(90 days)
For percutaneous introduction of catheters into the vasculature while preventing the backflow of blood.
16 Et 18 french versions of the Braun Hemostasis Introducer with silicone gasket, in lengths of 10 - 40 cm.
The provided document is a 510(k) summary for a medical device (catheter introducer and vessel dilator) and does not contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy. It focuses on demonstrating substantial equivalence to previously cleared devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies in the context of AI/ML, human readers, ground truth, or training sets from this document.
The document mainly includes:
- Device Classification and Common Name: Catheter introducer and Vessel dilator (21 CFR 870.1340 and 870.1310).
- Substantial Equivalence: A comparison table demonstrating similarities to predicate devices (K894446, K931743, K871153, K930057, K945396).
- Device Description: 16 and 18 French versions of the Braun Hemostasis Introducer with specific gasket and length details.
- Intended Use: For percutaneous introduction of catheters into the vasculature while preventing blood backflow.
- Summary/Comparison of Technological Characteristics: Detailed comparison of labeling, packaging, intended use, physical characteristics (French sizes, lengths, materials), and anatomical sites with predicate devices.
This document is for a traditional medical device submission and does not describe a study involving algorithms, AI, or human reader performance.
§ 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).