(433 days)
EXEL Scalp Vein (butterfly) set is used for administration of IV solution or infusion of medication to the patient via vascular system.
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This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Exel Scalp Butterfly Vein Set." It confirms the device's substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details related to AI/algorithm performance.
The letter is an administrative notice confirming market clearance based on substantial equivalence, not a detailed technical report of device validation.
Therefore, I cannot provide the requested information from the given text.
To answer your request, I would need a technical report, a clinical study summary, or a specific performance validation document for the "Exel Scalp Butterfly Vein Set."
§ 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.