(143 days)
Not Found
Yes
The "Acumen Hypotension Prediction Index (HPI) feature" is described as providing "physiological insight into a patient's likelihood of future hypotensive events" and is explicitly mentioned as a "feature". This type of predictive analysis based on physiological data is a strong indicator of AI/ML technology being employed. While the summary doesn't explicitly use the terms "AI" or "ML" in the "Mentions AI, DNN, or ML" section, the description of the HPI feature aligns with the capabilities of such technologies.
No
The provided text consistently describes the devices as "diagnostic and monitoring tools" used for "hemodynamic monitoring" and to "measure cardiac output" and "hemodynamic parameters." There is no mention of the devices delivering therapy or treating a condition. The HPI feature explicitly states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "The Swan-Ganz catheters are diagnostic and monitoring tools."
No
The device description clearly outlines multiple hardware components including catheters, sensors, finger cuffs, and a monitoring platform. While software is likely involved in processing data, the core functionality relies on physical hardware.
Based on the provided information, none of these devices are IVDs (In Vitro Diagnostics).
Here's why:
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IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This examination happens outside the body.
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Device Descriptions and Intended Use: The descriptions and intended uses for all the listed devices (Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and the HemoSphere Advanced Monitor with its modules) clearly indicate that they are used for monitoring physiological parameters within or on the patient's body.
- Swan-Ganz catheters: Inserted into the pulmonary artery to monitor hemodynamic pressures in vivo.
- FloTrac sensors: Attached to pressure monitoring catheters to monitor pressures in vivo.
- ClearSight finger cuffs: Placed on the finger to non-invasively measure blood pressure and hemodynamic parameters on the body.
- HemoSphere Advanced Monitor: Receives data from the catheters and sensors to display and analyze hemodynamic parameters from the patient.
-
No Specimen Examination: There is no mention of these devices examining specimens (blood, tissue, etc.) outside the body.
Therefore, these devices fall under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Swan-Ganz catheters- Indications for Use:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Models 096F6. 096F6P. TS105F5. 131F7. 131F75P. 831F75. 834F75. and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
FloTrac sensors- Indications for Use:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥12 years of age.
ClearSight finger cuffs- Indications for Use:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere advanced monitoring platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients >12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere advanced monitoring platform.
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 pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. 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 Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable- Indications for Use:
The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular ressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards 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
§ 870.1240 Flow-directed catheter.
(a)
Identification. A flow-directed catheter is a device that incorporates a gas-filled balloon to help direct the catheter to the desired position.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 21, 2023
Edwards Lifesciencess LLC Anne Lo Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K231248
Trade/Device Name: Swanz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform Regulation Number: 21 CFR 870.1240 Regulation Name: Flow-Directed Catheter Regulatory Class: Class II Product Code: DYG, DQO, DRS, DXN, DQK Dated: April 30, 2023 Received: May 1, 2023
Dear Anne Lo:
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,
Robert T. Kazmierski -S
for
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) K231248
Device Name
Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform
Indications for Use (Describe)
Swan-Ganz catheters- Indications for Use:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary failure, cardiac disease including heart failure.
Models 096F6. 096F6P. TS105F5. 131F7. 131F75P. 831F75. 834F75. and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
FloTrac sensors- Indications for Use:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥12 years of age.
ClearSight finger cuffs- Indications for Use:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere advanced monitoring platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients >12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere advanced monitoring platform.
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 pediatic critical care patients requiring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. 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 Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable- Indications for Use: The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular ressure
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needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards 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."
4
| 510(k) Submitter | Edwards Lifesciences, LLC
One Edwards Way
Irvine, CA, USA 92614 | |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Primary Contact | Secondary Contact |
| | Anne Lo
Manager, Regulatory Affairs
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Telephone: (949) 250-3386
Fax: (949) 809 - 2954
Email: Anne_Lo@edwards.com | Karen O'Leary
Sr. Director, Regulatory Affairs
Edwards Lifesciences
One Edwards Way
Irvine, CA 92614
Telephone: (949) 610-9179
Fax: (949) 809 - 2954
Email: Karen_OLeary@edwards.com |
| Date Prepared | September 19, 2023 | |
| Trade Name | Swan-Ganz catheters
FloTrac sensors
ClearSight finger cuffs
HemoSphere Advanced Monitoring Platform | |
| Common Name | Swan-Ganz catheters: Cardiovascular Diagnostic Catheters
FloTrac sensors: Dual Disposable Pressure Transducer
ClearSight finger cuffs: Non-Invasive Blood Pressure Measurement System
HemoSphere Advanced Monitoring Platform: Programmable Diagnostic Computer | |
| Regulation
Number/
Regulation Name | Swan-Ganz catheters: 21 CFR §870.1240, 21 CFR §870.1200
FloTrac sensors: 21 CFR §870.2850
ClearSight finger cuffs: 21 CFR §870.1130
HemoSphere Advanced Monitor: 21 CFR §870.1425, 21 CFR §870.1230, 21 CFR §870. 2210, 21 CFR §870. 1130, 21 CFR §870.2770 | |
| Product Code | Swan-Ganz catheters: DYG, DQO
FloTrac sensors: DRS
ClearSight finger cuffs: DXN
HemoSphere Advanced Monitor: DQK, DQE, QAQ, DXN, DSB | |
| Regulation Class | Class II | |
| Predicate Device | Swan-Ganz catheters: K160084, cleared on May 03, 2016
FloTrac sensors: K152980, cleared on January 19, 2016
ClearSight finger cuffs: K190130, cleared on June 21, 2019
HemoSphere Advanced Monitoring System: K221833, cleared on Nov 7, 2022 | |
| Device
Description | Swan-Ganz Catheters:
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor
hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic
information to rapidly determine hemodynamic pressures and cardiac output when used with
a compatible cardiac output computer. | |
| | FloTrac Sensors: | |
| | The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to
pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor
minimally-invasively measures cardiac output and key hemodynamic parameters, which
assist the clinician in assessing the patient's physiologic status and support clinical decisions
related to hemodynamic optimization. The disposable sterile cable, with a red-connector
interfaces, exclusively with an Edwards cable that is specifically wired for the pressure
monitor being used. The disposable sterile cable, with a green-connector interfaces,
exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac
output monitoring devices or hardware. | |
| | The FloTrac sensor has a straight, flow-through design across the pressure sensors with an
integral flush device. | |
| | ClearSight finger cuffs:
The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system,
provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs
utilize the volume-clamp method to measure blood pressure with an inflatable bladder
wrapped around the middle phalanx of the finger. | |
| | HemoSphere Advanced Monitor Platform:
The HemoSphere Advanced Monitoring Platform was designed to simplify the customer
experience by providing one platform with modular solutions for their hemodynamic
monitoring needs. The user can choose from the available optional sub-system modules or
use multiple sub-system modules at the same time. This modular approach provides the
customer with the choice of purchasing and/or using specific monitoring applications based
on their needs. Users are not required to have all of the modules installed at the same time
for the platform to function. | |
| Indications
for
Use/Intended Use | Swan-Ganz catheters:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic
monitoring of adult critically ill patients including but limited to post major surgical
recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease
including heart failure. | |
| | Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and
834F75P are intended for adult and pediatric patients: | |
| | The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic
monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not
limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease,
pulmonary failure, cardiac disease including heart failure. | |
| | FloTrac sensors:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also
indicated for use with the Edwards arterial pressure based cardiac output monitoring devices
or hardware to measure cardiac output. They are intended to be used in adult patients. | |
| | Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients: | |
| | The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also | |
510(k) Summary- Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform
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indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age.
ClearSight finger cuffs:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
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 in a hospital environment. 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 Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.
HemoSphere Advanced Monitor with HemoSphere Pressure Cable (compatible with FloTrac sensors):
The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric 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 of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards 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