(126 days)
The proposed device, Kendall SCD™ Express™ KAMBIA™ Thigh Length TearAway Sleeves, are intended to be used with an intermittent pneumatic device to increase venous blood flow in at risk patients in order to help prevent deep vein thrombosis and pulmonary embolism.
The proposed device, Kendall SCD™ Express™ KAMBIA™ Thigh Length TearAway Sleeve, is a pneumatic compression device for applying pressure to a patient's leg for the prevention of Deep Vein Thrombosis (DVT). The proposed device is the same composition and design as the currently marketed Kendall T.E.D Sequential Compression Sleeves (K781357) with the additional of a new feature where the think length sleeve can be converted to a knee length sleeve. This new design allows the thigh bladder to be removed, leaving a functioning knee length sleeve. The purpose of the TearAway function is to allow the clinician to convert the device from a thigh length sleeve to a knee length sleeve without changing to a new sleove.
The proposed device consists of a pair of single-patient-use poly vinyl chloride (PVC) and nonwoven thigh length sleeves.
The Kendall SCD™ Express™ KAMBIA™,Thigh Length TearAway Sleeve is compatible with the Kendall SCD™ 5325 System Controller, the Kendall SCD™ Sequel™ System Controller and the Kendall SCD™ Response™ System Controller.
The controller provides air to the sleeves through tubing connected to each bladder. The controller system monitors the pressure in the bladders and releases the pressure by venting the air from the sleeve bladders through a valve system within the controller.
The thigh-length sleeve is designed to easily convert to a 2-bladder knee-length sleeve by removing the upper bladder at the perforation located between the thigh bladder and the calf bladder. The thigh bladder air supply line is disconnected from the tubing connector at which time a valve activates in the connector, restricting the air flow for the thigh bladder air line.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (Kendall SCD™ Express™ KAMBIA™ Thigh Length TearAway Sleeve), focusing on demonstrating substantial equivalence to a predicate device.
Specifically, the document states:
- Nonclinical Testing: "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This is the only mention of a "test" and it relates to biocompatibility, not the functional performance of the device (like pressure profiles, blood flow increase, or DVT prevention rates).
- Comparison to Predicate: The document largely focuses on comparing the proposed device's intended use, function, composition, and technological characteristics (including pressure profiles) to a legally marketed predicate device (Kendall SCD™ Thigh Length Sleeves) to establish substantial equivalence. It asserts that "Both the thigh and knee length predicate device sleeves have similar pressure profiles as the proposed Kendall SCD™ Express™ KAMBIA™ Thigh Length TearAway Sleeves," but it does not present a study or data to prove this similarity or define specific acceptance criteria for these profiles.
Therefore, I cannot provide the requested information in the table format or answer questions 2 through 9, as they pertain to a performance study that is not detailed in the provided text.
§ 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).