(67 days)
The TEGO™ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The TEGO™ is a needle-free capping device, which close the end of a catheter. The TEGO" will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
The TEGO™ is a needle-free capping device, which close the end of a catheter. The TEGO" will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.
The provided text is a 510(k) premarket notification letter from the FDA regarding the TEGO Needle Free Access Device. This document does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the FDA has reviewed the 510(k) submission and determined the device is substantially equivalent to legally marketed predicate devices. It lists the device name, regulation number, regulation name, regulatory class, and product code. It also discusses general controls provisions, additional controls for Class II/III devices, and other regulatory requirements. The enclosure provides the Indications for Use for the device.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided document.
§ 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.