(72 days)
The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.
The syringe has a graduated barrel, a plunger, a hub and a needle.
I apologize, but the provided text from the FDA 510(k) clearance letter for the Dragon Heart Piston Syringe does not contain the information needed to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.
This document is a clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It does not typically include the detailed technical study reports or performance data that would address your specific questions about acceptance criteria and study methodologies.
To obtain that information, you would generally need to refer to the full 510(k) submission document, which is not provided here.
§ 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).