(170 days)
Hypodermic single lumen needle: Device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
Piston Syringe: Device is used to inject fluids into, or withdraw fluids from the body.
Diabetic Insulin Syringe: Device intended to inject insulin below the surface of the skin.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a disposable syringe and needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.
The letter does not contain any information regarding acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications that would be needed to answer your request about a study proving the device meets acceptance criteria.
This type of document typically signals that the device's safety and effectiveness have been demonstrated through comparison to existing devices, often without needing new clinical studies if the technology is well-understood.
Therefore, I cannot extract the requested information from 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).