Universal Seal (5-12 mm)

The Universal Seal (5-12 mm) is a sterile, single-use cannula seal device that provides a seal within a port of entry for endoscopes, instruments, and accessories with diameters between 5 mm and 12 mm. It maintains insufflation during endoscopic procedures while minimizing gas leakage and allows air to flow in or out of the body cavity.

The subject device is identical to its predicate in mechanism of action, design features, dimensions, packaging materials, and most patient-contacting materials. The primary difference is a material change in indirect patient-contacting components: the duckbill changed from silicone to polyisoprene, and the lubricant changed from NuSil (MED-420) to NYEMED (NyeMed 7605).

Design verification and validation testing per ISO 10993-1:2018 for biocompatibility; shelf-life testing per ASTM F1980-22 for accelerated aging of sterile barrier systems; transit testing per ASTM D4169-23e1 for shipping container performance; and FDA guidance on biological evaluation of medical devices.

The subject device is substantially equivalent because it has the same intended use, indications for use, fundamental scientific technology, and similar technological characteristics as the predicate Universal Seal cleared under K241360. Performance testing including design verification, design validation with porcine and cadaver models, biocompatibility, shelf-life, and transit testing demonstrated that the material changes do not affect the device's safety or effectiveness.