(88 days)
gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:
- · Adjunctive use for the preventive treatment of cluster headache in adult patients.
- · The acute treatment of pain associated with episodic cluster headache in adult patients.
- · The acute treatment of pain associated with migraine headache in adult patients.
The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:
- . Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
- . Provides visible (light and display) and audible (beep) feedback regarding device and stimulation status.
- . Allows for multiple stimulations or doses; each stimulation or dose lasts 120 seconds, after which the device automatically turns off unless turned off earlier by the user/operator. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
- . Delivers up to a fixed number of doses within a 24-hour period; once the maximum daily number of doses has been reached, the device will not deliver any more doses until the following 24-hour period.
- Indicates on the display the number of remaining doses available in a 24-hour period. ●
The provided documentation describes the gammaCore Sapphire (non-invasive vagus nerve stimulator), which is indicated for:
- Adjunctive use for the preventive treatment of cluster headache in adult patients.
- The acute treatment of pain associated with episodic cluster headache in adult patients.
- The acute treatment of pain associated with migraine headache in adult patients.
The information primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance benchmarks against a gold standard for a diagnostic AI device. However, based on the clinical study presented, we can infer a primary efficacy outcome as an "acceptance criteria" and the reported device performance from that study.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Primary Endpoint) | Reported Device Performance (SoC + nVNS group vs. Control) |
|---|---|
| Significantly greater reduction in the mean number of Cluster Headache (CH) attacks per week. | Study Outcome: Mean reduction of 5.9 CH attacks per week for SoC + nVNS vs. 2.1 for Control. |
| Therapeutic Gain: 3.9 fewer attacks per week (95% CI: 0.5, 7.2; P=0.02). | |
| Higher 50% responder rates (proportion of subjects with ≥50% reduction in CH attacks). | Study Outcome: 40% responder rate for SoC + nVNS vs. 8.3% for Control (P |
§ 882.5892 External vagal nerve stimulator for headache.
(a)
Identification. An external vagal nerve stimulator for headache is a prescription device used to apply an electrical current to a patient's vagus nerve through electrodes placed on the skin for the treatment of headache.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system shall be fully characterized through non-clinical performance testing.(2) Software verification, validation, and hazard analysis shall be performed.
(3) Biocompatibility evaluation of the patient-contacting components of the device shall be performed.
(4) The device shall be tested for electrical, thermal, and mechanical safety, and for electromagnetic compatibility (EMC).
(5) The labeling must include:
(i) Instructions for proper use of the device, including placement of the device on the patient; and
(ii) Instructions on care and cleaning of the device.