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The gammaCore-S Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-S device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

gammaCore-S is a device that provides non-invasive Vagus Nerve Stimulation (nVNS) when applied to the side of the neck. This is a mild electrical stimulation of the vagus nerve, which runs through the neck and carries information to the central nervous system. Each stimulation with gammaCore-S lasts two minutes. The patient controls the stimulation strength.

This document is a 510(k) premarket notification for the gammaCore-S device, which is an external vagal nerve stimulator for headache. The document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.

The document states:

• "Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore-S."
• "The verification and validation activities, as identified by the risk analysis to ensure that the modified device is as safe and effective as the predicate device, have been completed and demonstrate that the predetermined acceptance criteria have been met."

Therefore, I cannot provide the requested information from this document because it explicitly states that clinical studies (which would typically contain such data) were not performed for this specific submission, as it relates to a modification of an already approved device.

To answer your request, a document detailing the clinical study or non-clinical performance data for the original gammaCore device (the predicate device) would be needed, or a document outlining the specific "predetermined acceptance criteria" and how they were met through non-clinical verification and validation activities for the gammaCore-S modifications.

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