(35 days)
Yes
The description explicitly mentions the "Acumen Hypotension Prediction Index feature" and the "Acumen Assisted Fluid Management (AFM) software feature," which provide "physiological insight" and "suggestions regarding the patient's physiological condition and estimated response to fluid therapy." While not explicitly stating "AI" or "ML," these features, particularly the prediction of future hypotensive events and suggestions for fluid therapy based on physiological data, strongly suggest the use of advanced algorithms that are characteristic of AI/ML applications in medical devices. The language used ("insight," "suggestions," "estimated response") goes beyond simple calculation of derived parameters and implies a more complex analytical process.
No
The device is described as a monitor that collects and displays physiological data. While this data can inform therapeutic decisions, the device itself does not administer therapy or directly treat a condition. It is explicitly stated that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter" and "No therapeutic decisions should be made based solely on the Assisted Fluid Management suggestions," emphasizing its role as a diagnostic/monitoring tool, not a therapeutic one.
Yes
Explanation: The device is described as monitoring various physiological parameters (cardiac output, hemodynamic parameters, venous oxygen saturation, fluid status, blood pressure, regional hemoglobin oxygen saturation) to provide "physiological insight" into a patient's condition, including predicting hypotensive events and estimating response to fluid therapy. This aligns with the definition of a diagnostic device, which is used to diagnose or aid in the diagnosis of a medical condition.
No
The device description explicitly states that the HemoSphere Advanced Monitoring platform consists of the HemoSphere Advanced Monitor (hardware) and several optional external hardware modules (Swan-Ganz Module, Oximetry Cable, Pressure Cable, Tissue Oximeter Module, ForeSight Oximeter Cable, ClearSight Module). While there is a mobile application (Viewfinder Remote) mentioned, it is described as a supplemental remote display and not the primary medical device itself. The core device is a hardware platform with associated software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- No mention of testing biological samples outside the body: The description focuses on monitoring physiological parameters directly from the patient (cardiac output, blood temperature, oxygen saturation, blood pressure, etc.) using catheters, sensors, and finger cuffs. IVDs are designed to examine specimens derived from the human body (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Focus on real-time physiological monitoring: The device is described as a "monitoring platform" for "hemodynamic monitoring" in critical care settings. This indicates real-time assessment of the patient's physiological state, not laboratory analysis of samples.
- No mention of reagents or laboratory procedures: IVDs typically involve the use of reagents and are used in a laboratory setting or at the point of care for testing samples. This device description does not mention any such components or procedures.
The device is clearly intended for in vivo monitoring of patients.
No
The provided text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section explicitly states '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-Gatheter 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 is indicated for use in adult and pediatric critical care patients requiring 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 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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November 7, 2022
Edwards Lifeciences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine, California 92614
Re: K223127
Trade/Device Name: HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, DQE, QAQ, MUD, DXN, DSB, QMS, FLL Dated: September 30, 2022 Received: October 3, 2022
Dear Michelle Ducca:
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
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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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Special 510(k) - HemoSphere Advanced Monitoring Platform
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K22XXXXX
Device Name
HemoSphere Advanced Monitoring Platform
Indications for Use (Describe)
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-Gatheter 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 is indicated for use in adult and pediatric critical care patients requiring 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 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 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."
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K223127 K22XXXX
510(k) Summary – HemoSphere Advanced Monitoring Platform
I. Submitter:
Sponsor: Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Establishment 2015691 Registration Number:
- Contact Person: Michelle Ducca Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614 michelle ducca@edwards.com Telephone: (949) 250-4113
Date Prepared: September 30, 2022
Device Information: II.
Platform Name HemoSphere Advanced Monitoring Platform
| Trade Name: | HemoSphere Advanced Monitor | |
|---|---|---|
| HemoSphere Swan-Ganz Module | ||
| HemoSphere Oximetry Cable | ||
| HemoSphere Pressure Cable | ||
| HemoSphere Technology Module | ||
| HemoSphere ForeSight Oximeter Cable (Subject) | ||
| HemoSphere ClearSight Module | ||
| Acumen Hypotension Prediction Index (HPI) for Minimally Invasive and | ||
| Non-Invasive technology | ||
| Viewfinder Remote (for non-invasive parameters) | ||
| 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 |
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Image /page/6/Picture/0 description: The image shows two lines of text. The first line reads "K223127" in a bold, sans-serif font. The second line reads "K22XXXXX" in a smaller, serif font. The two lines of text appear to be related, possibly representing a code or identifier with a masked version below.
| Product Code | DQK, Class II |
|---|---|
| for | DQE, Class II |
| HemoSphere | QAQ, Class II |
| Monitor and | |
| Accessories: | MUD, Class II |
| DXN, Class II | |
| DSB, Class II |
III. Predicate Device
HemoSphere Advanced Monitoring Platform, manufactured by Edwards Primarv Predicate: Lifesciences, K213682 cleared June 22, 2022, is being utilized for substantial equivalence to the device modularity, basic device functionality, graphical user interface (GUI), and same existing StO2 algorithm specifications. The subject device contains the same indications and intended use as the predicate device.
Fore-Sight Elite Module Tissue Oximeter, manufactured by Casmed Inc. (now Additional part of Edwards Lifesciences), K143675 cleared April 10, 2015, is being Predicate: utilized for substantial equivalence to the StO2 algorithm. This predicate contains the original StO2 algorithm for cerebral and somatic locations using all sensor sizes. It has the same principle of operation and similar intended and indications for use and performance as the subject device.
IV. Device Description:
Device The HemoSphere Advanced Monitoring platform was designed to simplify the customer experience by providing one platform with modular solutions for Description: 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 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 Oximeter Module (K190205 August 29, 2019), HemoSphere ForeSight Oximeter Cable (K213682 cleared June 22, 2022). and the HemoSphere ClearSight Module (K203687 cleared May 28, 2021).
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V. Indications for Use:
Indications for Note: There is no change to the Indication for Use statements from what was Use: previously cleared in K213682 on June 22, 2022
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 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 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 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