(187 days)
The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports.
The FlexNeedle™ is composed of a flexible catheter; a hub with elastomeric septum and side port; sideleg tubing with luer infusion fitting, cap, and pinch clamp; and an insertion stylet.
The provided text is a 510(k) summary for a medical device called FlexNeedle™. It describes the device, its intended use, and its similarities to predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or statistical analyses (like MRMC studies or standalone performance).
Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided input. The input focuses solely on regulatory submission aspects rather than scientific study details.
To answer your questions, I would need a different type of document, such as:
- A clinical study report
- A validation study report
- A performance specification document
- A scientific publication detailing the device's evaluation
§ 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.