(39 days)
Elcan Induction & Sampling Manifold for Stopcock] is a one or multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, bolus injection and elimination of reflux of fluids during operation.
Elcam I&S Manifold is composed of a body that fits for number of ports assembly (by bonding) and handles which are assembled into the ports bodies. Between each handle and port body an Elastomer is placed to function as a pressure activated valve. A small amount of UV Adhesive is applied in order to bond the product body to the female side ports. A check valve is assembled to the product body end (which is connected to the I.V Set) in order to eliminate back flow (reflux). A Rotor is assembled to the male luer (which is connected toward the patient) in order to enable connection locking. A small amount of lubricant is applied between the Elastomer and the port body. Same concept can be available for one single Stopcock (single I&S Stopcock will not include Check Valve unless otherwise required by end user). Elcam I&S Manifold will be available in a wide variety of configurations for use according to particular situation and the clinician's preference.
This looks like a 510(k) summary for a medical device submitted to the FDA. However, the provided document does not contain details about acceptance criteria, specific performance studies (other than general statements), sample sizes, ground truth establishment, or clinical study methodologies (like MRMC studies) typically found in a comprehensive study report.
The document states that "Standard testing relating functionality of the new product has been conducted on Elcam I&S Manifold, including testing related to product label claims and testing comparing performance with the predicate devices." and "A biocompatibility assessment was performed on the patient-contact and fluid path materials of Elcam I&S Manifold with satisfactory results." However, it does not elaborate on these tests or provide any quantitative results.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or other detailed study information. The provided text is a regulatory submission summary, not a detailed technical report of a performance study.
To provide the information you're asking for, a different type of document, such as a test report, a clinical study summary, or a more detailed performance data section from the 510(k) submission, would be necessary.
§ 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.