(30 days)
The Convoy Advanced Delivery Sheath Kit is intended to facilitate the intracardiac placement of interventional devices.
The Convoy Advanced Delivery Sheath Kit consists of: (1) a disposable Introducer Sheath, (2) a Vessel Dilator and (3) Guidewire with Guidewire Introducer. These devices are designed for the introduction of various types of cardiovascular catheters to the heart. The Introducer Sheaths are constructed in a range of curve reach configurations, diameters and lengths to respond to physician preferences. The Introducer Sheath configurations covered under the subject 510(k) Premarket Notification include 8.5 F and 9.5 F diameters, angles ranging from 0° - 180°, radius of curvatures ranging from 0.6" - 1.75", lengths of 60 cm - 101.5 cm, and may be configured with either one, two or three curves in a single or dual plane.
The provided text describes a 510(k) Pre-market Notification for the Convoy Advanced Delivery Sheath Kit, a medical device. However, the text does not contain any information regarding acceptance criteria, reported device performance metrics, or the details of a study (clinical or non-clinical) that proves the device meets specific acceptance criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It briefly mentions that "non-clinical testing conducted for the device showed the device met its design-input criteria, and was safe and effective for its intended use," but it does not elaborate on what those criteria were, what the results were, or the specifics of the testing methodology.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance and acceptance criteria.
§ 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).