(29 days)
The NAC™ PLUS Needleless Access Connector is an accessory to an Intravascular Ho NY O - - ES t reed as a secondary sterile injection site for delivery of fluids to a patient's vascular system through a cannula inserted into a vein or artery.
Not Found
I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device called "The NAC™ PLUS Needleless Access Connector". It discusses the device's regulatory classification, substantial equivalence to predicate devices, and general regulatory requirements.
However, it does not include:
- A table of acceptance criteria or reported device performance.
- Details about a study proving the device meets acceptance criteria, including sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Mention of ground truth types, training set sample sizes, or how training set ground truth was established.
This document is a regulatory approval letter, not a scientific study report or clinical trial summary.
§ 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.