(90 days)
The LySonix Lipoplasty Access Port is indicated for use as an access portal to the surgical site and to reduce trauma to the incision site caused by removal and re-entry of cannulas during lipoplasty procedures during aesthetic body contouring.
The LySonix Lipoplasty Access Port is an instrument access portal designed for use during lipoplasty procedures for aesthetic body contouring. The device is inserted into the incision site and threaded into place. Once in place, the device threads retain the device in place and allow for the insertion of the lipoplasty cannula. The Lipoplasty Access Portal is designed to be substantially equivalent to Endoscopic Access Devices intended to provide access for surgical instruments and to protect the incision site from trauma during repeated insertion of the cannula during surgical procedures.
The provided text does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document is an FDA 510(k) clearance letter for the Lysonix Lipoplasty Access Port, indicating that the device is substantially equivalent to a predicate device already on the market. This type of clearance typically relies on demonstrating similarity to an existing device rather than presenting new clinical study data with specific performance metrics and acceptance criteria.
Therefore, I cannot provide the requested information based on the provided text.
§ 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.