(30 days)
The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.
gammaCore Sapphire (gammaCore), like the predicate gammaCore-2 device, is a multi-use, hand-held, rechargeable, portable device consisting of a rechargeable battery, signal generating and amplifying electronics, with a slide control switch for user / operator control of the signal amplitude (relative range 0-40 continuous). Like gammaCore-2, gammaCore Sapphire:
- includes a charging station incorporated into the "clam shell" storage case connected to a power adapter to charge the device as necessary by the end user
- provides visible (light and display) and audible feedback (beep) 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
- . delivers 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.
- the number of remaining doses available in a 24-hour period is indicated on the . Display.
In comparison to the gammaCore-2 predicate K172270 (programmed by the manufacturer to deliver 24 doses per day up to a maximum of 99 days), gammaCore Sapphire can be programmed to deliver 24 doses per day for 10, 31, or 93 days and can be refilled / reloaded for additional 10, 31, or 93 day periods via an RFID card encoded and provided by electroCore or its authorized agent.
This document is a 510(k) Summary for the gammaCore Sapphire device, which is an external vagus nerve stimulator for headache. It focuses on demonstrating substantial equivalence to a predicate device (gammaCore-2) rather than presenting a novel device's performance data against acceptance criteria from a clinical study. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them (especially in the context of clinical efficacy) is not present in this document.
The document highlights non-clinical testing to demonstrate that the modifications to the device are safe and effective, focusing on the RFID refill functionality.
Here's a breakdown of what can and cannot be extracted from the provided text:
Preamble: The document states, "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." However, it does not provide the specific acceptance criteria or the detailed results of these verification and validation activities.
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided. The document states that "predetermined acceptance criteria have been met" for non-clinical testing related to the modifications (RFID refill functionality), but it does not list these criteria or the performance results. The focus is on demonstrating that the modification doesn't negatively impact safety or effectiveness compared to the predicate, not on a new clinical performance study.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a clinical test set. The document refers to "verification and validation activities" for non-clinical aspects (e.g., RFID functionality). No clinical test set data is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This relates to clinical studies establishing ground truth, which were not conducted for this 510(k) submission regarding the device modifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This relates to clinical studies and ground truth establishment, which were not performed in this context.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, a MRMC comparative effectiveness study was not done. This is a modification to an existing device (gammaCore-2 to gammaCore Sapphire), and the submission states: "Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore Sapphire." Therefore, there's no data on human reader improvement with AI assistance. The device is a stimulator, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a medical stimulator, not an algorithm, so "standalone performance" in the context of an algorithm is not relevant here. The device itself operates "standalone" in delivering stimulation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. This relates to clinical studies. For the non-clinical "verification and validation activities," the "ground truth" would be engineering specifications and functional performance (e.g., does the RFID card successfully load the correct number of doses, is the Bluetooth feature accessible only by the manufacturer, etc.). No clinical ground truth on patient outcomes is presented for a new study.
8. The sample size for the training set
- Not applicable. This is for machine learning models. This document describes a medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is for machine learning models.
Summary of what the document DOES state regarding studies:
- Nonclinical Testing: "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." This implies internal engineering and functional testing, not clinical studies.
- Clinical Data: "Clinical studies were not required to validate the modifications in the gammaCore Sapphire." This is a key point, meaning no new clinical trials were conducted to support this 510(k) submission for the device modifications. The substantial equivalence relies on the predicate device's existing clinical evidence and the non-clinical testing of the modifications.
§ 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.