(212 days)
No
The document describes a modular hemodynamic monitoring platform and a remote viewing application. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies. The focus is on data acquisition, display, and transmission.
No
The device is described as a "monitoring platform" that provides a "remote display of monitored hemodynamic parameter data" and "visualize hemodynamic and volumetric data," indicating it is for diagnostic and monitoring purposes rather than direct therapeutic intervention.
Yes
The device is described as a "HemoSphere Advanced Monitoring Platform" that "provides a means to interact with and visualize hemodynamic and volumetric data on the monitor screen." It monitors "hemodynamic parameter data," "physiological alarm notifications," "historical trend data," and "parameter waveform data." These functions are inherently diagnostic as they provide clinicians with data to assess a patient's physiological state and identify potential issues.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform consists of a physical "HemoSphere Advanced Monitor" and several optional external hardware modules (Swan-Ganz Module, Oximetry Cable, Pressure Cable, Technology Module, ForeSight Module, and ClearSight Module). While it includes a mobile application for remote viewing (Viewfinder Remote), the core device is a hardware platform with integrated software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes monitoring hemodynamic parameters and displaying data from sensors and catheters connected to the patient. This is direct physiological monitoring, not testing of samples taken from the body.
- Device Description: The description details a platform that interacts with external modules and sensors connected to the patient to measure physiological data. It does not mention analyzing biological samples.
- Anatomical Site: The anatomical sites listed are all locations within or on the patient's body where sensors or catheters are placed for direct measurement.
- Performance Studies: The performance studies focus on bench simulations of physiological parameters, electrical safety, wireless coexistence, software verification, and usability. There is no mention of studies involving the analysis of biological samples.
In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes. The HemoSphere Advanced Monitoring Platform directly measures physiological parameters in vivo (within the living body) rather than analyzing samples in vitro (in a test tube or other artificial environment).
N/A
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 monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
- When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects 23 kg.
- When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects 40 kg; 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 contains the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 22, 2022
Edwards Lifesciences, LLC Manthan Damani Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K213682
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote Regulation Number: 21 CFR 870.1425
Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB, QMS, FLL Dated: November 19, 2021 Received: November 22, 2021
Dear Manthan Damani:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K213682
Device Name
HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry cable and Edwards is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 40 kg.
· When used with Medium Sensors, the ForeSight Oximeter Cable is indicated for use on pediatric subjects 23 kg.
· When used with Small Sensors, the ForeSight Oximeter Cable is indicated for cerebral use on pediatric subjects Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
K213682
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 | | |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|-----------------|
| Establishment
Registration
Number: | 2015691 | | |
| Contact
Person: | Manthan Damani
Senior Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
manthan_damani@edwards.com
Telephone: (949) 250-7853 | | |
| Date: | June 22, 2022 | | |
| Platform
Name | HemoSphere Advanced Monitoring Platform | | |
| Trade Name: | HemoSphere Advanced Monitor
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable
HemoSphere Pressure Cable
HemoSphere Technology Module ( subject )
HemoSphere ForeSight Oximeter Cable ( subject )
HemoSphere ClearSight Module
Acumen Hypotension Prediction Index software feature ( subject )
Acumen Assisted Fluid Management software feature ( subject )
Viewfinder Remote ( subject ) | | |
| Common
Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| Classification
Name for
HemoSphere
Monitor and
Accessories: | Programmable Diagnostic Computer
Fiberoptic Oximeter Catheter
Adjunctive Predictive Cardiovascular Indicator
Oximeter, Tissue Saturation (Non-Invasive)
System, Measurement, Blood-Pressure, Non-Invasive
Plethysmograph, Impedance
Adjunctive Open Loop Fluid Therapy Recommender
Thermometer, Electronic, Clinical | 21 CFR 870.1425 | 21 CFR 870.1230 |
| | | 21 CFR 870.2210 | 21 CFR 870.2700 |
| | | 21 CFR 870.1130 | 21 CFR 870.2770 |
| | | 21 CFR 870.5600 | 21 CFR 880.2910 |
510(k) Summary – HemoSphere Advanced Monitoring Platform
6
| Product Code
for
HemoSphere
Monitor and
Accessories: | DQK, Class II
DQE, Class II
QAQ, Class II
MUD, Class II
DXN, Class II
DSB, Class II
QMS, Class II
FLL, Class II |
|------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary
Predicate
Device for
HemoSphere
Monitor and
Accessories: | HemoSphere Advanced Monitoring Platform, manufactured by Edwards Lifesciences,
K203687 cleared May 28, 2021, is being utilized for substantial equivalence to the device
modularity, basic device functionality, graphical user interface (GUI) used, core predictive
algorithm for the Acumen Hypotension Prediction Index (HPI) feature, and cybersecurity
features. The indications for use are also similar to the subject device. |
| Secondary
Predicate
Devices for
HemoSphere
Monitor and
Accessories: | FORE-SIGHT ELITE Tissue Oximeter Module (K190270, cleared October 21, 2019),
manufactured by Edwards Lifesciences, is being utilized for substantial equivalence to the
tissue hemoglobin feature and indications for use. |
| | Acumen Assisted Fluid Management (AFM) feature on EV1000A Clinical Platform
(DEN190029, granted November 13, 2020), manufactured by Edwards Lifesciences, is
being utilized for substantial equivalence to the Acumen Assisted Fluid Management
(AFM) software feature and indications for use. |
| | HemoSphere Advanced Monitoring Platform (K211465, cleared July 08, 2021),
manufactured by Edwards Lifesciences, is being utilized for substantial equivalence to the
connectivity features of the HemoSphere Advanced monitor to allow it to connect to the
Viewfinder Remote mobile application as well as for the Viewfinder Remote application
itself. |
| Device
Description: | The HemoSphere Advanced Monitoring platform was designed to simplify the customer
experience by providing one platform with modular solutions for their hemodynamic
monitoring needs. The user can choose from the available optional sub-system modules or
use multiple sub-system modules at the same time. This modular approach provides the
customer with the choice of purchasing and/or using specific monitoring applications based
on their needs. Users are not required to have all of the modules installed at the same time
for the platform to function. |
| | HemoSphere Advanced Monitoring Platform, subject of this submission, consists of the
HemoSphere Advanced Monitor that provides a means to interact with and visualize
hemodynamic and volumetric data on the monitor screen and its five (5) optional external
modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the
HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure
Cable (K180881 Cleared, November 16, 2018), HemoSphere Technology Module
(previously referred to as "Tissue Oximetry Module"; K190305 cleared, August 29, 2019), |
7
HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K203687 cleared, May 28, 2021). The HemoSphere Advanced Monitor also has wired and wireless capabilities which was originally used only for connecting to a Hospital Information System (HIS) for data charting purposes. This capability is now used to allow it to stream continuously monitored data to the Viewfinder Remote, a mobile device-based application, for remote viewing the information (K211465 cleared July 8, 2021). The remotely transmitted data from the patient monitoring sessions include all hemodynamic parameter data and the associated physiological alarm notifications, historical trend data, and parameter waveform data.
A high-level overview of the new features and modifications that have been implemented as part of this subject submission are listed below:
-Addition of new features, algorithm, and/or technology to the HemoSphere Platform:
- o Tissue Hemoglobin
- The updated ForeSight Oximeter Cable (previously referred to as "FORE-SIGHT ELITE Oximeter Module/FSM") with the Tissue Hemoglobin algorithm (K190270 cleared October 21, 2019) has been incorporated into the HemoSphere Monitoring Platform. The tissue hemoglobin parameter includes relative changes in oxygenated and deoxygenated hemoglobin concentrations for assessment of oxygenation changes as well as their sum total hemoglobin concentration, under the sensor when used with a compatible host monitor. As such, the indications for use and intended use of the existing HemoSphere Advanced Monitor have been expanded to include the ability to measure relative change in total hemoglobin. Additionally, since the HemoSphere Advanced Monitor will act as the host monitor, the graphical user interface (GUI) of the Monitor is being updated to allow display of the hemoglobin parameter.
- Assisted Fluid Management software feature: O
- The Edwards' Acumen™ Assisted Fluid Management (AFM) ■ software feature (DEN190029 granted on November 13, 2020) has been incorporated into the HemoSphere Advanced Monitoring Platform to recognize patterns of fluid responsiveness (i.e., hemodynamic data and past responses to fluid) and recommend when fluid administration is expected to improve the patient's hemodynamic state. This AFM software feature (AFM algorithm + AFM GUI) is now being incorporated as part of the HemoSphere Advanced Monitor. No modifications have been made to the previously granted AFM algorithm.
8
- Updates to existing features, algorithm, and/or technology to the HemoSphere Platform:
- HPI Smart Alerts and Smart Trends o
. The Acumen Hypotension Prediction Index (HPI) algorithm defines hypotensive events as mean arterial pressure (MAP) 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.
11
- . 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