(29 days)
The AccuCath™ Intravascular Catheter is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath™ IV Catheter is suitable for use with power injectors.
The AccuCath™ Intravascular Catheter has usable length catheters of 1.25 and 2.25 inches in 18, 20, and 22 gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The AccuCath™ IV Catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. The AccuCath™ IV Catheter is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, and a guidewire within the lumen of the needle which is connected to a slider, spring and release button.
This document is a 510(k) premarket notification for the AccuCath™ Intravascular Catheter. It is a submission to demonstrate substantial equivalence to a legally marketed predicate device, not a study evaluating the performance of an AI/ML device against acceptance criteria.
The document does not contain any information about a study proving a device meets acceptance criteria in the context of AI/ML performance metrics such as accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating that a modification to a previously cleared medical device (an intravascular catheter) is substantially equivalent to its predicate.
Specifically:
- It describes a traditional medical device (intravascular catheter), not an AI/ML device.
- The "Performance Tests" section explicitly states that "no verification or validation activities were required" and "it is not necessary to conduct additional performance tests including verification and validation" because the changes are limited to labeling modifications and do not impact design, materials, performance, or risk profile.
Therefore, I cannot provide the requested information as it is not present in the provided text.
§ 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).