(90 days)
The Aspiration and Infusion Cannulae and Needles indications for use are for Aesthetic Body Contouring.
The principles of operation and technology incorporated in the Cannulae and Needles are equivalent to fluid, soft tissue, and exudate removal and infusion instruments generally used for aspiration and infusion, utilizing a hollow Stainless Steal tube with multiple tip, handle and attachment connectors that are in a reusable and disposable configuration.
I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) premarket notification for Lipoplasty/Liposuction Aspiration and Tumescent Infusion Cannulae and Needles, indicating that the device is substantially equivalent to a previously marketed device. It does not include performance data, study designs, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study's results 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.