(192 days)
The Swan-Ganz pacing-TD catheters are indicated for use for temporary, atrial, ventricular, or A-V sequential cardiac pacing of adult surgical and/or critically ill patients. This includes, but is not limited to, patients with arrythmias, acute myocardial infarction, cardiac surgery, and coronary angiography. In addition, these catheters are indicated for use in hemodynamic monitoring of patients experiencing medical conditions such as, but not limited to, post-major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, stroke, and cardiac disease including heart failure.
The Swan-Ganz bipolar pacing catheters are indicated for use in surgical and/or critically ill cardiac patients who may benefit from temporary, transvenous right ventricular pacing.
The Chandler transluminal V-pacing probe is a transluminal bipolar pacing probe, which must be used with a Swan-Ganz Paceport catheter is indicated for use in adult surgical and/or critically ill cardiac patients. This includes, but is not limited to, patients with arrhythmias, acute myocardial infarction, cardiac surgery and coronary angiography.
The Swan-Ganz Pacing Catheters and Pacing Probes are a series of specialized catheters and pacing probes, which are temporarily inserted into the central circulatory system vasculature to facilitate temporary atrial, ventricular, or A-V sequential pacing and to serve as diagnostic and/or therapeutic tools. The catheters may be used to overdrive suppression of arrhythmias and diagnosis of complex arrhythmias. The pacing catheters and probes may be used for ECG detection during placement but are not intended to be used for ECG monitoring.
I am sorry, but based on the provided text, there is no information about the acceptance criteria and study proving the device meets those criteria in the context of an AI/ML powered medical device. The document is a 510(k) summary for a set of physical medical devices (catheters and pacing probes) and does not mention any AI or machine learning components.
Therefore, I cannot provide the requested information, including:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- MRMC comparative effectiveness study results or effect size
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
The document focuses on the substantial equivalence of the Swan-Ganz Pacing Probe and Catheters to predicate devices based on design, material, chemical composition, principle of operation, and compliance with biocompatibility and bench testing standards.
§ 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).