(90 days)
The PSI-TEC Liposuction Aspirator(s) indications for use is for esthetic body contouring.
Aesthetic Body Contouring.
Powered Suction Pump(s)/Aspirator(s) which use an electrically (AC) driven vacuum pump generating a negative pressure for the removal of fat/adipose, soft tissue, and general surgical waste. The Psi-Tec Aspirator 2 also has the capability to capture the waste air "exhaust" (that creates the negative pressure) in an enclosed container. This now, contained and pressurized air, can then be utilized for driving other devices requiring the use of pressurized air.
This document is a 510(k) premarket notification for a medical device (Psi-Tec Liposuction Aspirator), which means it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria.
Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.
Here's why and what kind of information you would typically find in a document that does address your request:
- 510(k) Notifications: These submissions aim to show that a new device is as safe and effective as another legally marketed device (the predicate device). This is usually done by demonstrating similar technological characteristics and indications for use, often through performance testing that is not a full-blown clinical study with acceptance criteria as you've described.
- Premarket Approval (PMA) Applications (or De Novo submissions for novel devices): These types of FDA submissions would typically include detailed clinical study data, acceptance criteria, and comprehensive reports proving the device's safety and effectiveness.
Based only on the provided text, I can infer the following, but cannot provide the detailed information you requested:
- Device Name: Psi-Tec Liposuction Aspirator
- Indications for Use: Aesthetic Body Contouring (stated on page 3 and 5)
- Predicate Device: Psi-Tec Aspirator(s) (K880392, Substantial Equivalence Date: 05 March 1998)
- Nature of the Submission: 510(k) summary, aiming to demonstrate substantial equivalence, not to present novel clinical trial data.
To answer your specific questions, I would need a different type of document, such as a summary of a clinical trial report or a performance data section from a PMA application.
§ 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.