(207 days)
The Nexus I.V. Needless Access Cannula are intended for use to administer IV fluids / medication to the patients vascular system through a needle free system that aids in the prevention of necdle stick injuries.
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I am sorry, but the provided text does not contain any information regarding the acceptance criteria, device performance, or study details. The document is an FDA 510(k) clearance letter for an "I.V. Needless Access Cannula for Intravascular Administration," indicating that the device has been found substantially equivalent to a legally marketed predicate device.
The letter mentions:
- Trade/Device Name: I.V. Needless Access Cannula for Intravascular Administration
- Regulation Number: 21 CFR 880.5440
- Regulation Name: Intravascular Administration Set
- Regulatory Class: II
- Product Code: FPA
- Indications for Use: To administer IV fluids/medication to the patients' vascular system through a needle-free system that aids in the prevention of needle stick injuries.
- 510(k) Number: K081123
However, it does not include any data from studies, acceptance criteria, sample sizes, expert qualifications, or ground truth information that would allow me to answer your specific questions about device performance and the study details. This type of information is typically found in the 510(k) summary or in the full 510(k) submission, neither of which is provided here.
§ 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.