Cefaly® device is a supraorbital transcutaneous nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.

Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.

The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates a sedative effect and is intended to treat migraine headaches.

AI/ML Overview

This document describes the CEFALY® device, a supraorbital transcutaneous nerve stimulator for the prophylactic treatment of episodic migraine. It is a 510(k) premarket notification for a modified version of an already legally marketed device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a 510(k) for a modified version of the CEFALY® device. The core of this submission is substantial equivalence to a predicate device (the original CEFALY® device, De Novo Number DEN120019 and 510(k) Number K122566). The document explicitly states that the "scientific technology of the modified Cefaly® device are identical to those of the original version of the Cefaly® device" and "The modified version of the Cefaly® has exactly the same output stimulation parameters than the legally marketed Cefaly®."

Therefore, the acceptance criteria are implicitly that the modified device's performance, particularly its safety and effectiveness for its indicated use, is equivalent to the predicate device. The performance is reported as being identical to the predicate.

Acceptance Criteria (Implicit from Substantial Equivalence to Predicate)	Reported Device Performance (Modified CEFALY®)
Safety and Effectiveness for Prophylactic Treatment of Episodic Migraine	As safe and effective as the legally marketed predicate CEFALY® device. Risk analysis showed no unacceptable risk.
Output Stimulation Parameters	Exactly the same as the legally marketed predicate CEFALY® device.
Intended Use	Identical to the legally marketed predicate CEFALY® device: prophylactic treatment of episodic migraine in patients 18+ years.

2. Sample size used for the test set and the data provenance

The provided document for the 510(k) (K160237) does not describe a new clinical study with an independent test set for the modified device. Instead, it relies on demonstrating substantial equivalence to a predicate device. The modifications concern "power supply, the dimensional specifications, and the fixing system between the device and the electrode." The submission indicates that a "risk analysis did not show any unacceptable risk resulting from these device modifications."

Therefore, there is no information about a "test set" in the context of evaluating a new algorithm or clinical performance for this specific 510(k) submission. Any clinical data supporting the original predicate device (DEN120019, K122566) would be the basis for efficacy and safety, but that data is not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As there is no new clinical study or test set described for the modified device in this 510(k) submission, this information is not available in the provided text.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable, as no new test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The device is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an algorithm-only performance study. The CEFALY® device is a physical medical device (nerve stimulator), not an algorithm or AI. Hence, this question is not applicable in the context of this device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the predicate device, the "ground truth" for its safety and effectiveness would have been established through clinical trials and medical assessments related to migraine frequency, intensity, and duration, as well as adverse events. The specific methodologies (e.g., patient-reported outcomes, physician diagnosis, headache diaries) are not detailed in this 510(k) summary but would have been part of the original De Novo or 510(k) submission for the predicate. For this modified device, the "ground truth" is its equivalence to the predicate device's established performance based on identical stimulation parameters and a risk analysis of the changes.

8. The sample size for the training set

Not applicable, as this is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as this is a physical medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2016

CEFALY Technologies Jean-Yves Mignolet R&D Manager ZI des Hauts Sarts 4eme Avenue 5 Herstal, Liege, 4040 Belgium

Re: K160237

Trade/Device Name: CEFALY® Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: January 29, 2016 Received: February 1, 2016

Dear Mr. Mignolet.

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. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{1}------------------------------------------------

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160237

Device Name Cefaly®

Indications for Use (Describe)

The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

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

X 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 unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for "CEFALY Technology". The word "CEFALY" is in a larger font than the word "TECHNOLOGY", and the registered trademark symbol is next to the "Y" in "CEFALY". Above the text is a maroon-colored design that looks like two curved lines meeting in the middle.

ZI des Hauts-Sarts
4ème AVENUE N° 5-6
4040 Herstal
BELGIQUE

Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02

www.cefaly-technology.com

Section 6

510(k) Summary

Submitter Name:	CEFALY Technology
Address:	Zoning Industriel des Hauts Sarts, 4e avenue, 5HERSTALB 4040BELGIUM
Phone:	+ 32 4 367 67 22
Fax:	+ 32 4 367 67 02
Contact Person:	Jean-Yves MIGNOLET (R&D Manager)
This summary was prepared on:	January 2016

Device Trade or Proprietary Name: Cefaly® Device Common or usual name: Supraorbital transcutaneous nerve stimulator

Device Classification Name: Stimulator, Nerve. Electrical, Transcutaneous, For Migraine Classification Product Code: PCC

Substantial Equivalency is claimed against the following legally marketed device: Cefaly®. The De Novo Number is DEN120019 and the 510(k) Number is K122566.

Description of the device:

Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of the word "CEFALY" in a gray sans-serif font, with the word "TECHNOLOGY" in a smaller font below it. Above the word "CEFALY" are two curved lines that meet in the middle, forming a shape that resembles a roof. The lines are a dark red color.

ww.cefalv-technology.com

Intended use of the device:

The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.

Comparison between the original and the modified, improved version of the Cefaly®:

The intended use and the scientific technology of the modified Cefaly® device are identical to those of the original version of the Cefaly® device. The modified version of the Cefaly® has exactly the same output stimulation parameters than the legally marketed Cefaly®. The device modifications concern the power supply, the dimensional specifications, and the fixing system between the device and the electrode. The risk analysis did not show any unacceptable risk resulting from these device modifications (see Section 15). The modified version of the Cefaly® is therefore as safe and as effective than the legally marketed Cefaly®.

Regulation Number and Section

§ 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.