(243 days)
JMS Extension Set with Planecta™, Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor are accessories and to be used with a primary vascular access device for fluid administration and blood sampling. Planecta™ with a luer slip syringe or male luer connector to allow needle-less access to the vascular path for injection or withdrawal of fluids or blood. Planecta™ Lock / Adaptor will be used as an adaptor for connection with luer lock syringe or other lock-connecting devices. These device accessories are intended for single use only.
JMS Extension Set with Planecta™ (stand alone unit) and Planecta™ Lock / Adaptor will reduce the risk of accidental needle stick injury as a needle will not be used or required throughout the procedure for injection or withdrawal of fluid.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding an intravascular administration set. It discusses regulatory information, classification, and indications for use. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval letter and does not delve into the specific details of the technical studies underpinning the device's substantial equivalence.
§ 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.