Search Results

The AXIOS Stent and Delivery System is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts ≥ 6 cm in size, with ≥ 70% fluid content that are adherent to the bowel wall. Once placed, the AXIOS Stent functions as a port allowing passage of standard and therapeutic endoscopes to facilitate debridement, irrigation and cystoscopy. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst resolution.

The AXIOS Stent and Delivery System is designed to secure the apposition of tissue, minimize stent displacement and create a large access/drainage lumen. The AXIOS Stent and Delivery System is provided sterile, disposable and intended for single patient use. The stent is preloaded within the AXIOS delivery catheter. The Delivery System consists of a catheter and an integrated handle with manual controls for positioning and deploying the AXIOS stent. The Delivery System is designed to be used in the gastrointestinal tract in conjunction with commercially available echoendoscopes with a 3.7 mm diameter or larger working channel and is compatible with commercially-available 0.035-inch insulated endoscopic guidewires.

This document is a 510(k) premarket notification for the AXIOS Stent and Delivery System. It explains that the device's labeling (Directions For Use - DFU) is being modified to align with a previously cleared version, and therefore, no new studies or acceptance criteria are being presented for the device itself.

The document states: "No additional verification or validation activities were required to support the DFU changes proposed in this submission for the AXIOS Stent with Delivery System. The MR data and clinical data that supported the proposed labeling modifications were also used to support the same labeling changes that were cleared for the AXIOS with Electrocautery Enhanced Delivery System per K150692."

Therefore, based on the provided text, there is no new study described within this specific submission that proves the device meets new acceptance criteria. The submission relies on previously conducted studies for the predicate device (K150692) to support the DFU changes.

As such, I cannot provide the requested information regarding acceptance criteria and a study from this document, as it explicitly states no new studies were required for this submission. The "Conclusion" also reinforces this, stating: "The modified DFU of the AXIOS Stent and Delivery System is substantially equivalent to the predicate devices."

Ask a specific question about this device