Nerivio

K201824 · Theranica Bio-Electronics, Ltd. · QGT · Oct 23, 2020 · Neurology

Device Facts

• Record ID: K201824
• Device Name: Nerivio
• Applicant: Theranica Bio-Electronics, Ltd.
• Product Code: QGT · Neurology
• Decision Date: Oct 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5899
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nerivio is intended for acute treatment of migraine with or without aura in patients 18 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.

Device Story

Wearable, battery-powered armband; delivers low-energy electrical pulses to upper arm for 45-minute treatments. Controlled via mobile application (Bluetooth); user adjusts stimulation intensity (0-40mA). Used in home environment by patient at onset of migraine or aura. Mobile app displays status, progress, and battery level. Device provides non-pharmacological neuromodulation to relieve migraine pain and associated symptoms. Benefits include acute migraine relief and potential reduction in functional disability.

Clinical Evidence

Two prospective, open-label, single-arm, multicenter studies in chronic migraine patients (n=42 and n=91). Primary endpoint: proportion of participants achieving pain relief at 2 hours. Study 1: 50.0% achieved pain relief at 2 hours; 83.3% sustained relief at 24 hours. Study 2: 59.3% achieved pain relief at 2 hours; 71.1% sustained relief at 24 hours. Adverse events were rare, mild, and resolved without intervention. No serious device-related adverse events reported.

Technological Characteristics

Wearable armband with LiMnO2 battery. Biphasic rectangular modulated waveform; max output 40mA; 25 cm2 electrode area. 45-minute treatment duration. Connectivity via Bluetooth to mobile app. Standards: ANSI AAMI ES60601-1, IEC 60601-1-11, IEC 60601-2-10, EN IEC 60601-1-2, ANSI C63.27, ISO 10993.

Indications for Use

Indicated for acute treatment of migraine with or without aura in adults 18 years or older. Prescription use, self-administered in home environment at onset of migraine headache or aura.

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.

Predicate Devices

• Nerivio Migra (DEN180059)

Submission Summary (Full Text)

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10/23/2020

Theranica Bio-Electronics LTD. % Janice Hogan Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103

Re: K201824

Trade/Device Name: Nerivio Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk and limb electrical stimulator to treat headache Regulatory Class: Class II Product Code: QGT Dated: September 28, 2020 Received: September 28, 2020

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 (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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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 [phone] or 301-796-7100).

Sincerely,

Xiaorui Tang -S

Xiaorui Tang Acting Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K201824

Device Name

Nerivio

Indications for Use (Describe)

The Nerivio is intended for acute treatment of migraine with or without aura in patients 18 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.

Type of Use (Select one or both, as applicable)

| <span style="font-size:120%"><b> </b></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------------|
| <span style="font-size:120%"><b> </b></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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#### 510(k) SUMMARY

#### Theranica Bio-Electronics LTD.'s Nerivio

#### Submitter

Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya, ISRAEL, 4250438

Phone: [phone]

Facsimile: [phone]

Contact Person: Dagan Harris

Date Prepared: October 22, 2020

Name of Device: Nerivio

Common or Usual Name: Nerivio

Classification Name: Trunk and limb electrical stimulator to treat headache

Regulatory Class: Class II

Product Code: QGT

#### Predicate Device:

Device Name: Nerivio Migra Manufacturer: Theranica Bio-Electronics LTD. 510(K) Number: DEN180059

#### Device Description:

The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.

The device hardware consists of an armband intended to be worn on a user's upper arm. The armband contains the electronic circuitry and the battery in a plastic storage case as well as two electrodes that are attached to the interior of the armband and placed against the user's skin.

The device is operated and controlled via software that is installed and run on a user's personal mobile device such as a mobile phone or tablet. The device hardware communicates with the mobile application through a 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 or stop the stimulation program, and to view device status such as the device's connection state, a progress bar for stimulation duration, battery level, and user notifications.

The patient is instructed to adjust the intensity to the strongest stimulation level below the perceived pain level. Treatments with Nerivio are intended to be self-administered by the user immediately after the onset of migraine headache or aura.

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# Intended Use / Indications for Use

The Nerivio is intended for acute treatment of migraine with or without aura in patients 18 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.

### Summary of Technological Characteristics

Both the device and the predicate device function as remote electrical neuromodulation (REN) devices that utilize electro-stimulation that relieves migraine headache, 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.

| Characteristic | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Submission Number | K201824 | DEN180059 | N/A |
| Device Name | Nerivio | Nerivio Migra | Minor modification<br>for marketing |
| Manufacturer | Theranica Bio-<br>Electronics LTD. | Theranica Bio-<br>Electronics LTD. | Same |
| Indications for Use | The Nerivio is intended<br>for acute treatment of<br>migraine with or without<br>aura in patients 18<br>years of age or older. It<br>is a prescription use,<br>self-administered<br>device for use in the<br>home environment at<br>the onset of migraine<br>headache or aura. | The Nerivio Migra is<br>indicated for acute<br>treatment of migraine<br>with or without aura in<br>patients 18 years of age<br>or older who do not<br>have chronic migraine.<br>It is a prescription use,<br>self-administered<br>device for use in the<br>home environment at<br>the onset of migraine<br>headache or aura. | Modified to<br>remove limitation<br>for the treatment<br>of chronic<br>migraine |
| Prescription or OTC | Prescription | Prescription | Same |
| Electrical waveform | Biphasic rectangular,<br>modulated | Biphasic rectangular,<br>modulated | Same |
| Electrical output | | | |
| Max output voltage<br>500 Ω<br>2 KΩ<br>10 ΚΩ | 20V (measured)<br>60V (measured)<br>60V (measured) | 20V (measured)<br>60V (measured)<br>60V (measured) | Same |
| Max output current<br>500 Ω<br>2 KΩ<br>10 KΩ | 40 mA<br>30 mA<br>6mA | 40 mA<br>30 mA<br>6mA | Same |
| Maximum phase charge | 8µC | 8µC | Same |
| Maximum average<br>current (500Ω) | 1.76mA | 1.76mA | Same |
| Maximum current<br>density (peak) (500Ω) | 1.6mA/cm2 | 1.6mA/cm2 | Same |
| Maximum current<br>density (r.m.s) (500Ω) | 0.34mA/cm | 0.34mA/cm | Same |
| Maximum average<br>current density (abs<br>value) (500Ω) | 0.07mA/cm2 | 0.07mA/cm2 | Same |
| Maximum average<br>power density (500Ω) | 1.41mW/cm2 | 1.41mW/cm2 | Same |
| Frequency | | | |
| Primary phase duration<br>[µSec] | 200 | 200 | Same |
| Pulse Duration [µSec] | 400 | 400 | Same |
| Electrode Area | 25 cm2 | 25 cm2 | Same |
| Treatment location | Upper arm | Upper arm | Same |
| Treatment duration | 45 min. | 45 min. | Same |
| Reusable | Yes | Yes | Same |
| # of treatments per one<br>device | 12 treatments | 8 treatments | Allows for more<br>treatments prior to<br>replacement.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Power source | LiMnO2 cell battery | Lithium-Ion battery | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| On/off button | Power push-button | ON/OFF switch | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Dimensions | Device - 12.0 x 7.5 x 1.5<br>cm<br>Armband - 48.0 x 10.0<br>x 0.3 cm | Device+Armband =<br>49.0 X 11.0 X 3.0 cm | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Weight | Device - 50 gr<br>Armband - 33 gr | 125 gr (device +<br>armband) | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Shelf life | 24 months | 9 months | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Mobile Application | Yes | Yes | Same function for |
| | | | |
| | | | Different GUI.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Biocompatibility | Yes. | Yes | Different armband<br>coating material.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Sterile | No | No | Same |
| Processor control | Yes. | Yes | Same |
| Wireless control | Yes. | Yes | Same |
| Automatic<br>overload trip | Yes. | Yes | Same |
| Automatic no<br>load trip | Yes. | Yes | Same |
| Automatic shut<br>off | Yes. | Yes | Same |
| Stimulation<br>intensity control | Yes. | Yes | Same |

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Table 1 provides a comparison between the key functional features of the Nerivio and predicate device.

| Characteristic | Subject Device | Predicate Device | Comparison |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Submission Number | K201824 | DEN180059 | N/A |
| Device Name | Nerivio | Nerivio Migra | Minor modification<br>for marketing |
| Manufacturer | Theranica Bio-<br>Electronics LTD. | Theranica Bio-<br>Electronics LTD. | Same |
| Indications for Use | The Nerivio is intended<br>for acute treatment of<br>migraine with or without<br>aura in patients 18<br>years of age or older. It<br>is a prescription use,<br>self-administered<br>device for use in the<br>home environment at<br>the onset of migraine<br>headache or aura. | The Nerivio Migra is<br>indicated for acute<br>treatment of migraine<br>with or without aura in<br>patients 18 years of age<br>or older who do not<br>have chronic migraine.<br>It is a prescription use,<br>self-administered<br>device for use in the<br>home environment at<br>the onset of migraine<br>headache or aura. | Modified to<br>remove limitation<br>for the treatment<br>of chronic<br>migraine |
| Prescription or OTC | Prescription | Prescription | Same |
| Electrical waveform | Biphasic rectangular,<br>modulated | Biphasic rectangular,<br>modulated | Same |
| Electrical output | | | |
| Max output voltage | | | Same |
| 500 Ω | 20V (measured) | 20V (measured) | |
| 2 KΩ | 60V (measured) | 60V (measured) | |
| 10 KΩ | 60V (measured) | 60V (measured) | |
| Max output current | | | Same |
| 500 Ω | 40 mA | 40 mA | |
| 2 KΩ | 30 mA | 30 mA | |
| 10 KΩ | 6mA | 6mA | |
| Maximum phase charge | 8µC | 8µC | Same |
| (500Ω) | | | |
| Maximum average<br>current (500Ω) | 1.76mA | 1.76mA | Same |
| Maximum current<br>density (peak) (500Ω) | 1.6mA/cm2 | 1.6mA/cm2 | Same |
| Maximum current<br>density (r.m.s) (500Ω) | 0.34mA/cm | 0.34mA/cm | Same |
| Maximum average<br>current density (abs<br>value) (500Ω) | 0.07mA/cm2 | 0.07mA/cm2 | Same |
| Maximum average<br>power density (500Ω) | 1.41mW/cm2 | 1.41mW/cm2 | Same |
| Frequency | | | |
| Primary phase duration<br>[µSec] | 200 | 200 | Same |
| Pulse Duration [µSec] | 400 | 400 | Same |
| Electrode Area | 25 cm² | 25 cm² | Same |
| Treatment location | Upper arm | Upper arm | Same |
| Treatment duration | 45 min. | 45 min. | Same |
| Reusable | Yes | Yes | Same |
| # of treatments per one<br>device | 12 treatments | 8 treatments | Allows for more<br>treatments prior to<br>replacement.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Power source | LiMnO2 cell battery | Lithium-Ion battery | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| On/off button | Power push-button | ON/OFF switch | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Dimensions | Device – 12.0 x 7.5 x 1.5<br>cm<br>Armband - 48.0 x 10.0<br>x 0.3 cm | Device+Armband =<br>49.0 X 11.0 X 3.0 cm | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Weight | Device - 50 gr<br>Armband - 33 gr | 125 gr (device +<br>armband) | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Shelf life | 24 months | 9 months | Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Mobile Application<br>software | Yes | Yes | Same function for<br>treatment control.<br>Different GUI.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Biocompatibility | Yes. | Yes | Different armband<br>coating material.<br>Does not raise<br>different questions<br>of safety and<br>effectiveness. |
| Sterile | No | No | Same |
| Processor control | Yes. | Yes | Same |
| Wireless control | Yes. | Yes | Same |
| Automatic<br>overload trip | Yes. | Yes | Same |
| Automatic no<br>load trip | Yes. | Yes | Same |
| Automatic shut<br>off | Yes. | Yes | Same |
| Stimulation<br>intensity control | Yes. | Yes | Same |

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Table 1 – Comparison between subject and predicate devices

# Performance Data

# Non-Clinical Tests:

Nerivio non-clinical bench tests addressed verification and validation of the hardware and software. Device performance testing is summarized in Table 2.

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| Test | Test description | |
|----------------------|-----------------------------------------------------------------------------|------------------------|
| Safety tests | According to ANSI AAMI ES60601-1, IEC 60601-1-11 and IEC60601-2-10 | |
| EMC and radio tests | According to EN IEC 60601-1-2 | |
| Wireless coexistence | According to ANSI C63.27 | |
| FCC | According to 47CFR<br>part 15.347<br>part 15.205<br>part 15.207 part 15.209 | |
| | Biocompatibility | According to ISO 10993 |

Table 2 – Nerivio non-clinical tests list

In addition, the company conducted internal bench tests to verify and validate the device battery's lifetime and safety, firmware testing, system testing, mobile application software testing and usability testing. In all instances, the Nerivio functioned as intended and expected.

# Clinical Tests:

Two clinical studies of the Nerivio device in…