(15 days)
The Medegen Pressure Rated Extension Sets are intended for use in today's growing professional healthcare environment, including healthcare facilities, home care and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The Medegen Pressure Rated Extension Sets allow the user to add medication into the primary line without the use of a needle. The Medegen Pressure Extension Sets may also be used with low-pressure power injectors rated up to 325 psi.
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This document is a 510(k) premarket notification approval letter for the Medegen Pressure Rated Extension Set. It declares the device substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
The entire document focuses on the regulatory approval process and states that the device can be marketed. It does not include the technical study details requested in your prompt.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance details
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.