Sonopet iQ Ultrasonic Aspirator System (5500-050-000)

The Sonopet iQ Ultrasonic Aspirator System is a surgical device that uses ultrasonic vibration (25 kHz) combined with irrigation and aspiration to fragment, emulsify, and remove unwanted soft and hard tissue while preserving adjacent structures. It is indicated for use in various surgical procedures including neurosurgery, gastrointestinal, urological, plastic, general, orthopedic, gynecological, thoracic, laparoscopic, and thoracoscopic surgery, with a contraindication against use for uterine fibroids.

The subject device retains identical core technology to the predicate: piezo-electric sinusoidal non-continuous ultrasonic energy, forced irrigation via peristaltic pump, and vacuum-based aspiration. The key modification is addition of Ethernet-based inter-device communications capability and optional RISE (Reimagining Integrated Surgical Experience) software functionality, which allows centralized control via compatible Stryker devices and optional foot pedal assignment for multiple handpieces, while maintaining the same console GUI, hand controller options, and system settings adjustment methods.

Not stated in this summary. The document references 'FDA guidance documents and recognized standards' for software/wireless technology, EMC and electrical safety, but does not name specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because it maintains identical intended use, indications, operating principles, energy source (AC powered), and primary functional outputs (ultrasonic fragmentation/emulsification/aspiration) as the predicate K213824. The new communications and RISE functionality are software additions that do not alter the fundamental tissue removal mechanism or safety profile; comprehensive nonclinical testing (software/wireless, EMC/electrical safety, bench, simulated use, and human factors testing) demonstrated the modifications raise no new safety or effectiveness concerns compared to the predicate device.