(148 days)
This device is intended to facilitate placing a catheter through the skin into a vein or artery.
Not Found
I am sorry, but the provided document is a 510(k) clearance letter for a medical device (Footprint Medical 1.9 Fr PICC Introducer). This type of document does not contain information related to acceptance criteria, device performance studies, or AI/software validation studies.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a predicate device already on the market. It typically involves comparing the device's technological characteristics and intended use to a legally marketed predicate device, and often includes bench testing to ensure the device meets basic safety and performance standards relevant to its design. It does not typically include clinical trials or detailed performance studies with ground truth establishment in the way that AI-powered devices would require.
Therefore, I cannot provide the requested information based on the text provided.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).