(89 days)
Not Found
No
The summary describes a transcutaneous electrical nerve stimulator with adjustable intensity and a mobile app for status display. There is no mention of AI, ML, or any adaptive or learning algorithms based on patient data or treatment outcomes. The performance studies focus on the efficacy of the stimulation itself, not on the performance of any AI/ML component.
Yes
The device is indicated for the acute treatment of migraine and clinical studies demonstrate its effectiveness in reducing pain, which aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The device is a transcutaneous electrical nerve stimulator indicated for the acute treatment of migraine. It delivers electrical pulses for therapeutic purposes, rather than to diagnose a condition.
No
The device description clearly states it is an external non-invasive neurostimulator with physical electrodes, a stimulation unit, a rechargeable battery, and an on-board user interface. While it has an optional mobile application, the core functionality and therapeutic action are delivered through hardware.
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 treatment of migraine with or without aura." This describes a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a "transcutaneous electrical nerve stimulator" that applies electrical pulses to the scalp. This is a physical treatment method, not a method for analyzing biological samples.
- Mechanism of Action: The device stimulates nerves (trigeminal and occipital) to treat migraine. This is a direct interaction with the body for therapeutic purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Relivion® device does not fit this description. It is a therapeutic device.
N/A
Intended Use / Indications for Use
The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.
Product codes (comma separated list FDA assigned to the subject device)
PCC
Device Description
The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.
The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.
The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.
The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp at the forehead and occiput
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
self-used at home
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)
Performance - Bench Testing: The Relivion® device underwent performance testing, including software validation and device verification tests. It was successfully verified that the Relivion® output parameters meet the product's specifications.
Electrical Safety and Electromagnetic Compatibility: The system was tested per the applicable electrical safety and electromagnetic compatibility standards listed including: IEC 60601-1 Ed. 3.1, IEC 60601-1-2 Ed. 4.0, IEC 60601-1-11 Ed. 2.0, IEC 60601-2-10 Ed. 2.1, IEC 60601-1-6 Ed. 3.1, IEC 62366 Ed. 1.0, IEC 62304 Ed. 1.1. All results were passing.
Software Testing: The software was also subject to verification and validation testing, and results demonstrated that the system performed as intended. Cybersecurity risks were also identified and addressed.
Biocompatibility: The Relivion® is a device that contacts intact skin surface for a limited time (
§ 882.5891 Transcutaneous electrical nerve stimulator to treat headache.
(a)
Identification. A transcutaneous electrical nerve stimulator to treat headache is a device used to apply an electrical current to a patient's cranium through electrodes placed on the skin.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety.
(3) The technical parameters of the device, including waveform, output modes, maximum output voltage and current (with 500, 2,000, and 10,000 ohm loads), pulse duration, frequency, net charge (µC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm
2 , r.m.s.), maximum average current (mA), maximum average power density (W/cm2 ), and the type of impedance monitoring system must be fully characterized.(4) Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted.
(5) Appropriate software verification, validation, and hazard analysis must be performed.
(6) Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population.
(7) Labeling must include the following:
(i) Appropriate contraindications such as not for use in subjects with an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
(ii) Appropriate warnings such as not to apply the device on the neck or chest, not to use the device in the presence of electronic monitoring equipment, not to use in the bath or shower, not to use while sleeping, not to use while driving, not to use while operating machinery.
(iii) Appropriate precautions such as the long-term effects of chronic use of the device are unknown.
(iv) A summary of the expected risks and benefits of using the device.
(v) A summary of the clinical performance data, including information on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
(vi) Information on how the device operates and the typical sensations experienced during treatment.
(vii) A detailed summary of the device technical parameters.
(viii) An expiration date/shelf life for the electrodes and the number of times they can be reused.
(ix) Disposal instructions.
0
February 16, 2021
Image /page/0/Picture/1 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Neurolief Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2320 Philadelphia, Pennsylvania 19103
Re: K203419
Trade/Device Name: Relivion Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator to Treat Headache Regulatory Class: Class II Product Code: PCC Dated: November 19, 2020 Received: November 19, 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
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,
Patrick Antkowiak Acting 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
Indications for Use
Expiration Date: 06/30/2023 See PRA Statement below.
Form Approved: OMB No. 0910-0120
510(k) Number (if known) K203419
Device Name Relivion®
Indications for Use (Describe)
The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unlessit displays a currently valid OMB number."
FORM FDA 3881 (6/20)
3
510(k) SUMMARY
Image /page/3/Picture/1 description: The image shows the logo for Neuroleaf Brain Innovation. The logo consists of a stylized brain icon on the left and the text "Neuroleaf" above "Brain Innovation" on the right. The brain icon and text are all in a light blue color.
RELIVION®
| Applicant Name: | Neurolief Ltd.
12 Giborei Israel St.
Netanya, Israel 4250412
Tel: +972-9-3730288 |
| ----------------- | ------------------------------------------------------------------------------------------- |
|---|
Contact Person: Michal Kedar-Datel Clinical & Regulatory Affairs Director Neurolief Ltd. Tel: +972-9-3730288
Date Prepared: November 19, 2020
Relivion® Trade Name:
Classification Name: 21 CFR 882.5891 Transcutaneous electrical nerve stimulator to treat headache
Product Code: PCC
Classification: Class II
Classification Panel: Neurology
Predicate Device: CEFALY Technology's Cefaly® Acute (K171446)
Intended Use/Indication for Use:
4
The Relivion® transcutaneous electrical nerve stimulator is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older. It is a prescription device to be self-used at home.
Device Description:
The Relivion® is an external non-invasive neurostimulator designed for transcutaneous electrical nerve stimulation. The Relivion® headset integrates three pairs of output electrodes which come in contact with the subject's scalp at the forehead and occiput. The electrodes deliver the stimulation pulses produced by the headset's stimulation unit to the subject's scalp. The frontal electrodes stimulate the trigeminal (supraorbital and supratrochlear) nerve branches and the posterior electrodes stimulate the greater occipital nerve branches.
The Relivion® includes single-use replaceable electrode pads that are positioned on-top of the electrodes prior to treatment and are wetted by the user before use, in order to provide proper conductivity between the electrodes and the scalp.
The Relivion® is powered by a rechargeable battery and the headset incorporates an on-board user interface that enables the user to activate/deactivate the device and to adjust the stimulation intensity. Upon treatment activation, the treatment automatically runs and ends after 60 minutes or alternatively, the user can stop the treatment when desired.
The Relivion® can communicate via a low energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone. The Relivion® mobile application is optional and it is used to display the device status and provide indications and alerts.
Technological Characteristics:
The Relivion® treats migraines by stimulating the trigeminal and occipital nerve branches by a transcutaneous electrical nerve stimulation. Trigeminal and occipital electrical nerve stimulation induces neuromodulation of these nerve pathways and by that reduces pain associate with migraine and associated symptoms.
The Relivion® includes single-use, replaceable electrode pads that are positioned on-top of the headset electrodes and are wetted by the user before each use. Water releasing covers are located on the outer side of each back occipital electrode and are used to release moisture from the electrode pads to the scalp in order to provide proper electrical conductivity between the electrodes and the scalp.
The Relivion® headset adjusts to various head sizes and contours and can be worn comfortably. The headset includes two flexible arms that penetrate under the hair layers while the headset is worn.
The Relivion® headset incorporates an on-board user interface and can communicate via a low
5
energy Bluetooth link with the Relivion® dedicated mobile application on the user's smartphone, which displays the device status and provides indications and alerts.
Performance Data:
Neurolief conducted several performance tests to demonstrate that the Relivion® device complies with performance standards and that it functions as intended.
Performance - Bench Testing: The Relivion® device underwent performance testing, including software validation and device verification tests. It was successfully verified that the Relivion® output parameters meet the product's specifications.
Electrical Safety and Electromagnetic Compatibility: in addition, the system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.
- . IEC 60601-1 Ed. 3.1, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Ed. 4.0, Medical Electrical Equipment Part 1-2: General requirements for . safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
- IEC 60601-1-11 Ed. 2.0, Medical electrical equipment Part 1-11: General requirements . for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- IEC 60601-2-10 Ed. 2.1, Medical electrical equipment Part 2-10: Particular requirements ● for the basic safety and essential performance of nerve and muscle stimulators
- IEC 60601-1-6 Ed. 3.1, Medical electrical equipment Part 1-6: General requirements for . basic safety and essential Performance - Collateral Standard: Usability
- IEC 62366 Ed. 1.0 Medical devices Part 1: Application of usability engineering to medical ● devices
- IEC 62304 Ed. 1.1, Medical device software Software life-cycle processes .
Software Testing: The software was also subject to verification and validation testing, and results demonstrated that the system performed as intended. Cybersecurity risks were also identified and addressed.
Biocompatibility: The Relivion® is a device that contacts intact skin surface for a limited time (