Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers

The Flexiva Pulse and Flexiva Pulse ID laser fibers are single-use, sterile fiber optic devices that transmit Ho:YAG laser energy from cleared laser consoles to urological anatomy for endoscopic procedures. They are indicated for vaporization, ablation, hemostasis, coagulation, excision, resection, incision of soft tissue, and lithotripsy of urinary calculi, with variants including TracTip configurations featuring ball-shaped output tips.

The proposed device has identical technological characteristics to the predicate (K210925): same indications for use, single-use sterile design, ethylene oxide sterilization, Tyvek packaging, identical fiber sizes (242, 365, 550, 910 μm), and identical overall lengths. The only material change is a new secondary coating resin that was evaluated through design verification testing including bent transmission, fiber durability during firing, connector temperature, and laser system output accuracy.

Not stated in this summary. The document references design verification testing but does not cite specific ISO, IEC, or ASTM consensus standards.

Substantial equivalence is established through identical indications for use, identical technological and performance characteristics, and design verification testing of the secondary coating resin change that demonstrates the new material performs as safely and effectively as the predicate. Biocompatibility assessment confirmed no risks associated with the material change, and all key design parameters (sizes, lengths, sterilization, packaging, connector type) remain identical to the predicate K210925 device.