(90 days)
The Basic, Median, Dominant and Vario Suction Pumps are indicated for vacuum extraction, aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Not Found
This document is a 510(k) clearance letter from the FDA for Medela, Inc.'s Basic, Median, Dominant, and Vario Suction Pumps. It states that the devices are substantially equivalent to pre-amendments devices and can be marketed.
Crucially, this document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. This letter simply grants regulatory clearance based on a determination of substantial equivalence, without detailing the underlying performance data or studies.
Therefore, I cannot provide the requested information based on the provided text.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.