(171 days)
THE LOSS OF RESISTANCE SYRINGE IS INTENDED TO BE USED FOR THE DETECTION AND CONFIRMATION OF THE PLACEMENT OF THE EPIDURAL NEEDLE INTO THE EPIDURAL SPACE PRIOR TO EPIDURAL ANESTHESIA. THIS SYRINGE IS INTENDED FOR THE LOSS OF RESISTANCE TECHNIQUE ONLY. IT IS NOT INTENDED FOR ASPIRATION OR INJECTION.
Not Found
The provided documents are a 510(k) premarket notification approval letter and the "Indications For Use" statement for the TE ME NA Loss of Resistance Syringe, 10CC. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The letter explicitly states that the device is "substantially equivalent" to devices marketed prior to May 28, 1976. This means that the FDA determined the new device is as safe and effective as a legally marketed predicate device, without requiring extensive clinical trials or performance studies that would typically be detailed in a Device Performance section.
Therefore, I cannot provide the requested information based on the given input.
§ 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).