gammaCore-2

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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); {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) Device Name gammaCore-2 Indications for Use (Describe) 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. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 Marlow<br>Chief Executive Officer<br>M Squared Associates, Inc.<br>Office: 855-776-0638 x201<br>Fax: 703-562-9797<br>MMarlow@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 | {4}------------------------------------------------ ## 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ ### 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.