(57 days)
The 10F Sheath and Dilator Set is indicated for introduction of therapeutic devices into the vasculature, excluding coronary and neuro vasculature.
The 10F Sheath and Dilator Set is designed for single use and intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature. The 10F Sheath and Dilator Set consists of a 10F reinforced Introducer Sheath and a matching 10F radiopaque Dilator.
The 10F Introducer sheath is a coil reinforced sheath with a Platinum Iridium radiopaque marker band. The sheath has a hemostasis valve and a side port with stopcock. The 10F dilator is made of radiopaque, non-reinforced material with an atraumatic tip to minimize blood loss. The device does not include any coating.
The provided document describes a 510(k) premarket notification for the "10F Sheath and Dilator Set" and establishes its substantial equivalence to a predicate device based on in vitro performance testing and technological characteristics. It does not include information about an AI-powered device or a study proving that an AI device meets acceptance criteria. Thus, I cannot populate the requested table or answer the questions related to AI device performance.
However, I can extract the acceptance criteria and the study performed for the 10F Sheath and Dilator Set (a non-AI medical device).
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Radiopacity | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Visual | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Dimensional | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Simulative Use | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Leakage (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Kink Test (System) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Tensile (Sheath and Dilator) | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Luer testing | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Shipping Qualification | (Implicit performance standard) | Met acceptance criteria demonstrating substantial equivalence. |
| Biocompatibility | **According to ISO 10993-1:2020 for an external communicating, circulating blood device with limited duration |
§ 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).