(18 days)
The Endo GIA™ Staplers with Endo GIA™ Single Use Duet TRS™ Reloads with Tri-Staple™ Technology 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.
This 510(k) shall describe a new Reload cartridge with Tri-Staple™ technology for use with the currently marketed Endo GIA™ Stapler. The new Duet TRS™ Reload with Tri-Staple™ Technology bears the identical design characteristics as the Endo GIA™ Reloads with Tri-Staple™ Technology described in predicate submissions K083519 and K090419 with the exception that the Reloads have pre-attached staple line reinforcement material which is a synthetic absorbable film prepared from synthetic polyester composed of glycolide, dioxanone, and trimethylene carbonate. The staple line reinforcement material is supplied on each Reload undyed (natural) and is secured to the anvil and cartridge with BIOSYN™ synthetic absorbable suture.
The Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology when used with the Endo GIA™ Stapler places two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows.
Duet TRS™ Reloads with Tri-Staple™ Technology place two sets of triple-staggered rows of titanium staples along with two layers of absorbable tissue reinforcement material (one layer on cartridge side and one layer on anvil side) and simultaneously divide the tissue and tissue reinforcement material between the two sets of triple-staggered rows. These Reloads have a stepped cartridge configuration whereby for each set of triple-staggered rows, the staples in the outer row are a taller height than the staples in the middle row which in turn are a taller height than the staples in the inner row closest to the cut line. The size of the staples is determined by the selection of the appropriate single use Reload.
The document describes the Endo GIA™ Duet TRS™ Reload with Tri-Staple™ Technology, which is a new reload cartridge for the existing Endo GIA™ Stapler. This device is intended for use in abdominal, gynecologic, pediatric, and thoracic surgery for resection, transection, and creation of anastomoses, including liver substance, hepatic vasculature, and biliary structures.
Here’s an breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench Tests | Deemed safe and effective, performs as intended (comparable to predicates) | Evaluated: Firing force, staple line pull apart strength, staple formation |
| In Vivo Tests | Deemed safe and effective, performs as intended (comparable to predicates) | Evaluated: Staple formation, hemostasis, burst strength, lung air leak |
| Staple Line Reinforcement Material | Retain measurable mechanical strength through 14 days; absorption complete between 90-110 days. | Studies indicate the material can be expected to meet these criteria. |
| Biocompatibility | All components in accordance with ISO Standard 10993-1. | All components are comprised of materials that are in accordance with ISO Standard 10993-1. |
| Substantial Equivalence | Substantially equivalent to predicate devices with regard to stapling and staple line reinforcement technologies. | The device is substantially equivalent with regard to these technologies. |
Note: The document states that the evaluations were conducted "to demonstrate that the ...device... is safe and effective and performs as intended." While specific numerical acceptance criteria are not explicitly listed in this summary, the successful completion of these tests and the FDA's clearance (K103263) imply that the device met the established criteria for safety and effectiveness, likely by demonstrating equivalence to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the bench or in vivo test sets. It simply states that "Bench and in vivo performance evaluations were conducted." The data provenance is not explicitly mentioned (e.g., country of origin). The testing would be considered prospective as it was conducted to demonstrate the safety and effectiveness of the new device for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies described are performance tests (bench and in vivo) rather than studies requiring expert interpretation for ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the described studies are performance tests (bench and in vivo) and not studies involving expert adjudication of findings.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, 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 reload, not an AI-assisted diagnostic or therapeutic tool that would typically involve a multi-reader multi-case study for human reader performance improvement.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a medical device (surgical stapler reload), not an algorithm. The "standalone" performance here would refer to the device's functional performance, which was assessed through bench and in vivo tests.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" would be established by validated engineering and material science standards and measurements (e.g., precise force measurements, visual inspection of staple formation, tensile strength testing).
For the in vivo tests, the "ground truth" would be established by direct observation and measurement in animal models (as is common for such medical device testing), assessing outcomes like proper staple formation, lack of bleeding (hemostasis), and structural integrity (burst strength, absence of air leaks).
8. The Sample Size for the Training Set
This information is not applicable. This device is a mechanical surgical stapler reload, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this type of medical device.
§ 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.