(29 days)
The Outback® Catheter is intended to facilitate placement and positioning of guidewires/catheters within the peripheral vasculature. The Outback® Catheter is not intended for use in the coronary or cerebral vasculature.
The Outback® catheter is a sterile, single use device comprised of three primary elements. 1) guide tip, [deployment shaft], 2) catheter shaft and 3) deployment handle with a control knob. Upon proximal retraction of the guide via the control knob, the guide's curved tip is positioned coaxially within the noscone. In this configuration the catheter may be tracked over a guide wire to the selected vascular site. The guidewire is then retracted into the guide, allowing the curved guide tip to be advanced from the nosecone end port. The radiopaque nosecone and guide tip facilitate placement into the selected region of the vascular site, with fluoroscopic guidance. Upon proper placement of the guide tip, the guide wire may be advanced through the guide and into the desired location. The guide tip is then retraced into the nosecone, and the catheter is proximally retraced leaving the guide wire in place in the vasculature.
This document is a 510(k) summary for the LuMend Outback® Catheter, indicating it's a device for facilitating guidewire and catheter placement in peripheral vasculature. It makes no mention of a study involving artificial intelligence or machine learning, which are typically the subjects of acceptance criteria and performance studies in the context of AI/ML devices. Therefore, I cannot extract the requested information from the provided text.
Specifically, the document:
- Does not include a table of acceptance criteria or reported device performance.
- Does not mention sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
- Does not discuss Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Does not specify the type of ground truth used, training set sample size, or how ground truth for training was established.
The provided text focuses on regulatory approval, device description, and comparison to a predicate device based on its intended use and design, rather than a performance study as would be conducted for an AI/ML medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).