(109 days)
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.
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.
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.
§ 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).