(91 days)
Not Found
Yes
The summary explicitly mentions the "Global Hypoperfusion Index (GHI) algorithm" and the "Acumen Hypotension Index (HPI) feature," both of which are described as providing "physiological insight into a patient's likelihood of future hemodynamic instability" or "future hypotensive events." While the terms "AI" or "ML" are not directly used, the description of these features as predictive algorithms that analyze physiological data to forecast future events strongly suggests the use of AI/ML techniques. The summary also mentions the Acumen assisted fluid management (AFM) software feature which "offers suggestions regarding the patient's physiological condition and estimated response to fluid therapy," further indicating the use of advanced analytical algorithms.
No.
The device is indicated for monitoring and providing physiological insights, and explicitly states that no therapeutic decisions should be made based solely on its predictions or suggestions.
Yes
Explanation: The device is indicated for monitoring various hemodynamic parameters and uses algorithms like the Global Hypoperfusion Index (GHI) and Acumen Hypotension Index (HPI) to provide physiological insight into a patient's likelihood of future hemodynamic events, which are diagnostic indicators. While it notes that no therapeutic decisions should be made solely on these predictions, the core function is to assess and provide information about a patient's current and future physiological state, which falls under diagnostic purposes.
No
The device description explicitly states it is a "Monitoring Platform" and mentions hardware components like the "HemoSphere Monitor, the ClearSight Module, Pressure Controller, Heart Reference and finger cuff" in the Electrical Safety and EMC testing section. While it includes software features and algorithms, it is not solely software.
Based on the provided text, the HemoSphere Alta monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- HemoSphere Alta's Function: The HemoSphere Alta monitor is a hemodynamic monitoring platform. It measures and displays physiological parameters directly from the patient's body (e.g., cardiac output, blood pressure, oxygen saturation) using various sensors and catheters. While it uses blood temperature for thermodilution and measures venous oxygen saturation, it is not analyzing a specimen in the traditional sense of an IVD. It's measuring parameters in vivo or directly from the circulating blood within the patient.
- Intended Use: The intended use clearly describes monitoring hemodynamic parameters in critical care patients. This is a physiological monitoring function, not an in vitro diagnostic test.
- Lack of Specimen Analysis: The description focuses on the device's ability to interact with and visualize data from sensors and catheters placed within or on the patient. There is no mention of collecting and analyzing a sample outside of the body.
Therefore, the HemoSphere Alta monitor falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
HemoSphere Alta Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [CO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
HemoSphere Alta monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requring 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 Alta Monitor with HemoSphere Pressure Cable
The HemoSphere Alta 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer 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
§ 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).
0
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October 31, 2023
Edwards Lifesciences, LLC Varad Raghuwanshi - Sr. Manager Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K232294
Trade/Device Name: HemoSphere Alta 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, QNL Dated: July 31, 2023 Received: August 1, 2023
Dear Varad Raghuwanshi:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K232294
Device Name
HemoSphere Alta Advanced Monitoring Platform
Indications for Use (Describe) HemoSphere Alta Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable and Edwards Swan-Ganz catheters is indicated for use in adult and pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [CO]) and derived hemodynamic parameters in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
HemoSphere Alta monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric crtical care patients requring 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 Alta Monitor with HemoSphere Pressure Cable
The HemoSphere Alta 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer 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 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/5/Picture/1 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in white, set against a gray square background. The letter 'E' is partially overlaid with a circular design, adding a modern touch to the classic letterform. Below the square, the name 'Edwards' is written in a simple, sans-serif font.
510(k) Summary – HemoSphere Alta Advanced Monitoring Platform
I. Submitter:
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact Person: | Varad Raghuwanshi
Sr. Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 756-4502
Fax: (949) 809-2972 |
Date Prepared: July 28, 2023
II. Device Information:
| Platform Name
| (Name of the Device) | HemoSphere Alta Advanced Monitoring Platform |
|---|---|
| Trade Name: | HemoSphere Alta Advanced Cardiac Monitor |
| HemoSphere Alta Advanced Smart Recovery Monitor | |
| HemoSphere Alta All-on-One monitor | |
| Acumen Hypotension Prediction Index software feature | |
| Acumen Assisted Fluid Management software feature | |
| Right Ventricular Pressure Feature | |
| Global Hypoperfusion Index Feature | |
| CCO Cable - HemoSphere Alta monitoring platform | |
| Common Name: | Programmable Diagnostic/Oximetry/Ejection Fraction/ Noninvasive blood |
| pressure measurement computer/Adjunctive predictive Cardiovascular | |
| Indicator/Adjunctive Open Loop Fluid Therapy Recommender | |
| Classification | |
| Name: | 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 21 CFR 870.2700 |
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Image /page/6/Picture/1 description: The image shows a logo for a company or organization, featuring a large letter 'E' in a grid-like background. The 'E' is stylized and appears to be partially overlaid with a circular design. Below the logo, the word 'Edwards' is written in a simple, sans-serif font, indicating that this is likely the name associated with the logo.
| Noninvasive blood pressure measurement system | 21 CFR 870.1130 |
|---|---|
| Impedance plethysmograph | 21 CFR 870.2770 |
| Thermometer, Electronic, Clinical | 21 CFR 880.2910 |
| Adjunctive Open Loop Fluid Therapy Recommender | 21 CFR 870.5600 |
| Medium-Term Adjunctive Predictive Cardiovascular | |
| Indicator | 21 CFR 870.2210 |
| Product Code
and Regulatory
| Class: | DQK, Class II |
|---|---|
| DQE, Class II | |
| QAQ, Class II | |
| MUD, Class II | |
| DXN, Class II | |
| DSB, Class II | |
| FLL, Class II | |
| QMS, Class II | |
| QNL, Class II |
III. Predicate Device
| Primary
Predicate Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards
Lifesciences, K213682, cleared on June 22, 2022. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Additional
Predicate
Devices: | HemoSphere Advanced Monitoring Platform by Edwards Lifesciences,
K221704 cleared on Nov 22, 2022, utilized for the Right Ventricular
Pressure (RVP) parameter.
Global Hypoperfusion Index (GHI) algorithm by Edwards Lifesciences
K231038 cleared on July 26, 2023 utilized for the Global Hypoperfusion
Index (GHI) parameter. |
IV. Device Description
The HemoSphere Alta™ Advanced Monitoring Platform is Edwards' next-Device generation platform that provides a means to interact with and visualize Description: hemodynamic and volumetric data on a screen. The HemoSphere Alta™ Monitoring Platform provides an improved user interface utilizing the existing Edwards technologies and algorithms commercially available in the HemoSphere Advanced Monitoring Platform.
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Image /page/7/Picture/1 description: The image shows a logo for a company or organization, featuring a large letter 'E' superimposed over a grid pattern. The grid is composed of small squares, and the letter 'E' is white, contrasting with the gray background of the grid. Below the grid and letter, the word 'Edwards' is written in a serif font, indicating that this is likely the name of the company or brand represented by the logo.
V. Indications for Use:
HemoSphere Alta Advanced Monitor with Swan-Ganz Technology
The HemoSphere Alta monitor when used with the HemoSphere Alta Swan-Ganz patient cable 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 in a hospital environment. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes. The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
HemoSphere Alta monitor with HemoSphere Oximetry Cable
The HemoSphere Alta monitor when used with the HemoSphere oximetry cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
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Image /page/8/Picture/1 description: The image shows a logo for Edwards. The logo features a large, white letter 'E' superimposed over a gray grid pattern. The word 'Edwards' is written in a serif font below the letter 'E'.
HemoSphere Alta Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Alta 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure The HemoSphere Alta Advanced Monitoring Platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight /ForeSight Jr sensors, and ClearSight/Acumen IQ finger cuffs.
A comprehensive list of parameters available while monitoring with the HemoSphere Alta Advanced Monitor and a connected Swan-Ganz patient cable are listed below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population.
| Parameter | Description | Patient
Population | Hospital
Environment |
|-----------|------------------------------------------------------|------------------------|-----------------------------------------------------------|
| CO | continuous cardiac output | Adult only | Operating Room,
Intensive Care Unit,
Emergency Room |
| sCO | STAT cardiac output | | |
| CI | continuous cardiac index | | |
| sCI | STAT cardiac index | | |
| EDV | right ventricular end diastolic volume | | |
| sEDV | STAT right ventricular end diastolic
volume | | |
| EDVI | right ventricular end diastolic volume
index | | |
| sEDVI | STAT right ventricular end diastolic
volume index | | |
| HRavg | averaged heart rate | | |
| LVSWI | left ventricular stroke work index | | |
| PVR | pulmonary vascular resistance | | |
| PVRI | pulmonary vascular resistance index | | |
| RVEF | right ventricular ejection fraction | | |
| sRVEF | STAT right ventricular ejection fraction | | |
| RVSWI | right ventricular stroke work index | | |
| SV | stroke volume | | |
| SVI | stroke volume index | | |
| SVR | systemic vascular resistance | | |
| SVRI | systemic vascular resistance index | | |
| iCO | intermittent cardiac output | Adult and
Pediatric | |
| iCI | intermittent cardiac index | | |
| iSVR | intermittent systemic vascular resistance | | |
| iSVRI | intermittent systemic vascular resistance
index | | |
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Image /page/11/Picture/1 description: The image shows a logo for Edwards. The logo features a large, white letter "E" superimposed over a grid pattern. The letter "E" is partially enclosed within a white circle. Below the graphic is the word "Edwards" in a simple, sans-serif font.
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Alta Advanced Monitor and a connected HemoSphere oximetry cable are as listed below:
| Parameter | Description | Patient
Population | Hospital
Environment |
|-----------|----------------------------------|------------------------|-----------------------------------------------------------|
| SvO2 | Mixed Venous Oxygen Saturation | Adult and
Pediatric | Operating Room,
Intensive Care Unit,
Emergency Room |
| ScvO2 | Central Venous Oxygen Saturation | | |
A comprehensive list of parameters available while monitoring with the HemoSphere Alta monitor and both a connected HemoSphere Alta Swan-Ganz patient cable and Oximetry cable are listed below:
| Parameter | Description | Patient
Population | Hospital
Environment |
|-----------|---------------------------------------------------------------------|------------------------|-----------------------------------------------------------|
| DO2 | Oxygen Delivery | | |
| DO2I | Oxygen Delivery Indexed | | |
| VO2 | Oxygen Consumption | | |
| VO2e | Estimated Oxygen Consumption when
ScvO2 is being monitored | Adult and
Pediatric | Operating Room,
Intensive Care Unit,
Emergency Room |
| VO2I | Oxygen Consumption Index | | |
| VO2Ie | Estimated Oxygen Consumption Index
when ScvO2 is being monitored | | |
| GHI | global hypoperfusion index | Adult only | |
A comprehensive list of parameters available while monitoring with the HemoSphere Alta monitor and both a connected HemoSphere Alta Swan-Ganz patient cable and pressure cable are listed below:
| Parameter | Description | Patient
Population | Hospital
Environment |
|-----------|-------------------------------|-----------------------|-----------------------------------------|
| CO20s | 20-second cardiac output | | |
| CI20s | 20-second cardiac index | Adult only | Operating room,
intensive care unit, |
| SV20s | 20-second stroke volume | | emergency room |
| SVI20s | 20-second stroke volume index | | |
A comprehensive list of parameters available while monitoring with the HemoSphere Alta monitor and a connected HemoSphere pressure cable are listed below:
| Parameter | Description | Patient
Population | Hospital
Environment |
|-----------|----------------------------------------------------------|-----------------------|-----------------------------------------------------------|
| CO/
CI | Continuous Cardiac Output¹/ Continuous
Cardiac Index1 | Adult only | Operating Room,
Intensive Care Unit,
Emergency Room |
| CVP | Central Venous Pressure | | |
| DIAART | Systemic arterial diastolic blood
pressure | | |
| DIAPAP | pulmonary artery diastolic blood | | |
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Image /page/12/Picture/1 description: The image shows a logo with a large white letter 'E' superimposed on a gray grid background. The grid is composed of small squares, creating a structured pattern behind the letter. Below the grid and letter, the word 'Edwards' is written in a serif font, indicating that this is likely a company or brand logo.
| pressure | |||
|---|---|---|---|
| Systolic slope2 | |||
| Eadyn | Dynamic Arterial Elastance2 | ||
| MAP | Mean Arterial Pressure | ||
| MPAP | Mean Pulmonary Arterial Pressure | ||
| PPV | pulse pressure variation1 | ||
| PR | Pulse rate | ||
| SV/ | Stroke Volume1/ | ||
| SVI | Stroke Volume Index1 | ||
| SVR/ | Systemic Vascular Resistance1/ Systemic | ||
| SVRI | Vascular Resistance1 Index | ||
| SVV | Stroke Volume Variation1 | ||
| SYSART | Systolic Blood Pressure | ||
| SYSPAP | Systolic pulmonary artery blood pressure | ||
| RVEDP | Right Ventricular End Diastolic Pressure | ||
| RV dP/dt | Maximal right ventricular systolic slope | ||
| SYSRVP | Systolic Right Ventricular Pressure | ||
| DIARVP | Right Ventricular Diastolic Pressure | ||
| MRVP | Mean Right Ventricular Pressure | ||
| PRRVP | Right Ventricular Pulse Rate | ||
| HPI | Acumen Hypotension Prediction Index | Operating Room, | |
| Intensive Care Unit | |||
| 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 Alta monitor and a connected HemoSphere pressure cable are listed below:
| AFM output | Patient Population | Hospital
Environment |
|----------------------------------------------------------------------------------------------|-----------------------|-------------------------|
| Fluid Bolus Suggested | | |
| Test Bolus Suggested | ≥18 years of age only | Operating room |
| Fluid Not Suggested | | |
| Suggestions Suspended | | |
| Bolus In Progress... | | |
| Bolus Complete | | |
| Bolus Complete; Analyzing
Hemodynamic Response | | |
| Tracked Case Vol. | | |
| AFM outputs are available when using an Acumen IO sensor and if the AFM feature is activated | | |
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Alta monitor and both a connected HemoSphere pressure cable and oximetry cable are listed below:
| Parameter | Description | Patient Population | Hospital
Environment |
|-----------|---------------------------------------------------------------|--------------------|-----------------------------------------------------------|
| DO2 | Oxygen Delivery | | |
| DO2I | Oxygen Delivery Indexed | | Operating Room,
Intensive Care Unit,
Emergency Room |
| VO2 | Oxygen Consumption | Adult only | |
| VO2e | Estimated Oxygen Consumption
when ScvO2 is being monitored | | |
| VO2I | Oxygen Consumption Index | | |
13
Image /page/13/Picture/1 description: The image shows a logo for Edwards. The logo features a large, white letter 'E' superimposed on a gray square grid. There are also some white circles behind the letter 'E'. The word 'Edwards' is written in black below the logo.
| VO2Ie | Estimated Oxygen Consumption
Index when ScvO2 is being
monitored | | |
| ------- | ------------------------------------------------------------------------ | -- | -- |
|---|
Tissue oxygen saturation, StO2, can be monitored with the HemoSphere Alta monitor and a connected ForeSight oximeter cable as listed below.
| Parameter | Description | Patient Population | Hospital
Environment |
|-----------|----------------------------------------|---------------------|----------------------------------------|
| StO2 | Tissue oxygen saturation | Adult and Pediatric | Operating Room, |
| △ctHb | relative change in total
hemoglobin | Adult and Pediatric | Intensive Care Unit,
Emergency Room |
A comprehensive list of parameters available while monitoring with the HemoSphere Alta Advanced Monitor and a connected Pressure controller are listed below:
| Parameter | Description | Patient Population | Hospital
Environment |
|-----------|---------------------------------------------------------------------|--------------------|-----------------------------------------------------------|
| CO/CI | Continuous Cardiac Output/
Continuous Cardiac Index | | Operating Room,
Intensive Care Unit,
Emergency Room |
| DIA | Noninvasive arterial diastolic blood
pressure | | |
| MAP | Noninvasive Mean Arterial Pressure | | |
| PPV | pulse pressure variation | | |
| PR | Noninvasive Pulse rate | | |
| SV/SVI | Stroke Volume/
Stroke Volume Index | Adult only | |
| SVR/SVRI | Systemic Vascular Resistance/
Systemic Vascular Resistance Index | | |
| SVV | Stroke Volume Variation | | |
| SYS | Systolic Blood Pressure | | |
| dP/dt | Maximal slope of the arterial
pressure upstroke1 | | |
| Eadyn | Dynamic Arterial Elastance1 | | |
| HPI | Acumen Hypotension Prediction
Index1 | | Operating Room
only |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere advanced monitor and both a connected pressure controller and oximetry cable are listed below:
| Parameter | Description | Sub-System
Module
Used | Patient
Population | Hospital
Environment |
|-----------|------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------------|----------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | | | |
| VO2 | Oxygen Consumption | HemoSphere
ClearSight
Module and
HemoSphere
Oximetry
Cable | Adult only | Operating
Room,
Intensive
Care Unit |
| VO2e | Estimated Oxygen Consumption
when ScvO2 is being monitored | | | |
| VO₂I | Oxygen Consumption Index | | | |
| VO2Ie | Estimated Oxygen Consumption
Index when ScvO2 is being
monitored | | | |
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Image /page/14/Picture/1 description: The image shows a logo with the letter 'E' in white, overlaid on a gray square grid. The letter 'E' is stylized with curved lines and circles, giving it a modern and elegant appearance. Below the square is the word 'Edwards' in a simple, sans-serif font.
VI. Comparison of Technological Characteristics with the Predicate Devices:
The subject and predicate devices are based on the following same technological elements:
- Indication and Intended Use: The subject device has the same intended use and indication as the predicate.
- Technological characteristics: The subject device has the same technological characteristics as the predicate. Both subject and predicate devices use the same technologies and algorithms to provide hemodynamic monitoring.
- Accessories/Components: The subject and the predicate device both use the same accessories, Pressure controller, Heart Reference Sensor, ClearSight/Acumen IQ Cuffs for measurement of non-invasive parameters.
The following technological differences exist between the subject and predicate devices:
- Hardware: The subject device includes new hardware for the monitor with high resolution larger display to facilitates improved user interface. In addition, the new hardware integrates the existing subsystem modules available with the predicates device within the monitor (non-modular) to provide more accessible and faster set up.
- Software: The subject device includes an updated software ■ architecture to support the new integrated hardware (nonmodular).
- 트 Graphical User Interface (GUI): The subject device includes an updated user interface to allow improved accessibility and utilization of multiple functions intuitively on one screen and provides additional customization options.
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Image /page/15/Picture/1 description: The image shows a logo for Edwards. The logo features a large, white letter "E" superimposed on a gray square. The letter "E" is stylized with a globe design incorporated into its form. Below the square, the word "Edwards" is written in a simple, sans-serif font.
In addition, voice and gesture functionalities have been included for limited feature sets to provide user convenience.
A brief description of the key highlights of the subject HemoSphere Alta™ Advanced Monitoring Platform and a comparative overview with the predicate HemoSphere Advanced Monitoring Platform is provided below:
- & New Hardware to integrate the existing HemoSphere subsystem modules:
The HemoSphere Alta Advanced Monitoring Platform includes new hardware for the monitor with higher resolution and larger display size that connects with the existing HemoSphere cables and accessories: HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ForeSight Oximeter Cable, Pressure Controller, and Heart Reference Sensor.
Contrary to the current HemoSphere Advanced Monitoring Platform, which incorporates a modular approach, the subject HemoSphere Alta™ Monitoring Platform integrates the existing HemoSphere subsystem modules (HemoSphere Swan Ganz Module, HemoSphere Technology Module, HemoSphere ClearSight Module) into the Monitor to bring together Edwards existing Critical Care technologies to a unified platform. This integrated system approach facilitates more accessible and faster set up.
-
- Improved Graphical User Interface (GUI)- New GUI for the existing features and functionality currently available on the existing HemoSphere Platform:
The HemoSphere Alta™ Advanced Monitoring Platform includes a larger monitor display with an updated user interface. The updated user interface allows users to access, organize and utilize multiple functions intuitively on one screen, and it also provides additional customization options for users to select the information they need.
- Improved Graphical User Interface (GUI)- New GUI for the existing features and functionality currently available on the existing HemoSphere Platform:
In addition, optional voice and gesture functionalities have been included for limited feature sets of non-critical activities to provide user convenience.
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Image /page/16/Picture/1 description: The image shows a logo for Edwards. The logo features a large, white letter 'E' superimposed over a grid pattern. The grid pattern is composed of gray squares. Below the logo, the word 'Edwards' is written in a serif font.
-
- Technologies and Algorithms- Uses the same core technologies and algorithms as the HemoSphere Platform:
Technologies: -
The HemoSphere Alta Monitoring Platform uses the existing core technologies commercially available with the predicate HemoSphere Advanced Monitoring Platform. The following five (5) existing core technologies are integrated into the Subject HemoSphere Alta monitoring Platform:
- Swan Ganz (Invasive) O
- Pressure using an Arterial line (Minimally Invasive) O
- Venous Oximetry (Invasive) O
- Tissue Oximetry (Non-Invasive) O
- ClearSight (Non-Invasive) O
Algorithms: -
The HemoSphere Alta Monitoring Platform uses the existing algorithms commercially available with the predicate HemoSphere Advanced Monitoring Platform to facilitate hemodynamic monitoring.
- ಳು Updated software architecture to integrate the existing HemoSphere Advanced Monitoring Platform technologies:
The HemoSphere Alta Monitoring Platform includes an updated software architecture to support the new integrated hardware (nonmodular). The software architecture for the subject HemoSphere Alta platform allows improved connection between the host software and hardware compared to the predicate HemoSphere platform to facilitate efficient integration between hardware and software and enhance maintenance and extendibility.
& Modifications to the Labeling of the existing associated accessories to include HemoSphere Alta Monitoring Platform:
- The ClearSight/Acumen IQTM Finger Cuffs (Cleared in ■ K160552 June 1, 2016, and K190130 June 21, 2019) indications for use are being updated to add the HemoSphere Alta Monitoring Platform to the indications for use as part of this subject 510(k). No other changes are occurring to the ClearSight/Acumen IQ Finger Cuffs.
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Image /page/17/Picture/1 description: The image shows the logo for Edwards. The logo features a gray square with a white letter "E" inside. The letter "E" is partially obscured by a white circle. Below the square, the word "Edwards" is written in a serif font.
| Edwards | ||
|---|---|---|
| The Pressure Controller (Cleared in K160552 June 1, 2016) indications for use are being updated to add the HemoSphere Alta Monitoring Platform to the indications for use as part of this subject 510(k). No other changes are occurring to the Pressure Controller/Wrist Unit. | ||
| The Heart Reference Sensor (K182245 cleared November 30, 2018) indications for use are being updated to add the HemoSphere Alta Monitoring Platform to the indications for use as part of this subject 510(k). No other changes are occurring to the Heart Reference Sensor. | ||
| The following verification activities were performed in support of a substantial equivalence determination. | ||
| Performance | ||
| Data: | Usability Study | |
| Usability study was conducted per FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices” to investigate primary operating functions and critical tasks of the system for any usability issues regarding the HemoSphere Alta Advanced Monitoring Platform that may lead to patient or user harm. |
The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm.
System Verification (Non-Clinical Performance):
Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the design and materials used did not adversely affect the safety and effectiveness of the subject device.
Measured and derived parameters were tested using a bench simulation. Additionally, system integration and mechanical testing was successfully conducted to verify the safety and effectiveness of the device. All tests passed. | |
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Image /page/18/Picture/1 description: The image shows a logo for Edwards. The logo features a large, stylized letter "E" in white, set against a gray square background with a grid pattern. Below the square, the word "Edwards" is written in a simple, sans-serif font.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject HemoSphere Advanced Monitoring Platform, consisting of the HemoSphere Monitor, the ClearSight Module, Pressure Controller, Heart Reference and finger cuff. The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366-1, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49 and IEC 80601-2-49. All tests passed.
Software Verification
Software verification testing were conducted, and documentation was provided per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". All tests passed.
Clinical Performance
No new clinical testing was performed in support of the subject 510(k).
The technological characteristics of the subject and predicate devices are Conclusion identical. The HemoSphere Alta Advanced Monitoring Platform has successfully passed functional and performance testing, including software verification and validation, system integration, mechanical, electrical, human factor usability, and safety testing. The testing performed demonstrates that the HemoSphere Alta Advanced Monitoring Platform is substantially equivalent to the legally marketed predicates.