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.
Device Story
Wearable, battery-powered Remote Electrical Neuromodulation (REN) device; delivers low-energy electrical pulses to upper arm for 45 minutes. Controlled via mobile app (Android/iOS) via Bluetooth; user adjusts stimulation intensity (0-40mA) to strongest level below pain threshold. Hardware includes microcontroller, LED, power button, and electrodes (disposable pad for NerivioInfinity; embedded for Nerivio). Used at home by patient at migraine onset (acute) or every other day (preventive). Output allows user to manage treatment, view status, and track battery/usage. Benefits include migraine pain relief and reduction in migraine frequency. Clinical decision-making supported by patient-controlled intensity adjustments based on perceived pain.
Clinical Evidence
Retrospective analysis of real-world data (n=293, aged 6-11). Safety: no adverse events reported. Effectiveness: consistent headache relief (72.2%), freedom from headache (36.0%), functional disability relief (83.3%), and freedom from functional disability (38.9%). Results statistically equivalent to adolescent cohort (12-17) from predicate K223169. Bench testing and human factors validation (100% success rate in critical/knowledge tasks) also provided.
Technological Characteristics
REN device; biphasic rectangular modulated waveform; max output 40mA; 100-120Hz frequency; 45-minute treatment duration. NerivioInfinity: rechargeable Li-Ion battery, replaceable electrode pad. Nerivio: non-rechargeable LiMnO2 battery, embedded electrodes. Connectivity: Bluetooth to mobile app. Sterilization: non-sterile. Software: firmware-controlled.
Indications for Use
Indicated for acute and/or preventive treatment of migraine with or without aura in patients 8 years of age or older. Prescription use, self-administered in home environment.
Regulatory Classification
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.
Special Controls
In combination with the general controls of the FD&C Act, the trunk and limb electrical stimulator to treat headache is subject to the following special controls: 1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include: a) Characterization of the electrical stimulation, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω , 2kQ. and 10k≤2 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); b) Characterization of the impedance monitoring system; and c) 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: a) Instructions for use, including the typical sensations experienced during treatment: b) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications; c) A shelf life for the electrodes and reuse information; and d) Instructions on care and cleaning of the device.
*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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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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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)
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.
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 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.
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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.
# 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<br>(K232152) | Subject Device | Predicate Device<br>(K223169) | |
| Indications for Use | NerivioInfinity is<br>indicated for acute<br>and/or preventive<br>treatment of migraine<br>with or without aura in<br>patients 8 years of<br>age or older. It is a<br>prescription use, self-<br>administered device<br>for use in the home<br>environment at the<br>onset of migraine<br>headache or aura for<br>acute treatment, or<br>every other day for<br>preventive treatment. | NerivioInfinity is<br>indicated for acute<br>and/or preventive<br>treatment of migraine<br>with or without aura in<br>patients 12 years of<br>age or older. It is a<br>prescription use, self-<br>administered device<br>for use in the home<br>environment at the<br>onset of migraine<br>headache or aura for<br>acute treatment, or<br>every other day for<br>preventive treatment. | Nerivio is indicated<br>for acute and/or<br>preventive treatment<br>of migraine with or<br>without aura in<br>patients 8 years of<br>age or older. It is a<br>prescription use, self-<br>administered device<br>for use in the home<br>environment at the<br>onset of migraine<br>headache or aura for<br>acute treatment, or<br>every other day for<br>preventive treatment. | Nerivio is indicated<br>for acute and/or<br>preventive treatment<br>of migraine with or<br>without aura in<br>patients 12 years of<br>age or older. It is a<br>prescription use, self-<br>administered device<br>for use in the home<br>environment at the<br>onset of migraine<br>headache or aura for<br>acute treatment, or<br>every other day for<br>preventive treatment. | Modified –<br>minimum age<br>limit in<br>subject<br>devices is 8<br>years of age,<br>versus 12<br>years of age<br>in the<br>predicate<br>devices. |
| Prescription or OTC | Prescription | Prescription | Prescription | Prescription | Same |
| Number of channels | 1 | 1 | 1 | 1 | Same |
| Electrical waveform | Biphasic rectangular,<br>modulated | Biphasic rectangular,<br>modulated | Biphasic rectangular,<br>modulated | Biphasic rectangular,<br>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<br>(K232152) | Subject Device | Predicate Device<br>(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…
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