(290 days)
The Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
The Maclin Power Intravascular Administration Sets are devices 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 one or more of the following: tubing, flow regulators, drip chamber, filters, backflow valves, fluid delivery tubing, clamps, connectors between parts of the set, needleless connectors, needleless Y sites, burettes, extension sets, Y tubing connector, protection caps and a hollow spike to connect the tubing to an IV bag or other infusion fluid container. Maclin Power will offer both standard sets and custom sets to meet customer specifications.
The provided text describes a 510(k) submission for the "Maclin Power IV Administration Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with acceptance criteria.
Therefore, the document does not contain the specific information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC).
The document states:
- "Bench test and biocompatibility tests were performed on the device and are included in this submission. The results of these tests supported the safety and effectiveness of the Maclin Power IV administration sets." This implies that some testing was done to meet regulatory requirements, but the details of those tests, including specific acceptance criteria and detailed performance metrics, are not provided in this summary.
- The entire submission hinges on "Substantial Equivalence" to previously marketed devices (CLAVE Connector, VITALCARE I.V. Administration Set, BURETTE-IN LINE, INTRAVASCULAR IV SET). This means the focus is on showing the new device is as safe and effective as existing ones, not necessarily on proving it meets new, pre-defined performance criteria through a novel study reported in this summary.
In summary, based solely on the provided text, the requested information about acceptance criteria and the detailed study demonstrating device performance cannot be extracted. The document is a regulatory summary for a 510(k) submission, which typically focuses on equivalence rather than detailed performance study reporting.
§ 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.