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The ECHELON™ 3000 and ECHELON ENDOPATH™ families of staplers and reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ECHELON™ 3000 45mm and 60mm Staplers are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The ECHELON™ 3000 Staplers 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 devices are available in two different configurations (ECHELON™ 3000 45mm Staplers and ECHELON™ 3000 60mm Staplers) and three different shaft lengths (Compact, Standard, and Long). The device utilizes battery power to fire the device. The instruments are packaged with a primary lithium battery pack that must be installed prior to use. There are specific requirements for disposing of the battery pack noted in the Instructions for Use Battery Pack Disposal section of the package insert.

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 instrument lock-out feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

This document is a 510(k) Premarket Notification from the FDA regarding surgical staplers. It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, ground truth methodology, MRMC studies, etc.) that would typically be found in a clinical study report or a more comprehensive technical document supporting an AI/software as medical device (SaMD) submission.

The document primarily focuses on demonstrating substantial equivalence to existing predicate devices (ECHELON 3000 45mm and 60mm Staplers, K213633). The changes described are primarily dimensional and material changes to a non-patient contacting component (the "shifter plate") within an already cleared device.

Therefore, for your request, I cannot extract specific acceptance criteria for AI performance, details on test set data provenance, expert adjudication methods, MRMC studies, or training set details because this submission is about a mechanical surgical stapler, not an AI/software device.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states:

• "The premarket submission did not rely on the assessment of clinical performance data to demonstrate device performance and equivalence."
• Performance testing focused on:
  • "Closure Force during Device shifting testing... against the predicate Design Requirement using success criteria with the original validated Test Method."
  • "Side by side component level testing... to confirm equivalent or better strength and wear properties" (e.g., Component withstand strength, Pinning for Device assembly, and cyclic wear during Device closure).

In summary, the provided text does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of AI/SaMD. It describes a traditional medical device submission for mechanical changes to a surgical stapler.

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