(41 days)
The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy. For use for infusion of I.V. fluids, blood, blood products and drugs. Change per CDC guidelines or per hospital Protocol.
The MPS Huber Needle Extension Set is a family of sterile and non-pyrogenic devices used for transdermal infusion via subcutaneous access ports. These devices consist of angled non-coring stainless steel needle bonded to microbore infusion tubing ending with a standard female luer connector with luer-lock. Each set is provided with a needle tip protector, luer cap, and color coded stabilization wings. Various configurations may also include Y injection sites, and clamps typically associated with standard microbore tubing infusion sets. Each MPS Huber Needle Extension Set is sterilized in sealed individual pouches or trays. Full labeling information is provided with each MPS Huber Needle Extension Set. Multi-unit shelf packs of individual pouches or trays are provided for convenience.
The provided text does not contain information about acceptance criteria or a study proving that the device meets such criteria. This document is a 510(k) summary for the MPS Huber Needle Extension Set, focusing on its substantial equivalence to a predicate device, GISH VASTACK®, rather than a study demonstrating performance against specific acceptance criteria.
The key points from the provided text are:
- Device Description and Intended Use: The MPS Huber Needle Extension Set is a sterile, non-pyrogenic device for transdermal infusion via subcutaneous access ports, intended for use with implanted infusion ports for continuous or intermittent infusion therapy of IV fluids, blood, blood products, and drugs.
- Predicate Device: Gish VASTACK®
- Technological Comparison: The MPS Huber Needle Extension Set is substantially equivalent in materials, design, and intended use to the predicate device. The only design variation is in the needle grip, which is not expected to affect safety or effectiveness.
- Nonclinical Testing: Plastic component materials and bonding agents were tested per ISO 10993 Biological Testing of Medical and Dental Materials, indicating they are safe and biocompatible. Component metals are stated to meet an ASTM standard where biocompatibility is indicated.
- Conclusion: The device is deemed substantially equivalent to the legally marketed predicate device.
Therefore, I cannot provide a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria based on this submission. The document explicitly focuses on substantial equivalence based on material testing and design comparison, not on performance against quantitative acceptance criteria in a clinical or non-clinical study for efficacy or performance metrics typically found in such studies.
§ 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.