(216 days)
The Automatically Retractable Safety Syringe is used for aspiration of fluids from vials and a variety of fluid injections into the human body through subcutaneous and muscle.
It has a detachable needle with a dedicated fitting. The Automatically Retractable Safety Syringe contains an inner mechanism used to allow the needle to be retracted inside the plunger of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination.
Automatically Retractable Safety Syringe
The provided document is a 510(k) clearance letter from the FDA for the "Automatically Retractable Safety Syringe". It describes the indications for use and states that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.
Therefore, I cannot provide the requested information based on the text provided. This document is a regulatory approval, not a technical study report.
§ 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).