(153 days)
The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The Echelon Endoscopic Linear Cutter Reload, Black is a thick tissue reload for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Powered Flex) in both 45mm and 60mm configurations. It is an addition to the current Echelon reload family and will provide a closed staple height of 2.3 mm for use in thick tissue such as gastric, lung and solid organ.
The Echelon Endoscopic Linear Cutter Reload, Black is loaded into an Echelon Linear Cutter and delivers staples into the tissue when the instrument is fired.
The design and performance of the new device, Echelon Endoscopic Linear Cutter Reload, Black, is based on the predicate, Echelon Endoscopic Linear Cutter Reload, Green.
The provided document is a 510(k) summary for the Echelon Endoscopic Linear Cutter Reload, Black. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, detailed study results, or information about sample sizes for testing sets, ground truth establishment, or clinical performance metrics that would typically be found in a detailed validation study report.
The document states that:
"Performance Data Bench and Animal testing was performed to demonstrate that the new features do not affect safety and effectiveness and that the device will perform as intended."
This indicates that studies were conducted, but the specifics requested in your prompt are not provided within this summary.
Therefore, I cannot populate the table or provide the detailed information you requested based on the given text.
To answer your request, a more comprehensive device validation report or test results document would be needed.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.