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.

Device Description

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.

AI/ML Overview

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.

Summary

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December 7, 2017

eletroCore, LLC Mike Romaniw VP, Quality Assurance & Regulatory Affairs 150 Allen Road, Suite 201 Basking Ridge, New Jersey 07920

Re: K172270

Trade/Device Name: gammaCore-2 Regulation Number: 21 CFR 882.8592 Regulation Name: External vagal nerve stimulator for headache Regulatory Class: Class II Product Code: PKR Dated: July 28, 2017 Received: July 28, 2017

Dear Mike Romaniw:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2017.12.07 16:04:44 -05'00'

for Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name gammaCore-2

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)| > Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for the gammaCore-S 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the information upon which the substantial equivalence determination is based.

Applicant:	electroCore® LLC
	150 Allen Road, Suite 201
	Basking Ridge, New Jersey 07920
	Ph: 973-290-0097
	Fax: 973-290-9171

Establishment Registration Number: 3009060963

Contact:	Mike Romaniw
	VP, Quality Assurance & Regulatory Affairs
	Office: 973-355-6702
	Fax: 973-290-9171
	mike.romaniw@electrocorellc.com

Alternate Contact:	Marie MarlowChief Executive OfficerM Squared Associates, Inc.Office: 855-776-0638 x201Fax: 703-562-9797MMarlow@msquaredassociates.com
Date submitted:	December 5, 2017
Proprietary Name:	gammaCore-2®
Common Name:	External vagal nerve stimulator for headache
Classification Status:	Class II
Product Codes:	PKR

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Predicate Device: gammaCore-S K171306

Device Description: 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.

Indication for Use: 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.

Summary of Technological Characteristics: The gammaCore-2 modifications include a a change from a two-button control of the stimulation intensity to a slide control, a "dead front" display screen which indicates the device status, minor changes to the stainless steel stimulation surface geometry and connection, and a charging station employing wireless inductive charging technology. Additionally, minor software updates were required as a result of these changes.

Summary of 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.

The following testing was conducted:

Verification for wireless inductive charging and battery performance

IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6: Amendment 1 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

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IEC 60601-2-10: Amendment 1 - Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators

IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

IEC 62366: Medical devices - Part 1: Application of usability engineering to medical devices

ISTA Standard 3A: General Simulation Performance Tests

Additional risks are the same as those submitted in the original submission and have been mitigated in by the same methods. Declarations of Conformity with design controls are provided.

Substantial Equivalence Discussion:

Similarities

The GammaCore-2 device technology is identical to the device technology used in the gammaCore- S. The similarities include:

. Intended use and indication for use:
. Signal Outputs and waveforms
. Materials used for patient contact surfaces

Differences

The differences between the gammaCore-2 and the gammaCore-S can be summarized as "a change in the user interfaces and recharging capabilities". Minor changes to the stainless steel stimulation surface geometry and connection of the gammaCore-2 create a convex stimulation surface contacting the patient compared to the flat stimulation surfaces of the gammaCore-S. The twobutton control used to turn the gammaCore-S device on and off, as well as to increase or decrease the treatment signal amplitude is replaced by a on/off button and slide control to increase or decrease the treatment signal amplitude, and an LCD panel, and an LED on the gammaCore-S is now a "dead front" LED display on the gammaCore-2. The subject device offers a battery charging station incorporated into the storage case employing wireless inductive charging technology. gammaCore-2 includes a wireless inductive charging station incorporated into the "clam shell" storage case to charge the device as necessary; previous gammaCore devices were not rechargeable.

Summary: The gammaCore-2 has the same intended use as the predicate gammaCore-S device.

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K172270

The gammaCore-2 does not alter the fundamental scientific technology of the device because it does not change the operating principle or device output. The modification to the user interface and recharging capabilities does not impact the device for its intended use in the acute treatment of pain associated with episodic cluster headaches in adult patients.

Clinical Data: Clinical studies were not required to validate the modifications in the gammaCore-2.

Conclusion: The gammaCore-2 described in this submission based on the information provided is substantially equivalent to the predicate.

Regulation Number and Section

§ 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.