(148 days)
CMS Noncor Infusion Set(s) with or without Injection Site are designed for easy insertion into vascular access devices for safe administration of continuous and/or bolus infusion of pain control medications, chemotherapeutic agents and pharmaceuticals. CMS Noncor infusion set(s) are available in all commonly used needle gauges and lengths, sets include macrobore or microbore tubing with or without injection site.
CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site
This document is a 510(k) clearance letter from the FDA for a medical device called "CMS Noncor Infusion Set(s) and CMS Noncor Infusion Set(s) with Injection Site."
Unfortunately, this document does not contain the requested information regarding acceptance criteria, device performance studies, ground truth establishment, or sample sizes.
Here's why:
- 510(k) Clearance: A 510(k) letter signifies that the FDA has determined the device is "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use and technological characteristics as the predicate, or that any differences do not raise new questions of safety and effectiveness.
- Focus of the Document: This specific document focuses on:
- Confirming the FDA's review and determination of substantial equivalence.
- Listing the regulation numbers and names for the device.
- Outlining the general controls and regulations the manufacturer must comply with.
- Stating the intended use of the device.
To fulfill your request, you would typically need to refer to a detailed study report, a design verification and validation document, or a performance testing summary submitted as part of the 510(k) application. These documents would contain the technical data, test protocols, acceptance criteria, and results.
Since this information is not available in the provided text, I cannot generate the table or answer the specific questions about the study design.
§ 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.