(59 days)
Provides access to patients vascular system to administer IV fluids Is used in blood drawing Aid in prevention of needlestick injury.
Daisy Protected Scalp Vein Set
This document is a 510(k) clearance letter from the FDA for a medical device called the "Daisy Protected Scalp Vein Set." It confirms that the device is substantially equivalent to a predicate device already on the market.
However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. The letter is a regulatory approval, not a scientific study report. It mentions the "indications for use" for the device, which are:
- Provides access to patients vascular system to administer IV fluids
- Is used in blood drawing
- Aid in prevention of needlestick injury.
Without the actual 510(k) submission document or a separate study report, I cannot provide the requested details about acceptance criteria, device performance, study design, sample sizes, ground truth establishment, or expert involvement. The letter itself does not include this information.
§ 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.