(149 days)
Introcan Safety® 3 Closed Intravascular Catheter is inserted into a patient's vascular system for short term use to sample blood, monitor blood pressure or administer fluids and blood intravascularly.
The Introcan Safety® 3 Closed IV Catheter consists of an over-the-needle, peripheral intravascular catheter made of radiopaque polyurethane, an integrated bidirectional septum, a stabilization platform, and a passive safety needle shielding mechanism. Introcan Safety® 3 Closed IV Catheter design is described as a closed IV catheter since it protects clinicians and patients from blood exposure. Since the needle is withdrawn through a septum that seals after the needle has been removed, blood is thus contained within the Introcan Safety 3 device. The pressure exerted on the needle as it passes through the septum wipes blood from the needle further reducing potential blood exposure. The Introcan Safety® 3 Closed IV Catheter has an integrated stabilization platform is designed to improve catheter stability while minimizing catheter movement within the vessel. The passive safety needle-shielding mechanism of the Introcan Safety® 3 Closed IV Catheter is located inside the catheter hub. Upon withdrawal of the needle, the safety shield engages as the needle passes through the catheter hub and deploys automatically to shield the needle tip. The safety shield protects during disposal, aiding in the prevention of needlestick injuries. Once the safety shield engages and shields the needle tip, the user is unable to re-insert the needle, which aids in the prevention of catheter shearing.
This document is a 510(k) premarket notification from the FDA, evaluating a medical device (Introcan Safety® 3 Closed IV Catheter). This type of document is not a study demonstrating the performance of an AI/ML powered device, but rather a regulatory review for a traditional medical device (an intravascular catheter).
Therefore, I cannot extract the information requested as the document does not contain details about:
- Acceptance criteria for an AI/ML model
- Performance of an AI/ML model (e.g., Sensitivity, Specificity, AUC)
- Sample sizes for AI/ML test or training sets
- Ground truth establishment by experts for AI/ML
- MRMC studies for AI/ML
- Standalone AI algorithm performance
The document primarily focuses on demonstrating substantial equivalence to a predicate device through bench testing (functional and performance testing) for mechanical and physical properties of the catheter, not diagnostic or predictive performance of an AI model. The tests listed (Dynamic Tensile, Air Tightness, Flow Rate, etc.) are standard engineering tests for physical devices.
§ 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).