(137 days)
Yes
The summary explicitly mentions the "Acumen Hypotension Prediction Index feature" which provides "physiological insight into a patient's likelihood of future hypotensive events". This type of predictive analysis based on physiological data is characteristic of AI/ML algorithms. While the summary states "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter", the predictive nature of the feature strongly suggests the use of AI/ML.
No.
The device is indicated for monitoring and assessing hemodynamic parameters, not for providing therapy. It explicitly states for the Acumen HPI feature that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter."
Yes
Explanation: The device is indicated for monitoring various hemodynamic parameters and providing physiological insight into a patient's condition, which aligns with the definition of a diagnostic device.
No
The device description explicitly states that the HemoSphere Advanced Monitoring Platform consists of a "HemoSphere Advanced Monitor" which provides a screen for interaction and visualization, and "five (5) optional external modules". This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The HemoSphere Advanced Monitoring Platform and its modules are designed to monitor physiological parameters directly from the patient's body (e.g., cardiac output, venous oxygen saturation, blood pressure, tissue oxygen saturation) using various sensors and catheters.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The measurements are taken in vivo (within the living body).
Therefore, the HemoSphere Advanced Monitoring Platform falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / 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 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 is indicated for use in adult and pediatric crtical care patients requring 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
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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Image /page/0/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 7, 2022
Edwards Life Sciences LLC Varad Raghuwanshi Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K221833
Trade/Device Name: HemoSphere Advanced Monitor. HemoSphere SwanGanz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module, HemoSphere ClearSight Module Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DSB, DQK, DQE, MUD Dated: June 21, 2022 Received: June 23, 2022
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.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221833
Device Name
HemoSphere Advanced Monitor. HemoSphere SwanGanz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue Oximeter Module, HemoSphere ClearSight Module
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 cable and Edwards is indicated for use in adult and pediatric crtical care patients requring 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 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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Image /page/4/Picture/0 description: The image shows a logo with a large letter 'E' in white, set against a gray square background. The 'E' is stylized with a grid pattern and circular lines intersecting it. Below the square, the word 'Edwards' is written in a simple, sans-serif font.
510(k) Summary – HemoSphere Advanced Monitoring Platform
I. Submitter:
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 | | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|
| Establishment
Registration
Number: | 2015691 | | |
| Contact Person: | Varad Raghuwanshi
Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
Telephone: (949) 756-4502
Fax: (949) 809-2972 | | |
| Date Prepared: | October 8, 2022 | | |
| II. Device Information: | | | |
| Platform Name
(Name of the Device) | HemoSphere Advanced Monitoring Platform | | |
| Trade Name: | HemoSphere Advanced Monitor
HemoSphere Swan-Ganz Module
HemoSphere Oximetry Cable
HemoSphere Pressure Cable
HemoSphere Tissue Oximetry Module and FORE-SIGHT ELITE Tissue
Oximeter Module
HemoSphere ClearSight Module | | |
| Common Name: | Cardiac Output/Oximetry/Ejection Fraction Computer | | |
| Classification
Name: | Programmable Diagnostic Computer
Fiberoptic Oximeter Catheter
Adjunctive Predictive Cardiovascular Indicator
Oximeter | 21 CFR 870.1425
21 CFR 870.1230
21 CFR 870.2210
21 CFR 870.2700 | |
Impedance plethysmograph
Noninvasive blood pressure measurement system 21 CFR 870.1130
21 CFR 870.2770
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Image /page/5/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in a gray color, set against a square background that is also gray. The letter 'E' is overlaid with a circular design, giving it a modern and sophisticated look. Below the square logo, the word 'Edwards' is written in a simple, sans-serif font.
| Product Code | DQK, Class II |
|---|---|
| and Regulatory | DQE, Class II |
| Class: | QAQ, Class II |
| MUD, Class II | |
| DXN, Class II | |
| DSB, Class II |
III. Predicate Device
Primary HemoSphere Advanced Monitoring Platform manufactured by Edwards Predicate Device: Lifesciences, K201446 cleared October 1, 2020.
IV. Device Description
Device HemoSphere Advanced Monitoring Platform consists of the HemoSphere Description: 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), and the HemoSphere ClearSight Module (K201446 Cleared October 1, 2020).
V. Indications for Use:
Note: There is no change to the Indication for Use statements from what was cleared in K201446 on October 1, 2020.
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.
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Image /page/6/Picture/0 description: The image shows a logo for Edwards. The logo features a large, stylized letter 'E' in white, set against a gray background divided into a grid of squares. The letter 'E' is partially overlaid with a circular design composed of thin white lines. Below the grid, the word 'Edwards' is written in a simple, sans-serif font.
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.
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