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The Angioslide eXtraTM Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter with Embolic Capture Feature is indicated for peripheral translyminal angioplasty and containment of embolic material during angioplasty, for the femoral, iliac, ilio-femoral, popliteal, tibial, peroneal, and profunda arteries.

The Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture is not intended for use in the renal, cerebral, coronary or carotid vasculature.

The Angioslide eXtra™ Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter is a single-use disposable over-the-wire co-axial dual lumen catheter with a foldable balloon near the distal tip. The balloon catheter consists of the balloon located near the distal atraumatic soft tip, the telescopic shaft and the handle.

One lumen is used for inflation of the balloon and is accessed via the inflation port. The other lumen, starting at the quidewire port. allows access to the distal tip for guidewire insertion (max. 0.035"). The balloon has two radiopague markers for positioning the balloon relative to stenosis. The radiopaque markers indicate the dilating section of the balloon and help in balloon placement. The balloon is designed to provide an inflatable segment of known diameter and length at specified pressure.

The shaft comprises the outer shaft and the inner shaft. The distal end of the balloon is connected to the inner shaft and the proximal end of the balloon is connected to the outer shaft. The inner shaft is connected to the pulling rod and the outer shaft is connected to the handle body. The pulling rod lock locks the handle body and the pulling rod together. The distal end of the balloon is folded inwards towards the proximal end of the balloon, by unlocking the pulling rod lock counter-clockwise and retracting the pulling rod. The inward-folding of the balloon forms a cavity and allows for collection of embolic material.

Here's an analysis of the Angioslide eXtra™ PTA Balloon Catheter with Embolic Capture Feature based on the provided 510(k) summary, focusing on acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly lay out a table of acceptance criteria with corresponding performance metrics from the studies for the device itself in a quantitative manner. Instead, the document describes the types of tests performed and states that the "results of the MC-LEADER and MC-LEADER Supplemental Studies met performance goals derived from historical literature describing PTA performance." For the animal study, it states: "The results of this study demonstrated that the safety and performance of the Angioslide eXtra™ PTA Balloon Catheter was substantially equivalent to that of the control article when used in an in vivo model."

However, based on the identified endpoints from the clinical studies, we can infer the performance goals the device aimed to meet:

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