(28 days)
The VasoPress Pump (Model VP500DM) is an external pneumatic compression device for use with VasoPress DVT garments, and is intended to lower the risk of deep vein thrombosis (DVT) in patients who may be at risk.
VasoPress DVT Supreme Mini, Pump Model No. VP500DM
I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is a 510(k) premarket notification letter from the FDA to Compression Therapy Concepts regarding the VasoPress DVT Supreme Mini pump. It states that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices for the indication of lowering the risk of deep vein thrombosis (DVT). It also outlines regulatory requirements but does not include any performance study details.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).