(113 days)
The IV extension tubing kits provide the user with a "ready-to-use" set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The kits are indicated for one-time use.
The IV extension tubing set is indicated for use with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device and the foam tape strips are indicated to provide a method for catheter securement.
The APLICARE skin prep pad is indicated to prepare the skin prior to application of a dressing or bandage.
The intravenous extension tubing kits will consist of an intravenous extension tubing set, a Vital-Hold catheter stabilization device, two foam tape strips and an APLICARE skin protectant prep pad. The intravenous extension sets may contain any of Baxter's cleared access ports (e.g., Interlink Injection Site, Clearlink Luer Activated Valve or V-Link Luer Activated Valve).
The IV extension tubing set is used with a vascular access device for administration and withdrawal of fluids.
The Vital-Hold catheter stabilization device is used to help anchor medical intravenous tubes and lines requiring mechanical stability while installed on the skin surface of a patient.
The two foam tape strips with release liners are used to assist with line stabilization.
The APLICARE skin protectant prep pad is a sterile pad saturated in skin prep solution. The prep solution prepares the skin prior to application of a dressing or bandage. When dry, the prep agent leaves a thin polymer film on the skin surface providing a clean surface for adhesion and a barrier to the natural body oils that can affect adhesion.
The IV extension tubing set, the Vital-Hold catheter stabilization device, the two foam tape strips and the APLICARE skin protectant prep pad will be integrated into one sterile unit blister package to provide the user with a "ready-to-use" set up avoiding the need to acquire/assemble components from various manufacturers)
The provided text describes an Intravenous Extension Tubing Kit and its components, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Summary, which is a premarket notification submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It focuses on the device's description, intended use, and comparison to existing devices, rather than detailed performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information. The sections you asked for, such as sample sizes, ground truth establishment, expert qualifications, and MRMC studies, are not present in this document.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.