(162 days)
Yes
The summary explicitly mentions the "Acumen Hypotension Index feature" and the "Right Ventricular Pressure (RVP) algorithm," both of which are described as providing "physiological insight" and are likely based on complex data analysis, strongly suggesting the use of AI/ML. The term "algorithm" in this context, especially for predictive or insightful features, often implies ML.
No
The device is described as a "Monitor" and is indicated for "monitoring hemodynamic parameters." It provides "additional quantitative information" for reference and explicitly states "no therapeutic decisions should be made based solely on" some of its parameters. This indicates its role is observational and diagnostic, not therapeutic.
Yes
The device monitors physiological parameters such as cardiac output, venous oxygen saturation, and blood pressure, and provides "physiological insight into a patient's likelihood of future hypotensive events" and "hemodynamic status of the right ventricle of the heart", which are all forms of diagnostic information used to understand a patient's medical condition. However, it explicitly states that "no therapeutic decisions should be made based solely on" some of these parameters, indicating it provides information for diagnosis rather than directly guiding treatment.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform consists of the HemoSphere Advanced Monitor (which provides a screen for visualization) and five optional external hardware modules (Swan-Ganz Module, Oximetry Cable, Pressure Cable, Technology Module, ForeSight Module, and ClearSight Module). This indicates the device is a system with both hardware and software components, not software-only.
Based on the provided information, the HemoSphere Advanced Monitor with its various modules is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- HemoSphere Function: The HemoSphere system, as described, is a hemodynamic monitoring system. It measures and derives physiological parameters directly from the patient's body (e.g., cardiac output, blood pressure, oxygen saturation) using invasive or non-invasive sensors and catheters. It does not analyze samples taken from the body.
- Intended Use: The intended use statements clearly describe monitoring physiological parameters in critical care and surgical patients. This is consistent with a patient monitoring device, not an IVD.
- Device Description: The description details a platform with modules that connect to sensors and catheters placed on or in the patient.
- Performance Studies: The performance studies focus on system verification, software verification, and usability, which are typical for patient monitoring devices. There is no mention of studies involving the analysis of biological specimens.
Therefore, the HemoSphere Advanced Monitor and its modules fall under the category of patient monitoring devices, not In Vitro Diagnostic devices.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere Advanced Monitor when used with the HemoSphere Swan-Ganz Module and Edwards Swan-Ganz Catheters is indicated for use in adult and pediatric critical care patients requiring 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 crtical 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 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 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 =40 kg (large sensors); pediatric subjects >=3 kg (Medium Sensors); 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 22, 2022
Edwards Lifesciences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine. California 92614
Re: K221704
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, QDE, QAQ, MUD, DXN, DSB, QMS, QNL Dated: October 19, 2022 Received: October 20, 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
1
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,
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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Indications for Use
510(k) Number (if known) K221704
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 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 crtical 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 Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure 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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K221704
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 | | |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------|
| Establishment
Registration
Number: | 2015691 | | |
| Contact
Person: | Michelle Ducca
Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
michelle_ducca@edwards.com
Telephone: (949) 250-4113 | | |
| Date: | November 11, 2022 | | |
| Platform
Name | HemoSphere Advanced Monitoring Platform | | |
| Trade Name: | HemoSphere Advanced Monitor (subject)
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable
HemoSphere Pressure Cable (subject)
Acumen Hypotension Prediction Index (HPI) for Minimally Invasive and Non-
invasive technologies
HemoSphere Tissue Oximetry Module
HemoSphere FORE-SIGHT ELITE Tissue Oximetry Module
HemoSphere ClearSight Module
Right Ventricular Pressure Feature (subject) | | |
| Common
Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| Classification
Name for
HemoSphere
Monitor and
Accessories: | Programmable Diagnostic Computer
Fiberoptic Oximeter Catheter
Adjunctive Predictive Cardiovascular Indicator
Oximeter, Tissue Saturation (Non-Invasive)
System, Measurement, Blood-Pressure, Non-Invasive
Plethysmograph, Impedance | 21 CFR 870.1425
21 CFR 870.1230
21 CFR 870.2210
21 CFR 870.2700
21 CFR 870.1130 | 21 CFR 870.2770 |
510(k) Summary – HemoSphere Advanced Monitoring Platform
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| 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
QNL, Class II |
| ------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------- |
|---|
- HemoSphere Advanced Monitoring Platform, manufactured by Edwards Primarv Predicate: Lifesciences, K203687 cleared May 28, 2021, is being utilized for substantial equivalence to the device modularity, basic device functionality, graphical user interface (GUI) used, similar existing algorithm for the Right Ventricular Pressure (RVP) feature. The indications for use are also similar to the subject device.
- Philips IntelliVue (K161531, cleared July 1, 2016) manufactured by Philips Additional Predicates: Medizin Systeme Boeblingen GmbH, is being utilized for substantial equivalence to the Right Ventricular Pressure (RVP) feature in terms of technology and similar indications/intended use.
- Device The HemoSphere Advanced Monitoring platform was designed to simplify the Description: 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 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 Technology Module (K190205 August 29, 2019). HemoSphere ForeSight Module (K180003, May 10, 2018), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module Indications 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 (CO) and intermittent (iCO)] and derived hemodynamic
7
parameters. It mav 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 yenous 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 3 kg.
- . When used with Small Sensors, the FORE-SIGHT ELITE tissue oximeter module is indicated for cerebral use on pediatric subjects