(57 days)
The ECHELON, ECHELON ENDOPATH™ and ECHELON FLEX™ families of Endoscopic Linear Cutters and Reloads are intended for transection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
The ENDOPATH ECHELON™ and ECHELON FLEX™ families of endoscopic linear cutters are sterile, single patient use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. The ECHELON 60 instruments have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The shaft can rotate freely in both directions and an articulation mechanism on articulating instruments enables bending the distal portion of the shaft to facilitate lateral access of the operative site. The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads come in five colors corresponding to different closed staple heights, with the intention of being used in different tissue thickness. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. The instruments are packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping and transportation. The instruments' lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being used in different tissue thickness. The ECHELON ENDOPATH™ Echelon Endoscopic Linear Cutter Reloads (+ Gripping Surface Technology) are designed for use with the Echelon Endoscopic Linear Cutter devices (Echelon, Echelon Flex, Echelon Flex Powered and Echelon Flex Powered Plus) in a 60mm configuration.
This document describes a 510(k) premarket notification for the "Echelon Endoscopic Linear Cutter Reloads" where the primary purpose is to demonstrate substantial equivalence to a predicate device, not to prove that a novel device meets specific acceptance criteria through a full-scale clinical trial. Therefore, many of the requested categories regarding clinical study design, ground truth, and expert involvement are not applicable to this type of submission.
Here's a breakdown based on the provided document, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical targets in the same way a clinical efficacy study would. Instead, the performance objective was to demonstrate substantial equivalence to the predicate device through bench testing. The "reported device performance" is essentially that the subject reloads demonstrated equivalence to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device for: | Yes, demonstrated substantial equivalence. |
| - Force to Close | Equivalent performance to predicate. |
| - Staple Form Quality | Equivalent performance to predicate. |
| - Formed Staple Height | Equivalent performance to predicate. |
| - Staple Line Integrity | Equivalent performance to predicate. |
| - Improved cartridge pan retention at the proximal end of the reload (primary goal) | Achieved. |
2. Sample size used for the test set and the data provenance
The document states "Bench testing was performed...". It does not specify the exact sample size for the bench tests.
- Sample size: Not specified.
- Data provenance: Bench testing results, assumed to be conducted by the manufacturer, Ethicon Endo-Surgery, LLC. The country of origin and whether it's retrospective or prospective are not detailed, but bench testing is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a bench study demonstrating substantial equivalence to a predicate device, not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" here is the physical performance of the stapler reloads against engineering specifications and comparison to the predicate device.
4. Adjudication method for the test set
Not applicable. There was no clinical test set requiring adjudication from medical experts.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No. A multi-reader multi-case study is typically performed for diagnostic devices where human readers interpret medical images or data. This submission is for a surgical stapler reload, which is not a diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical surgical stapler reload, not an AI algorithm.
7. The type of ground truth used
Not applicable in the conventional sense of clinical ground truth (like pathology or outcomes data). The "ground truth" for the bench testing would be the objective measurements and engineering standards for the physical properties of the stapler reloads, such as staple dimensions, closing force, and staple line integrity, compared against the predicate device's performance.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.