(122 days)
Yes
The "Acumen Hypotension Prediction Index feature" is described as providing "physiological insight into a patient's likelihood of future hypotensive events" and is based on "associated hemodynamics." While not explicitly stating AI/ML, this type of predictive analysis based on physiological data is a common application of these technologies in medical devices. The description of it as "additional quantitative information" also aligns with the output of predictive algorithms.
No
The device is described as a "monitor" and provides "physiological insight" and "additional quantitative information" for "reference only," explicitly stating "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates its primary function is monitoring and assessment, not providing therapy.
Yes
The HemoSphere Advanced Monitor and its modules are indicated for monitoring various physiological parameters (e.g., cardiac output, oxygen saturation, blood pressure) in critical care patients, which classifies it as a diagnostic device because it provides information about a patient's physiological state to aid in medical diagnosis and management.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform consists of a physical monitor and several optional external hardware modules (Swan-Ganz Module, Oximetry Cable, Pressure Cable, Tissue Oximetry Module, FORE-SIGHT ELITE Tissue Oximeter Module, and ClearSight Module). It also mentions interfacing with physical components like catheters, sensors, pressure controllers, and finger cuffs. While software is a component, the device is clearly a hardware-based system with integrated software.
Based on the provided text, the HemoSphere Advanced Monitor with its various modules is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The HemoSphere Advanced Monitor and its modules are described as monitoring hemodynamic parameters (like cardiac output, blood pressure, oxygen saturation) directly from the patient's body using various sensors and catheters. These are in vivo measurements, not in vitro analysis of specimens.
- Intended Use: The intended use statements consistently describe monitoring physiological parameters in critical care and perioperative settings. There is no mention of analyzing biological samples.
- Device Description: The device description details the monitor and external modules that interface with the patient (e.g., Swan-Ganz Module, Oximetry Cable, Pressure Cable, Tissue Oximetry Module, ClearSight Module with finger cuff). This aligns with in vivo monitoring.
Therefore, the HemoSphere Advanced Monitor and its associated modules are considered in vivo monitoring devices, not In Vitro Diagnostic devices.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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 of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cathetry catheters is indicated for use in adult and pediativ critical care patients requiring of venous oxygen saturation (Sv02 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximeter 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 3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects 3 kg, pediatric subjects
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 16, 2021
Edwards Lifesciences, LLC Varad Raghuwanshi Sr. Specialist, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K201446
Trade/Device Name: HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB
Dear Varad Raghuwanshi:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 1, 2020. Specifically, FDA is updating this SE Letter as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact LT Stephen Browning, OHT2: Office of Cardiovascular Devices, 240-402-5241, Stephen.Browning(@fda.hhs.gov.
Sincerely,
Jennifer W. Shih -S
for LT 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 1, 2020
Edwards Lifesiences, LLC Varad Raghuwanshi Sr. Specialist, Regulatory Affairs One Edwards Wav Irvine, California 92614
Re: K201446
Trade/Device Name: HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, DOE, OAO, MUD, DXN, DSB Dated: May 29, 2020 Received: June 1, 2020
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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S5
LT 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
3
Indications for Use
510(k) Number (if known) K201446
Device Name
HemoSphere Advanced Monitoring Platform
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cathetry catheters is indicated for use in adult and pediativ critical care patients requiring of venous oxygen saturation (Sv02 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximeter 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 3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor and a person is not required to respond to a collection of
'An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary – HemoSphere Advanced Monitoring Platform
I. Submitter:
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 | Product Code
and Regulatory
Class: | DQK, Class II |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|---------------|
| Establishment
Registration
Number: | 2015691 | | DQE, Class II |
| Contact Person: | Varad Raghuwanshi
Sr. Specialist, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 756-4502
Fax: (949) 809-2972 | | QAQ, Class II |
| Date Prepared: | May 29, 2020 | | MUD, Class II |
| II.
Device Information: | | | DXN, Class II |
| Platform Name
(Name of the
Device) | HemoSphere Advanced Monitoring Platform | | DSB. Class II |
| Trade Name: | HemoSphere Advanced Monitor
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable
HemoSphere Pressure Cable
HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue
Oximeter Module
HemoSphere ClearSight Module (subject) | | |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| 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
21 CFR 870.2700 | | |
6
III. Predicate Device
Primary HemoSphere Advanced Monitoring Platform manufactured by Edwards Predicate Device: Lifesciences, K190205 (cleared August 29, 2019).
Additional EV1000 Clinical Platform Non-Invasive NI and ClearSight™ Finger Cuffs Predicate or ClearSight™ System K160552 (cleared June 1, 2016) Devices: utilized for the ClearSight Module (Non-invasive) parameters.
ClearSight finger cuff K190130 (cleared June 21, 2019) utilized for the ClearSight finger cuff used with ClearSight Module
EV1000 Clinical Platform Non-Invasive NI and ClearSight™ Finger Cuffs or ClearSight™ System K182245 (cleared November 30, 2018) utilized for the Heart Reference Sensor
FORE-SIGHT ELITE Module (smart cable) (K180003, cleared May 10, 2018) for tissue oximetry.
Nexfin Model 2 (cleared K122381 on April 22, 2013) utilized as a reference predicate for the ClearSight workflow option.
IV. Device Description
Device HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize Description: hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue Oximetry Module (K190205 August 29, 2019), FORE-SIGHT ELITE Tissue Oximeter Module (K180003, May 10, 2018), and the subject HemoSphere ClearSight Module.
The subject HemoSphere ClearSight module is a non-invasive subsystem module intended to continuously and noninvasively measure blood
7
pressure and associated hemodynamic parameters. HemoSphere ClearSight module is intended to provide ClearSight functionality (Non-Invasive) previously cleared in EV1000 Clinical Platform NI (K160552 June 1, 2017) to the HemoSphere Advanced Monitoring Platform. It provides power, communications, air and an interface to connect with currently cleared and commercially available Edwards Lifesciences ClearSight System (K160552 June 1, 2016) which includes ClearSight finger cuffs (K160552 June 1, 2016 and K190130 June 21, 2019), Pressure Controller/Wrist Unit (K160552 June 1, 2016), Heart Reference Sensor (K182245 Nov 30, 2018), and the HemoSphere Advanced Monitor (K190205 August 29, 2019).
V. Indications for Use:
Note: The indication for Use statements are identical for all the previously cleared technologies (K190205 cleared August 29, 2019). with the exception of the addition of indication for subject HemoSphere ClearSight Module.
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards 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.
8
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 A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere Swan-Ganz module are listed below. Only iCO, iCI, iSVR, and iSVRI are available to the pediatric patient population.
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Populat
ion | Hospital
Environm
ent |
|---------------|---------------------------------------------------------|----------------------------------|---------------------------|-----------------------------|
| CO | continuous cardiac output | | | |
| sCO | STAT cardiac output | HemoSp | Adult | Operating |
| CI | continuous cardiac index | here | only | Room, |
| sCI | STAT cardiac index | Swan- | | Intensive |
| EDV | right ventricular end
diastolic volume | Ganz | | Care Unit, |
| sEDV | STAT right ventricular
end diastolic volume | Module | | Emergency Room |
| EDVI | right ventricular end
diastolic volume index | | | |
| sEDVI | STAT right ventricular
end diastolic volume
index | | | |
| HRavg | averaged heart rate | | | |
| LVSW | 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 | | | |
| RVSW | 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 | | | |
10
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-
System
Module
Used | Patient
Population | Hospital
Environment |
| ----------- | ------------- | ---------------------------------- | ----------------------- | ------------------------- |
|---|
11
| SvO2 | Mixed Venous Oxygen
Saturation | HemoSp
here
Oximetry
Cable | Adult
and
Pediatric | Operating
Room,
Intensive
Care Unit,
Emergency Room |
|-------|-------------------------------------|-------------------------------------|---------------------------|-----------------------------------------------------------------|
| ScvO2 | Central Venous Oxygen
Saturation | | | |
A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-Ganz module and oximetry cable are listed below:
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Populat
ion | Hospital
Environm
ent |
|---------------|------------------------------------------------------------------------|----------------------------------------------|---------------------------|-----------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | HemoSp
here | | |
| VO2 | Oxygen Consumption | | | Operating
Room,
Intensive
Care Unit,
Emergency Room |
| VO2e | Estimated Oxygen
Consumption when
ScvO2 is being monitored | Swan-Ganz
Module
and
HemoSp
here | Adult
and
Pediatric | |
| VO2I | Oxygen Consumption
Index | | | |
| VO2Ie | Estimated Oxygen
Consumption Index when
ScvO2 is being monitored | Oximetry
Cable | | |
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:
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Populat
ion | Hospital
Environm
ent |
|---------------|-------------------------------------------------------------|-------------------------------------|---------------------------|-----------------------------------------------|
| CO/
CI | Continuous Cardiac
Output1/ Continuous
Cardiac Index1 | | | Operating
Room, |
| CVP | Central Venous Pressure | HemoSp
here
Pressure
Cable | Adult
only | Intensive
Care Unit,
Emergenc
y Room |
| DIA | Systemic arterial diastolic
blood
pressure | | | |
| DIAPAP | pulmonary artery diastolic
blood
pressure | | | |
12
| dP/dt | Systolic slope2 | ||
|---|---|---|---|
| Eadyn | Dynamic Arterial | ||
| Elastance2 | |||
| MAP | Mean Arterial Pressure | ||
| MPAP | Mean Pulmonary Arterial | ||
| Pressure | |||
| PPV | pulse pressure variation1 | ||
| PRART | Pulse rate | ||
| SV/ | Stroke Volume1/ | ||
| SVI | Stroke Volume Index1 | ||
| SVR/ | Systemic Vascular | ||
| Resistance1/ Systemic | |||
| SVRI | Vascular Resistance1 | ||
| Index | |||
| SVV | Stroke Volume Variation1 | ||
| SYS | Systolic Blood Pressure | ||
| HPI | Acumen Hypotension | ||
| Prediction Index |
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:
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Populat
ion | Hospital
Environm
ent |
|---------------|------------------------------------------------------------------------|----------------------------------|---------------------------|---------------------------------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | HemoSp
here | | |
| VO2 | Oxygen Consumption | | | Operating
Room,
Intensive
Care Unit,
Emergenc
y Room |
| VO2e | Estimated Oxygen
Consumption when ScvO2
is being monitored | Swan-
Ganz
Module | Adult | |
| VO2I | Oxygen Consumption
Index | and
HemoSp
here | only | |
| VO2Ie | Estimated Oxygen
Consumption Index when
ScvO2 is being monitored | Oximetry
Cable | | |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-
13
| Parameter | Description | Sub-System
Module Used | Patient
Population | Hospital
Environment |
|-----------|-------------------------------------|---------------------------------------------------------|-----------------------|-------------------------|
| CO20s | 20-second
cardiac output | HemoSphere | Adult
only | Operating
room, |
| CI20s | 20-second
cardiac index | Swan-Ganz
module and
HemoSphere
pressure cable | | intensive
care unit, |
| SV20s | 20-second
stroke volume | | | emergency
room |
| SVI20s | 20-second
stroke volume
index | | | |
Ganz Module and a connected HemoSphere pressure cable are as listed below.
Tissue oxygen saturation, StO2, can be monitored with the HemoSphere Advanced Monitor, a connected HemoSphere Tissue Oximetry Module, and the FORE-SIGHT ELITE Tissue Oximeter Module. Refer to the FORE-SIGHT ELITE HemoSphere Advanced Monitoring Platform Operators Manual for specific information on the intended use environment and patient population.
| Parame
ter | Description | Sub-System
Module Used | Patient
Popula
tion | Hospital
Environm
ent |
|---------------|-----------------------------|------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------|
| StO2 | Tissue oxygen
saturation | HemoSphere
Tissue
Oximetry
Module and
Fore-Sight
Elite Module | Adult
and
Pediatri
c | Operating
Room,
Intensive
Care Unit,
Emergency
Room |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight module are listed below
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Popula
tion | Hospital
Environm
ent |
|---------------|-----------------------------------------------------------|--------------------------------------------|---------------------------|----------------------------------|
| CO/CI | Continuous Cardiac
Output/ Continuous
Cardiac Index | HemoSp
here
ClearSig
ht
Module | Adult
only | Operating
Room,
Intensive |
| DIA | noninvasive arterial
diastolic blood
pressure | | | Care Unit,
Emergenc
y Room |
14
| MAP | Noninvasive Mean Arterial
Pressure |
|------|--------------------------------------------------|
| PPV | pulse pressure variation |
| PR | Noninvasive Pulse rate |
| SV/ | Stroke Volume/ |
| SVI | Stroke Volume Index |
| SVR/ | Systemic Vascular |
| SVRI | Resistance Systemic
Vascular Resistance Index |
| SVV | Stroke Volume Variation |
| SYS | Systolic Blood Pressure |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere ClearSight module and oximetry cable are listed below
| Parame
ter | Description | Sub-
System
Module
Used | Patient
Populat
ion | Hospital
Environm
ent |
|---------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------|----------------------------------------------|
| DO2 | Oxygen Delivery | | | |
| DO2I | Oxygen Delivery Indexed | HemoSp
here
ClearSig
ht
Module
and
HemoSp
here
Oximetry
Cable | Adult
only | Operating
Room,
Intensive
Care Unit |
| VO2 | Oxygen Consumption | | | |
| VO2e | Estimated Oxygen
Consumption when ScvO2
is being monitored | | | |
| VO2I | Oxygen Consumption
Index | | | |
| VO2Ie | Estimated Oxygen
Consumption Index when
ScvO2 is being monitored | | | |
15
VI. Comparison of Technological Characteristics with the Predicate Devices:
The existing HemoSphere Advanced Monitoring Platform which is the primary predicate for this submission consists of:
- I HemoSphere Advanced Monitor
- 트 HemoSphere Swan-Ganz Module
- 트 HemoSphere Oximetry Cable
- 트 HemoSphere Pressure Cable
- I HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
- I Acumen Hypotension Prediction Index (use with FloTrac only)
The subject and predicate devices are based on the following same technological elements:
- Platform: The subject device uses the same platform as the Predicate (K190205 cleared August 29, 2019).
- I Non-Invasive technology: The subject and Predicate (K160552 June 1, 2016) are Noninvasive blood pressure measurement systems and use the same method of measurement.
- . Accessories/Components: The subject and the Predicate (K160552 June 1, 2016) device both use previously cleared Pressure controller, Heart Reference Sensor and ClearSight Cuffs for measurement of non-invasive parameters.
The following technological differences exist between the subject and predicate devices:
- Algorithm update: An updated optional continuous cardiac output algorithm has been incorporated into the HemoSphere Advanced Monitoring Platform. This algorithm provides the option for a more responsive Continuous Cardiac Output (averaged 20 seconds) parameter as compared to that from the existing algorithm (average of 3 to 7 minutes). The new Algorithm uses the same SwanGanz Module and Pressure Cable to provide already available cardiac output parameters as the predicate K190205 August 29, 2019.
16
- 트 Algorithm update: For the key blood pressure (Noninvasive) parameters (MAP, SYS, DIA and PR) the algorithm has been changed to the existing algorithm used by HemoSphere Advanced Monitoring Platform (K190205 cleared August 29, 2019) to compute hemodynamic parameters (CO, CVP. MAP, DIA, MPAP, SV, SYS) when used with HemoSphere Pressure Cable (minimally invasive).
- ' Algorithm update: The FORE-SIGHT ELITE Tissue Oximeter Module algorithm for determining StO2 was updated to make more robust to better handle sensor disruption scenarios caused by user or environmental factors and made more dynamic for pediatric applications by increasing StO2 responsiveness. There are no new features with this algorithm update, and the device has comparable clinical accuracy when compared to the predicate device.
The purpose of this 510(k) submission is to add the following additional new features and modifications to the HemoSphere Advanced Monitoring Platform (K190205, cleared August 29, 2019):
Addition of the ClearSight™ (Non-Invasive) functionality to the HemoSphere Advanced Monitoring Platform (K190205, previously cleared August 29, 2019):
- HemoSphere ClearSight Module (HEMCSM10): A new sub-system module: ClearSight Module (subject of this 510(k) submission) is being added to the HemoSphere Advanced Monitoring Platform (K190205, previously cleared August 29, 2019.
- ClearSight Calibration feature (Optional feature): ClearSight Calibration provides an additional option to the user to manually calibrate blood pressure (BP) to an external reference.
- ClearSight workflow options: Allows the user flexibility to choose the mode of monitoring based on the patient's position throughout the monitoring session.
-
- Modifications to existing elements of the HemoSphere Advanced Monitoring Platform (previously cleared in K190205, August 29, 2019):
17
- I Graphical User Interface Modifications: The graphical user interface (GUI) is being updated to include additional screens specifically for the non-invasive (or ClearSight™) blood pressure and hemodynamic parameters.
- I Fluid Responsiveness Test for ClearSight: This feature is currently cleared for the minimally invasive (FloTrac) modes (K190205, cleared August 29, 2019). This same feature is now being made available for non-invasive ClearSight mode.
- I Cybersecurity Updates: Cybersecurity enhancements have been made to the HemoSphere Advanced Monitoring Platform toaddress Cybersecurity risks.
- I New Continuous Cardiac Output Algorithm: An updated cardiac algorithm (FastCCO) has been implemented for continuous cardiac output. This algorithmprovides the option for a more responsive Continuous Cardiac Output parameter as compared to the existing algorithm cleared in K163381 on April 14, 2017.
- I FORESIGHT ELITE Tissue Oximeter Module Algorithm update: The FORE-SIGHT ELITE Tissue Oximeter Module algorithm for determining StO2 was updated to make more robust to better handle sensor disruption scenarios caused by user or environmental factors and made more dynamic for pediatric applications by increasing StO2 responsiveness. There are no new features with this algorithm update, and the device has comparable clinical accuracy when compared to the predicate device.
& Modifications to the Labeling of HemoSphere Advanced Monitoring Platform (previously cleared in K190205, August 29, 2019):
- I The HemoSphere Advanced Monitoring Platform Operator's Manual (Cleared in K190205 August 29, 2019) is being updated to include and address the additional and modified features that are the subject of this subject 510(k) premarket notification.
- I The ClearSight™ Finger Cuffs (Cleared in K160552 June 1, 2016 and K190130 June 21, 2019) indications for use are being updated to add the HemoSphere Advanced
18
| Performance
Data: | monitoring Platform to the indications for use as part of this subject 510(k). No other changes are occurring to the ClearSight Finger Cuffs. The Pressure Controller/Wrist Unit ( Cleared in K160552 June 1, 2016 ) indications for use are being updated to add the HemoSphere Advanced 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 Advanced 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 for the modifications being made as part of this submission.
Usability Study
Usability study was conducted per FDA's guidance document " Applying Human Factors and Usability Engineering to Medical Devices " to investigates primary operating functions and critical tasks of the system for any usability issues regarding HemoSphere 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, individual modules were tested at a system level to verify the safety of these modules. They were also integrated as a system and verified for their safety and effectiveness. All tests passed. |
| ---------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
19
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 Sensor 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.
Wireless Coexistence Testing
Bench and simulated environment testing were performed on the entire HemoSphere Advanced Monitoring Platform, including all sub-system modules and interfacing analog inputs and outputs. All tests passed.
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". Software on each of the individual modules was tested at a sub-system level to ensure the safety of the device. All tests passed.
The technological characteristics of the predicates and subject device are Conclusions identical. The HemoSphere Advanced Monitoring Platform has successfully passed functional and performance testing, including software verification and validation, and bench studies. The test performed to demonstrate that the HemoSphere Advanced Monitoring Platform including the subject new features for the HemoSphere ClearSight Module and modified features for the platform is substantially equivalent to the legally marketed predicates.