gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

· The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
· The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
· Adjunctive use for the preventive treatment of cluster headache in adult patients.
· The acute treatment of pain associated with episodic cluster headache in adult patients.

Device Description

The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).
The gammaCore Sapphire:

. Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
Provides visible (light and display) and audible (beep) feedback 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. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
. Delivers up to 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.
Indicates on the display the number of remaining doses available in a 24-hour period. .

AI/ML Overview

The provided text describes a 510(k) summary for the gammaCore Sapphire device, which is an external vagal nerve stimulator for headache. This submission seeks to expand the indications for use to include the adolescent population for the preventive and acute treatment of migraine headache.

Based on the information provided, here's a breakdown regarding acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) because this is a 510(k) submission for an expanded indication of an already cleared physical medical device, not a new AI/ML-driven diagnostic or prognostic device. The "acceptance criteria" in this context are related to demonstrating substantial equivalence to a predicate device and safety and effectiveness in the new population. The substantial equivalence comparison table (Table 1) acts as the primary "performance" comparison.

Acceptance Criteria (Implied)	Reported Device Performance (Subject Device vs. Predicate)
Intended Use	Same
Indication for Use	Expanded to adolescents (age 12+) for preventive and acute migraine treatment. Supported by extrapolation from adult data and a small adolescent study.
Rx vs OTC	No change (Prescription use)
Treatment Protocol for Migraine (Acute & Preventive)	No change compared to adults (same 120-second stimulation cycle, number of stimulations, and daily schedule)
Patient-Contacting Materials	No change (SS, ABS-PC, SignaGel electrode gel)
Electrical Classification	No change (UL 60601-1 Class III Type BF Applied Part)
Waveform/Frequency	No change (Sinusoidal wave, symmetrical biphasic 5000-Hz pulses at 25 Hz)
Maximum Output	No change (30V, 60 mA peak)
Load Impedance	No change (450-550 ohms)
Power Supply	No change (3V LiFePo4 battery)
Service Life	No change (3 Years from date of manufacture)
Controls	No change (Control slide)
Output Regulation	No change (Device software and control slide)
Device Status Display	Differences in user interface that do not impact safety or effectiveness.
Battery Charger	No change (Qi-compatible wireless charger in clam shell storage case)
RFID Refill/Reload Capability	No change (Allows refilling/reloading)
Device Diagnostics (Bluetooth)	No change (Provides diagnostics for manufacturer)
Alarm Signals	No change (Start-up, Session complete, Errors/depleted battery, No doses left, Expired/no days left, Low battery, Reloading error, Card error)
Display/Message	No change to core output display, minor user interface differences considered not to impact safety/effectiveness.

Sample sizes used for the test set and the data provenance

For the expansion of indications to adolescents, the primary "test set" for safety and effectiveness relied heavily on:
- Extrapolation from adult clinical data: This is clearly stated, meaning the adult data from prior studies (PRESTO, PREMIUM, EVENT) served as a large part of the basis.
- Small adolescent study: "a small study was performed evaluating the use of gamma Core Sapphire in the acute treatment of migraine in adolescent population. As described in Grazzi et al¹, in nine (9) adolescents, 46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
- Sample size for adolescent study: 9 adolescents.
- Data provenance: The Grazzi et al. study is a published peer-reviewed paper (Neurol Sci. 2017 May). The document does not specify the country of origin for the Grazzi study, but typically these are international clinical trials. It is a prospective study as it evaluates the use in a group of adolescents.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. For a device like nVNS, the efficacy is typically self-reported by patients (e.g., pain reduction, headache freedom) and assessed by clinicians based on established diagnostic criteria for migraine. The Grazzi et al. paper would contain specifics on patient selection and outcome assessment, but that detail is not within this 510(k) summary. Given it's a treatment device, "ground truth" would be clinical outcomes (e.g., headache resolution) rather than an expert-adjudicated label on an image.
Adjudication method for the test set

Not applicable in the context of this device. Adjudication methods like 2+1 or 3+1 are common in image-based AI studies where expert consensus is needed to establish a definitive diagnosis for a test image. Here, clinical outcomes are measured after device use.
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 MRMC comparative effectiveness study was done, as this is not an AI-assisted diagnostic device. It is a physical neuromodulation device. Therefore, no information on human reader improvement with AI assistance is applicable or provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. The gammaCore Sapphire is a physical device that delivers therapy and is used by a human patient. It does not operate as a standalone algorithm or AI.
The type of ground truth used

The ground truth for the effectiveness of the device in the expanded indication (adolescents) is based on:
- Clinical Outcomes Data: Self-reported pain relief and resolution of migraine symptoms, as well as the absence of requiring rescue medication. The Grazzi et al. study reported "46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication."
- Adult Clinical Trial Results: The prior 510(k)s (K173442, K191830) relied on outcomes from multi-center, randomized, double-blind, sham-controlled clinical studies (PRESTO, PREMIUM, EVENT) for adults.
The sample size for the training set

Not explicitly applicable in the context of this device because it's not an AI/ML algorithm that is "trained" on data in the traditional sense. The device's technological characteristics are fixed. The clinical studies (PRESTO, PREMIUM, EVENT, and the Grazzi et al. study) provide the evidence base that informed the safety and effectiveness, rather than a "training set" for an algorithm. The total sample sizes for these studies are not fully detailed in this 510(k) summary but would be found in the referenced prior 510(k) documents and publications. The adult studies would have had considerably larger sample sizes than the 9 adolescents mentioned.
How the ground truth for the training set was established

Again, "training set" and "ground truth" establishment in the AI/ML sense are not directly applicable. The "ground truth" for the effectiveness shown in the supporting clinical studies (for both adults and adolescents) was established through clinical trial methodology:
- Randomized, double-blind, sham-controlled study designs comparing the device to a sham control.
- Measurement of defined clinical endpoints, such as pain reduction, headache freedom, and reduction in headache frequency.
- Reporting of adverse events to assess safety.

Summary

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Image /page/0/Picture/0 description: The image shows the date February 12, 2021. The month is February, the day is the 12th, and the year is 2021. The date is written in a clear, legible font. The date is likely used for record-keeping or documentation purposes.

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

Re: K203546

Trade/Device Name: gammaCore Sapphire Regulation Number: 21 CFR 882.5892 Regulation Name: External vagal nerve stimulator for headache Regulatory Class: Class II Product Code: PKR, QAK Dated: December 2, 2020 Received: December 4, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Patrick Antkowiak Assistant Director (Acting) DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Not yet known

Device Name

gammaCore Sapphire Non-invasive Vagus Nerve Stimulator

Indications for Use (Describe)

gammaCore Sapphire (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore is indicated for:

· The preventive treatment of migraine headache in adolescent (age 12 and older) and adult patients.
· The acute treatment of pain associated with migraine headache in adolescent (age 12 and older) and adult patients.
· Adjunctive use for the preventive treatment of cluster headache in adult patients.
· 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-Co

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

The following information is provided as required by 21 CFR §807.92 for the electroCore gammaCore Sapphire 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, Inc. 150 Allen Road, Suite 201 Basking Ridge, New Jersey 07920 Ph: 973-290-0097 Fax: 973-290-9171

Establishment Registration Number: 3009060963

Contact:	Mike RomaniwExec VP, Systems & OperationsOffice: 973-355-6702Fax: 973-290-9171Mike.Romaniw@electroCore.com
Alternate Contact:	Eric J. LieblerSVP, NeurologyMobile: 908-938-9780Eric.Liebler@electroCore.com
Alternate Contact:	Deborah Lavoie GrayeskiSr. Project ManagerM Squared Associates, Inc.Office: 347-954-0418Fax: 703-562-9797dgrayeski@MSquaredAssociates.com
Alternate Contact:	Janice M. Hogan, Esq.PartnerHogan Lovells US LLPDirect: 267-675-4611Janice.Hogan@HoganLovells.com

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Date of Submission:	February 12, 2021
Proprietary Name:	gammaCore Sapphire
Common Name:	External vagal nerve stimulator for headache
Classification Status:	Class II
Product Codes:	PKR, QAK
Predicate Device:	gammaCore Sapphire, K191830

Indication for Use: The gammaCore Sapphire Non-invasive Vagus Nerve Stimulator is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. The gammaCore Sapphire device is indicated for:

The preventive treatment of migraine headache in adolescent (age 12 and older) and adult . patients.
. The acute treatment of pain associated with migraine headache in adolescents (age 12 and older) and adult patients.
. Adjunctive use for the preventive treatment of cluster headache in adult patients.
. The acute treatment of pain associated with episodic cluster headache in adult patients.

Device Description: The gammaCore Sapphire (gammaCore) is a multiuse, handheld, rechargeable, portable device consisting of a rechargeable battery and signal-generating and amplifying electronics, with a slide control switch for user/operator control of the signal amplitude (relative range, 0-40 continuous).

The gammaCore Sapphire:

. Includes a charging station incorporated into the "clam shell" storage case connected to a power adapter for charging of the device as necessary by the end user.
Provides visible (light and display) and audible (beep) feedback 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. Note: One dose is defined as one stimulation cycle lasting 120 seconds (2 minutes).
. Delivers up to 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.
Indicates on the display the number of remaining doses available in a 24-hour period. .

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The device will be provided to the patient/user with an initial 10-, 31-, or 93-day RFID card on the basis of the healthcare provider's prescription. Additional (refill/reload) cards will be provided in response to a user/patient request based on a prescription from his or her healthcare provider. The refill/reload RFID cards will be programmed by electroCore or its authorized agent. This is a specialized application for dispensing the device therapy.

When a 10-, 31-, or 93-day refill/reload card is requested by a patient/user (in accordance with a prescription from a healthcare provider) for a unique device serial number, an RFID card is encoded with the appropriate dosage according to the prescription. The gammaCore RFID card loading application uses a proprietary encoding algorithm to encrypt the therapy days and doses per day on the refill/reload RFID card using near field communication (NFC) protocols.

The encoded refill/reload RFID card is then provided to the user/patient who requested the refil/reload of the device, along with one to six additional tubes of conductive gel (the number of conductive gel tubes provided is based on the 10-, 31-, or 93-day refill/reload being provided). On receipt of the RFID card, the user/patient refills/reloads his or her gammaCore device by placing the RFID card across the face of the device (with the device turned on). The device will display "refill" icon as the device reads the RFID card. The device will signal (beeping twice) when it has been loaded with the programmed doses. The device will now be ready for use as treatment. The RFID card can be used for only one refill/reload: upon completion of the device refill/reload, the card can be thrown away.

In addition, a Bluetooth® feature will be enabled to facilitate diagnostics of any devices returned by patients/users to the manufacturer, to allow determination of the number of days the device was used and/or the number of doses, as well as any days/doses remaining on the device. The Bluetooth feature will not be accessible to the patient/user; it is accessible only to the device manufacturer.

The subject device delivers the same energy and maintains the same operational characteristics as the gammaCore Sapphire device cleared in K191830. No changes in design or manufacturing process have been made that could affect device functionality. All functional aspects of the device remain the same as K191830, including the strength and nature of the device outputs.

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Summary of Technological Characteristics:

There are no changes to the technological characteristics of the gammaCore Sapphire for this expanded labeling.

Summary of Non-clinical Testing:

There are no changes to the technological characteristics of the gammaCore Sapphire for this expanded labeling; no additional non-clinical or performance testing is required.

Summary of Clinical Data:

gammaCore Sapphire is the same as the predicate device and no technological changes have occurred. Thus, clinical testing was not conducted for this premarket notification, nor was required to support the safety and performance of the gammaCore Sapphire for the expanded Intended Use/Indications for Use population. Please refer to:

K173442 for further information regarding the multicenter, randomized, double-blind, parallel-. group, sham-controlled clinical study (PRESTO) supporting the safety and effectiveness of gammaCore Sapphire for the acute treatment of pain associated with migraine headache.
. K191830 for further information regarding the prospective, randomized, sham-controlled, multicenter studies (PREMIUM and EVENT studies) supporting the safety and effectiveness of gammaCore Sapphire for the preventive treatment of migraine headache.

Clinical data to support use of gamma Core Sapphire for preventive and acute treatment of migraine headache in the adolescent population has been extrapolated from clinical data in adult populations for the same indication. In addition to extrapolation of adult data, a small study was performed evaluating the use of gamma Core Sapphire in the acute treatment of migraine in adolescent population. As described in Grazzi et al', in nine (9) adolescents, 46.8% of treated migraine attacks were considered successfully treated and did not require any rescue medication. No device-related adverse events were observed. These results are consistent with those seen in adults and further supports the safety and effectiveness of the gamma Core Sapphire device in adolescents.

1 Grazzi L, Egeo G, Liebler E, Padovan AM, Barbanti P. Non-invasive vagus nerve stimulation (nVNS) as symptomatic treatment of migraine in young patients: a preliminary safety study. Neurol Sci. 2017 May:38(Suppl 1):197-199. doi: 10.1007/s10072-017-2942-5. PMID: 28527086.

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Substantial Equivalence Discussion:

gammaCore Sapphire technology is identical to the device technology cleared under K191830. There have been no changes in the technological characteristics or intended use of the gammaCore Sapphire. Therefore, there are no new issues of safety or effectiveness, thus, the subject gammaCore Sapphire is substantially equivalent to the predicate gammaCore Sapphire device.

Summary:

Table 1 establishes the substantial equivalence of the subject device to that of the predicate device.

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Table 1. Substantial Equivalence Comparison Table

	gammaCore Sapphire(Predicate Device)	gammaCore Sapphire(Subject Device)	Substantial Equivalence
510(k) Number	K191830	TBD
Intended Use	The gammaCore Sapphire is a device thatprovides non-invasive vagus nervestimulation (nVNS) when applied to theside of the neck. This is a mild electricalstimulation of the vagus nerve, whichruns through the neck and carriesinformation to the central nervoussystem. Each stimulation withgammaCore lasts 2 minutes. The patientcontrols the stimulation strength.	The gammaCore Sapphire is a device thatprovides non-invasive vagus nervestimulation (nVNS) when applied to theside of the neck. This is a mild electricalstimulation of the vagus nerve, whichruns through the neck and carriesinformation to the central nervoussystem. Each stimulation withgammaCore lasts 2 minutes. The patientcontrols the stimulation strength.	Same; no change in intended use
Indication for Use	The gammaCore Sapphire is indicatedfor:• The preventive treatment of clusterheadache (CH) in adult patients.• The acute treatment of painassociated with episodic clusterheadache (eCH) in adult patients.• The acute treatment of painassociated with migraine headachein adult patients.• The preventive treatment ofmigraine headache in adult patients.	The gammaCore Sapphire is indicatedfor:• The preventive treatment of clusterheadache (CH) in adult patients.• The acute treatment of painassociated with episodic clusterheadache (eCH) in adult patients.• The acute treatment of painassociated with migraine headachein adolescents (age 12 and older)and adult patients.• The preventive treatment ofmigraine headache in adolescent(age 12 and older) and adultpatients.	Clinical data from the adult populationhas been fully extrapolated to support theexpanded labeling for use of gammaCoreSapphire in adolescent patients for thepreventive and acute treatment ofmigraine headache. Questions of safety oreffectiveness have been addressed in thesupporting data.
Rx vs OTC	Prescription use	Prescription use	No change
	gammaCore Sapphire(Predicate Device)	gammaCore Sapphire(Subject Device)	Substantial Equivalence
510(k) number	K191830	TBD
	Acute treatment of migraine:120-second stimulation cycle, 2 bilateralstimulations up to 3times a day	Acute treatment of migraine:120-second stimulation cycle, 2 bilateralstimulations up to 3times a day	No change in treatment protocol foradolescents compared to adults.
Migraine Treatmentrecommendation	Preventive treatment of migraine:120-second stimulation cycle,2 consecutive stimulations on either sideof the neck as follows:• First daily treatment: within 1 hour ofwaking• Second daily treatment:4-6 hours after the first daily treatment• Third daily treatment: within 1 hourbefore going to sleep	Preventive treatment of migraine:120-second stimulation cycle,2 consecutive stimulations on either side ofthe neck as follows:• First daily treatment: within 1 hour ofwaking• Second daily treatment:4-6 hours after the first daily treatment• Third daily treatment: within 1 hourbefore going to sleep
Patient- contactingmaterials	SS, ABS-PC, SignaGel electrode gel	SS, ABS-PC, SignaGel electrode gel	No change in materials
Electricalclassification	UL 60601-1 Class III Type BF AppliedPart	UL 60601-1 Class III Type BF AppliedPart	No change in classification
Waveform/frequency	Sinusoidal wave, symmetrical biphasic5000-Hz pulses at a rate of 25 Hz	Sinusoidal wave, symmetrical biphasic5000-Hz pulses at a rate of 25 Hz	No change in waveform or frequency
Maximum output	30V (peak), 60 mA(peak)	30V (peak), 60 mA(peak)	No change in outputs
Load impedance	450-550 ohms	450-550 ohms	No change in impedance
Power supply	3V LiFePo4 battery	3V LiFePo4 battery	No change in power supply voltage
Service life	3 Years from date of manufacture	3 Years from date of manufacture	No change in service life
Controls	Control slideIncrease slide up/decrease slide down	Control slideIncrease slide up/decrease slide down	No change in circuitry or controls of thesubject and predicate devices
Output regulation	Device software and control slide	Device software and control slide
	gammaCore Sapphire(Predicate Device)	gammaCore Sapphire(Subject Device)	Substantial Equivalence
Device status display	LED screen	LED screen	Differences between the subject deviceand reference device represent changesin the user interface. These changes donot impact the safety or effectiveness ofthe device.
Battery charger	Qi-compatible wireless charger in clamshell storage case	Qi-compatible wireless charger in clamshell storage case
RFID refill/reloadcapability	Allows refilling/reloading of the numberof days/doses for which the device canprovide treatment; allows for continueduse of same device for extended periodsof time	Allows refilling/reloading of the number ofdays/doses for which the device canprovide treatment; allows for continueduse of same device for extended periods oftime
Device diagnostics,Bluetooth	Provides for diagnostics by manufacturerof returned devices, including number ofdays device was used, number of dosesdelivered, and remaining days/doses	Provides for diagnostics by manufacturerof returned devices, including number ofdays device was used, number of dosesdelivered, and remaining days/doses
Start-up	Yes	Yes
Session complete	Yes	Yes
Errors/depletedbattery	Yes	Yes	No change in available alarm signals
No doses left	Yes	Yes
Expired/no days left	Yes	Yes
Start-up(powered on)	Light on	Light on	No change to display/message in thesubject and predicate devicesDifferences between the subject deviceand reference device represent changesin the user interface. These changes donot impact the safety or effectiveness ofthe device.
Unit ready (poweredon)	LED doses remaining for 24-hr period	LED doses remaining for 24-hr period
Dose complete	LED days and doses remaining and lastamplitude	LED days, doses remaining, and lastamplitude
Errors/depletedbattery	E# display	E# display
No doses remaining	LED doses 00	LED doses 00
	gammaCore Sapphire(Predicate Device)	gammaCore Sapphire(Subject Device)	Substantial Equivalence
Expired/no days left	LED doses/days remaining	LED doses/days remaining
Low battery	LED display battery charge indicator	LED display battery charge indicator
Reloading error	LED display if refill process fails	LED display if refill process fails
Card error	LED display if refill card fails	LED display if refill card fails

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Conclusion:

The gammaCore Sapphire device is the same as the predicate device and no technological or intended use changes have occurred. Therefore, no new issues of safety or effectiveness are raised. Thus, gammaCore Sapphire is substantially equivalent to the predicate device.

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.