(30 days)
The Denali® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
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Pulmonary thromboembolism when anticoagulants are contraindicated.
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Failure of anticoagulant therapy for thromboembolic disease.
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Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced.
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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 a short 10 French dilator, an introducer sheath and long 8 French dilator, and a preloaded Denali® Filter in a storage tube with a pusher. The 15cm, 10 French dilator accepts a 0.035" guidewire and is intended for predilatation. The long 8 French dilator accepts a 0.035" quidewire 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 is a 510(k) summary for the Denali® Filter System, indicating that no new performance testing was conducted because the device is identical to a previously cleared predicate device. Therefore, it does not contain the specific information required to complete your request regarding acceptance criteria and a study proving the device meets those criteria.
The submission is an update for including 2-year clinical data in the Instructions for Use (IFU) for the previously cleared device. It explicitly states: "No changes have been made to the subject Denali® Filter or Delivery System. The purpose of the submission is to update the IFU for inclusion of the 2-year clinical data." And further, "Therefore, no performance testing was performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption."
To obtain the information you're looking for, you would need to refer to the original 510(k) submission for the predicate device (K143208) or the Investigational Device Exemption (IDE) data for the Denali® Filter System.
§ 870.3375 Cardiovascular intravascular filter.
(a)
Identification. A cardiovascular intravascular filter is an implant that is placed in the inferior vena cava for the purpose of preventing pulmonary thromboemboli (blood clots generated in the lower limbs and broken loose into the blood stream) from flowing into the right side of the heart and the pulmonary circulation.(b)
Classification. Class II. The special controls for this device are:(1) “Use of International Standards Organization's ISO 10993 ‘Biological Evaluation of Medical Devices Part I: Evaluation and Testing,’ ” and
(2) FDA's:
(i) “510(k) Sterility Review Guidance and Revision of 2/12/90 (K90-1)” and
(ii) “Guidance for Cardiovascular Intravascular Filter 510(k) Submissions.”