(163 days)
Multi-lumen central venous catheters are used to measure central venous pressure, to infuse fluids, to sample venous blood and to infuse parenteral nutrition (TPN) or medications.
The Argon multi-lumen central venous catheter has a polyurethane body with multiple lumens. Diameters will be from 4 French through 7 French and lengths 10 cm through 30 cm. Each lumen extends from the vicinity of the distal tip to the main (bifurcation) hub, where it branches into dedicated extension lines. The largest lumen extends all the way to the distal tip. It is used for device placement using a guide wire and then to infuse fluids. The other lumens exit the catheter body at side ports that are near the distal tip but are at varying distances proximal to the tip. Functionally, the lumens are used to measure central venous pressure, to sample venous blood and to infuse parenteral nutrition (TPN) or medications. With multiple lumens more than one function can be accomplished for the patient at the same time. When a side port is not actively being used a saline drip is run to prevent thrombosis in the lumen. The extension hub for each lumen is labeled to provide positive identification of lumen size and location. The body has depth markings, measured in cm from the distal end, that facilitate correct placement of the tip. The device is radiopaque to allow verification of location in the patient. The atraumatic distal tip minimizes patient trauma during insertion.
The provided text is a 510(k) summary for the Argon Multi-Lumen Central Venous Catheter, which is a medical device. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way described in your request.
Instead, the document focuses on:
- Comparison to a legally marketed predicate device (Medex Safe-Cath K960764): It highlights similarities in materials (polyurethane) and intended use.
- Demonstration of improvements: The document claims improvements in the manufacturing process (deeper molding of the multiple lumen tube into the bifurcation hub, solvent-bonded extension tubes leading to stronger break forces, and identification printing on extension hubs instead of lines).
- Biocompatibility testing: It mentions the device has been tested to international standards for biocompatibility.
- Radiopacity: It states that Barium Sulfate is included in the main tube to cause radiopacity.
- Clinical Data: Explicitly states "Clinical data are not needed for this device."
Therefore, I cannot extract the information required for your detailed request because the document does not contain the type of study data, acceptance criteria, or ground truth establishment relevant to performance metrics like sensitivity, specificity, or AUC, which are typically found in AI/ML medical device studies.
Here's a summary of why the requested information cannot be provided based on the input:
- Table of acceptance criteria and reported device performance: Not present. The document focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance metrics with acceptance criteria benchmarks.
- Sample size for the test set and data provenance: Not applicable. No test set for performance evaluation is mentioned.
- Number of experts and qualifications for ground truth: Not applicable. No ground truth establishment for a performance study is described.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not done/mentioned. The document explicitly states clinical data are not needed.
- Standalone performance study: Not done/mentioned.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable. The device is a physical catheter, not an AI/ML algorithm requiring a training set.
- How ground truth for the training set was established: Not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).