(33 days)
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism. The Univec Sliding Sheath mechanism is used to aid in the prevention of needle stick injuries. This device is used in the same manner as a standard Bifurcated Needle to deliver vaccine or allergen to the patient.
The Univec Bifurcated Sliding Sheath Syringe is a safety version of a bifurcated needle attached to a syringe barrel with the Univec Sliding Sheath Syringe mechanism.
I am sorry, but based on the provided document, I cannot answer your request. The document is an FDA 510(k) clearance letter for a medical device (Univec Bifurcated Sliding Sheath Syringe), which confirms its substantial equivalence to a predicate device. However, it does not include information about acceptance criteria for device performance, specific studies proving performance, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.
The document primarily focuses on regulatory classification and general compliance with FDA regulations, not detailed performance validation data.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).