(134 days)
The Single Use Circular Stapler has application throughout the alimentary tract for end to side and side to side anastomoses.
The Single Patient Use Endo Cutter and Reload is intended for transection, and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive general, gynecologic, thoracic, and pediativ surgical procedures. It can be used with tissue buttressing materials.
The Single Patient Use Linear Cutter and Reload are intended for use in multiple open or minimally invasive surgical procedures for the transection of tissues. Linear cutters are also intended for creation of anastomoses in these procedures.
The Single Patient Use Linear Stapler and Reload has applications in abdominal, gynecological, pediatric and thoracic surgical procedures for resection of tissue and creation of anastomosis, including occlusion of the left atrial appendage in open procedures. They may be used for transection and resection of pancreas.
The Single Use Hemorrhoidal Circular Stapler has application throughout the anal to perform surgical treatment of hemorrhoidal disease.
The Single Patient Use Transverse Cutter and Reload is intended for transection and or creation of anastomoses. The instrument has application in multiple open or minimally invasive general (gastrointestinal and skeletal muscle stapling), gynecologic, urologic, and thoracic surgical procedures.
The Single Patient Use Transverse Cutter and Reload places four staggered curved row of titanium staples on the tissue upon activation, and cut the tissue between staple lines. The device is available in 40mm length with reload in 3.8mm and 4.5mm staple size. The device may be reloaded and fired up to 5 times in a single procedure.
Single Use Circular stapler 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 resect by the circular knife, and then a circular anastomosis is created. The stapler are available in 21mm, 29mm, 32mm and 34mm six specifications. The staple sizes are 4.8mm and 5.5mm.
Single Patient Use Endo Cutter and Reload places two, triple-staggered rows of titanium staples and simultaneously divides the tissue from central line. The devices are available in 30mm, 45mm and 60mm three lengths. Reloads are available in six staple sizes to accommodate various tissue thicknesses: 2.0mm, 2.5mm, 3.5mm, 3.8mm, 4.1mm, 4.2mm. The device may be reloaded and fired up to 5 times in a single procedure.
Single Patient Use Linear Stapler and Reload places a double staggered row of titanium staples and is available in 30mm, 45mm, 60mm, 75mm and 90mm staple for use in various applications. Three staple sizes (2.5mm, 3.8mm and 4.5mm) are available to accommodate various tissue thicknesses. It may be reloaded and fired up to 4 times for a total 5 firing in a single procedure.
Single Patient Use Linear Cutter and Reload place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The devices are available in 55mm, 60mm, 75mm, 80mm and 100mm lengths. Reloads are available in four staple sizes to accommodate various tissue thicknesses: 2.5mm, 4.2mm and 4.5mm. It may be reloaded and fired up to 4 times for a total 5 firings in a single procedure.
Single Use Hemorrhoidal Circular Stapler 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 stapler are available in 30mm, 34mm and 36mm four specifications. The staple size is 4.5mm. It cannot be reloaded.
The provided document is a 510(k) Summary for TGS Medical Co., Ltd.'s range of stapling devices (Circular Stapler, Hemorrhoidal Circular Stapler, Linear Stapler, Linear Cutter, Endo Cutter, and Transverse Cutter). The acceptance criteria and supporting studies are presented in the form of non-clinical tests to establish substantial equivalence to predicate devices, rather than a standalone clinical study on the effectiveness of the proposed devices.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." The acceptance criteria are essentially compliance with specific international and national standards related to medical devices. The reported device performance is that the proposed device complies with these standards, demonstrating substantial equivalence to the predicate devices.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Complies |
| ISO 10993-5:2009 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) | Complies |
| ISO 10993-10:2010 (Biological evaluation of medical devices - Part 10: Test for irritation and delayed-type hypersensitivity) | Complies |
| USP 38-NF 33 (Bacterial Endotoxins Tests) | Complies |
| ASTM F 88/F88M-09 (Standard test method for seal strength of flexible barrier materials) | Complies |
| ISO 11137-2: 2013 (Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose) | Complies |
Additionally, the comparison tables (Table 1 through Table 6) implicitly define acceptance criteria by comparing the proposed device's characteristics against those of the predicate devices. The "reported device performance" in these tables is that the proposed device's characteristics (e.g., intended use, cutting mechanism, operation principle, safety mechanism, closed staple height, closed staple form, patient-contact material, sterilization, endotoxin limit, labeling) are "Same" as or comparable to the predicate devices, or compliant with relevant regulations (e.g., 20 EU for Endotoxin Limit, Conforms with 21 CFR 801 for Labeling).
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Non clinical tests were conducted to verify that the proposed device met all design specifications..." However, it does not provide details on the specific sample sizes used for each of the non-clinical tests (e.g., number of devices tested for seal strength, number of samples for cytotoxicity). The data provenance is also not explicitly stated beyond being "non clinical tests." There is no indication of country of origin for the testing itself, nor whether the data is retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The document refers to non-clinical tests against established standards and predicate devices, which implies adherence to standardized methodologies rather than expert consensus on a test set.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The evaluation is based on non-clinical tests against defined standards and comparison to predicate devices, not on human adjudication of a test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable. The device is a surgical stapler, not an AI-assisted diagnostic or therapeutic device that involves human readers or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
This information is not applicable. The device is a physical surgical stapler, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" is implied by the established international and national standards (e.g., ISO 10993 series, USP, ASTM, ISO 11137-2) and the characteristics of the legally marketed predicate devices. The tests evaluate compliance with these standards and equivalence to the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a 510(k) submission for mechanical surgical devices, not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above.
§ 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.