LoFric Elle Pro

The LoFric Elle Pro is a sterile, single-use intermittent urinary catheter for female patients. It is pre-lubricated with a hydrophilic coating and comes in a sealed package with wetting fluid that activates the catheter surface upon use. The device is available in three diameters (10Fr, 12Fr, 14Fr) in a single 10 cm length with a straight (Nelaton) tip.

The subject device is substantially identical to the predicate LoFric Elle (K211212) in materials, coating, wetting fluid, packaging, sterilization method, and user interface. The key difference is the number of drainage eyelets: the subject device has 12 eyelets arranged in a vertical spiral configuration with harmonized sizing, compared to 2 eyelets in the predicate device.

ISO 20696:2018 (catheter flow rate and strength), ISO 10993-1:2018 (biocompatibility), ISO 11607-1 and 11607-2 (packaging and sterilization validation), ISO 11137-1:2006 and ISO 11137-2:2013 (radiation sterilization), ASTM D4169-16 and D4332-14 (shipping and conditioning), and internal bench testing for bending stiffness, friction, and coating performance.

Substantial equivalence is established because the subject device maintains the same indication for use, fundamental design, materials, manufacturing method, and packaging as the predicate. The increase in drainage eyelets from 2 to 12 was evaluated through nonclinical testing that confirmed the change does not adversely affect safety or effectiveness. All biocompatibility, sterilization, and performance testing either replicates or leverages predicate data.