Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The Swan-Ganz thermodilution A-V Paceport catheter (Model 991F8) is indicated for the assessment of a patient's hemodynamic condition through simultaneous right atrial, right ventricular, and pulmonary artery or wedge pressure monitoring, cardiac output determination, and for infusing solutions. The A-V Paceport catheter (Model 991F8) is also indicated for standby temporary ventricular, atrial, or A-V sequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

ControlCath thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Torque Support Thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The primary indications for the Swan-Ganz CCO thermodilution catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Models with CEDV capabilities are also indicated for volumetric determinations. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions.

The primary indications for the CCOmbo EDV TD catheters include: Acute heart failure, Severe hypovolemia, Complex circulatory situations, Medical emergencies, Adult respiratory distress syndrome, Gram negative sepsis, Multi system organ failure, Drug intoxication, Acute renal failure, Hemorrhagic pancreatitis, Intra and post-operative management of high risk patients, History of pulmonary or cardiac disease, Fluid shifts (e.g., extensive intra-abdominal operations), Management of high-risk obstetrical patients, Diagnosed cardiac disease, Toxemia, Premature separation of placenta, Cardiac output determinations, Volumetric determinations, Differential diagnosis of mitral regurgitation and ventricular septal rupture, Diagnosis of cardiac tamponade. Secondary indications include the following: Blood Sampling, Infusion of saline and dextrose solutions.

Swan-Ganz oximetry TD catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions. The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Device Description

The Swan-Ganz catheters are well known pulmonary artery catheters intended for use on critical care patients. A Swan-Ganz Catheter includes an inflatable balloon at the tip, which facilitates its placement into the pulmonary artery through the flow of blood. The catheters can be grouped together based on functionality. The Swan-Ganz catheters can be used with compatible cardiac output patient monitors and/or with oximetry modules (depending on the model number) to transmit signals for hemodynamic pressure monitoring, cardiac output measurements, and/or oximetry measurements. The Swan-Ganz catheters are to be used with the Edwards and/or Edwards' compatible patient monitors, such as the Vigilance II.

AI/ML Overview

The provided document is a 510(k) premarket notification for Edwards Lifesciences, LLC Swan Ganz Catheters. This document outlines the device's indications for use and includes a 510(k) summary (Section 5).

However, it does not contain information regarding detailed acceptance criteria, a study proving the device meets these criteria, sample sizes for test or training sets, expert qualifications, or adjudication methods for AI/software-as-a-medical-device (SaMD) performance evaluation. The document primarily focuses on demonstrating substantial equivalence to predicate devices for its intended physiological monitoring functions and includes an update regarding MRI compatibility.

Therefore, I cannot extract the specific information requested in your bullet points related to acceptance criteria and study details for an AI/SaMD device from this document. The "Key Performance Specifications" section explicitly states: "The proposed contraindication change and the MR Safe claim do not have any effect on the design, materials, technology and operating principles of current legally marketed device. Therefore no additional performance testing was required."

The "Functional/Safety Testing" section mentions: "Swan-Ganz Flow Directed Monitoring catheter was evaluated for MRI compatibility and was confirmed to be MR Safe". This refers to the physical safety of the catheter in an MRI environment, not a performance evaluation in the context of diagnostic accuracy or clinical effectiveness that would typically involve acceptance criteria and comparative studies for a software device.

Without the requested details, I am unable to generate the bulleted list of acceptance criteria and study information.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 3, 2016

Edwards Lifesciences, LLC Mugdha Dongre Specialist. Regulatory Affairs One Edwards Way Irvine, California 92614

Re: K160084

Trade/Device Name: Swan Ganz Catheters Regulation Number: 21 CFR 870.1240 Regulation Name: Flow-Directed Catheter Regulatory Class: Class II Product Code: DYG, DQE, DQO, KRA Dated: March 21, 2016 Received: March 22, 2016

Dear Mugdha Dongre:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours, Shawn W. Forrest -S 2016.05.03 12:50:36 -04'00' for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160084

Device Name Swan-Ganz Catheters

Indications for Use (Describe)

Device Name: Swan-Ganz Flow-Directed Monitoring catheters- Double and Triple Lumen Indications For Use:

Models: 111F7, 111F7P, S111F7, 123F6, 123F6P, T123F6, 110F5, 116F4, 115F7, 115F7P, 114F7 and 114F7P Swan-Ganz flow-directed monitoring catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

Device Name: Swan-Ganz- Thermodilution, VIP and VIP+, True Size Indications For Use:

Models: 131F7, 131VF7P, 141F7, 143TF7, 151F7, 831F75, 831F75P, 831VF75P, 834F75, 096F6, 996F6P, TS105F5 and 132F5

Swan-Ganz thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen utilization coefficient, and intrapulmonary shunt fraction.

Device Name: Swan-Ganz- Thermodilution Paceport catheters, Thermodilution A-V Paceport catheters Indications For Use:

Model 931F75

The Swan-Ganz thermodilution Paceport catheters (Model 931F75) are used for assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. The Paceport catheter (Model 931F75) may also be used for standby temporary ventricular pacing. The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen utilization coefficient, and intrapulmonary shunt fraction.

Model 991F8

Device Name: Swan-Ganz- Polymer Blend True Size ControlCath Thermodilution catheters, Synthetic ControlCath Thermodilution Catheters, Polymer Blend True Size Torque Support Thermodilution catheter Indications For Use:

Models: C144F7, S144F7, C145F6N, C146F7 and S9FC146F7

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K160084

balance and the calculation of derived parameters such as oxygen utilization coefficient, and intrapulmonary shunt fraction.

Model: T173F6

Device Name: Swan-Ganz Continuous Cardiac Output Thermodilution catheters - CCO Catheters, CCO/ SvO2/ VIP Catheters, CCO V CCO/ CEDV Catheters, CCOmbo V CCO/SvO2/CEDV Catheters, CCOmbo V CCO/SvO2/ CEDV/VIP Catheters

Indications For Use:

Models: 139F75, 744F75, 746F8, 177F75N, 774F75 and 777F8

The primary indications for the Swan-Ganz CCO thermodilution catheters include:

· Acute heart failure
Severe hypovolemia
· Complex circulatory situations
· Medical emergencies
· Adult respiratory distress syndrome
· Gram negative sepsis
· Drug intoxication
· Acute renal failure
· Hemorrhagic pancreatitis
· Intra and post-operative management of high risk patients
· History of pulmonary or cardiac disease
· Fluid shifts (e.g., extensive intra-abdominal operations)
· Management of high-risk obstetrical patients
· Diagnosed cardiac disease
· Toxemia
· Premature separation of placenta
· Cardiac output determinations
· Differential diagnosis of mitral regurgitation and ventricular septal rupture
Diagnosis of cardiac tamponade

Models with CEDV capabilities are also indicated for volumetric determinations

Secondary indications include the following:

· Blood Sampling
· Infusion of saline and dextrose solutions

Device Name: Swan-Ganz Continuous Cardiac Output/End Diastolic Volume Thermodilution catheter- CCOmbo EDV CCO/SvO2/EDV/VIP

Indications For Use:

Model: 757F8

The primary indications for the CCOmbo EDV TD catheters include:

· Acute heart failure
Severe hypovolemia
· Complex circulatory situations
· Medical emergencies
· Adult respiratory distress syndrome
· Gram negative sepsis
· Multi system organ failure
· Drug intoxication
· Acute renal failure

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· Hemorrhagic pancreatitis
· Intra and post-operative management of high risk patients
· History of pulmonary or cardiac disease
· Fluid shifts (e.g., extensive intra-abdominal operations)
· Management of high-risk obstetrical patients
· Diagnosed cardiac disease
· Toxemia
Premature separation of placenta
· Cardiac output determinations
· Volumetric determinations
· Differential diagnosis of mitral regurgitation and ventricular septal rupture
· Diagnosis of cardiac tamponade

Secondary indications include the following:

· Blood Sampling
· Infusion of saline and dextrose solutions

Device Name: Swan-Ganz Oximetry TD catheters, Oximetry Paceport catheter, VIP Oximetry catheter

Indications For Use:

Models: 631F55N, 780F75M and 782F75M

The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

Device Name: Swan-Ganz Right Heart Ejection Fraction Oximetry catheter

Indications For Use:

Models: D754F75 and 759F75

The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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SECTION 5 – 510(k) SUMMARY

	Swan-Ganz catheters 510(k)
510(k) Submitter	Edwards Lifesciences, LLC
Contact Person	Mugdha DongreEdwards LifesciencesOne Edwards WayIrvine, CA 92614Tel: (949) 250-5167
Date Prepared	January 13th, 2016
Trade Name	Swan-Ganz catheters
Common Name	Cardiovascular Diagnostic Catheters
Classification Name	DYG – Catheter, flow directedDQE – Catheter, Oximeter, FiberopticDQO – Catheter, Intravascular, DiagnosticKRA – Catheter continuous flush
Regulation Class/Product Code	DYG-870.1240DQE-870.1230DQO-870.1200KRA-870.1210
Predicate Device(s)	K001063, K810124, K810352, K820222, K894168, K905458,K910204, K924661, K934742, K951566
Device Description	The Swan-Ganz catheters are well known pulmonary artery cathetersintended for use on critical care patients. A Swan-Ganz Catheterincludes an inflatable balloon at the tip, which facilitates its placementinto the pulmonary artery through the flow of blood. The catheters canbe grouped together based on functionality.The Swan-Ganz catheters can be used with compatible cardiac outputpatient monitors and/or with oximetry modules (depending on themodel number) to transmit signals for hemodynamic pressuremonitoring, cardiac output measurements, and/or oximetrymeasurements. The Swan-Ganz catheters are to be used with theEdwards and/or Edwards' compatible patient monitors, such as theVigilance II.
Models	Base Catheters:111F7, 111F7P, S111F7, 123F6, 123F6P, T123F6, 110F5, 116F4,115F7, 115F7P, 114F7, 114F7P, 131F7, 131F7P, 131VF7P 141F7,143TF7, 151F7, 831F75, 831F75P, 831VF75P, 834F75, 096F6,096F6P, TS105F5 132F5, 931F75, 991F8, C144F7, S144F7, C145F6NC146F7, S9FC146F7, T173F6Advanced Catheters:139F75, 744F75, 746F8, 177F75N, 774F75, 777F8, 757F8, 631F55N,780F75M, 782F75M, D754F75, 759F75
Device Characteristics	Single Use, Sterile (EtO)

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	Swan-Ganz catheters
	Device Name: Swan-Ganz Flow-Directed Monitoring catheters
	Double and Triple Lumen
	Indications For Use:
	Models: 111F7, 111F7P, S111F7, T111F7, 123F6, 123F6P, T123F6,110F5, 116F4, 115F7, 115F7P, 114F7 and 114F7P
	Swan-Ganz flow-directed monitoring catheters are indicated for theassessment of a patient's hemodynamic condition through directintracardiac and pulmonary artery pressure monitoring. Secondaryindications are for sampling blood and infusing solutions.
	Device Name: Swan-Ganz- Thermodilution, VIP and VIP+, True Size
	Indications For Use:
	Models: 131F7, 131F7P, 131VF7P, 141F7, 143TF7, 151F7, 831F75,831F75P, 831VF75P, 834F75, 096F6, 096F6P, TS105F5 and 132F5
	Swan-Ganz thermodilution catheters are indicated for the assessmentof a patient's hemodynamic condition through direct intracardiac andpulmonary artery pressure monitoring, cardiac output determination,and for infusing solutions.
	The distal (pulmonary artery) port also allows sampling of mixedvenous blood for the assessment of oxygen transport balance and thecalculation of derived parameters such as oxygen consumption, oxygenutilization coefficient, and intrapulmonary shunt fraction.
Indications for Use/Intended Use	Device Name: Swan-Ganz- Thermodilution Paceport catheters,Thermodilution A-V Paceport catheters
	Indications For Use:
	Model 931F75
	The Swan-Ganz thermodilution Paceport catheters (Model 931F75) areused for assessment of a patient's hemodynamic condition throughdirect intracardiac and pulmonary artery pressure monitoring, cardiacoutput determination, and for infusing solutions. The Paceport catheter(Model 931F75) may also be used for standby temporary ventricularpacing.
	The distal (pulmonary artery) port also allows sampling of mixedvenous blood for the assessment of oxygen transport balance and thecalculation of derived parameters such as oxygen consumption, oxygenutilization coefficient, and intrapulmonary shunt fraction.
	Model 991F8
	The Swan-Ganz thermodilution A-V Paceport catheter (Model 991F8)is indicated for the assessment of a patient's hemodynamic conditionthrough simultaneous right atrial, right ventricular, and pulmonaryartery or wedge pressure monitoring, cardiac output determination, andfor infusing solutions. The A-V Paceport catheter (Model 991F8) isalso indicated for standby temporary ventricular, atrial, or A-Vsequential pacing using the Model D98100 Chandler Transluminal V-pacing probe and/or Model D98500 A-pacing probe. The distal(pulmonary artery) port also allows sampling of mixed venous blood
for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Device Name: Swan-Ganz- Polymer Blend True Size ControlCath Thermodilution catheters, Synthetic ControlCath Thermodilution Catheters, Polymer Blend True Size Torque Support Thermodilution catheter
Indications For Use:Models: C144F7, S144F7, C145F6N, C146F7 and S9FC146F7ControlCath thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions.The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Model: T173F6Torque Support Thermodilution catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions.The distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Device Name: Swan-Ganz Continuous Cardiac Output Thermodilution catheters - CCO Catheters, CCO/SvO2 Catheters, CCO/SvO2/ VIP Catheters, CCO V CCO/ CEDV Catheters, CCOmbo V CCO/SvO2/CEDV Catheters, CCOmbo V CCO/SvO2/ CEDV/VIP Catheters
Indications For Use:Models: 139F75, 744F75, 746F8, 177F75N, 774F75 and 777F8The primary indications for the Swan-Ganz CCO thermodilution catheters include:• Acute heart failure• Severe hypovolemia• Complex circulatory situations• Medical emergencies• Adult respiratory distress syndrome• Gram negative sepsis• Drug intoxication• Acute renal failure• Hemorrhagic pancreatitis
• History of pulmonary or cardiac disease
• Fluid shifts (e.g., extensive intra-abdominal operations)
• Management of high-risk obstetrical patients
• Diagnosed cardiac disease
• Toxemia
• Premature separation of placenta
• Cardiac output determinations
• Differential diagnosis of mitral regurgitation and ventricular septal rupture
• Diagnosis of cardiac tamponade
Models with CEDV capabilities are also indicated for volumetric determinations
Secondary indications include the following:
• Blood Sampling
• Infusion of saline and dextrose solutions
Device Name: Swan-Ganz Continuous Cardiac Output/End Diastolic Volume Thermodilution catheter, CCOmbo EDVCCO/SvO2/EDV/VIP
Indications For Use:
Model: 757F8
The primary indications for the CCOmbo EDV TD catheters include:
• Acute heart failure
• Severe hypovolemia
• Complex circulatory situations
• Medical emergencies
• Adult respiratory distress syndrome
• Gram negative sepsis
• Multi system organ failure
• Drug intoxication
• Acute renal failure
• Hemorrhagic pancreatitis
• Intra and post-operative management of high risk patients
• History of pulmonary or cardiac disease
• Fluid shifts (e.g., extensive intra-abdominal operations)
• Management of high-risk obstetrical patients
• Diagnosed cardiac disease
• Toxemia
• Premature separation of placenta
• Cardiac output determinations
• Volumetric determinations
• Differential diagnosis of mitral regurgitation and ventricular septal rupture
• Diagnosis of cardiac tamponade
Secondary indications include the following:
• Blood Sampling
• Infusion of saline and dextrose solutions

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Device Name:	Swan-Ganz Oximetry TD catheter- Oximetry catheters, Oximetry Paceport catheter, VIP Oximetry catheter
Indications For Use:	Models: 631F55N, 780F75M and 782F75MSwan-Ganz oximetry TD catheters are indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring, cardiac output determination, continuous mixed venous oxygen saturation monitoring, and for infusing solutions.The oximetry Paceport catheters (model 780F75M) are also indicated for standby temporary ventricular pacing using the model D98100 Chandler transluminal V-pacing probe. For all models, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Device Name:	Swan-Ganz Right Heart Ejection Fraction Oximetry catheter
Indications For Use:	Models: D754F75 and 759F75The REF/Ox catheters (Models D754F75 and 759F75) are indicated for continuous mixed venous oxygen saturation in addition to the prior listed indications. For Models D754F75 and 759F75, the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.
Environment of Use	Healthcare facility/hospital
Materials of Use	Polyvinyl Chloride, Pellethane, Tanatlum, Nylon, Stainless Steel, Latex or Synthetic material.
Key Performance Specifications	The proposed contraindication change and the MR Safe claim do not have any effect on the design, materials, technology and operating principles of current legally marketed device. Therefore no additional performance testing was required.
Comparative Analysis	The scientific technology and materials of the subject device are unchanged from the legally marketed predicate device.The proposed MR safe claim (Models: 111F7, 111F7P, S111F7, T111F7, 123F6, 123F6P, T123F6, 110F5, 116F4, 115F7, 115F7P, 114F7, 114F7P) has been evaluated and was confirmed to be MR Safe.Additional contraindications were added to IFUs to maintain consistency across the product family.
Functional/ Safety Testing	Swan-Ganz Flow Directed Monitoring catheter was evaluated for MRI compatibility and was confirmed to be MR Safe
Comparision ofTechnology toPredicate Devices	Performace evaluation was conducted to compare the proposeddevice(s) to the predicate devices(s). The result of the performanceevaluation indicates that the scientific technology and material of theproposed devices are unchanged from the legally marketed device(s)(predicate).The change made to the proposed device is a modification of the MRIstatus to MR Safe. There are no changes to the design, materials ormanufacturing process.
Conclusion	Swan-Ganz catheters have been shown to be safe, effective, andsubstantially equivalent to the respective predicate devices (Swan-Ganz catheters) for their intended use in hospitals and other appropriateclinical environments.

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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).