(144 days)
The primary indications for the Swan-Ganz IQ Pulmonary Arterial catheter includes:
- 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
Secondary indications include the following:
- Blood Sampling
- Infusion of saline and dextrose solutions
Intended Use- Swan-Ganz IQ catheter:
The Swan-Ganz IQ catheter (model AIQSGF8) is for use in patients who require hemodynamic monitoring. It is intended to be used in combination with clinical pressure monitoring, equipment to measure right heart and pulmonary artery pressures, and with a compatible cardiac output computer to measure intermittent cardiac output. Model AIOSGF8 also measures mixed venous oxygen saturation.
The Edwards Swan-Ganz catheters are used to monitor the hemodynamic status of critically ill and injured patients. The existing catheters give clinicians the ability to measure right heart pressures, pulmonary artery occlusion pressure ("wedge"), sample mixed venous blood from the pulmonary artery, as well as measure cardiac output through thermodilution when used with a bedside physiologic monitor and pressure transducers.
The Edwards Swan-Ganz product line is comprised of Standard (Base) and Advanced Technology monitoring catheters. The standard Swan-Ganz catheter measures: right heart pressures, thermodilution cardiac output (room temperature and chilled) and provides a mechanism for pulmonary artery blood sampling for laboratory analysis.
The subject Swan-Ganz IO catheter combines from the existing Advanced catheter design (model 777F8) and the Paceport catheter design (model 780F75M). Using the 777F8 model as the base design, the new catheter modifies the design to remove the thermal filament functionality and replaces it with an additional port which will allow for pressure monitoring at the right ventricular level. The RV port is utilized just like the Swan-Ganz Paceport Oximetry catheter model 780F75M.
Just like the existing advanced catheters, the Swan-Ganz IQ catheter provides the same functionality as the standard and Advanced Technology Swan-Ganz catheters by providing the ability to continuously monitor the patient's balance between oxygen delivery and consumption as well as the ability to help investigate the root cause of an imbalance through analysis of the components of stroke volume (preload, afterload, and contractility).
The provided text is a 510(k) summary for the Edwards Lifesciences Swan-Ganz IQ Pulmonary Arterial Catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Crucially, this document is NOT for an AI/ML device. It describes a physical medical device (a catheter) and its modifications. Therefore, the concept of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or human-in-the-loop improvement) is not applicable here.
The document discusses "functional and performance testing" which are typical for physical medical devices, such as:
- Packaging, shelf life, sterilization, biocompatibility
- Bench testing:
- Frequency response testing
- Pressure tubing pull testing
- Lumen burst pressure testing per ISO 10555-1:2013 and IEC 60601:2015 Amd.1:2020.
The conclusion states that "Completion of all performance verification and validation activities demonstrated that the subject device meets its predetermined design and performance specifications." This refers to engineering and safety specifications of a physical device, not the performance of an AI algorithm on a dataset.
Therefore, I cannot provide the requested information (table of acceptance criteria, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) because the device described in this 510(k) summary is a physical catheter, not an AI/ML diagnostic tool.
§ 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).