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 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI™ feature is intended for use in surgical or non-surgical 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 Acumen 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 ClearSight Module:
The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for adult and pediatric patients 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 and Acumen IQ finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.
The Edwards Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into 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 surgical 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 Acumen 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.

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.

AI/ML Overview

This document is a 510(k) summary for Edwards Lifesciences' Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform. The core of this submission is to expand the indications for use of these devices to include pediatric patients (≥12 years of age), in addition to their existing adult indications.

The information regarding acceptance criteria and the study that proves the device meets those criteria, as detailed in your request, is primarily found in the "Device Verification and Validation" and "Conclusion" sections. However, the FDA summary document only provides a high-level overview. It does not contain the detailed acceptance criteria table, precise performance metrics, sample sizes, ground truth establishment methods, or specific details about expert adjudication or MRMC studies, which are typically found in the full 510(k) submission or supporting clinical trial reports.

Based on the provided text, here's what can be extracted and what information is not present:

Key Takeaway from the FDA 510(k) Summary:

The primary purpose of this 510(k) submission is to expand the indicated patient population for the listed devices from adult-only to include pediatric patients aged 12 years and older. The submission claims that the devices perform similarly in this expanded pediatric population compared to adults, meeting predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Not Provided in this Document. The document states "within predefined acceptance criteria" but does not list these criteria or the specific reported device performance metrics against them.

Acceptance Criteria Category	Specific Metric (e.g., Accuracy, Precision, AUC Threshold)	Acceptance Threshold	Reported Device Performance
Hemodynamic Parameter Measurement	Not specified	Not specified	Not specified
Safety	Not specified	Not specified	"no issues of safety"
Effectiveness	Not specified	Not specified	"effective in measuring cardiac output"
Consistency	Not specified	Not specified	"consistent and within predefined acceptance criteria." "similar performance to an adult population."

Study Details (Based on available information):

Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "the target pediatric population in a clinical study" but does not provide the number of patients.
- Data Provenance:
  - Country of Origin: Not specified in this summary. Clinical studies are often multi-center, but no specific locations are mentioned.
  - Retrospective or Prospective: Not explicitly stated, but the phrase "clinical study" typically implies prospective data collection for regulatory submissions, especially for expanding indications to a new population.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. Given the nature of these hemodynamic devices, ground truth would likely be established by clinical measurements and potentially other validated reference methods, rather than expert interpretation of images or signals in the same way a radiologist might interpret an X-ray. Clinical experts (e.g., intensivists, anesthesiologists, cardiologists) would be involved in patient selection, data collection, and overseeing the study.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. This type of adjudication (e.g., multi-reader consensus) is more common in image-based diagnostic AI studies. For device performance measurement, agreement with a reference standard is the typical method.
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:
- MRMC Study: Not applicable/not performed for this type of device and study. MRMC studies are primarily for evaluating AI's impact on human interpretation tasks (e.g., radiologists reading images). This submission is for devices that directly measure physiological parameters and provide data, with one feature (Acumen HPI) providing "physiological insight" for reference. The study focuses on the device's performance in a new patient population, not on how it assists human readers in interpreting complex cases, except perhaps by providing accessible data. The Acumen HPI feature specifically states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," indicating it's an informational tool rather than a definitive diagnostic AI assist requiring a MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The study evaluated the devices' performance in the pediatric population. The devices themselves are "standalone" in that they acquire and process physiological signals to output parameters. The statement "The data demonstrate the performance in the expanded pediatric population ≥ 12 years of age and is substantially equivalent to their respective predicate devices for adult patient population ≥ 18 years of age" suggests an evaluation of the device's measurement accuracy and consistency.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not explicitly stated, but for hemodynamic monitoring devices, ground truth is typically established by:
  - Reference Standards/Comparative Measurements: Comparing the device's measurements (e.g., cardiac output, blood pressure) against established, precise, and often more invasive or gold-standard methods (e.g., thermodilution, invasive arterial line measurements from validated transducers).
  - Clinical Outcomes/Safety Data: Demonstrating safety and effectiveness in the target population through clinical monitoring and observation.
- The document states "clinical data presented in this 510(k) demonstrates the performance of hemodynamic parameters expanded to pediatric patients ≥ 12 years of age... are consistent and within predefined acceptance criteria," implying comparisons to a reference or expected range.
The sample size for the training set:
- Training Set Size: Not applicable/not specified. These devices measure physiological parameters; they are not "AI algorithms" in the sense of needing a large training dataset to learn patterns for classification or prediction (except for the Acumen HPI feature, but no details on its development or training are provided here). The focus of this 510(k) is the application of existing technology to a new age group, not the development of a new pattern-recognition algorithm.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there's no mention of a traditional AI training set. The devices likely use established physiological models and algorithms for calculating parameters. If the Acumen HPI feature involved machine learning, its training ground truth would likely be based on recorded physiological data and subsequent hypotensive events. However, the document does not elaborate on the development of this specific feature in the context of this 510(k).

Summary

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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

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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:

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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPTM feature is intended for use in surgical or non-surgical 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 Acumen 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 ClearSight Module - Indications for Use:

The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for adult and pediatic patients 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 and Acumen 10 finger cuff indications for use statements for information on target patient population specific to the finger cuff being used.

The Edwards Acumen Hypotension Prediction Index (HPI) feature provides the clinician with physiological insight into 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 surgical 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 Acumen 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Submitter	Edwards Lifesciences, LLCOne Edwards WayIrvine, CA, USA 92614
Contact Person	Primary Contact	Secondary Contact
	Anne LoManager, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 250-3386Fax: (949) 809 - 2954Email: Anne_Lo@edwards.com	Karen O'LearySr. Director, Regulatory AffairsEdwards LifesciencesOne Edwards WayIrvine, CA 92614Telephone: (949) 610-9179Fax: (949) 809 - 2954Email: Karen_OLeary@edwards.com
Date Prepared	September 19, 2023
Trade Name	Swan-Ganz cathetersFloTrac sensorsClearSight finger cuffsHemoSphere Advanced Monitoring Platform
Common Name	Swan-Ganz catheters: Cardiovascular Diagnostic CathetersFloTrac sensors: Dual Disposable Pressure TransducerClearSight finger cuffs: Non-Invasive Blood Pressure Measurement SystemHemoSphere Advanced Monitoring Platform: Programmable Diagnostic Computer
RegulationNumber/Regulation Name	Swan-Ganz catheters: 21 CFR §870.1240, 21 CFR §870.1200FloTrac sensors: 21 CFR §870.2850ClearSight finger cuffs: 21 CFR §870.1130HemoSphere 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, DQOFloTrac sensors: DRSClearSight finger cuffs: DXNHemoSphere Advanced Monitor: DQK, DQE, QAQ, DXN, DSB
Regulation Class	Class II
Predicate Device	Swan-Ganz catheters: K160084, cleared on May 03, 2016FloTrac sensors: K152980, cleared on January 19, 2016ClearSight finger cuffs: K190130, cleared on June 21, 2019HemoSphere Advanced Monitoring System: K221833, cleared on Nov 7, 2022
DeviceDescription	Swan-Ganz Catheters:The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitorhemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnosticinformation to rapidly determine hemodynamic pressures and cardiac output when used witha compatible cardiac output computer.
	FloTrac Sensors:
	The FloTrac sensor is a sterile, single use kit that monitors pressures when attached topressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensorminimally-invasively measures cardiac output and key hemodynamic parameters, whichassist the clinician in assessing the patient's physiologic status and support clinical decisionsrelated to hemodynamic optimization. The disposable sterile cable, with a red-connectorinterfaces, exclusively with an Edwards cable that is specifically wired for the pressuremonitor being used. The disposable sterile cable, with a green-connector interfaces,exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiacoutput monitoring devices or hardware.
	The FloTrac sensor has a straight, flow-through design across the pressure sensors with anintegral 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 cuffsutilize the volume-clamp method to measure blood pressure with an inflatable bladderwrapped around the middle phalanx of the finger.
	HemoSphere Advanced Monitor Platform:The HemoSphere Advanced Monitoring Platform was designed to simplify the customerexperience by providing one platform with modular solutions for their hemodynamicmonitoring needs. The user can choose from the available optional sub-system modules oruse multiple sub-system modules at the same time. This modular approach provides thecustomer with the choice of purchasing and/or using specific monitoring applications basedon their needs. Users are not required to have all of the modules installed at the same timefor the platform to function.
IndicationsforUse/Intended Use	Swan-Ganz catheters:The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamicmonitoring of adult critically ill patients including but limited to post major surgicalrecovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac diseaseincluding heart failure.
	Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and834F75P are intended for adult and pediatric patients:
	The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamicmonitoring of critically ill adult and pediatric patients ≥ 12 years of age including but notlimited 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 alsoindicated for use with the Edwards arterial pressure based cardiac output monitoring devicesor 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 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI™ feature is intended for use in surgical or non-surgical 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 Acumen 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 ClearSight Module:

The HemoSphere advanced monitor when used with the HemoSphere ClearSight module, pressure controller and a compatible Edwards finger cuff are indicated for adult and

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	pediatric patients in which the balance between cardiac function, fluid status and vascularresistance needs continuous assessment. It may be used for monitoring hemodynamicparameters in conjunction with a perioperative goal directed therapy protocol in a hospitalenvironment. In addition, the noninvasive system is indicated for use in patients with co-morbidities for which hemodynamic optimization is desired and invasive measurements aredifficult. The HemoSphere advanced monitor and compatible Edwards finger cuffsnoninvasively measures blood pressure and associated hemodynamic parameters.
	Refer to the ClearSight finger cuff and Acumen IQ finger cuff indications for use statementsfor information on target patient population specific to the finger cuff being used.
	The Edwards Acumen Hypotension Prediction Index (HPI) feature provides the clinicianwith physiological insight into patient's likelihood of future hypotensive events (defined asmean arterial pressure < 65 mmHg for at least one minute in duration) and the associatedhemodynamics. The Acumen HPI feature is intended for use in surgical patients receivingadvanced hemodynamic monitoring. The Acumen HPI feature is considered to be additionalquantitative information regarding the patient's physiological condition for reference onlyand no therapeutic decisions should be made based solely on the Acumen HypotensionPrediction Index (HPI) parameter.
	Refer to the Intended Use statement for a complete list of measured and derived parametersavailable for each patient population.
ComparisontoPredicate Device	The subject devices of this Traditional 510(k) are identical to the predicate devicescleared in the above listed 510(k)s in terms of the design, performance specifications,technological characteristics, software, hardware, and algorithm with the exception ofthe indications for use and the labeling. Differences in the indications for use to addpediatric patient population do not raise any new concerns of safety and effectiveness.
	The clinical data presented in this 510(k) demonstrates the performance of hemodynamicparameters expanded to pediatric patients ≥ 12 years of age for Swan-Ganz catheters,FloTrac sensors, ClearSight finger cuffs and compatible HemoSphere sub-system modulesare consistent and within predefined acceptance criteria. The data demonstrate theperformance in the expanded pediatric population ≥ 12 years of age and is substantiallyequivalent to their respective predicate devices for adult patient population ≥ 18 years ofage.
DeviceVerificationandValidation	The subject devices were evaluated in the target pediatric population in a clinical studyand results of the study demonstrate that devices can be used in that population withno issues of safety and effectiveness.
Conclusion	The data provided demonstrates that use of the FloTrac, ClearSight and Swan-Ganztechnologies is safe and effective in measuring cardiac output in pediatric subjects ≥ 12years of age, with similar performance to an adult population. The subject devices aresubstantially equivalent to their respective predicate devices.

Regulation Number and Section

§ 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).