The ASAHI Gaia has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as its predicates.

The ASAHI Gaia has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, shelf life and operating principles as the predicate devices. Performance data demonstrates that the device functions as intended, and is as safe and effective as its predicates.