(124 days)
The Circular Staplers with Staples have applications throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
The Linear Staplers with Single Use Loading Units have application in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
The Procedure Sets for Prolapse and Hemorrhoids have application for general surgical treatment of hemorrhoids.
The Endoscopic Linear Cutting Staplers with Single Use Loading Units have applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection of liver substance, hepatic vasculature and biliary structures.
The Linear Cutting Staplers with Single Use Loading Units have application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
The proposed device, Circular Staplers with Staples, is a sterilized and disposable surgical instrument intended to be used throughout the alimentary tract for the creation of end-to-end, end-to-side and side-to-side anastomoses in both open and laparoscopic surgeries.
It places a double staggered, circular row of titanium staples upon activation, which was achieved by squeezing the handles firmly as far as they could go. Immediately after formation of the staples, the excess tissue will be resected by the circular knife, so a circular anastomosis is created.
The staple is available in two specifications which are 4.8 mm and 3.5 mm to be used per different thickness of the tissue.
The proposed device, Linear Staplers with Single Use Loading Units (SULU) is a sterilized and disposable surgical instrument intended to beused in the resection of tissue for abdominal, gynecological, pediatric and thoracic surgical procedures.
It places a double staggered row of titanium staples and isavailable in 30 mm, 45 mm, 60 mm and 90 mm staple line length for use in various applications. Three staple sizes (2.5mm, 3.5 mm and 4.8 mm) are available to accommodate various tissue thicknesses. Each stapler could be reloaded no more than 7 times for total 8 firings.
The proposed device, Procedure Sets for Prolapse and Hemorrhoids is a sterilized and disposable surgical instrument, which has application for general surgical treatment of hemorrhoids.
It is a set of instruments that place a double staggered, circular row of titanium staples. Immediately after the formation of staples, the circular knife blade resects the excess of compressed mucosa. The sets are commonly used in the procedures for prolapsed and hemorrhoids. They are also used for other applications when circular or semicircular stapling of anorectic tissue is required.
The proposed device, Endoscopic Linear Cutting Staplers with Single Use Loading Units (SULU)is a sterilized and disposable surgical instrument, which has applications in general, gynecologic, pediatric and thoracic surgery for resection, and creation of anastomoses. They may be used for transection and resection of liver substance, hepatic vasculature and biliary structures.
It places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The size of the staples is decided by selecting 2.0 mm, 2.5 mm, 4.0 mm or 4.8 mm SULU.
The Endoscopic Linear Cutting Staplers are available in two kinds, which are Articulating and Straight. In addition, the Single Use Loading Units are also available in Articulating and Straight types. The Articulating Staplers could adjust the direction of the Single Use Loading Units (SULU) within a specified range if used together with Articulating SULU. The Articulating Staplers could also be used together with straight SULU without articulating features. The Straight stapler could only be used together with straight SULU.
When using the Endoscopic Linear Cutting Staplers with the 2.0, 2.5, 3.5 and 4.0 SULU, a 12 mm or larger trocar sleeve with a converter should be used. When using the Endoscopic Linear Cutting Staplers with the 4.8 SULU, a 15 mm trocar sleeve should be used. Endoscopic Linear Cutting Staplers may be reloaded and fired no more than 25 times in a single procedure. Each instrument can accommodate the following SULU specifications: 30-2.0, 30-2.5, 45-2.0, 45-2.5, 45-3.5, 45-4.0, 45-4.8,60-2.5, 60-3.5, 60-4.0, 60-4.8.
The proposed device, Linear Cutting Staplers with Single Use Loading Units(SULU)is a sterilized and disposable surgical instrument, which has application in abdominal, gynecological, thoracic and pediatric surgery transection, resection, and the creation of anastomoses.
It places two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The Linear Cutting Staplers and SULU are available in 60 mm, 80 mm, and 100 mm lengths. SULU'are available in two staple sizes to accommodate various tissue thicknesses: 3.8 mm and 4.8 mm.
The provided text describes surgical staplers and their intended use, along with a statement of substantial equivalence to predicate devices based on non-clinical bench testing. However, it does not include the information typically associated with establishing acceptance criteria and proving a device meets those criteria through a clinical or algorithmic study, especially in the context of AI or imaging devices.
Specifically, the document focuses on:
- Device Identification and Description: Detailing different types of surgical staplers (circular, linear, endoscopic linear cutting, etc.) and their intended surgical applications (anastomoses, tissue resection, treatment of hemorrhoids).
- Predicate Devices: Identifying previously cleared devices for comparison.
- Non-Clinical Test Conclusion: Stating that "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. These tests include: Package Integrity Testing, Physical Performance Testing, Sterilization Validation and Endotoxin Testing."
- Substantial Equivalence Conclusion: Affirming that the proposed devices are substantially equivalent to the predicate devices in safety and effectiveness.
Based on the provided text, the requested information regarding acceptance criteria, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set), and comparative effectiveness for AI-assisted performance is absent.
The document describes a traditional 510(k) submission for a physical medical device (surgical staplers), where the safety and effectiveness are established through bench testing and comparison to a predicate device, rather than through clinical studies involving human subject data or algorithmic performance metrics. Therefore, I cannot extract the requested information.
§ 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.