Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000))

The Solo+ Tympanostomy Tube Device (TTD) is a single-use, sterile surgical instrument that delivers a tympanostomy (ventilation) tube through the tympanic membrane in a single procedure. It combines myringotomy creation, tube positioning, and placement functions and is indicated for office-based use in pediatric patients 6 months and older.

The device features a handpiece with a cartridge assembly containing a retractable myringotomy knife and pre-loaded tympanostomy tube made of medical-grade silicone and stainless steel. Activation is via push button (compared to slider button on the secondary predicate). It uses manual myringotomy technique and is single-patient use, sterile, with identical functional components and deployment mechanism to the primary predicate device K232702.

ISO 10993-1 (Biological evaluation of medical devices) was used for biocompatibility testing, including cytotoxicity, sensitization, irritation, acute/subchronic toxicity, implantation studies, and pyrogenicity. Design verification and validation tests covered functional testing, sterilization validation, bioburden/endotoxin validation, MRI safety, and visualization assessment.

The proposed device has identical intended use, indications, and technological characteristics to the primary predicate K232702 (both deliver tympanostomy tubes in office settings via manual myringotomy with push-button activation). Non-clinical test results were identical to the predicate. Clinical data from 20 patients (36 ears) ages ≥24 months demonstrated 90% successful placement and 86.1% delivery success without additional instruments, comparable to predicate performance. The expanded patient population (6 months and older vs. predicate's 6–24 months) is supported by the secondary predicate (Hummingbird TTS) which covers the same expanded age range, demonstrating safety and effectiveness across the broader pediatric population.