(122 days)
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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module 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 FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
When used with large sensorsis indicated for use on adults and transitional adolescents ≥40 kg.
When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects >3 kg.
When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Refer to the ClearSight finger cuff indications for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor that provides a means to interact with and visualize hemodynamic and volumetric data on a screen and five (5) optional external modules: the HemoSphere Swan-Ganz Module (K163381 Cleared, April 14, 2017), the HemoSphere Oximetry Cable (K163381 Cleared, April 14, 2017), HemoSphere Pressure Cable (K180881 Cleared, November 16, 2018), HemoSphere Tissue 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 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).
The provided text is a 510(k) Summary for the "HemoSphere Advanced Monitoring Platform" and its associated modules, specifically focusing on the addition of the "HemoSphere ClearSight Module" and platform modifications. This document describes the device's technical characteristics, regulatory classification, and performance data to demonstrate substantial equivalence to predicate devices.
However, the document does not contain the specific acceptance criteria for the device performance study or the detailed results of a comparative effectiveness study (like MRMC) showing how human readers improve with AI vs. without AI assistance. The provided text primarily focuses on technical verification and validation, electrical safety, electromagnetic compatibility, and software verification to demonstrate that the modified device functions as intended and safely. It refers to "predetermined design and performance specifications" but does not explicitly list these specifications or the raw performance data against them.
Based on the provided information, I can extract and infer the following:
1. A table of acceptance criteria and the reported device performance:
The document states: "Completion of all verification and validation activities demonstrated that the subject devices meet their predetermined design and performance specifications." However, it does not explicitly list these predetermined specifications or quantifiable performance metrics (e.g., accuracy, precision, bias) for the device's measurements in a table format.
The performance data mentioned includes:
- Usability Study: "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): "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."
- Electrical Safety and Electromagnetic Compatibility (EMC): "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."
Therefore, a table of specific quantifiable acceptance criteria and reported numerical performance values cannot be constructed from the provided text. The acceptance criteria appear to be qualitative (e.g., "without any usability issues," "All tests passed," "meets their predetermined design and performance specifications") or compliance with standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify a sample size for any clinical or test data set. All tests described are bench simulations or technical verifications rather than clinical trials with patient data.
- Data Provenance: Not applicable as no patient data test sets are described for performance evaluation. The "bench simulation" implies laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The tests described are technical and bench-based, not involving expert interpretation of patient data to establish ground truth for performance evaluation of AI/algorithm outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert review or adjudication process for a test set is mentioned.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. The document describes a "Programmable Diagnostic Computer" that measures hemodynamic parameters. It does not refer to an AI component that assists human readers (e.g., radiologists interpreting images) or that would necessitate an MRMC study. The "Hypotension Prediction Index (HPI)" is described as "additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter," indicating it is not a primary diagnostic tool requiring human-in-the-loop performance evaluation in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the device and its algorithms were tested in a standalone fashion through "System Verification (Non-Clinical Performance)" using "bench simulation." The statement "Measured and derived parameters were tested using a bench simulation... All tests passed" indicates algorithm-only performance testing against simulated inputs. However, no specific metrics of this standalone performance (e.g., accuracy against a gold standard) are provided, only that it "passed."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the "System Verification (Non-Clinical Performance)," the ground truth would have been established by the simulated inputs used in the bench testing. These would be controlled and known values of physiological parameters. For the "Electrical Safety and EMC" and "Wireless Coexistence Testing," the ground truth is compliance with established regulatory and technical standards (e.g., IEC 60601 series).
8. The sample size for the training set:
- The document describes a device that measures and derives physiological parameters. It mentions "Algorithm update" for continuous cardiac output and tissue oximetry, but it does not mention any machine learning or AI models that would require training data. The term "algorithm" here likely refers to deterministic computational methods rather than learned models. Therefore, there is no mention of a training set sample size.
9. How the ground truth for the training set was established:
- As the document does not mention the use of machine learning or AI models with training sets, this question is not applicable. The algorithms described appear to be based on pre-programmed physiological models and equations, not learned from data.
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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
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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
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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
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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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module
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Traditional 510(k) – HemoSphere Advanced Monitoring Platform
The noninvasive FORE-SIGHT ELITE tissue oximeter module 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 FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
· When used with large sensorsis indicated for use on adults and transitional adolescents ≥40 kg.
· When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects >3 kg.
· When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects < 8 kg and non-cerebral use on pediatric subjects <5kg.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Refer to the ClearSight finger cuff indications for information on target patient population specific to the finger cuff being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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
I. Submitter:
| Sponsor: | Edwards Lifesciences LLCOne Edwards WayIrvine, CA 92614 | Product Codeand RegulatoryClass: | DQK, Class II |
|---|---|---|---|
| EstablishmentRegistrationNumber: | 2015691 | DQE, Class II | |
| Contact Person: | Varad RaghuwanshiSr. Specialist, Regulatory AffairsOne Edwards WayIrvine, CA 92614Telephone: (949) 756-4502Fax: (949) 809-2972 | QAQ, Class II | |
| Date Prepared: | May 29, 2020 | MUD, Class II | |
| II.Device Information: | DXN, Class II | ||
| Platform Name(Name of theDevice) | HemoSphere Advanced Monitoring Platform | DSB. Class II | |
| Trade Name: | HemoSphere Advanced MonitorHemoSphere Swan-Ganz ModuleHemoSphere Oximetry CableHemoSphere Pressure CableHemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE TissueOximeter ModuleHemoSphere ClearSight Module (subject) | ||
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | ||
| ClassificationName: | Programmable Diagnostic Computer21 CFR 870.1425Fiberoptic Oximeter Catheter21 CFR 870.1230Adjunctive Predictive Cardiovascular Indicator21 CFR 870.2210Oximeter21 CFR 870.2700 |
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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
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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.
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Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable
The HemoSphere Advanced Monitor when used with the HemoSphere Pressure Cable is indicated for use in critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac, Acumen IQ and TruWave DPT sensor indications for use statement for information on target patient population specific to the sensor being used.
The Edwards Lifesciences Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in operating room (OR) patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Tissue Oximetry Module
The noninvasive FORE-SIGHT ELITE tissue oximeter module is intended for use as an adjunct monitor of absolute regional hemoglobin oxygen saturation of blood under the Sensors in individuals at risk for reducedflow or no-flow ischemic states. The FORE-SIGHT ELITE tissue oximeter module is intended to allow for the display of StO2 on the HemoSphere advanced monitor.
- . When used with large sensorsis indicated for use on adults and transitional adolescents ≥40 kg.
- . When used with Medium Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for use on pediatric subjects ≥3 kg.
- . When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects <8 kg and non-cerebral use on pediatric subjects <5kg.
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Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere ClearSight Module
Note: The ClearSight indication is identical to the Predicate K160552 (Cleared June 1, 2016) with the exception of the addition of the HemoSphere Advanced Monitoring Platform.
The HemoSphere Advanced Monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for patients over 18 years of age in which the balance between cardiac function, fluid status and vascular resistance needs continuous assessment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements are difficult. The HemoSphere advanced monitor and compatible Edwards finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters.
Refer to the ClearSight finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
Intended Use: The HemoSphere Advanced Monitoring Platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting. The HemoSphere advanced monitoring platform is intended for use with compatible Edwards Swan-Ganz and oximetry catheters, FloTrac sensors, Acumen IQ sensors, TruWave DPTs, ForeSight Elite sensors, and ClearSight finger cuffs.
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.
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| 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 enddiastolic volume | Ganz | Care Unit, | |
| sEDV | STAT right ventricularend diastolic volume | Module | Emergency Room | |
| EDVI | right ventricular enddiastolic volume index | |||
| sEDVI | STAT right ventricularend diastolic volumeindex | |||
| HRavg | averaged heart rate | |||
| LVSW | left ventricular strokework index | |||
| PVR | pulmonary vascularresistance | |||
| PVRI | pulmonary vascularresistance index | |||
| RVEF | right ventricular ejectionfraction | |||
| sRVEF | STAT right ventricularejection fraction | |||
| RVSW | right ventricular strokework index | |||
| SV | stroke volume | |||
| SVI | stroke volume index | |||
| SVR | systemic vascularresistance | |||
| SVRI | systemic vascularresistance index | |||
| iCO | intermittent cardiac output | AdultandPediatric | ||
| iCI | intermittent cardiac index | |||
| iSVR | intermittent systemicvascular resistance | |||
| iSVRI | intermittent systemicvascular resistance index |
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A comprehensive list of parameters available for adult and pediatric patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere oximetry cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| ----------- | ------------- | ---------------------------------- | ----------------------- | ------------------------- |
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| SvO2 | Mixed Venous OxygenSaturation | HemoSphereOximetryCable | AdultandPediatric | OperatingRoom,IntensiveCare Unit,Emergency Room |
|---|---|---|---|---|
| ScvO2 | Central Venous OxygenSaturation |
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:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphere | ||
| VO2 | Oxygen Consumption | OperatingRoom,IntensiveCare Unit,Emergency Room | ||
| VO2e | Estimated OxygenConsumption whenScvO2 is being monitored | Swan-GanzModuleandHemoSphere | AdultandPediatric | |
| VO2I | Oxygen ConsumptionIndex | |||
| VO2Ie | Estimated OxygenConsumption Index whenScvO2 is being monitored | OximetryCable |
A comprehensive list of parameters available for adult patient populations while monitoring with the HemoSphere Advanced Monitor and a connected HemoSphere pressure cable are as listed below:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous CardiacOutput1/ ContinuousCardiac Index1 | OperatingRoom, | ||
| CVP | Central Venous Pressure | HemoSpherePressureCable | Adultonly | IntensiveCare Unit,Emergency Room |
| DIA | Systemic arterial diastolicbloodpressure | |||
| DIAPAP | pulmonary artery diastolicbloodpressure |
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| dP/dt | Systolic slope2 | ||
|---|---|---|---|
| Eadyn | Dynamic ArterialElastance2 | ||
| MAP | Mean Arterial Pressure | ||
| MPAP | Mean Pulmonary ArterialPressure | ||
| PPV | pulse pressure variation1 | ||
| PRART | Pulse rate | ||
| SV/ | Stroke Volume1/ | ||
| SVI | Stroke Volume Index1 | ||
| SVR/ | Systemic VascularResistance1/ Systemic | ||
| SVRI | Vascular Resistance1Index | ||
| SVV | Stroke Volume Variation1 | ||
| SYS | Systolic Blood Pressure | ||
| HPI | Acumen HypotensionPrediction 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:
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphere | ||
| VO2 | Oxygen Consumption | OperatingRoom,IntensiveCare Unit,Emergency Room | ||
| VO2e | Estimated OxygenConsumption when ScvO2is being monitored | Swan-GanzModule | Adult | |
| VO2I | Oxygen ConsumptionIndex | andHemoSphere | only | |
| VO2Ie | Estimated OxygenConsumption Index whenScvO2 is being monitored | OximetryCable |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and both a connected HemoSphere Swan-
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| Parameter | Description | Sub-SystemModule Used | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO20s | 20-secondcardiac output | HemoSphere | Adultonly | Operatingroom, |
| CI20s | 20-secondcardiac index | Swan-Ganzmodule andHemoSpherepressure cable | intensivecare unit, | |
| SV20s | 20-secondstroke volume | emergencyroom | ||
| SVI20s | 20-secondstroke volumeindex |
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.
| Parameter | Description | Sub-SystemModule Used | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| StO2 | Tissue oxygensaturation | HemoSphereTissueOximetryModule andFore-SightElite Module | AdultandPediatric | OperatingRoom,IntensiveCare Unit,EmergencyRoom |
A comprehensive list of parameters available while monitoring with the HemoSphere advanced monitor and a connected HemoSphere ClearSight module are listed below
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| CO/CI | Continuous CardiacOutput/ ContinuousCardiac Index | HemoSphereClearSightModule | Adultonly | OperatingRoom,Intensive |
| DIA | noninvasive arterialdiastolic bloodpressure | Care Unit,Emergency Room |
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| MAP | Noninvasive Mean ArterialPressure |
|---|---|
| PPV | pulse pressure variation |
| PR | Noninvasive Pulse rate |
| SV/ | Stroke Volume/ |
| SVI | Stroke Volume Index |
| SVR/ | Systemic Vascular |
| SVRI | Resistance SystemicVascular 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
| Parameter | Description | Sub-SystemModuleUsed | PatientPopulation | HospitalEnvironment |
|---|---|---|---|---|
| DO2 | Oxygen Delivery | |||
| DO2I | Oxygen Delivery Indexed | HemoSphereClearSightModuleandHemoSphereOximetryCable | Adultonly | OperatingRoom,IntensiveCare Unit |
| VO2 | Oxygen Consumption | |||
| VO2e | Estimated OxygenConsumption when ScvO2is being monitored | |||
| VO2I | Oxygen ConsumptionIndex | |||
| VO2Ie | Estimated OxygenConsumption Index whenScvO2 is being monitored |
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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.
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- 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):
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- 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
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| PerformanceData: | 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 StudyUsability 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. |
|---|---|
| ---------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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.
§ 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).