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The 018 Radial Balloon Catheter is indicated for Percutaneous Transluminal Angioplasty (PTA) dilation of peripheral vasculature stenosis in the iliac, femoral, poplited, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The 018 Radial Access Rx Dilatation Catheter is a co-axial rapid exchange (RX) catheter system with a semi compliant balloon at the distal end designed for use with a 0.018" guidewire. The guidewire will pass through a lumen from an RX access bond. The balloon has two radiopaque markers that aid in the placement of the balloon within the stenosis. The balloon and catheter shaft are coated with a hydrophilic coating. The proximal end of the catheter has a single standard luer hub connector for connection of an inflation device. The inflation device is used to inflate and deflate the balloon with a contrast medium. The clearance between the inner and outer shafts acts as the passage for the inflation medium for balloon expansion. The device is used by positioning the balloon catheter over a guidewire. The balloon is aligned under fluoroscopy in the diseased vessel at the area to be treated. The balloon is then inflated with inflation media to pressures ranging between the nominal and the rated burst pressure to dilate the occluded area. On completion the balloon is then deflated under vacuum and removed from the patient. The 018 Radial Access Rx Dilatation Catheter is provided sterile via ethylene oxide and is intended for single use only.

This document is a 510(k) premarket notification for a medical device called the "Sublime Radial Access 018 RX Dilatation Catheter." It is NOT a study describing the acceptance criteria and proof that a device meets them.

The document states:

• No clinical studies were required for this device.
• The device was compared to a predicate device (Sublime™ Radial Access 014 RX PTA Dilatation Catheter K200700).
• Differences between the new device and the predicate device were verified through performance bench testing.

Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not available in this document because no clinical study was conducted.

The document lists performance bench tests that were conducted:

• Rated burst pressure (RBP)
• Inflation & deflation time
• Balloon diameters at nominal pressure
• Simulated use - pushability & trackability
• Coating lubricity
• Coating durability
• Coating length
• Ancillary tool compatibility (guidewire)
• Tip profile
• Multiple inflation/fatigue & leak test
• Tensile strength
• Flexibility & kink
• Particulates
• Torque Strength

These bench tests are "performance data" that were used to demonstrate substantial equivalence to a predicate device, not to prove the device meets specific acceptance criteria based on human clinical data. The acceptance criteria for these bench tests would typically be established specifications derived from the predicate device's performance or industry standards. However, the specific values for these acceptance criteria and the reported performance for each are not provided in this document.

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