Dorado™ PTA Balloon Dilatation Catheter

The Dorado™ PTA Balloon Dilatation Catheter is an over-the-wire balloon catheter designed for percutaneous transluminal angioplasty (PTA) of peripheral arteries including renal, iliac, femoral, popliteal, tibial, peroneal, and subclavian vessels, as well as for treating obstructive lesions in dialysis fistulae and for post-dilatation of peripheral stents. The device features a proprietary non-compliant, low-profile balloon with radiopaque markers and an atraumatic tip, available in multiple configurations of balloon diameters (3-10 mm), lengths (1.5-20 cm), and catheter shaft lengths (40-135 cm).

The subject device is substantially identical to the predicate device in indications, target population, principle of operation, fundamental scientific technology, packaging materials, sterilization method, and design specifications. The primary difference is a Pebax grade material change in the balloon. Minor modifications include a line extension change (dimensional, material, and packaging adjustments) and a tip configuration change, neither of which warranted separate 510(k) submissions.

ISO 10993-1:2018 for biocompatibility testing (cytotoxicity, sensitization, irritation/intracutaneous toxicity, systemic toxicity, and hemocompatibility including hemolysis, thrombogenicity, and complement activation). The submission also references FDA guidance documents on non-clinical testing of medical devices and internal risk assessment procedures.

The device demonstrates substantial equivalence through identical indications for use, target patient population, and principle of operation compared to the predicate device cleared in 2007. Comprehensive in vitro testing—including trackability, balloon burst strength, fatigue, sheath compatibility, dimensional verification, and biocompatibility—confirmed that the subject device met all predetermined acceptance criteria and performance specifications. Although the Pebax material grade was changed, the testing confirmed equivalent mechanical and biocompatibility performance, and minor design modifications did not alter the fundamental safety or effectiveness profile, supporting equivalence to the legally marketed predicate.