(79 days)
The SoundVASER System is indicated for use in the following surgical specialties when the fragmentation, emulsification, and aspiration of soft tissue is desired:
- Neurosurgery -
- Gastrointestinal and Affiliated Organ Surgery -
- Urological Surgery -
- Plastic and Reconstructive Surgery -
- General Surgery -
- -Orthopedic Surgery
- Gynecological Surgery -
- Thoracic Surgery -
- -Laparoscopic Surgery
The SoundVASER System is indicated for use when the fragmentation, emulsification, and aspiration of subcutaneous fatty tissues for aesthetic body contouring is desired.
The SoundVASER System is comprised of an ultrasonic generator (110/120 and 220/240 VAC, 50 & 60 Hz), an ultrasonic surgical handpiece with an ultrasonic surgical probe, and a suction/irrigation subsystem. The ultrasonic surgical handpiece converts electrical energy supplied by the ultrasonic generator into vibratory motion. The vibratory motion is applied to the ultrasonic surgical probe that is attached to the ultrasonic surgical handpiece. The vibratory motion at the tip of the ultrasonic surgical probe fragments and emulsifies contacted soft tissues. The suction/irrigation subsystem is used to remove the fragmented tissues.
The provided text is a 510(k) summary for the SoundVASER System, which outlines its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria.
Therefore, the document does not contain information on acceptance criteria, a study proving device performance against those criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for a test or training set.
The document explicitly states: "The SoundVASER System is similar with regard to design, operation, materials, methods of sterilization, and intended use to the predicate devices indicated above. Therefore, no new safety or efficacy issues are created and the SoundVASER System is substantially equivalent to the predicate devices." This highlights that the submission relies on demonstrating substantial equivalence to already approved devices rather than presenting new performance data against acceptance criteria.
§ 878.5040 Suction lipoplasty system.
(a)
Identification. A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.(b)
Classification. Class II (special controls). Consensus standards and labeling restrictions.