(147 days)
The Progenikine Concentrating System is used in medical procedures involving the harvesting of autologous adipose tissue. The Progenikine® Concentrating System is used for concentrating adipose tissue harvested with a legally marketed lipoplasty system. The Progenikine Concentrating System is intended for use in the following surgical specialties when the concentration of harvested adipose tissue is desired.
Neurosurgery, Gastrointestinal Surgery, Urological Surgery, Plastic and Re-constructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Laparoscopic Surgery, Arthroscopic Surgery.
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This document is a 510(k) clearance letter for a medical device (Progenikine Concentrating System). It does not contain any information about acceptance criteria, device performance data, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods), MRMC studies, or standalone algorithm performance.
The letter confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls. It primarily addresses regulatory aspects such as registration, listing, labeling, manufacturing practices, and adverse event reporting.
Therefore, it is not possible to extract the requested information (acceptance criteria, study details, etc.) from the provided text. This document is a regulatory approval notice, not a study report.
§ 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.