HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)

The HOTWIRE RF Guidewire is a sterile, single-use device that delivers radiofrequency energy to create an atrial septal defect in the heart. It consists of a stainless steel core wire with polymer insulation, a floppy distal segment with an uninsulated electrode coil, and visual markers for alignment with transseptal sheaths. The device is used with compatible third-party intravascular sheaths, dilators, and RF electrosurgical generators.

The subject device shares identical fundamental design, materials (stainless steel core, insulating polymer jacket), dimensions, and configuration with the predicate device. The key difference is a modified distal taper length, which is similar to the reference device (Baylis ProTrack RF Anchor Wire K150709) and does not raise new safety or effectiveness concerns.

ASTM D4332 (environmental conditioning), ASTM D4169 (transportation simulation), and IEC 60601-2-2 (electrosurgical equipment safety). Performance testing included visual/dimensional inspection, simulated use, arc integrity, tensile strength, torque, fracture resistance, flexing, and tip flexibility tests.

The subject device is substantially equivalent because it has identical intended use (creation of atrial septal defect), identical fundamental RF energy technology and operational principle, and identical or nearly identical design and materials compared to the predicate K240900. The minor design modification (distal taper length) is supported by reference to a cleared predicate with the same feature and by comprehensive performance testing that met all acceptance criteria without raising new safety questions. Sterilization (gamma radiation, SAL 10-6), packaging validation, and shelf life testing (1 year) all demonstrated equivalence to the predicate device.