Portare System (FA-001)

The PORTARE System is a flexible nasopharyngoscope designed for endoscopic examination of nasal passages and upper airway anatomy in adults within hospital or clinical settings. It comprises a single-use disposable endoscope handle with a steerable insertion tube, chip-on-tip camera, and LED light source that connects to a reusable wireless module to transmit images and video to a tablet viewer application.

The PORTARE System shares the predicate's sterile single-use/reusable component design, chip-on-tip camera, LED light source, direction of view, articulation angle, lack of working channel, and terminal sterilization method. Key differences include field of view, depth of field, insertion tube diameter and length, wireless transmission capability, rechargeable battery power source, and reprocessing method; however, performance and safety testing confirmed these differences raise no new safety or effectiveness questions.

ISO 8600 (endoscope optics), ISO 12233 and ISO 15739 (optical performance), ISO 11135 (sterilization validation), ISO 10993 series (biocompatibility), IEC 60601 series (electrical safety and electromagnetic compatibility), IEC 62133-2 (battery safety), IEC 62471 (photobiological safety), ANSI C63.10 (RF safety), ANSI C63.27 (wireless coexistence), ANSI/AAMI ST98 (cleaning validation), and ASTM standards for package integrity.

The PORTARE System is substantially equivalent to the predicate (Ambu aScope RLS Slim) because it shares the same intended use, indication, environment, fundamental design of connecting disposable and reusable components for visualization, and optical/sterilization methods. Although the PORTARE differs in wireless transmission, tube dimensions, power source, and reprocessing approach, comprehensive performance testing across optical, mechanical, software, cybersecurity, electrical safety, and biocompatibility domains demonstrated these technological differences do not present new safety or effectiveness concerns, supporting equivalence for the stated indications.