gammaCore-S

K171306 · Electrocore, LLC · PKR · May 30, 2017 · Neurology

Device Facts

• Record ID: K171306
• Device Name: gammaCore-S
• Applicant: Electrocore, LLC
• Product Code: PKR · Neurology
• Decision Date: May 30, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5892
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Non-invasive vagus nerve stimulator (nVNS) applied to side of neck; delivers mild electrical stimulation to vagus nerve. Patient-operated; controls stimulation intensity via two-button interface. Device features LCD screen and LED for status indication. Each stimulation session lasts two minutes. Intended for acute pain relief in episodic cluster headache patients. Device output (signal waveforms) remains identical to predicate. Modifications limited to user interface (buttons/LCD replacing thumbwheel/single LED) and associated firmware updates. No clinical data required for modifications; verification/validation testing confirmed safety and performance.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, verification, and validation activities confirming that modified device meets predetermined acceptance criteria.

Technological Characteristics

Non-invasive electrical stimulator. Patient-contact materials identical to predicate. Two-button interface for power and intensity control; LCD screen and LED for status. Power source identical to predicate. Software updated to support new UI components.

Indications for Use

Indicated for acute treatment of pain associated with episodic cluster headache in adult patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• gammaCore (DEN150048)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 30, 2017

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

Re: K171306

Trade/Device Name: gammaCore-S Regulation Number: 21 CFR 882.8592 Regulation Name: External Vagal Nerve Stimulator For Headache Regulatory Class: Class II Product Code: PKR Dated: May 2, 2017 Received: May 3, 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

William J. Heetderks -S 2017.05.30 16:12:38 -04'00'

- 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-S

Indications for Use (Describe)

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.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|----------------------------------------------------------|--|
|----------------------------------------------------------|--|

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# Section 6: 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: [phone] |
| Establishment Registration Number: | 3000060063 |

Establishment Registration Number: 3009060963

| Contact: | Mike Romaniw |
|--------------------------------------------|--------------|
| VP, Quality Assurance & Regulatory Affairs | |
| Office: 973-355-6702 | |
| Fax: [phone] | |
| [e-mail] | |

- Alternate Contact: Marie Marlow Chief Executive Officer M Squared Associates, Inc. Office: 855-776-0638 x201 Fax: [phone] [e-mail] Date submitted: 02 May 2017 gammaCore-S® Proprietary Name: Common Name: External vagal nerve stimulator for headache Classification Status: Class II
- Product Codes: PKR

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#### Predicate Device: gammaCore-DEN150048

Device Description: 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.

Indication for Use: 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.

Summary of Technological Characteristics: The gammaCore-S modifications include a change from a thumbwheel control to a two button control for power on/off and control of the stimulation intensity as well as the addition of a small LCD screen which indicates the device status. 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.

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

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

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#### Differences

The differences between the gammaCore-S and the gammaCore can be summarized as "a change in the user interface". The thumb-wheel potentiometer used to turn the gammaCore device on and off, as well as to increase or decrease the treatment signal amplitude, and the single LED that served as a status indicator to the user have been replaced by a pair of buttons, an LCD panel, and an LED. The buttons serve to turn the gammaCore-S on and off, as well as to increase / decrease the treatment signal amplitude. The LCD panel and LED provide device status information to the user.

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

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