(27 days)
The Signia™ Stapler, when used with Endo GIA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads and Signia™ loading units with Tri-Staple™ 2.0 single-use cartridges, has applications in abdominal, gynecological, pediatric, and thoracic surgery for resection, and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature, and biliary structures and for transection and resection of the pancreas.
The Signia™ Stapler, when used with Endo GIA™ curved tip single use reloads or Tri-Staple™ 2.0 curved tip single-use reloads, can be used to blunt dissect or separate target tissue from other certain tissue.
The Signia™ Stapler, when used with Endo GIA™ single use Radial Reloads with Tri-Staple™ Technology, has applications in open or minimally invasive general abdominal, gynecologic, pediatric and thoracic surgery for resection and transection of tissue and creation of anastomosis, as well as application deep in the pelvis, i.e., low anterior resection. It may be used for transection of liver substance, hepatic vasculature and biliary structures and for transection and resection of the pancreas.
The Signia™ Stapler, when used with Endo GIA™ single use reinforced reloads with Tri-Staple™ Technology preloaded with polyglycolic acid staple line reinforcement or Tri Staple™ 2.0 single use reinforced reloaded with polyglycolic acid staple line reinforcement, has applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection of tissue and creation of anastomosis. It may be used for transection of liver substance, hepatic vasculature and biliary structures, and for transection and resection of the pancreas.
The Signia™ Stapler is a battery powered microprocessor controlled surgical stapler that provides push-button powered maneuverability and firing of compatible Covidien stapling reloads. The Signia™ Stapler is compatible with Endo GJA™ single-use reloads, Endo GIA™ single-use reloads with Tri-Staple™ Technology, Tri-Staple™ 2.0 single use reloads, and Signia™ loading units with Tri-Staple™ Otape - roomnology, The Signia™ Stapler when used with the abovementioned family of Endo GIA™ reloads is a surgical device for stapling and cutting tissues. The Signia™ Stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. All of which stay unchanged when compared to the predicate device.
The Signia™ Stapler is composed of the Signia™ Power Handle, Signia™ Power Shell, and Signia™ The Signia - System accessories include the Signia™ Reusable Insertion Guide, Signia™ Manual Retraction Tool, Signia™ Single Bay Charger, Signia™ Sterilization Tray, and this submission introduces a new accessory, Signia™ Four-Bay Smart Charger. The Smart Charger's primary purpose introduces a new as the Signia Single-Bay Charger in K160176, but the difference is that Smart Charger offers enhanced features such as four charging stations, a touch-screen LCD display, and data management interface in order to improve user convenience.
This document describes a 510(k) premarket notification for a medical device: the Signia™ Four-Bay Smart Charger, an accessory to the Signia™ Stapler. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document explicitly states that no clinical study has been performed to demonstrate performance of the device itself. The substantial equivalence is based on non-clinical studies. Therefore, it is not possible to provide information on acceptance criteria and a study proving device performance as requested, because such a study was explicitly stated as not performed.
The document focuses on the safety and technological characteristics of the charger accessory and its equivalence to a prior charger, not on clinical performance of the stapler system which it charges.
Here's why the requested information cannot be extracted from the provided text:
- No Clinical Performance Data: The statement "Clinical performance data -- No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies" directly contradicts the premise of the questions regarding device performance, acceptance criteria, and study details.
- Focus on Charger, Not Stapler: The device under review (Signia™ Four-Bay Smart Charger) is an accessory to the Signia™ Stapler. The 510(k) submission focuses on the charger's safety and features (e.g., four charging stations, touchscreen, data management) as substantially equivalent to an existing charger, not on the clinical performance of the stapler itself in surgical procedures.
- "Acceptance Criteria" for a Charger: While there are non-clinical acceptance criteria mentioned for the charger (Software V&V, Electrical Safety, EMC Testing, Usability Evaluation), these are engineering and regulatory compliance criteria, not clinical performance metrics tied to patient outcomes or diagnostic accuracy. They do not involve "device performance" in the sense of a medical outcome.
Therefore, I cannot fulfill your request for specific details on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical performance, as the document clearly states no such clinical study was done for this submission.
The information provided is specific to the regulatory approval process for an accessory and its non-clinical testing.
§ 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.