(132 days)
The gammaCore-2 Non-invasive Vagus Nerve Stimulator is intended to provide noninvasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore-2 device is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.
gammaCore-2 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-2 lasts two minutes. The patient controls the stimulation strength.
This document describes the gammaCore-2 device and its substantial equivalence to a predicate device (gammaCore-S). It's a 510(k) submission, which focuses on demonstrating equivalence rather than proving de novo safety and effectiveness. Therefore, the information provided is tailored to that purpose.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission like this, "acceptance criteria" and "device performance" are typically framed in terms of meeting recognized standards and demonstrating that the modified device is as safe and effective as the predicate device, rather than explicit numerical performance metrics for a clinical indication. The document states that clinical studies were not required to validate the modifications.
The acceptance criteria are implied by the conformity to various IEC standards and the verification/validation activities. The "reported device performance" is that these activities demonstrated that the predetermined acceptance criteria have been met.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with IEC 60601-1 (Basic safety & essential performance) | Testing conducted; declarations of conformity provided. |
| Compliance with IEC 60601-1-2 (Electromagnetic disturbances) | Testing conducted; declarations of conformity provided. |
| Compliance with IEC 60601-1-6 (Usability) | Testing conducted; declarations of conformity provided. |
| Compliance with IEC 60601-2-10 (Nerve and muscle stimulators) | Testing conducted; declarations of conformity provided. |
| Compliance with IEC 60601-1-11 (Home healthcare environment) | Testing conducted; declarations of conformity provided. |
| Compliance with IEC 62366 (Usability engineering) | Testing conducted; declarations of conformity provided. |
| Compliance with ISTA Standard 3A (General Simulation Performance Tests) | Testing conducted; declarations of conformity provided. |
| Verification of wireless inductive charging and battery performance | Verification testing completed; predetermined acceptance criteria met. |
| Risk analysis identifying and mitigating risks | Risks are the same as the original submission and mitigated by same methods. |
| Modified device is as safe and effective as the predicate device | Demonstrated through verification and validation activities. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" in the traditional sense of a study involving human subjects for performance evaluation of the device's indications for use. The testing described is primarily nonclinical verification and validation testing against engineering standards and risk analysis. Therefore, there is no information on:
- Sample size for a test set (clinical data was not required for the modifications).
- Data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set for performance evaluation was involved, this information is not applicable and not provided in the document. The evaluation was focused on engineering and design changes.
4. Adjudication Method for the Test Set
As there was no clinical test set in the context of performance studies, no adjudication method is mentioned or relevant to this 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically for image-based diagnostic devices to assess human reader performance with and without AI assistance. The gammaCore-2 is an external vagal nerve stimulator, and its modifications (user interface, charging) did not necessitate such a study.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Not applicable/Not done. The gammaCore-2 is a nerve stimulator, not an algorithm or AI system for standalone performance evaluation in the way this question typically implies (e.g., in diagnostic imaging AI). The "device performance" here refers to its physical and functional attributes, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established engineering standards and safety/performance requirements outlined in the IEC and ISTA standards, as well as the functional specifications for the device's wireless charging and battery performance. The device's performance was validated against these predetermined technical criteria. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the modifications described in this 510(k).
8. The Sample Size for the Training Set
Not applicable/Not provided. There is no "training set" mentioned or implied, as this is not an AI/machine learning device that would require a training set for model development. The submission focuses on hardware and software modifications and their compliance with existing standards.
9. How the Ground Truth for the Training Set was Established
Not applicable/Not provided. As mentioned above, there is no training set for an AI/ML model.
§ 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.