(135 days)
The Autosuture™ ENDO GIA™ Staplers with ENDO GIA™ Single Use Loading Units (SULUs) have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
The Autosuture™ ENDO GIA™ Staplers when used with the ENDO GIA™ Curved-Tip Single Use Loading Unit (SULUs) can be used to blunt dissect or separate target tissue from other certain tissue.
The Autosuture™ ENDO GIA™ Staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the appropriate Single Use Loading Unit (SULU). The staplers will accommodate any of the single use loading units that are available in 30 mm, 45 mm and 60 mm lengths.
This 510(k) reports a new version of our currently marketed Autosuture™ ENDO GIA™ Staplers (K061095). This new version is considered a modification of the currently marketed Autosuture™ ENDO GIA™ Staplers. The modifications are as follows:
- Ergonomic and performance enhancements to the ENDO GIA™ Stapler Instrument.
- Addition of ENDO GIA™ Single Use Loading Units (SULUs) with Tri-Staple™ technology. Tri-Staple™ technology means that each of the two triple-staggered rows has a stepped configuration whereby the staples in the outer row are a taller height then the staples in the middle row which in turn are a taller height than the staples in the inner row. The ENDO GIA™ SULUs with Tri-Staple™ technology are available in articulating 30 mm, 45 mm and 60 mm length cartridges.
- Addition of ENDO GIA™ Single Use Loading Units (SULUs) which have a curved-tip anvil configuration. The curved-tip can be used to dissect and manipulate tissue when locating target tissue for subsequent firing and placement of staples.
The provided document is a 510(k) summary for a surgical stapler. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding detailed acceptance criteria, device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details.
The document states: "Bench and animal model performance evaluations were completed to verify that the Autosuture™ ENDO GIA™ Staplers with the new ENDO GIA™ Single Use Loading Units are safe and effective and perform as intended." This indicates that performance data was generated, but the specifics of what those performance evaluations entailed and what criteria were used for acceptance are not provided in this public summary.
Therefore, I cannot fulfill your request with the information given. The provided text is a regulatory submission summary, not a detailed study report.
§ 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.