(321 days)
This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly.
This device will be used to inject into IV ports (not directly into the patient or into arterial lines).
Not Found
The provided text is a 510(k) premarket notification letter from the FDA regarding the Daxor Max100 Syringe. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot fulfill the request to describe these details.
The document only states the device's indications for use: "This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly. This device will be used to inject into IV ports (not directly into the patient or into arterial lines)."
§ 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).