(10 days)
The GORE Introducer Sheath with Silicone Pinch Valve is indicated for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.
This 510(k) is being submitted for a minor modification to the product configuration made to the GORE Introducer Sheath with Silicone Pinch Valve cleared under K032073. The proposed modification that is subject of this 510(k) submission is to offer an additional 18Fr size introducer sheath to the current product line. No other changes are being made to the GORE Introducer Sheath with Silicone Pinch Valve or its packaging as cleared under K032073.
The provided text is a 510(k) summary for the GORE Introducer Sheath with Silicone Pinch Valve, specifically for a minor modification to add an 18Fr size. This document describes the device, its intended use, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of device performance metrics commonly used for AI/ML devices (e.g., sensitivity, specificity, AUC).
The "studies" mentioned in this document are focused on demonstrating substantial equivalence through various tests, assessments, and comparisons to the predicate device, primarily to show that adding a new size does not raise new safety or effectiveness concerns. These are typically engineering or bench testing and comparison of physical and mechanical properties, not clinical or diagnostic performance studies.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details because this document does not contain that type of information. This submission is for a material/design change to an existing device, not a new device requiring a comprehensive performance study against specific acceptance criteria for diagnostic accuracy.
§ 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).