(197 days)
The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient.
The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters.
This document is a 510(k) summary for an Intravascular Administration Set from July 10, 1996. It details a medical device classification and states its substantial equivalence to previously marketed devices. However, it does not provide any information about acceptance criteria, device performance metrics, clinical studies, or data provenance. The document predates many of the standardized reporting requirements for clinical performance studies, especially those involving AI or detailed efficacy metrics.
Therefore, I cannot fulfill the request for information regarding performance, study design, expert involvement, or ground truth as this information is not present in the provided text. The document focuses solely on establishing substantial equivalence based on materials, manufacturing, and general function, rather than presenting a performance study with detailed acceptance criteria.
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JUL 10 1996
SUMMARY OF SAFETY AND EFFECTIVENESS
RE: 510(k) NOTIFICATION Intravascular Administration Set
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR part 807.92.
The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters. Various configurations are substantially equivalent to pre-amendment devices or to devices found substantially equivalent to prior devices in 510(k) Nos. K944320 and/or K860605. Components of the sets are made of the same materials usually used by previously-marketed sets and both packaging and sterilization procedures are consistent with those generally used in the medical device industry.
Robert T. Merrick Regulatory Consultant
Dated: 12/15/95
§ 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.