Search Results

The Denali™ Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

-Pulmonary thromboembolism when anticoagulants are contraindicated

-Failure of anticoagulant therapy for thromboembolic disease

-Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

-Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

The Denali™ Filter may be removed according to the instructions supplied under the Section labeled: Optional Procedure for Filter Removal.

The Denali™ Vena Cava Filter is a venous interruption device designed to prevent pulmonary embolism. The Denali™ Filter can be delivered via the femoral and jugular/subclavian approaches. A separate delivery system is available for each approach. The Denali™ Filter is designed to act as a permanent filter. When clinically indicated, the Denali™ Filter may be percutaneously removed after implantation according to the instructions provided under the "Optional Procedure for Filter Removal" section in the Instructions for Use.

The Denali™ Filter consists of twelve shape-memory laser-cut nickel-titanium appendages. These twelve appendages form two levels of filtration with the legs providing the lower level of filtration and the arms providing the upper level of filtration. The Denali™ Filter is intended to be used in the inferior vena cava (IVC) with a diameter less than or equal to 28mm.

The Denali™ Vena Cava Filter System consists of an introducer sheath, an 8 French dilator, and a preloaded Denali™ Filter in a storage tube with a pusher. The 8 French dilator accepts a 0.035" guidewire and allows for an 800 psi maximum pressure contrast power injection. Radiopaque marker bands on the end of the dilator aid in measuring the maximum indicated IVC diameter. They are spaced at a distance of 28mm (outer-to-outer). The 55cm, 8.4 French I.D. introducer sheath contains a radiopaque marker and hemostasis valve with a side port. The pusher advances the filter through the introducer sheath to the predeployment mark and is then used to fix the filter in place while the filter is unsheathed.

This document, K240257, pertains to a 510(k) premarket notification for the "Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit." It explicitly states that no changes have been made to the subject Denali™ Filter or Delivery System and that no performance testing was performed. The purpose of the submission is solely to update the Instructions for Use (IFU) for inclusion of the PRESERVE study summary data.

Therefore, there is no information in this document regarding new acceptance criteria for the device or a study performed to prove the device meets new acceptance criteria. The approval is based on the substantial equivalence to a predicate device (K160866) and the clinical testing previously provided to the FDA under an Investigational Device Exemption.

As the request asks to describe the acceptance criteria and the study that proves the device meets the criteria, and this document states no new testing was performed, I cannot provide the requested information from this document.

Summary of available information:

• No new acceptance criteria or device performance reported in this document. The submission focuses on updating the Instructions for Use with summary data from the PRESERVE study, which was previously conducted for the predicate device.
• No new studies were conducted for this submission. The document explicitly states: "Therefore, no performance testing was performed." and "The clinical testing was previously provided to FDA under the Investigational Device Exemption."

All other questions regarding sample size, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, and training set details are not applicable or cannot be answered from the provided text, as no new studies or performance evaluations were conducted for this 510(k) submission.

Ask a specific question about this device