(99 days)
The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
The Ulti Care Low Dead Space syringe is substantially equivalent to the Becton Dicksnson MedSaver The syringe. The device is intended to minimize the consumption of expensive pharmacenticals by reducing the distance between the calibrated barrel of the syringe and the needle. The devise has a permanently attached needle that eliminates the tip and hub-of a normal needle/syringe combination. This results in less waste of pharmaceutical and greater efficiency. The intended device has the same technological characteristics as the presently marketed Becton Dickinson MedSaver using a manually operated piston type hypodemic syringe, injected molded plastic parts, a synthetic latex gasket and permanently attached stainless steel needle.
The provided text describes a 510(k) submission for the UltiCare Disposable Syringe. It focuses on establishing substantial equivalence to a predicate device (Becton Dickinson MedSaver™) and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
The document is a regulatory submission for market clearance, outlining the device's intended use, technological characteristics, and comparison to a legally marketed predicate. It does not detail specific performance studies or acceptance criteria beyond stating substantial equivalence.
Therefore, I cannot provide the requested information based on the given 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).