Sonata Transcervical Fibroid Ablation System 2.2

The Sonata Transcervical Fibroid Ablation System 2.2 is a radiofrequency ablation device that combines ultrasound imaging with RF energy delivery through a single integrated handpiece. It is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding, using a uterine-sparing approach without incisions or material uterine distension.

The modified device has identical technological characteristics (design, material, principle of operation, energy source) to the predicate device K240503. The only differences are a change to materials, labeling artwork, and cable length of the Sonata Dispersive Electrode.

Not stated in this summary. The document references 'FDA recognized standards' and the same methods and criteria used in the predicate device submission but does not explicitly name specific ISO, IEC, or ASTM standards.

The device is substantially equivalent because the modifications are limited to materials, labeling artwork, and dispersive electrode cable length—minor changes that do not alter the fundamental design, operation, or energy source. Verification and validation testing on the modified device demonstrated compliance with applicable design requirements using established methods; all testing met acceptance criteria, confirming the modified device is as safe and effective as the predicate.