(169 days)
These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.
The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore. The extension sets may include pinch or slide clamps.
The provided text describes a 510(k) summary for the Med-Rx® Extension Sets, but it does not contain information about acceptance criteria or a study that proves the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Medex Extension Sets) based on materials, packaging, sterilization, and intended use. It does not include:
- A table of acceptance criteria and reported device performance: This document primarily details intended use, classification, and claims of substantial equivalence, not performance metrics.
- Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, or type of ground truth for a test set.
- Sample size or ground truth establishment for a training set.
The document states: "There are no differences in the characteristics of the subject device and the predicate(s)." This statement, along with the subsequent FDA letter granting substantial equivalence, indicates that the approval was based on the device being comparable to a pre-existing, legally marketed product, rather than on new performance studies against specific acceptance criteria.
Therefore, I cannot provide the requested information from the given text as it is not present in the 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.