Tula Tympanostomy Tube Delivery Device

The Tula Tympanostomy Tube Delivery Device is a single-use, handheld device that creates a myringotomy (opening in the eardrum) and delivers a pre-loaded tympanostomy tube through the tympanic membrane in a single automated action lasting less than 500 milliseconds. It is indicated for use in office or operating room settings to treat pediatric patients aged 6 months and older and adult patients.

The subject device uses an automated operation mechanism with a stainless steel shaft and transparent polycarbonate tip, compared to the predicate device's manual mechanism. Both devices have the same pre-loaded tube design, principles of operation, materials (medical-grade silicone), sterilization method (ethylene oxide), and biocompatibility. The subject device expands the indication to include operating room use and adult patients, whereas the predicate was limited to office settings and pediatric patients.

Biocompatibility testing per ISO 10993-1 and FDA Guidance on biological evaluation of medical devices. The sterilization method achieves a minimum sterility assurance level (SAL) of 10⁻⁶ via ethylene oxide gas, previously approved for a PMA device. Quality Management System Regulation (21 CFR Part 820) requirements including ISO 13485 design controls, nonconforming product, corrective action, and preventative action provisions.

The subject device is substantially equivalent because it has the same intended use and principle of operation as the predicate (Hummingbird Tympanostomy Tube System, K221254), utilizes similar biocompatible materials, and demonstrates comparable clinical performance with high procedural success rates (87.4% in pivotal study) and no device-related serious adverse events. Although technological differences exist (automated vs. manual mechanism, expanded indications), these differences do not raise new safety or effectiveness questions and are consistent with the reference device (Tula TDS, K171239) previously cleared under K171239.