(134 days)
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
This is a description of a medical device 510(k) premarket notification for the "MICROFLO-SAFE Scalp Vein Set." As such, it details the intended use and classification of the device, rather than a clinical study evaluating its performance against specific acceptance criteria.
The information provided does not contain the specific details required to answer your questions regarding acceptance criteria, device performance, study types, sample sizes, ground truth establishment, or expert qualifications. This document is a regulatory filing, not a clinical study report.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study proving the device meets acceptance criteria, an MRMC study, or a standalone study based on the provided text. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance.
§ 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.