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The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is intended to be used in conjunction with a PTA balloon to facilitate dilation and apposition of the scoring/constraining surface to the stenal in the iliac, femoral, ilio-popliteal, infra-popliteal, and renal arteries, and for treatment of obstructive or synthetic arteriovenous dialysis fistulae. Not for use in the coronary or neuro-vasculature.

The XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter is a balloon dilation scoring/constraining catheter. It consists of a metal alloy wire shaft connected to the metal alloy expandable constraining structure (CS) at the distal atraumatic tapered tip. It works with offthe-shelf compliant and semi-compliant balloons to expand the constraining structure and is designed to facilitate uniform, atraumatic balloon expansion, vessel scoring, and rewrap within small or distal vessels and arteries. The XO Constrain catheter is designed to be used with balloons between the sizes of 6 - 20mm in length and 1.5 - 4.0mm in diameter and may work with PTA and peripheral use PTCA balloon catheters with a standard over-the-wire (OTW) or rapid exchange (RX) procedural approaches. The expansion of the CS is determined by the balloon inflation diameter. Upon deflation the CS returns to its original shape and is removed from the vessel along with the balloon catheter. The XO Constrain should not be used in the coronary or neuro-vasculature.

The device under consideration is the XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter.

Based on the provided text, the device's acceptance criteria are addressed through a series of Functional/Safety Testing and Animal Testing. The manufacturer, Transit Scientific, LLC, states that "All data met pre-determined acceptance criteria" for these tests and that the device is "substantially equivalent to the cited predicate device."

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various tests performed to ensure the device meets predefined acceptance criteria, but it does not explicitly state specific quantitative acceptance criteria or the numerical performance results for each test. Instead, it broadly states that "All data met pre-determined acceptance criteria."

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