(189 days)
This device is connected between a patient and a container of administrated solution, and is used for gravity feed infusion into a patient's vascular system for medical use and is intended for single use only.
Vented I.V. Set
I am unable to provide the detailed information requested regarding acceptance criteria and study designs based on the provided text. The document is a 510(k) clearance letter from the FDA for a "Vented I.V. Set" and primarily focuses on the regulatory aspects of marketing the device.
Here's why the requested information cannot be extracted:
- No information on acceptance criteria or performance studies: The letter confirms substantial equivalence to a predicate device and permits marketing, but it does not describe specific performance metrics, acceptance criteria, or the details of any studies conducted to demonstrate the device meets those criteria. Such details would typically be found in the 510(k) submission itself, not the FDA's clearance letter.
- Focus on regulatory compliance: The text discusses general controls, GMP regulations, labeling, and other regulatory obligations, but not the technical performance data that would be used to establish equivalence or safety and efficacy.
To answer your questions, I would require access to the actual 510(k) submission document, which would contain the performance data, testing methodologies, and clinical or non-clinical study results.
§ 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.