(118 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on electrical stimulation controlled by a mobile app with user-adjustable intensity. There is no mention of adaptive algorithms or learning from user data.
Yes
The device is indicated for the acute and/or preventive treatment of migraine, directly addressing a medical condition.
No
The device is indicated for the treatment of migraine, not for diagnosis.
No
The device description clearly states it is a "wearable, battery-powered device" that delivers electrical pulses and includes hardware components like electrodes, electronic circuitry, a battery, and a plastic case. While it is controlled by software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the acute and/or preventive treatment of migraine. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device delivers electrical pulses to the upper arm. This is a physical intervention, not a test performed on biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), which is a defining characteristic of IVD devices.
- Performance Studies: The performance studies focus on clinical outcomes related to migraine treatment (reduction in headache days, medication use), not on the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Nerivio device does not fit this description.
N/A
Intended Use / Indications for Use
The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 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.
Product codes
QGT
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 is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware. LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included.
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, stimulation duration, remaining number of treatments, 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 are intended to be self-administered by the user immediately after the onset of migraine headache or aura.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arm
Indicated Patient Age Range
12 years of age or older.
Intended User / Care Setting
Home environment. Self-administered device.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Tests:
As the Nerivio is identical to the predicate in its hardware and components. The subject device presents a few minor upgrades and additions in the software and firmware, with the main reflection on the user being the increased number of treatments it provides. Accordingly, non-clinical bench tests addressed verification and validation of the software, firmware, battery, and device performance.
The company conducted internal bench tests to verify and validate the device battery's lifetime reliability and safety, firmware verification testing, system specification testing, mobile application software testing. In all instances, the Nerivio functioned as intended and expected.
Clinical Tests:
Study type: Randomized, Controlled Trial (RCT), prospective, randomized, sham-controlled, multicenter study.
Sample size: 248 participants were eligible to be randomized into the treatment groups (Active 128, Sham 120), and made the ITT dataset.
Key results:
The primary efficacy endpoint was the mean change in number of migraine days per month comparing the 4-week baseline phase (weeks 1-4) with the last 28 days of the treatment phase (weeks 9-12). Treatment with Nerivio every other day is significantly more effective than sham, with a reduction of 3.97±0.41 Vs. 1.28±0.43 of migraine days in the active and sham groups, respectively (mean±SEM, p
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2023
Theranica Bioelectronics ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K223169
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: October 9, 2022 Received: October 11, 2022
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
1
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,
Jitendra V. Virani -S
CDR Jitendra Virani, MS MBA Assistant Director 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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510(k) Number (if known)
Device Name
Nerivio
Indications for Use (Describe)
The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 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)
Z 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 Nerivio
Submitter
Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya, ISRAEL, 4250438 Phone: Facsimile: +972-72-3909762 Contact Person: Dagan Harris Date Prepared: October 9, 2022
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
Regulation Number: 21 CFR 882.5899
Predicate Device:
Device name: Nerivio
Manufacturer: Theranica Bio-Electronics LTD.
510(k) Number: K203181
Device Description:
The Nerivio is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low enerqy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.
The device is composed of a pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, an electronic circuitry that includes firmware. LED indicator and a power button for activating the device and for wireless connection with Android and iOS mobile platforms and a battery contained in a plastic case situated within thermoplastic elastomers ("TPE") shell. In addition, an armband that is wrapped over the device to secure the Nerivio position on the user's arm is included.
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
4
stimulation program, and to view device status such as the device's connection state, stimulation duration, remaining number of treatments, 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 are intended to be self-administered by the user immediately affer the onset of migraine headache or aura.
Intended Use / Indications for Use
The Nerivio is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 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.
Summary of Technological Characteristics
Both the subject 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.
Table 1 provides a comparison between the key functional features of the Nerivio and predicate device.
| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Submission Number | K223169 | K203181 | N/A |
| Device Name | Nerivio | Nerivio | Same |
| Manufacturer | Theranica Bio-Electronics | ||
| LTD. | Theranica Bio-Electronics | ||
| LTD. | Same | ||
| Indications for Use | Nerivio is indicated for | ||
| acute or preventive | |||
| treatment of migraine with | |||
| or without aura in patients | |||
| 12 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 treatment of | |||
| migraine with or without | |||
| aura in patients 12 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. | Additional | ||
| indication for | |||
| preventive | |||
| treatment | |||
| Prescription or OTC | Prescription | Prescription | Same |
| Electrical waveform | Biphasic rectangular, | ||
| modulated | Biphasic rectangular, | ||
| modulated | Same | ||
| Electrical output | |||
| Max output voltage | |||
| 500 Ω | 20V (measured) | 20V (measured) | Same |
| 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 | 8µC | 8µC | Same |
| charge (500Ω) | |||
| Maximum average | 1.76mA | 1.76mA | Same |
| current (500Ω) | |||
| Maximum current | 1.6mA/cm2 | 1.6mA/cm2 | Same |
| density (peak) (500Ω) | |||
| Maximum current | 0.34mA/cm | 0.34mA/cm | Same |
| density (r.m.s) (500Ω) | |||
| Maximum average | 0.07mA/cm2 | 0.07mA/cm2 | Same |
| current density (abs | |||
| value) (500Ω) | |||
| Maximum average | 1.41mW/cm2 | 1.41mW/cm2 | Same |
| power density (500Ω) | |||
| Frequency | |||
| Primary phase duration | 200 | 200 | Same |
| [µSec] | |||
| 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 | Up to 18 treatments | 12 treatments | Additional 6 |
| device | treatments | ||
| Power source | LiMnO2 cell battery | LiMnO2 cell battery | Same |
| On/off button | Power push-button | Power push-button | Same |
| Dimensions | Device – 12.0x7.5x1.5 cm | Device - 12.0x7.5x1.5 cm | Same |
| Armband - 48.0x10.0x0.3 | Armband - 48.0x10.0x0.3 | ||
| cm | cm | ||
| Weight | Device - 50 gr | Device - 50 gr | Same |
| Armband - 33 gr | Armband - 33 gr | ||
| Shelf life | 24 months | 24 months | Same |
| Mobile Application | Yes | Yes | Same |
| software | |||
| Biocompatibility | Yes | Yes | Same |
| Sterile | No | No | Same |
| Processor control | Yes | Yes | Same |
| Wireless control | Yes | Yes | Same |
| Automatic overload trip | Yes | Yes | Same |
| Automatic no load trip | Yes | Yes | Same |
| Automatic shut off | Yes | Yes | Same |
| Mobile Application | Yes | Yes | Same |
| treatment control |
5
Table 1 – Comparison between subject and predicate devices
6
Performance Data
Non-Clinical Tests:
As the Nerivio is identical to the predicate in its hardware and components. The subject device presents a few minor upgrades and additions in the software and firmware, with the main reflection on the user being the increased number of treatments it provides. Accordingly, non-clinical bench tests addressed verification and validation of the software, firmware, battery, and device performance
The company conducted internal bench tests to verify and validate the device battery's lifetime reliability and safety, firmware verification testing, system specification testing, mobile application software testing. In all instances, the Nerivio functioned as intended and expected.
Clinical Tests:
A Randomized, Controlled Trial (RCT) of the Nerivio device in migraine patients was performed to assess the Nerivio safety and clinical efficacy in prevention of migraine. Specifically, it assessed the capability of the Nerivio device to reduce the number of migraine days, number of headache days and number of moderate/severe headache days in patients with migraine. The study was in compliance with 21 CFR parts 50, 56, and 812.
The study was a prospective, randomized, sham-controlled, multicenter study conducted at 15 sites. Eligible participants were adults (18–75 years old) who met the International Classification of Headache Disorders (ICHD-3) criteria for migraine, with 6 to 24 headaches per month (with at least 4 days a month on which their headaches and associated symptoms meet diagnostic criteria for migraine).
Participants had a 4-weeks period of "Baseline" phase. During that phase, participants were asked to complete a daily migraine diary using the electronic diary application installed on the participants' smartphones, while continue with their standard practice for migraine. Following the baseline period, and if were qualified to continue according to the study requirements, participants went into an 8weeks period of "Treatment" phase. During that phase, participants were asked to treat with the Nerivio device every other day with their optimal stimulation intensity and complete a daily migraine diary using the electronic diary application installed on the participants' smartphones, while continue with their standard practice for migraine. Participants were asked NOT to use the Nerivio for acute treatment during the Treatment phase, in order to reduce bias between the active and the sham groups. At the end of the treatment phase, participant went into a 4-weeks period of "follow-up" phase.
The primary efficacy endpoint was the mean change in number of migraine days per month comparing the 4-week baseline phase (weeks 1-4) with the last 28 days of the treatment phase (weeks 9-12). The main secondary endpoints were the mean changes in numbers of moderate/severe headache days, and headache days per month comparing the 4-week baseline phase (weeks 1-4) with the last 28 days of the treatment phase (weeks 9-12).
248 participants were eligible to be randomized into the treatment groups (Active 128. Sham 120), and made the ITT dataset.
The findings of the study show that treatment with Nerivio every other day is significantly more effective than sham.
7
There was a reduction of 3.97±0.41 Vs. 1.28±0.43 of migraine days in the active and sham groups, respectively (mean±SEM, p