(112 days)
No
The summary does not mention AI or ML, and the device description focuses on electrical stimulation and mobile app control without suggesting adaptive or learning algorithms.
Yes
The device is indicated for the acute and/or preventive treatment of migraine, delivering low-energy electrical pulses to the upper arm. This directly addresses a medical condition with the intent to treat or prevent, classifying it as a therapeutic device.
No
The device is indicated for the treatment of migraine, not for diagnosis. Its description focuses on electrical stimulation delivery, not on analyzing patient data to identify a condition.
No
The device description explicitly details hardware components including electrodes, electronic circuitry, battery, plastic enclosure, and an armband, in addition to the mobile application software.
Based on the provided information, the Neriviolnfinity is not an IVD (In Vitro Diagnostic) device.
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 (which is the hallmark of IVD devices).
- Lack of Biological Sample Analysis: There is no mention of the device collecting or analyzing any biological samples (like blood, urine, tissue, etc.).
- Mechanism of Action: The device works by delivering electrical stimulation, which is a therapeutic mechanism, not a diagnostic one.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Neriviolnfinity does not fit this description. It is a therapeutic device.
N/A
Intended Use / Indications for Use
The Neriviolnfinity 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 Neriviolnfinity 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, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable.
- . An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure.
- An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included.
The device is 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 duration, battery level, and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Neriviolnfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for prevention.
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. Prescription use.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
The Neriviolnfinity's design concept and performance is similar to that of the predicate device. The subject device presents a few minor upgrades and additions in the software and firmware, including additions of a rechargeable battery, disposable electrodes, and FOTA upgrade capability. Accordingly, a comprehensive non-clinical bench tests addressed verification and validation of the software, firmware, battery, biocompatibility, usability and device performance were performed.
The company conducted internal bench tests and external lab testing to verify and validate the device battery's safety, firmware verification testing, system performance and labeling verification testing, mobile application software testing. In all instances, the NerivioInfinity functioned and expected. Human factor (Usability) tests were performed to validate that all critical tasks related to use-errors and knowledge errors were successfully performed by representative intended users and/or mitigated to comply with requirements of usability standards.
Clinical Tests:
No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 8, 2023
Theranica Bioelectronics ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K232152
Trade/Device Name: 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: July 19, 2023 Received: July 19, 2023
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"
1
(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).
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.
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 V. Virani -S
CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological
2
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) K232152
Device Name
NerivioInfinity
Indications for Use (Describe)
The Neriviolnfinity 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 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)
区 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
K232152
Submitter
Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya, ISRAEL, 4250438 +972-72-3909755 Phone: Facsimile: +972-72-3909762 Contact Person: Dagan Harris
Date Prepared: July 19, 2023
Trade/Device Name: NerivioInfinity Common or Usual Name: NerivioInfinity Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk and limb electrical stimulator to treat headache Regulatory Class: Class II Product Code: QGT
Predicate Device:
Device name: Nerivio Manufacturer: Theranica Bio-Electronics LTD. 510(k) Number: K223169
Device Description:
The Neriviolnfinity 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, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable.
- . An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure.
- An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included.
5
The device is 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 duration, battery level, and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Neriviolnfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for prevention.
Intended Use / Indications for Use:
The Neriviolnfinity 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, 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.
Table 1 provides a comparison between the key functional features of the Neriviolnfinity and predicate device.
| Characteristic | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Submission | |||
| Number | K232152 | K223169 | |
| Device Name | NerivioInfinity | Nerivio | Modified |
| Manufacturer | Theranica Bio-Electronics | ||
| LTD. | Theranica Bio-Electronics | ||
| LTD. | Same | ||
| Indications for Use | NerivioInfinity is indicated for | ||
| acute and/or preventive | |||
| treatment of migraine with or | |||
| without aura in patients 12 | Nerivio is indicated for acute | ||
| and/or preventive treatment | |||
| of migraine with or without | |||
| aura in patients 12 years of | Same |
| Table 1. Comparison between subject and predicate devices | |||
|---|---|---|---|
| Characteristic | Subject Device | Predicate Device | Comparison |
| 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. | 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. | ||
| Prescription or OTC | Prescription | Prescription | Same |
| Electrical waveform | Biphasic rectangular, modulated | Biphasic rectangular, 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 (500Ω) | 8μC | 8μC | Same |
| Maximum average current (500Ω) | 1.76mA | 1.76mA | Same |
| Maximum current density (peak) (500Ω) | 1.6mA/cm2 | 1.6mA/cm2 | Same |
| Maximum current density (r.m.s) (500Ω) | 0.34mA/cm | 0.34mA/cm | Same |
| Maximum average current density (abs value) (500Ω) | 0.07mA/cm2 | 0.07mA/cm2 | Same |
| Characteristic | Subject Device | Predicate Device | Comparison |
| Maximum average | |||
| power density | |||
| (500Ω) | |||
| Frequency | 1.41mW/cm2 | 1.41mW/cm2 | Same |
| Primary phase | |||
| duration [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 device | Up to 18 treatments for each | ||
| disposable electrodes pad. No | |||
| limitation for device body unit | 18 treatments per one entire | ||
| device. | Different: | ||
| The subject | |||
| device uses | |||
| disposable | |||
| electrode | |||
| pads, and | |||
| thus the | |||
| device body | |||
| unit is | |||
| reusable | |||
| beyond 18 | |||
| treatments. | |||
| The predicate | |||
| device is | |||
| limited to 18 | |||
| uses. | |||
| Power source | Li-lon cell battery - | ||
| rechargeable | LiMnO2 cell battery - non- | ||
| rechargeable | Different: | ||
| Subject | |||
| device | |||
| includes a | |||
| rechargeable | |||
| battery. | |||
| On/off button | Power push-button | Power push-button | Same |
| Dimensions | Device - 7.9x3.5x1.7cm | Device (electrodes included)- | |
| 12.0x7.5x1.5 cm | Similar | ||
| Characteristic | Subject Device | Predicate Device | Comparison |
| Electrodes pad - | |||
| 13.7x7.6x5.3cm | Armband - 48.0x10.0x0.3 cm | ||
| Armband - 48.0x10.0x0.3 cm | |||
| Weight | Device – 38 gr | ||
| Electrode pad set – 15 gr | |||
| Armband - 33 gr | Device (including an embedded | ||
| pair of electrodes) - 50 gr | |||
| Armband - 33 gr | Similar | ||
| Mobile Application | |||
| software | Yes | Yes | Similar |
| 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 | |||
| treatment control | Yes | Yes | Same |
| Remote (over-the- | |||
| air) FW update | |||
| option | Yes | No | Different |
6
7
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Performance Data:
Non-Clinical Tests:
The Neriviolnfinity's design concept and performance is similar to that of the predicate device. The subject device presents a few minor upgrades and additions in the software and firmware, including additions of a rechargeable battery, disposable electrodes, and FOTA upgrade capability. Accordingly, a comprehensive non-clinical bench tests addressed verification and validation of the software, firmware, battery, biocompatibility, usability and device performance were performed.
The company conducted internal bench tests and external lab testing to verify and validate the device battery's safety, firmware verification testing, system performance and labeling verification testing, mobile application software testing. In all instances, the NerivioInfinity functioned and expected. Human factor (Usability) tests were performed to validate that all critical tasks related to
9
use-errors and knowledge errors were successfully performed by representative intended users and/or mitigated to comply with requirements of usability standards.
Clinical Tests:
No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device.
Conclusions
The Neriviolnfinity has the same intended use and indications for use and substantially similar technological characteristics as its predicate device. The modifications to the device and minor changes to the procedures for use related to the rechargeable battery do not raise different questions of safety or effectiveness. Performance data demonstrate that the NerivioInfinity is as safe and effective as the predicate device. Thus, the NerivioInfinity is substantially equivalent to its predicate device.