The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

Device Description

The Nerivio and NerivioInfinity are wearable, battery-powered, Remote Electrical Neuromodulation (REN) devices that are controlled by a mobile application. The systems deliver low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The devices are composed of:

A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective . film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable,
An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
An armband that is wrapped over the device to secure the device position on the user's arm is also included.

The devices are operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation, battery level (when connected to NerivioInfinity), remaining number of treatments (when connected to Nerivio), and user notifications.

The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Nerivio and NerivioInfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for migraine prevention.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:

The core of this submission is to expand the indicated age range of the Nerivio and NerivioInfinity devices to include children aged 8-11. Therefore, the acceptance criteria and study focus on demonstrating the safety and effectiveness of the device in this younger population, showing it is comparable to its performance in the previously cleared adolescent and adult populations.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an age range expansion for an already cleared device, the "acceptance criteria" are implicitly demonstrating comparable safety and effectiveness in the new age group (8-11 years old) to the previously cleared age group (12 years and older). The performance metrics align with what would be expected for a migraine treatment device.

Implicit Acceptance Criteria (for the 8-11 age group) and Reported Device Performance:

Acceptance Criteria (Implicit)	Reported Device Performance (6-11 years old*)
Safety: No new or increased safety concerns/adverse events.	No adverse events reported through customer service complaints and other product issue reports.
Acute Treatment Effectiveness:
Consistent headache relief.	72.2% of patients with available data (13/18) reported consistent headache relief. (Compared to prior adolescent data from K223169).
Consistent freedom from headache.	36.0% of patients (9/25) reported consistent freedom from headache. (Compared to prior adolescent data from K223169).
Consistent functional disability relief.	83.3% of patients with available data (15/18) reported consistent functional disability relief. (Compared to prior adolescent data from K223169).
Consistent functional disability freedom.	38.9% of patients (7/18) reported consistent functional disability freedom. (Compared to prior adolescent data from K223169).
Consistent disappearance of nausea/vomiting.	70.0% of patients (7/10) achieved consistent freedom from nausea/vomiting. (Compared to prior adolescent data from K223169).
Consistent disappearance of phonophobia.	50.0% of patients (4/8) achieved consistent freedom from phonophobia. (Compared to prior adolescent data from K223169).
Consistent disappearance of photophobia.	22.2% of patients (2/9) achieved consistent freedom from photophobia. (Compared to prior adolescent data from K223169).
Preventive Treatment Effectiveness:	Device use patterns over time are similar to effective use in the previously studied adolescent cohort.
Usability: Device can be safely and effectively used by the expanded age group.	Human Factors Testing: All critical tasks successfully performed with no use errors or close calls by 100% of child patients and their parents. All knowledge tasks successfully answered by 100% of participant parents. This validated that the devices can be used as intended by the expanded patient population (8-11 years old, with and without assistance of a parent).

*Note: The study population included patients aged 6-11 years old. The device indication sought and granted in the 510(k) is for 8 years of age or older. The use of data from 6-7 year olds in the study would further support the safety and effectiveness for 8-11 year olds, as younger children might present more challenges in terms of compliance or adverse events.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The clinical investigation included n=293 patients aged 6-11 at their first use of Nerivio (for safety and overall usage patterns in the real world). For effectiveness endpoints (acute treatment), analyses were performed on a subset of patients who completed voluntary pre- and post-treatment surveys, with the number of patients varying for each specific outcome (e.g., 18 for headache relief, 25 for headache freedom, 18 for functional disability, 10 for nausea/vomiting, 8 for phonophobia, 9 for photophobia).
Data Provenance: The study consisted of a retrospective analysis of prospectively-collected real-world data for children in the United States. The data was collected between May 2020 to October 2023.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of study does not involve expert readers establishing ground truth in the traditional sense (e.g., for image interpretation). The "ground truth" for effectiveness is patient-reported outcomes of migraine symptoms, consistent with how efficacy trials for migraine treatments are typically conducted. Safety data is collected via customer service reports, which are also patient-reported or initiated.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where multiple expert readers interpret subjective data (like medical images) and their disagreements need to be resolved to establish ground truth. This study relies on patient-reported outcomes for effectiveness and adverse event reporting for safety.

5. 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

Not applicable. This device is a standalone therapeutic device for migraine treatment, not an AI-assisted diagnostic tool that would involve human "readers" interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This is a device that directly treats a condition; it's not an AI algorithm that provides a diagnosis or analysis. Therefore, a "standalone algorithm performance" evaluation is not relevant in the same way it would be for an AI diagnostic device. The device's performance is its direct therapeutic effect, not its output as an algorithm.

7. The Type of Ground Truth Used

The ground truth for effectiveness was patient-reported outcomes (PROs) on migraine symptoms (headache pain, functional disability, nausea/vomiting, phonophobia, photophobia) via voluntary pre- and post-treatment surveys. For safety, the ground truth was based on reported adverse events through customer service complaints and other product issue reports.

8. The Sample Size for the Training Set

Not applicable. This is not a study validating an AI model that requires a distinct training set. The clinical investigation is a real-world study assessing the device's performance in a new age group. The "knowledge" or "training" for the device itself comes from its prior development and existing clinical data which supported its previous clearances for older populations.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" in the context of an AI/ML model for this specific submission. The established efficacy and safety data from prior clinical trials in adolescents and adults (e.g., K223169 and K232152) serve as the benchmark against which the performance in the 8-11 age group is compared for equivalence.

Summary

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October 08, 2024

Theranica Bio-Electronics Ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market St. Floor 23 Philadelphia, Pennsylvania 19103

Re: K241756

Trade/Device Name: Nerivio; NerivioInfinity Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk And Limb Electrical Stimulator To Treat Headache Regulatory Class: Class II Product Code: QGT Dated: June 18, 2024 Received: June 18, 2024

Dear Janice Hogan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Page

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jitendra

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CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241756

Device Name

Nerivio:

NerivioInfinity

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

Theranica Bio-Electronics LTD.'s NerivioInfinity and Nerivio

Submitter

Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanva. ISRAEL. 4250438 Phone: +972-72-3909755 Facsimile: +972-72-3909762 Contact Person: Dagan Harris

Date Prepared: October 8, 2024

Name of Device: Nerivio (NerivioInfinity)

Common or Usual Name: Nerivio (NerivioInfinity)

Regulation Name: Trunk and limb electrical stimulator to treat headache

Regulatory Class: Class II

Regulation Number: 21 CFR 882.5899

Product Code: QGT

Predicate Devices

Primary predicate: NerivioInfinity, Theranica Bio-Electronics LTD. (K232152)

Secondary predicate: Nerivio, Theranica Bio-Electronics LTD. (K223169)

Device Description

The devices are composed of:

A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective . film. In NerivioInfinity, the electrodes are embedded in a disposable, replaceable pad. In Nerivio, the electrodes are not disposable or replaceable,
An electronic circuitry that includes microcontroller with firmware, LED indicator, a power button for activating the device, and Bluetooth radio for wireless connection to Android and iOS mobile platforms. The circuitry also includes a battery, which is rechargeable in NerivioInfinity and not rechargeable in Nerivio.
An armband that is wrapped over the device to secure the device position on the user's arm is also included.

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Intended Use / Indications for Use

NerivioInfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.

The subject devices' indications for use are identical to the predicate devices except for the addition of children aged 8-11 to the indicated age range. This modification does not change the device's overall intended use of treating and preventing migraines through electrical stimulation of the trunk or limb.

Summary of Technological Characteristics

The technological characteristics of the subject Nerivio are identical to those of the predicate NerivioInfinity (K232152) and Nerivio (K223169), respectively. Both the subject devices and the predicate devices function as remote electrical neuromodulation (REN) devices that utilize electrostimulation that relieves migraine headache, and/or reduces the number of migraine days (depends on the treatment regime), using equivalent output parameters. The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.

The Nerivio app has been updated since the prior clearance (K223169) so that it integrates the functionality of the NerivioInfinity app as cleared under K232152. Both the NerivioInfinity are now operated by the same mobile app, with only minor differences compared to the predicates to address this integration which do not raise different questions of safety or effectiveness.

Table 1 provides a comparison between the key functional features of the subject devices and predicate devices.

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Characteristic	NerivioInfinity		Nerivio		Comparison
	Subject Device	Predicate Device(K232152)	Subject Device	Predicate Device(K223169)
Indications for Use	NerivioInfinity isindicated for acuteand/or preventivetreatment of migrainewith or without aura inpatients 8 years ofage or older. It is aprescription use, self-administered devicefor use in the homeenvironment at theonset of migraineheadache or aura foracute treatment, orevery other day forpreventive treatment.	NerivioInfinity isindicated for acuteand/or preventivetreatment of migrainewith or without aura inpatients 12 years ofage or older. It is aprescription use, self-administered devicefor use in the homeenvironment at theonset of migraineheadache or aura foracute treatment, orevery other day forpreventive treatment.	Nerivio is indicatedfor acute and/orpreventive treatmentof migraine with orwithout aura inpatients 8 years ofage or older. It is aprescription use, self-administered devicefor use in the homeenvironment at theonset of migraineheadache or aura foracute treatment, orevery other day forpreventive treatment.	Nerivio is indicatedfor acute and/orpreventive treatmentof migraine with orwithout aura inpatients 12 years ofage or older. It is aprescription use, self-administered devicefor use in the homeenvironment at theonset of migraineheadache or aura foracute treatment, orevery other day forpreventive treatment.	Modified –minimum agelimit insubjectdevices is 8years of age,versus 12years of agein thepredicatedevices.
Prescription or OTC	Prescription	Prescription	Prescription	Prescription	Same
Number of channels	1	1	1	1	Same
Electrical waveform	Biphasic rectangular,modulated	Biphasic rectangular,modulated	Biphasic rectangular,modulated	Biphasic rectangular,modulated	Same
Max output voltage					Same
500 Ω	20V (measured)	20V (measured)	20V (measured)	20V (measured)
2 KΩ	60V (measured)	60V (measured)	60V (measured)	60V (measured)
10 KΩ	60V (measured)	60V (measured)	60V (measured)	60V (measured)
Characteristic	NerivioInfinity		Nerivio		Comparison
	Subject Device	Predicate Device(K232152)	Subject Device	Predicate Device(K223169)
Max output current					Same
500 Ω	40 mA	40 mA	40 mA	40 mA
2 KΩ	30 mA	30 mA	30 mA	30 mA
10 ΚΩ	6 mA	6 mA	6 mA	6 mA
Maximum phase	8 µC	8 µC	8 µC	8 µC	Same
charge (500Ω)
Maximum average	1.76 mA	1.76 mA	1.76 mA	1.76 mA	Same
current (500Ω)
Maximum current	1.6 mA/cm²	1.6 mA/cm²	1.6 mA/cm²	1.6 mA/cm²	Same
density (peak) (500Ω)
Maximum current	0.34 mA/cm	0.34 mA/cm	0.34 mA/cm	0.34 mA/cm	Same
density (r.m.s) (500Ω)
Maximum average	0.07 mA/cm²	0.07 mA/cm²	0.07 mA/cm²	0.07 mA/cm²	Same
current density (abs
value) (500Ω)
Maximum average	1.41 mW/cm²	1.41 mW/cm²	1.41 mW/cm²	1.41 mW/cm²	Same
power density (500Ω)
Frequency	Range: 100-120 Hz	Range: 100-120 Hz	Range: 100-120 Hz	Range: 100-120 Hz	Same
	Average: 110 Hz	Average: 110 Hz	Average: 110 Hz	Average: 110 Hz
	(measured)	(measured)	(measured)	(measured)
Primary phase	200 µSec	200 µSec	200 µSec	200 µSec	Same
duration
Pulse duration	400 µSec	400 µSec	400 µSec	400 µSec	Same
Electrode area	25 cm²	25 cm²	25 cm²	25 cm²	Same
Treatment location	Upper arm	Upper arm	Upper arm	Upper arm	Same
Treatment duration	45 min.	45 min.	45 min.	45 min.	Same
Reusable	Yes	Yes	Yes	Yes	Same
# of treatments per	Up to 18 treatments	Up to 18 treatments	18 treatments per one	18 treatments per one	Same
one device	for each disposable	for each disposable	entire device.	entire device.
	electrodes pad. No	electrodes pad. No
Characteristic	NerivioInfinity		Nerivio		Comparison
	Subject Device	Predicate Device(K232152)	Subject Device	Predicate Device(K223169)
	limitation for devicebody unit	limitation for devicebody unit
Power source	Li-Ion cell battery -rechargeable	Li-Ion cell battery -rechargeable	LiMnO2 cell battery –non-rechargeable	LiMnO2 cell battery –non-rechargeable	Same
On/off button	Power push-button	Power push-button	Power push-button	Power push-button	Same
Dimensions	Device –7.9x3.5x1.7cmElectrodes pad –13.7x7.6x5.3cmArmband –48.0x10.0x0.3 cm	Device –7.9x3.5x1.7cmElectrodes pad –13.7x7.6x5.3cmArmband –48.0x10.0x0.3 cm	Device (electrodesincluded) –12.0x7.5x1.5 cmArmband –48.0x10.0x0.3 cm	Device (electrodesincluded) –12.0x7.5x1.5 cmArmband –48.0x10.0x0.3 cm	Same
Weight	Device – 38 grElectrodes pad - 15 grArmband - 33 gr	Device – 38 grElectrodes pad - 15 grArmband - 33 gr	Device (including anembedded pair ofelectrodes) – 50 grArmband - 33 gr	Device (including anembedded pair ofelectrodes) – 50 grArmband - 33 gr	Same
Mobile applicationsoftware	Yes	Yes	Yes	Yes	Same
Biocompatibility	Yes	Yes	Yes	Yes	Same
Sterile	No	No	No	No	Same
Processor control	Yes	Yes	Yes	Yes	Same
Wireless control	Yes	Yes	Yes	Yes	Same
Automatic overloadtrip	Yes	Yes	Yes	Yes	Same
Automatic no loadtrip	Yes	Yes	Yes	Yes	Same
Automatic shut off	Yes	Yes	Yes	Yes	Same
Mobile applicationtreatment control	Yes	Yes	Yes	Yes	Same
Remote (over-the-air)FW update option	Yes	Yes	No	No	Same

Table 1. Comparison between Subject and Predicate Devices

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Performance Data

Non-Clinical Tests:

Software testing was performed for the minor modifications made to the mobile application for the Nerivio device. The test results demonstrated that the device meets all design requirements and functions as intended.

Human factors testing was performed to evaluate use of the Nerivio and NerivioInfinity by representative patients aged 8-11, with and without assistance of a parent. For both devices, all critical tasks were successfully performed with no use errors or close calls by 100% of the child patients and their parents, and all knowledge tasks were successfully answered by 100% of participant parents. Therefore, the human factors testing successfully validated that the devices can be used as intended by the expanded patient population.

Clinical Investigation:

Theranica conducted a clinical study to evaluate Nerivio's safety and efficacy in the acute treatment of migraine in children in a real-world setting. The study consisted of a retrospective analysis of prospectively-collected real-world data for children in the United States who were prescribed Nerivio to treat migraine and used the device at least once between May 2020 to October 2023. The study population included n=293 patients, aged 6-11 at their first use of the Nerivio.

Safety data, collected primarily via customer service complaints and other reports of product issues, showed no adverse events. Effectiveness for acute treatment of migraine was evaluated in patients who completed the voluntary pre- and post-treatment surveys. Among these patients, rates of consistent relief or freedom from headache pain, functional disability, and specific migraine-associated symptoms were comparable to the results from prior clinical testing of the Nerivio in adolescent patients (aged 12 to 17) reported for the predicate device, K223169.

Consistent headache relief was reported by 72.2% of patients with available data (13/18), and consistent freedom from headache was reported by 36.0% (9/25). Consistent functional disability relief was reported by 83.3% (15/18) of patients with available data, and consistent functional disability freedom was reported by 38.9% (7/18). With respect to consistent disappearance of migraine associated symptoms, 70.0% (7/10) of patients achieved from nausea/vomiting, 50.0% (4/8) were from phonophobia, and 22.2% (2/9) were free from photophobia. Nerivio's effects on pain, disability and migraine symptoms in children aged 6-11 years old showed no significant differences from the results reported for adolescents in prior clinical testing statistically equivalent performance in both age groups.

Effectiveness for preventive treatment of migraine was evaluated in patients who used the device in a manner similar to that of the prevention treatment regime showing frequent use of the device in month one, suggestive of preventative treatments. In these patients, device use over time (change from Month 1 to Months 2 and 3) was similar to that of the previously reported adolescent cohort where device usage was more infrequent in subsequent months,

These data, in conjunction with prior studies of the Nerivio device, support the use of the device for the listed indications.

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Conclusions

The Nerivio and NerivioInfinity have the same intended use and indications for use as the predicate devices, except for the addition of children aged 8-11 years old to the indicated patient population. The addition of these patients does not alter the intended therapeutic use of the device, nor does it raise different questions of safety or effectiveness. Software testing, usability validation, and real-world clinical data demonstrate that NerivioInfinity are as safe and effective as the predicate devices.

Regulation Number and Section

§ 882.5899 Trunk and limb electrical stimulator to treat headache.

(a)
Identification. A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including the typical sensations experienced during treatment;
(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
(iii) A shelf life for the electrodes and reuse information; and
(iv) Instructions on care and cleaning of the device.