |||
| EDV | right ventricular end diastolicvolume | |||
| sEDV | STAT right ventricular enddiastolic volume | |||
| EDVI | right ventricular end diastolicvolume index | |||
| sEDVI | STAT right ventricular enddiastolic volume index | |||
| HRavg | averaged heart rate | |||
| LVSWI | left ventricular stroke work index | |||
| PVR | pulmonary vascular resistance | |||
| PVRI | pulmonary vascular resistanceindex | |||
| RVEF | right ventricular ejection fraction | |||
| sRVEF | STAT right ventricular ejectionfraction | |||
| RVSWI | right ventricular stroke work index | |||
| SV | stroke volume | |||
| SVI | stroke volume index | |||
| SVR | systemic vascular resistance | Adult andPediatric | ||
| SVRI | systemic vascular resistance index | |||
| BT | pulmonary artery blood temperature | |||
| iCO | intermittent cardiac output | |||
| 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:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| SvO2 | Mixed Venous Oxygen Saturation | HemoSphereOximetryCable | Adult andPediatric | OperatingRoom,Intensive CareUnit, |
| ScvO2 | Central Venous Oxygen Saturation | EmergencyRoom |
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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,Intensive CareUnit,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 | HemoSpherePressureCable | Adult only | OperatingRoom,Intensive CareUnit,EmergencyRoom |
| CVP | Central Venous Pressure | |||
| DIA | Systemic arterial diastolic bloodpressure | |||
| DIAPAP | pulmonary artery diastolic bloodpressure | |||
| dP/dt | Systolic slope² | |||
| Eadyn | Dynamic Arterial Elastance² | |||
| MAP | Mean Arterial Pressure | |||
| MPAP | Mean Pulmonary Arterial¹ Pressure | |||
| PPV | pulse pressure variation¹ | |||
| PRART | Pulse rate | |||
| SV/SVI | Stroke Volume¹/Stroke Volume Index¹ | |||
| SVR/SVRI | Systemic Vascular Resistance¹/Systemic Vascular Resistance¹Index | |||
| SVV | Stroke Volume Variation¹ | |||
| SYSART | Systemic Arterial Systolic BloodPressure | |||
| SYSPAP | Pulmonary Artery Systolic BloodPressure | |||
| HPI | Acumen Hypotension PredictionIndex² | |||
| ¹FloTrac parameters are available when using a FloTrac/Acumen IQ sensor and if the FloTrac feature is enabled. |
| 24Pl parameters are available when 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-SystemModule Used | PatientPopulation | HospitalEnvironment |
|---|---|---|---|
| Fluid Bolus Suggested | HemoSpherePressureCable | ≥18 years of ageonly | OperatingRoom |
| Test Bolus Suggested | |||
| Fluid Not Suggested | |||
| Suggestions Suspended | |||
| Bolus in Progress... | |||
| Bolus Complete | |||
| Bolus Complete; Analyzing HemodynamicResponse | |||
| Tracked Case Vol. | |||
| AFM outputs are available when using an Acumen IQ sensor and if the AFM feature is activated. |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable and a connected HemoSphere oximetry cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphereSwan-GanzModule andHemoSphere | Adult only | OperatingRoom,Intensive CareUnit, |
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | |||
| VO2I | Oxygen Consumption Index | |||
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored | HemoSphereOximetryCable |
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, |
| CI20s | 20-second cardiac index | Swan-Ganz | Intensive CareUnit, | |
| SV20s | 20-second stroke volume | Module andHemoSphere | EmergencyRoom | |
| SVI20s | 20-second stroke volume index | PressureCable |
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.
| Parameter | Description | Sub-System Module Used | Patient Population | Hospital Environment |
|---|---|---|---|---|
| ----------- | ------------- | ------------------------ | -------------------- | ---------------------- |
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| StO2 | Absolute regional hemoglobin oxygen saturation of blood under the sensors | ForeSight Oximeter Cable and | Adult and Pediatric | Operating Room,Intensive Care Unit,Emergency Room |
|---|---|---|---|---|
| ΔctHb | Relative change in Total Hemoglobin | HemoSphere Technology Module |
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 CardiacOutput/ContinuousCardiac Index | |||
| DIA | Noninvasive arterial diastolicbloodpressure | |||
| MAP | Noninvasive Mean ArterialPressure | |||
| PPV | pulse pressure variation | |||
| PR | Noninvasive Pulse rate | |||
| SV/SVI | Stroke Volume/Stroke VolumeIndex | HemoSphereClearSightModule | Adult only | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
| SVR/SVRI | Systemic Vascular ResistanceSystemic Vascular ResistanceIndex | |||
| SVV | Stroke Volume Variation | |||
| SYS | Systolic Blood Pressure | |||
| dP/dt | Maximal slope of thearterialpressure upstroke1 | |||
| Eadyn | Dynamic Arterial Elastance1 | |||
| HPI | Acumen HypotensionPredictionIndex1 | Operating Roomonly | ||
| 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 monitoredparameters use a reconstructed radial arterial waveform. SVR/SVRI are derived from CO/CI andMAP 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 | Adult only | OperatingRoom, |
| VO2 | Oxygen Consumption | Module and |
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| VO2e | Estimated Oxygen Consumptionwhen ScvO2 is being monitored | HemoSphereOximetry | Intensive CareUnit |
|---|---|---|---|
| VO2I | Oxygen Consumption Index | Cable | |
| VO2Ie | Estimated Oxygen ConsumptionIndex when ScvO2 is beingmonitored |
Intended Use of Viewfinder Remote:
Viewfinder Remote is a mobile application, which provides supplemental remote near real-time display of hemodynamic data measured by a connected HemoSphere advanced monitoring platform. Viewfinder Remote allows clinicians to view continuous monitoring data and alarms/alerts remotely for multiple patients. All displayed data is generated by connected HemoSphere advanced monitoring platforms, and not by Viewfinder Remote. Viewfinder Remote is intended for use by clinicians as a supportive visual aid, and not as a replacement for in-person patient monitoring with connected HemoSphere advanced monitoring platforms.
VI. Comparison of Technological Characteristics with the Predicate Devices:
The intended use, indications for use, labeling, instructions, and technological characteristics of the modified device remain unchanged between the subject and the predicate devices.
The following section provides a summary of the modification.
The purpose of this 510(k) submission is to introduce a modification to the HemoSphere ForeSight Oximeter Cable (model HEMFSM10) as part of the HemoSphere Advanced Monitoring Platform (cleared in K213682 on June 22, 2022):
-
Modification to the existing StO2 algorithm of the HemoSphere ForeSight Oximeter Cable (model HEMFSM10)
The existing HemoSphere ForeSight Oximeter cable, which includes the StO2 algorithm to measure tissue oxygen saturation, has been updated to bring the algorithm back to the existing specifications for specific adult somatic (arm and leg) locations using the ForeSight large sensor. -
The following verification activities were performed to evaluate the Performance modification being made as part of this submission. Pass/Fail criteria were Data: based on the specifications cleared for the predicate devices and test results showed substantial equivalence.
Algorithm Verification:
Algorithm performance was tested using the same method and criteria as previously used in the predicate device. The results establish that the
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modification did not adversely affect the safety and effectiveness of the subject device. All testing passed without exception.
System Verification
System verification activities confirmed that the modification to the device did not adversely affect the safety and effectiveness of the subject device, and the change in the algorithm was integrated without any concern. All integration passed with no exceptions The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification. All tests passed.
Design, materials, energy source, user interface, measurement principle and all performance specifications of the modified HemoSphere ForeSight Oximeter cable remain unchanged.
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). This verification included software design, development and traceability. There were no changes to the function, operation or parameters monitored. The same methods, protocols and acceptance criteria as the predicate device (K213682) were used to evaluate the modification. All tests passed.
Conclusions Overall Conclusion:
The technological characteristics of the subject and predicate devices are identical. The HemoSphere Advanced Monitoring platform has successfully passed functional and performance testing, including software verification, algorithm and system test. The conducted testing demonstrates that the modified software algorithm did not adversely affect the safety and effectiveness of the subject device and is substantially equivalent to the 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).