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The disposable hypodermic monopolar needles are FOR SINGLE USE ONLY in electromyography (EMG) in situations wherein it is desired to insert an electrode, in the form of a probe, into a patient to locate a particular muscle and then inject a medication into that muscle. The hypodermic needle with an open lumen is designed for muscle stimulation, motor unit action potential recording and drug delivery. Once the physician is satisfied with the location, he/she injects a drug therein via the lumen of the needle.

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The provided text is a 510(k) premarket notification letter from the FDA to TECA Corporation regarding their Disposable Monopolar Needle Electrodes and MyoJect Disposable Needle Electrodes. This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment.

Instead, this letter is a regulatory approval, stating that the devices are substantially equivalent to previously marketed devices and can be legally marketed. It confirms compliance with general controls and notes that the devices may be subject to additional controls if classified as Class II or III.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and the study proving the device meets them, as that data is not present in the provided text.

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