(110 days)
The Luer Lock/Slip Tip Syringe (Low Dead Space) without needle is to inject fluids into, or withdraw fluids from, the body.
The Luer Lock/Slip Tip Syringe (Low Dead Space) with exchangeable is used to inject fluids into, or withdraw fluids from, the body.
The Luer Lock Syringe (Low Dead Space) with Safety needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The Luer Lock and Slip Tip syringe (Low Dead Space) without Needle is a sterile, single-use, standard 3-piece piston hypodermic syringe.
The Luer lock and Slip Tip syringe (Low Dead Space) with exchangeable needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.
The Luer Lock Syringe (Low Dead Space) with Safety Needle is a Low Dead Space syringe in combination with a safety needle. The safety needle contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device (syringes). It details the device description, indications for use, comparison to a predicate device, and summaries of non-clinical testing.
However, it does not contain information related to an AI/ML powered device, acceptance criteria or a study proving that an AI/ML meets these criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device (AI/ML based) meets the acceptance criteria using this document.
The document discusses performance testing against established ISO standards for medical devices like sterile hypodermic syringes and needles, biocompatibility testing, sterility, and shelf life for physical devices, not AI/ML model performance.
§ 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).