(100 days)
The Kendall SCD™ System is designed to increase venous blood flow in at risk patients, including bariatric and morbidly obese patients, in order to help prevent Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
Kendall SCD™ and SCD Express™ Sleeves (Extra Large Knee, Extra Large Thigh) are pneumatic compression devices for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).
The SCD™ System is an intermittent pneumatic compression device for applying sequential, gradient pressure to a patient's legs for the prevention of DVT and PE. The SCD" System consists of a controller, a pair of tubing sets, and a pair of single-patientuse disposable sleeves. The SCD™ product line has been a standard in the mechanical DVT and PE prevention industry.
The provided document is a 510(k) premarket notification for Kendall SCD™ Sleeves and Kendall SCD Express™ Sleeves. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance metrics, detailed study designs, sample sizes for test or training sets, expert qualifications, ground truth establishment, or comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot provide the requested information from the given text. The document focuses on regulatory approval based on substantial equivalence rather than detailed performance study results.
§ 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).