(236 days)
The UNIVEC Sliding Sheath Syringe (K993996) is an Active Safety Feature for a hypodermic syringe. The Sliding Sheath Mechanism is used with a traditional disposable syringe or the Univec Auto-Destruct syringe. The Univec Sliding Sheath Syringe is used to aid in the prevention of needle stick injuries. After an injection, the shield is easily moved from an unextended to an extended position with one hand so that the needle tip is covered by a 360 degree enclosure. The scale is printed on the barrel in a way that allows the Healthcare worker to read through the sheath or from the backside of the sheath.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a medical device (UNIVEC Sliding Sheath Syringe), and an "Indications for Use" statement. It does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically found in study reports, design validation documents, or specific sections of a 510(k) submission that are not included here. Therefore, I cannot fulfill the request based on the provided text.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).