The acute treatment of migraine with or without aura in patients 18 years of age or older.
The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Device Description

The Cefaly® Dual device is a supraorbital transcutaneous electrical 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.

The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically.

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

AI/ML Overview

This document does not contain the detailed information necessary to complete the requested table and provide answers for all points. The provided text is a 510(k) summary for the Cefaly® Dual device, making a claim of substantial equivalence to two predicate devices (Cefaly® Acute and Cefaly®). While it describes the device's technical specifications and indications for use, it does not include the results of a clinical study or performance testing against specific acceptance criteria for efficacy or safety.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and reported device performance:

This information is not available in the provided text. The document focuses on showing the Cefaly® Dual is technically equivalent to its predicates. It does not present clinical performance data or acceptance criteria for that data in this summary.

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

This information is not available as no clinical test set or study data is presented.

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

This information is not available as no clinical test set or ground truth establishment is described.

4. Adjudication method for the test set:

This information is not available.

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:

This information is not available. The Cefaly® Dual is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic device that would involve human readers.

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

This information is not applicable. The Cefaly® Dual is a medical device, not an algorithm.

7. The type of ground truth used:

This information is not available.

8. The sample size for the training set:

This information is not available as no training set for a machine learning algorithm is mentioned.

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

This information is not available.

Summary of what the document does provide:

Device: Cefaly® Dual, a supraorbital transcutaneous electrical nerve stimulator.
Indications for Use:
- Acute treatment of migraine with or without aura in patients 18 years of age or older.
- Prophylactic treatment of episodic migraine in patients 18 years of age or older.
Mechanism of Action: Transmits electrical impulses via a supraorbital electrode to excite supratrochlearis and supraorbitalis nerves (external trigeminal nerve stimulation) to generate an analgesic effect.
Substantial Equivalence: Claimed against Cefaly® Acute (K171446) and Cefaly® (K160237). The Cefaly® Dual combines the stimulation programs and indications of these two predicate devices.
Technical Characteristics: Detailed comparison of Cefaly® Dual with its predicates, showing identical physical dimensions, weight, housing materials, electrodes, power source, pulse width, waveform, and net charge per pulse. The key difference is that Cefaly® Dual includes two fixed programs (one for acute treatment at 100 Hz, one for prophylactic at 60 Hz), whereas each predicate only had one.
Non-Clinical Performance Testing: Cefaly® Dual is compliant with the same international standards (IEC 60601-1, -1-2, -1-6, -1-11, -2-10, IEC 62366) as the predicate devices. This indicates electrical safety, electromagnetic compatibility, usability, and specific requirements for nerve stimulators.

The provided text is a regulatory submission for substantial equivalence based on technical and performance similarities to previously cleared devices, rather than a report on a clinical trial with specific acceptance criteria and outcome measurements for the new device.

Summary

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November 28, 2017

CEFALY Technology Jean-Yves Mignolet R&D Manager Rue Louis Plescia, 34 Seraing, BE 4102 Liege

Re: K173006

Trade/Device Name: Cefaly® Dual Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: September 25, 2017 Received: September 27, 2017

Dear Jean-Yves 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

William J. Heetderks -S 2017.11.28 12:38:40 -05'00'

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173006

Device Name Cefaly® Dual

Indications for Use (Describe)

The Cefaly® Dual is indicated for:

The acute treatment of migraine with or without aura in patients 18 years of age or older.
The prophylactic treatment of episodic migraine in patients 18 years of age or older.

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)

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Section 5 510(k) Summary

5.1. Submitter information

Submitter Name: CEFALY Technology Address: Rue Louis Plescia, 34 4102 Seraing BELGIUM + 32 4 367 67 22 Phone: + 32 4 367 67 02 Fax: Contact Person: Jean-Yves MIGNOLET (R&D Manager) This summary was prepared on: September 25, 2017

5.2. Device information

Device Trade or Proprietary Name: Cefalv® Dual Device Common or Usual Name (Regulation Description): Transcutaneous electrical nerve stimulator to treat headache Device Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (21 CRF 882.5891. Product Code PCC) Device Class: Class II

5.3. Substantial equivalency

Substantial Equivalency is claimed against the following legally marketed devices:

Cefaly® Acute (510(k) number K171446) ●
Cefaly® (510(k) number K160237) .

In particular, while the Cefaly® Acute has one stimulation program indicated for the acute treatment of migraine with or without aura and the Cefaly® has one stimulation program indicated for the prophylactic treatment of episodic migraine, the Cefaly® Dual device combines the output modes (stimulation programs) of the two predicate devices. Consequently, the Cefaly® Dual combines the indications for use of the two predicate devices (see Section 5.5).

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ww.cefalv-technology.com

5.4. Description of the device

The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically.

5.5. Indications for use of the device

The indications for use of the Cefaly® Dual are:

The acute treatment of migraine with or without aura in patients 18 years of age or older,
The prophylactic treatment of episodic migraine in patients 18 years of age or older.

5.6. Summary of the technological characteristics of the Cefaly® Dual in comparison with the predicate Cefaly® Acute and Cefaly® devices

The Cefaly® Dual device is significantly equivalent to the legally marketed devices Cefaly® Acute (K171446) and Cefaly® (K160237) in terms of technological characteristics (design, material, energy source), except for the button color, and it combines the output modes of the two predicate devices. In particular, while each predicate device offers a single stimulation program for given indications for use, the Cefaly® Dual offers these two different stimulation programs in a single device, and each stimulation program is associated with its specific FDA-approved indications for use.

The Cefaly® Dual device is made of a plastic casing identical to that of the predicate Cefaly® Acute and Cefaly® devices. Only the button color is changed to easily differentiate three devices. It works with the same electrode as the predicate devices. It is powered by the same battery. The electronics inside the device is also the software has been adapted. The Cefaly® Dual device delivers biphasic impulses of the same pulse shape and width (250 us)

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Rue Louis Plescia. 3 4102 Seraing - BELGIUM Tél.: +32 4 367 67 22 Fax: +32 4 367 67 02 www.cefaly-technology.com

than the predicate devices. The repetition frequency of the Cefaly® Dual device depends on the selected stimulation program. For the program indicated for the acute treatment of migraine (Program 1), the frequency is 100 Hz, as for the Cefaly® Acute. For the program indicated for the prophylactic treatment of episodic migraine (Program 2), the frequency is 60 Hz, as for the Cefaly®.

	Cefaly® Acute	Cefaly®	Cefaly® Dual
510 (k) Number	K171446	K160237	K173006
Manufacturer	CEFALY Technology	CEFALY Technology	CEFALY Technology
Weight	12 g	12 g	12 g
Dimensions	55 mm x 40 mm x 15 mm	55 mm x 40 mm x 15 mm	55 mm x 40 mm x 15 mm
Housing materials	Plastic PC	Plastic PC	Plastic PC
Electrodes	Cefaly® electrode	Cefaly® electrode	Cefaly® electrode
Power Source	1 rechargeable LiPo 3.7 V	1 rechargeable LiPo 3.7 V	1 rechargeable LiPo 3.7 V
	battery	battery	battery
Software provided	1 fixed program for the acutetreatment of migraine attacks(Program 1)	1 fixed program for theprophylactic treatment ofmigraine (Program 2)	2 fixed programs:- 1 fixed program for theacute treatment of migraineattacks (Program 1)- 1 fixed program forprophylactic treatment ofmigraine (Program 2)
Program 1:Max. output currentPulse widthPulse frequencySession duration	16 mA250 us, fixed100 Hz, fixed60 minutes	Not included	16 mA250 us, fixed100 Hz, fixed60 minutes
Program 2:Max. output currentPulse widthPulse frequencySession duration	Not included	16 mA250 us, fixed60 Hz, fixed20 minutes	16 mA250 us, fixed60 Hz, fixed20 minutes
Waveform	Biphasic	Biphasic	Biphasic
Shape	RectangularFull compensatedSymmetrical	RectangularFull compensatedSymmetrical	RectangularFull compensatedSymmetrical
Net charge (µC) perpulse	0	0	0
Maximum outputcurrent (mA):At 500 ohmsAt 2,000 ohmsAt 10,000 ohms	161 Q6	ા ર166	16166
Maximum currentdensity (mA/cm2,r.m.s) at 500 ohms	2.37	2.37	2.37

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Maximum averagepower density(W/cm2, r.m.s) at500 ohms	0.000047	0.000017	0.000047
-------------------------------------------------------------------	----------	----------	----------

5.7. Non-Clinical Performance Testing

The Cefaly® Dual device is compliant to the same international standards as the legally marketed Cefaly® Acute device (K171446) and Cefaly® device (K160237).

Standards	Cefaly® Acute	Cefaly®	Cefaly® Dual
IEC 60601-1	Yes	Yes	Yes
IEC 60601-1-2	Yes	Yes	Yes
IEC 60601-1-6	Yes	Yes	Yes
IEC 60601-1-11	Yes	Yes	Yes
IEC 60601-2-10	Yes	Yes	Yes
IEC 62366	Yes	Yes	Yes

5.8. Conclusion

The subject device is significantly equivalent to the legally marketed predicate Cefaly® Acute and Cefaly® devices.

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.