(35 days)
The NiTi HandSTC has applications throughout the alimentary tract in surgeries for resection, transaction, and the creation of anastomoses.
The NiTi HandSTC is a palm size linear cutter and stapler whose main parts are housed together enabling one hand operation by sequential pressing on the device lever.
The HandSTC applies 56 titanium staples in a line approximately 60mm long. The unformed staples are "U" shape which closed to form "B" shape. When the device is open the distance between the cartridge and the anvil is 4 cm.
The HandSTC device is supplied with one cartridge and can be reloaded for a total of 8 firings
The reloads are available in two sizes:
Blue- unformed staple leg height is 3.5 mm, staple dimension when closed is 1.5 mm. This cartridge closes to a gap of 0.8 mm and it is used for standard tissue and gastrointestinal applications.
Green- unformed staple leg height is 4.5 mm, staple dimension when closed is 2.0 mm. This cartridge closes to a gap of 1.3mm and it is used for gastrointestinal tract and thick tissues such as stomach and rectum applications.
This document is a 510(k) summary for the HandSTC medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document focuses on establishing substantial equivalence to predicate devices, which is a regulatory pathway for demonstration of safety and effectiveness, rather than performance against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text. The document states: "Based on validations and performance testing results, NiTi Medical Techologies Ltd. believes that the HandSTC is substantially equivalent to its predicate device cited above without raising new safety and/or effectiveness issues." However, the details of these validations and performance testing results, including acceptance criteria and study designs, are not included in this summary.
§ 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.