(259 days)
The indications for use and the contraindication are listed separately in this application.
The PAS Wrap System is composed of two leg wrap members constructed of an inflatable bladder enclosed in a fabric cover with an outside surface that will accept a Velcro fastener hook strip. Extending from one side of this enclosed bladder is an elastic fabric cut to conform to the shape of the calf area of the leg. This fabric is wrapped around the back of the calf and is attached to the other side of the bladder with a Velcro fastener. The Velcro fastener allows for a tight fit on various size legs. The inflation pump is attached to the bladders and is energized. The bladder on each leg is alternately inflated and deflated to yield approximately 65mm Hg pressure on the calf area of the leg. This pressure causes pooled blood to be expelled from the calf and to proceed toward the heart. This helps to prevent embolisms from forming in the calf area.
This appears to be a 510(k) summary for a medical device submitted to the FDA in 1996. The provided text describes the device and its intended use, but does not contain the information requested in your bullet points regarding acceptance criteria, study details, or performance data.
The summary describes the "albahealth PAS Wrap System," an inflatable leg wrap designed to prevent embolisms by alternately inflating and deflating to apply pressure to the calf. It mentions that the device is applied similarly to the "Jobst Athrombic Pump System 2000" and uses the "albahealth Pulsatile Anti-Embolism System pump" to deliver pressure. It also states that indications for use and contraindications are listed separately in the application and that "articles showing the benefits of this device and also MDR's and adverse experience reports" are summarized.
To answer your questions, I would need access to the full 510(k) submission, clinical study reports, or other documentation that details the performance testing and acceptance criteria. This summary only provides a high-level overview of the device and its predicate.
§ 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).