UltraScore™ Focused Force PTA Balloon

The UltraScore™ Focused Force PTA Balloon is a percutaneous angioplasty catheter used to dilate stenoses in peripheral arteries (iliac, femoral, popliteal, infra-popliteal, and renal) and treat obstructive lesions in arteriovenous dialysis fistulae. It features two scoring wires positioned 180° apart to provide focused force during balloon inflation and is compatible with 0.014" or 0.035" guidewires. The device is also used for post-dilatation of stents and stent grafts in peripheral vasculature.

The subject device is identical to the predicate device in intended use, indications, target population, operating principle, fundamental scientific technology, and sterilization method. The only modification is a new formulation of PTFE coating on the scoring wires due to supplier discontinuance of the original PTFE formulation.

ISO 10993-1:2009 for biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility, material mediated pyrogenicity, thrombogenicity, chemical characterization). Functional testing included sheath compatibility, inflation time, and deflation time per FDA guidance on non-clinical testing.

The subject device is substantially equivalent because it maintains identical indications for use, intended use, operating principle, and sterilization to the predicate device (K172571, cleared September 2017). The sole change—the new PTFE formulation on the scoring wires—was qualified through comprehensive in vitro testing and biocompatibility studies demonstrating it meets all acceptance criteria and poses no safety or effectiveness concerns.