(168 days)
The ETS 45, ETS-Flex45, and Compact-Flex 45 reprocessed, reloadable Endoscopic Linear Cutters are intended for transection, resection and/or anastomosis. These instruments have applications in open and minimally invasive general, gynecologic, urologic (including radical prostatectomy), thoracic and pediatric surgery. The ETS Flex 45, ETS 45 and ETS Compact Flex 45 device can be used with staple line or tissue buttressing materials such as bovine pericardium.
The ETS and ETS-Flex (articulating) reprocessed, reloadable Endoscopic Linear Cutters (35mm) have applications in general, gynecologic, urologic, and thoracic surgery for transection, and/or creation of anastomoses.
SterilMed's reprocessed Ethicon ETS Linear Cutter is a sterile, single patient use device. It delivers two double-staggered or two triple-staggered rows of staples while simultaneously dividing the tissue between the rows of staples. An articulation lever on the ETS-Flex Linear Cutter enables bilateral movement of the instrument jaws. These devices are reloadable linear cutters that allow for a maximum of 8 firings in a single surgical procedure.
Note: Only the linear cutter is the subject of this submission, the implantable staple and the staple cartridge are not reprocessed and therefore are not included.
The provided text does not contain detailed acceptance criteria for a device, nor does it describe a specific study that proves the device meets such criteria. Instead, the document is a 510(k) summary for the reprocessing of Ethicon ETS Endoscopic Linear Cutters, demonstrating substantial equivalence to predicate devices. It outlines the device description, intended use, and general functional and safety testing, but lacks the specific performance metrics and study details requested.
Therefore, I cannot provide the requested information in the structured table and numbered points. The document states:
"Representative samples of reprocessed Linear Cutters are tested to demonstrate appropriate functional characteristics. Process validation testing is performed to validate the cleaning and sterilization procedures as well as device packaging. In addition, the manufacturing process includes visual and validated functional testing of all products produced."
This indicates that testing was performed, but the specifics of acceptance criteria and the results of a study designed to prove these criteria are met are not included in the provided text.
§ 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.