(323 days)
For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block.
The Wand™ is a computer controlled syringe consisting of a stationary motor housing which includes a metal piston whose speed of advance is regulated by a foot switch thus controlling the flow rate of anesthetic being injected. The device utilizes hypodermic needles and standard 1.8mm pre-filled carpules manufactured by various third parties. The anesthetic agent reaches the needle by means of a length of flexible vinyl tubing. The handpiece is made of rigid PVC. The holster containing the anesthetic carpule, the tubing and the handpiece are sold in a sterile condition as a disposable assembly for one-time use. The materials, principal of operation and intended use are the same as other marketed piston and cartridge syringes.
The provided document is a 510(k) summary for "The Wand™ Syringe," which is a computer-controlled syringe for anesthetic delivery. This document focuses on demonstrating substantial equivalence to predicate devices and does not contain information about a formal study with acceptance criteria, sample sizes, expert ground truth, or adjudication methods for performance evaluation.
Therefore, I cannot provide the requested information from the given text. The document's purpose is to clear the device for market based on its similarity to existing devices, not to present a detailed performance study against specific acceptance criteria.
§ 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).