Search Results

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.

Ask a specific question about this device