(127 days)
The Richter Lipoplasty Cannulas and Accessories are intended for use in aesthetic body contouring.
The Richter Livoplasty Cannulas consist of a hollow stainless steel tube, with various tip shapes, lengths and diameters. The cannulas are provided with an attached aluminum handle for aspirator connection or with aluminum couplings for syringe connection. The cannulas are available with an optional PTFE coating. The Richter Lipoplasty cannulas are provided nonsterile
The provided text from the FDA 510(k) notification for "Richter Lipoplasty Cannulas And Accessories" does not contain information about acceptance criteria or a study proving the device meets those criteria.
This document is a letter from the FDA stating that the device is substantially equivalent to previously marketed devices, allowing it to proceed to market. It describes the device, identifies predicate devices, and confirms its intended use and classification. However, it does not include details about device performance metrics, clinical study design, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a study 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.