(27 days)
ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX families of endoscopic linear cutters and reloads are intended for transection, 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, ECHELON ENDOPATH and ECHELON FLEX families of endoscopic linear cutters and reloads are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON FLEX™ 45 mm Powered Plus instruments have a staple line that is approximately 45 mm long and a cut line that is approximately 42 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack. Refer to the Battery Pack Disposal section. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload. The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads are sterile, single patient use devices. They come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thicknesses. They are loaded into a Linear Cutter and deliver staples into the tissue when the instrument is fired. There are 70 staples in the 45mm length reload.
This document is a 510(k) Premarket Notification from the FDA regarding the "Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear Cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm". It is a medical device approval document and does not contain information about an AI/ML device study. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement, as these elements pertain to the evaluation of AI/ML device performance, which is not covered in this document.
§ 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.