(168 days)
Yes
The device description explicitly mentions the "Acumen Hypotension Prediction Index software feature (DEN160044 granted March 16, 2018)" and the "Acumen Assisted Fluid Management software feature (DEN190029 granted November 13, 2020)". While the summary doesn't detail the algorithms, the term "Prediction Index" and "Assisted Fluid Management" with associated software features strongly suggest the use of algorithms that could incorporate AI/ML for analyzing physiological data and providing insights or suggestions. The Acumen HPI feature is described as providing "physiological insight into a patient's likelihood of future hypotensive events," which is a predictive function often associated with AI/ML. The Acumen AFM feature provides "physiological insight into a patient's estimated response to fluid therapy" and offers "suggestions," also indicative of algorithmic analysis beyond simple calculations.
No.
The device is a monitoring platform that provides physiological insight to clinicians, rather than directly treating a condition. While it assists with fluid management, it explicitly states that "no therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions."
Yes
Explanation: The device is used for "monitoring of cardiac output" and "monitoring hemodynamic parameters." It provides "physiological insight into a patient's likelihood of future hypotensive events" and "physiological insight into a patient's estimated response to fluid therapy." All these functions involve gathering and interpreting medical data to assess a patient's health status, which is the definition of a diagnostic device.
No
The device description explicitly states that the HemoSphere Advanced Monitoring platform consists of the HemoSphere Advanced Monitor (a hardware component) and several optional external modules and cables, in addition to software features. It also mentions physical components like the Acumen IQ fluid meter, Acumen AFM Cable, Pressure Controller, Heart Reference Sensor, and finger cuffs. The performance studies include testing of electrical safety, EMC, mechanical properties, sterilization, packaging, and biocompatibility, all of which are associated with hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Function: The HemoSphere Advanced Monitor and its various modules are designed to directly monitor physiological parameters within the patient's body. This includes:
- Cardiac output and derived hemodynamic parameters (measured via catheters inserted into the pulmonary artery).
- Venous oxygen saturation (measured via oximetry catheters).
- Blood pressure and associated hemodynamic parameters (measured invasively via pressure cables or non-invasively via finger cuffs).
- Regional hemoglobin oxygen saturation (measured non-invasively via sensors on the skin).
- Tracking of fluid administered to the patient.
- Lack of Specimen Examination: The device does not examine specimens (like blood samples) outside of the body. It is directly connected to the patient to gather real-time physiological data.
The device is clearly described as a hemodynamic monitoring platform used in a critical care environment to assess a patient's circulatory status and related parameters. This falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found."
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 catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 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 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).
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June 9, 2023
Edwards Lifesciences, LLC Sara Pesian Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K223865
Trade/Device Name: HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, QAQ, MUD, DXN, DSB Dated: May 9, 2023 Received: May 10, 2023
Dear Sara Pesian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223865
Device Name
HemoSphere Advanced Monitoring Platform, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter
Indications for Use (Describe)
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous (CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry catheters is indicated for use in adult and pediatric critical care patients requiring of venous oxygen saturation (SvO2 and ScvO2) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable:
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used. The Edwards Acumen Hypotension Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 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 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) Summary – HemoSphere Advanced Monitoring Platform | |
|---|---|
| Sponsor: | Edwards Lifesciences LLC |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Establishment | |
| Registration | |
| Number: | 2015691 |
| Contact | |
| Person: | Sara Pesian |
| Manager, Regulatory Affairs | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| sara_pesian@edwards.com | |
| Telephone: (949) 250-4657 | |
| Date: | June 08, 2023 |
| Platform | |
| Name: | HemoSphere Advanced Monitoring Platform |
| Trade Name: | HemoSphere Advanced Monitor (subject device) |
| HemoSphere ClearSight Module (subject device) | |
| Heart Reference Sensor (subject device) | |
| Pressure Controller (subject device) | |
| HemoSphere Swan-Ganz Module | |
| HemoSphere Oximetry Cable | |
| HemoSphere Pressure Cable | |
| HemoSphere Technology Module | |
| HemoSphere ForeSight Oximeter Cable | |
| Acumen Hypotension Prediction Index software feature | |
| Acumen Assisted Fluid Management software feature with Acumen AFM Cable | |
| and Acumen IQ fluid meter (subject device) | |
| Viewfinder Remote | |
| Common | |
| Name: | Cardiac Output/Oximetry/Ejection Fraction Computer |
| Classification | |
| Name for | |
| HemoSphere | |
| Monitor and | |
| Accessories: | Programmable Diagnostic Computer 21 CFR 870.1425 |
| Fiberoptic Oximeter Catheter 21 CFR 870.1230 | |
| Adjunctive Predictive Cardiovascular Indicator 21 CFR 870.2210 | |
| Oximeter, Tissue Saturation (Non-Invasive) 21 CFR 870.2700 | |
| System, Measurement, Blood-Pressure, Non-Invasive 21 CFR 870.1130 | |
| Plethysmograph, Impedance 21 CFR 870.2770 | |
| Adjunctive Open Loop Fluid Therapy Recommender 21 CFR 870.5600 | |
| Thermometer, Electronic, Clinical 21 CFR 880.2910 | |
| 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 | The HemoSphere Advanced Monitoring Platform, manufactured by Edwards |
| Lifesciences, K213682 cleared June 22, 2022, is being utilized for substantial | |
| equivalence to the device modularity, basic device functionality, graphical user | |
| interface (GUI) used, core predictive algorithm for the Assisted Fluid | |
| Management software feature, and cybersecurity features. The indications for use | |
| are also similar to the subject device. | |
| 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 (K213682 cleared, June 22, 2022), | |
| HemoSphere ForeSight Module (K213682, June 22, 2022), and the HemoSphere | |
| ClearSight Module (K203687 cleared, May 28, 2021). Additionally, the | |
| HemoSphere Advanced Monitoring Platform includes the Acumen Hypotension | |
| Prediction Index software feature (DEN160044 granted March 16, 2018) and the | |
| Acumen Assisted Fluid Management software feature (DEN190029 granted | |
| November 13, 2020). The HemoSphere Advanced Monitor also has wired and | |
| wireless capabilities, which was originally used only for connecting to a Hospital | |
| Information System (HIS) for data charting purposes. This capability is now used | |
| to allow it to stream continuously monitored data to the Viewfinder Remote, a | |
| mobile device-based application, for remote viewing the information (K211465, | |
| cleared July 8, 2021). The remotely transmitted data from the patient monitoring | |
| sessions include all hemodynamic parameter data and the associated physiological | |
| alarm notifications, historical trend data, and parameter waveform data. |
510(k) Summary - HemoSphere Advanced Monitoring Platform
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HemoSphere Advanced Monitoring platform as cleared in K213682 cleared June 22, 2022, is being modified as follows:
-
- Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature (AFM algorithm + AFM GUI), which informs clinicians of patient fluid responsiveness (K213682, cleared June 22, 2022), allows for manual fluid tracking, and resides on the HemoSphere Advanced Monitor.
- Acumen Assisted Fluid Management Automated Fluid Tracking Mode:
The AFM software feature is being modified to allow for an automated fluid tracking mode as the default mode. Users can switch to the optional manual fluid tracking mode through the advanced settings menu. This automated fluid tracking mode for the AFM software feature is achieved via two components namely, the Acumen AFM Cable and the Acumen IQ fluid meter (both devices subject of this 510(k)). No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automated fluid tracking mode via the Acumen AFM cable and Acumen IO fluid meter.
The Acumen AFM Cable is a reusable cable that connects the Acumen IO fluid meter to the HemoSphere Advanced Monitoring Platform and converts the flow rate received from the Acumen IQ fluid meter to total volume for the HemoSphere monitor to be used by AFM software feature. No modifications have been made to the previously cleared AFM algorithm. AFM GUI screens have been updated to account for the automatic fluid tracking mode. The Acumen IQ fluid meter is a sterile, single use device that measures the flow of fluid delivered to a patient through the intravenous line to which it is connected.
When used together, the Acumen IQ fluid meter with the Acumen AFM Cable connected to a HemoSphere monitor, the fluid volume can be automatically tracked and displayed on the monitor as part of the AFM software feature screens.
2) Automatic Zeroing of the Heart Reference Sensor (HRS)
The ClearSight Module (CSM), initially cleared in K201446 on October 1, 2020, is a non-invasive monitoring platform that includes a Pressure Controller (PC2) that is worn on the wrist, a Heart Reference Sensor (HRS), and the ClearSight/Acumen IQ Finger Cuffs.
The Pressure Controller (also referred to as 'Wrist unit' or PC2) is connected to the patient via a wrist band. The Pressure Controller connects to the ClearSight Module (CSM) on one end and with the Heart Reference Sensor (HRS) and the finger cuff on the other. The connection to the CSM provides power and serial communication. The Pressure Controller is
8
designed to control the blood pressure measurement process and send the finger arterial pressure waveform to the CSM. The CSM software transforms the finger level blood pressure measurements into the conventional radial blood pressure.
In the predicate HemoSphere (K213682, cleared on June 22, 2022), as part of the ClearSight workflow, the user was required to zero the HRS prior to monitoring by aligning both ends of the HRS, the heart end and the finger end, and pressing the "0" button on the HemoSphere Graphical User Interface (GUI). After zeroing the HRS, the user is required to place both ends of the HRS in the appropriate location and then they can begin monitoring.
For the subject device, the Pressure Controller (PC2) firmware has been updated to include a mathematical model that automatically calculates the zero offset of the HRS based on the age of the specific HRS at the time of use. With the addition of the mathematical model, the user is no longer required to zero the HRS prior to start of monitoring since the system now has the zero-offset calculated. As such, the HemoSphere Advanced Monitor graphical user interface (GUI) was updated to remove the Zero HRS step as part of the Zero & Waveform screen and ClearSight setup.
The ClearSight Module firmware was also updated as part of support for the Automatic Zeroing of HRS feature. The firmware update included additional logging to support HRS calibration, bug fixes and updates to communication to the pressure controller to support display of proper HRS calibration information.
- Patient Query
As cleared in K213682, when the user queried for patient information, all patient records that match the search criteria were sent to the HemoSphere platform (from the Viewfinder Hub) for the user to review. With this update, only 30 records are shared at a time between the Viewfinder Hub and HemoSphere monitor.
4) Miscellaneous Updates
Miscellaneous updates include:
- Bug fixes -
- Cybersecurity updates -
- Operator's manual updates -
- Heart Reference Sensor Instructions for Use update -
Indications HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module
for Use:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-
Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output [continuous
9
(CO) and intermittent (iCO)] and derived hemodynamic parameters. Pulmonary artery blood temperature monitoring is used to compute continuous and intermittent CO with thermodilution technologies. It may also be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement below for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Oximetry Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Oximetry Cable and Edwards oximetry catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of venous oxygen saturation (SvO2 and Scv02) and derived hemodynamic parameters in a hospital environment. Refer to the Edwards oximetry catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function. fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ, and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure Primary Predicate . |
| Acumen Assisted Fluid
Management feature on
HemoSphere monitor
with automated
tracking via Acumen
AFM cable and
Acumen IQ fluid meter | HemoSphere advanced monitor with Acumen Assisted Fluid
Management software feature with manual fluid tracking mode
(K213682 cleared June 22, 2022).
This software feature was chosen as the primary predicate since the Assisted Fluid Management algorithm and feature, as cleared in this submission will be used on the HemoSphere Advanced Monitor. An additional option is being added to the HemoSphere Advanced Monitor that allows the user to automatically track amount of fluid administered via two components, namely, the Acumen AFM Cable and Acumen IQ fluid meter. |
| Automatic Zero of
Heart Reference Sensor | HemoSphere advanced monitor with HemoSphere ClearSight Module
(K213682 cleared May 22, 2022)
This device was chosen as the predicate since it allows zeroing of the Heart Reference Sensor prior to monitoring and is now being modified to automatically zero the HRS. |
| Patient Query | HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022)
This device was chosen as the predicate since it is the base platform with the patient query feature to which modifications are being made. There are no changes to the fundamental technology. |
| Miscellaneous Updates
(bug fixes,
cybersecurity, labeling) | HemoSphere Advanced Monitoring Platform (K213682, cleared June 22, 2022)
This device was chosen as the predicate since it is the base platform to which modifications (bug fixes and cybersecurity updates) are being made. There are no changes to the fundamental technology. |
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The following verification activities were performed in support of a substantial Performance Data (Bench equivalence determination for the modifications made to the HemoSphere Advanced Monitoring Platform due to the modifications to the Acumen Assisted and/or Clinical): Fluid Management software feature, Automatic Zeroing of the Heart Reference Sensor. Patient Ouery, and Bug and cybersecurity updates and to ensure the safety and effectiveness of the new Acumen AFM Cable and Acumen IQ fluid meter components.
System Verification (Non-clinical performance)
Completion of all verification and validation activities demonstrated that the subject devices and software meet their predetermined design and performance specifications. Verification activities performed confirmed that the modifications made to the HemoSphere Advanced Monitoring Platform did not adversely affect the safety and effectiveness of the subject device. The Acumen AFM Cable when connected to Acumen IQ fluid meter were tested at a system level to verify the safety of these components. AFM outputs when the fluid meter mode was unlocked using the Acumen AFM Cable and the Acumen IO fluid meter were tested using a bench simulation. All tests passed.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject HemoSphere Advanced Monitoring Platform, consisting of the HemoSphere Monitor, the Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen AFM Cable with Acumen IQ fluid meter. The system complies with the IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 62304, IEC 62366, IEC 60601-2-34, IEC 60601-2-57, IEC 60601-2-49, and ISO 81060-2. All tests passed.
Additionally, Electrical testing was performed on the Acumen IO fluid meter's disposable board and the Acumen AFM Cable's reusable board to ensure they meet all their electrical requirements specification
Software Verification
Software verification was performed per FDA's Guidance for Industry and FDA Staff. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005). The new advanced feature (AFM fluid meter mode) added to HemoSphere AFM Software was tested at a sub-system level to ensure the safety of the device. The Acumen AFM Cable and HemoSphere ClearSight Module firmware was tested to ensure the safety of the device. All tests passed.
Usability Study
Usability study was conducted per FDA's guidance document, Applying Human Factors and Usability Engineering to Medical Devices (issued February 3, 3016), to investigate primary operating functions and critical tasks of the system for any usability issues regarding AFM fluid meter mode on HemoSphere Advanced
18
Monitoring Platform that may lead to patient or user harm. The usability study demonstrated that the intended users could perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm.
Mechanical Testing
Mechanical testing was performed on the Acumen IO fluid meter and the Acumen AFM Cable to ensure they meet all their mechanical requirements specification. All tests passed.
Sterilization Validation
The Acumen IQ fluid meter is provided sterile. As such, sterilization validation and shelf life of the device was performed in accordance with the Edwards Quality System and the applicable standards.
Packaging Testing
Acumen IQ fluid meter packaging configurations were validated in accordance with the requirements of ISO 11607-1: 2009/A1: 2014. Shipping simulation and conditioning tests were completed to demonstrate the sterile barrier produced under the worst-case parameters and distribution conditions maintain sterile barrier integrity. Packaging testing was also performed on the Acumen AFM Cable. All test passed.
Biocompatibility Testing
Since the Acumen IQ fluid meter is considered to have indirect contact with the patient, biocompatibility testing was performed in accordance with the requirements of ISO 10993-1: 2009 - Biological Evaluation of Medical Devices -Part 1: Evaluation and testing within a risk management process and FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (June 16, 2016). All tests passed.
Clinical Performance
No new clinical testing was performed in support of the subject 510(k).
Overall Conclusion: Conclusions
The Acumen AFM Software Feature on HemoSphere Advanced Monitoring Platform with the subject modifications has successfully passed functional and performance testing, including software verification and validation ,bench, and usability studies. Completion of all performance verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications. Verification activities performed confirmed that the differences in the features and design did not adverselv affect the safety and effectiveness of the subject device. The testing performed demonstrates that the
19
HemoSphere Advanced Monitoring Platform with subject modifications to the Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Automatic Zeroing of the Heart Reference Sensor, Patient Query, bug fixes and cybersecurity updates is substantially equivalent to its legally marketed predicate device.