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The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits are indicated for use in the prevention of recurrent pulmonary embolism via permanent 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.
• G2 EXPRESS™ Filter may be removed according to the instructions supplied under the section labeled: Optional Procedure for Filter Removal.

The G2 EXPRESS™ Filter consists of 12 shape-memory nitinol wires emanating from a central nitinol sleeve with a snare tip. These 12 wires form two levels of emboli filtration: the legs provide the lower level of filtration and the arms provide the upper level of filtration. The G2 EXPRESS™ Filter is intended to be used in the inferior vena cava with diameters less than or equal to 28 mm.

The G2 EXPRESS™ Filter System - Femoral Delivery Kit consists of a 7 French inner diameter (I.D.) introducer catheter and dilator set and a storage tube preloaded with the G2 EXPRESS™ Filter and pusher system. The introducer catheter and dilator are used to gain access to the inferior vena cava via a femoral approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and the introducer catheter has two radiopaque marker bands on the distal end to assist in filter delivery. The pusher system is designed to pass through the introducer catheter.

The G2 EXPRESS™ Filter System – Jugular/Subclavian Delivery Kit consists of a 10 French I.D. introducer sheath and dilator set and a delivery device preloaded with the G2 EXPRESS™ Filter. The introducer sheath and dilator are used to gain access to the inferior vena cava via a jugular approach using the Seldinger technique. The dilator accepts a 0.038" guidewire and enables a contrast medium power injection up to 800 psi maximum pressure. The introducer sheath contains a radiopaque tip and hemostasis valve with a side port for injecting contrast medium via a syringe. The delivery device fits within the introducer sheath and consists of a side port for saline infusion and a delivery mechanism to deploy the G2 EXPRESS™ Filter.

The provided text is a 510(k) summary for a medical device (G2 EXPRESS™ Filter System) and does not contain the kind of detailed study information (acceptance criteria, specific study results, sample sizes, expert qualifications, etc.) that would allow for a complete answer to your request.

The document states: "The G2 EXPRESS™ Filter System – Femoral and Jugular/Subclavian Delivery Kits met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." However, it does not describe these acceptance criteria or the specific studies/data that prove they were met.

Therefore, I cannot provide an answer with the requested details from the given text.

To answer your request, I would need a different type of document, such as a full clinical study report, a detailed design validation report, or a comprehensive premarket submission that outlines the specific performance criteria and the data collected to demonstrate their fulfillment.

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