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 indicated for an OTC (also referred to as the Subject 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 Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. The electrical impulses generated by the Subject 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 (V1). 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 is a 510(k) premarket notification approval letter for the Cefaly® Dual device, indicating its substantial equivalence to a previously cleared predicate device. It primarily focuses on the device's technological characteristics, indications for use, and a non-clinical human factors study to support a change from prescription (Rx) to over-the-counter (OTC) use.

Based on the provided text, the device itself does not involve an AI/ML algorithm that requires specific acceptance criteria related to its performance in tasks like image classification or predictive modeling. Instead, it's a Transcutaneous Electrical Nerve Stimulator (TENS) device. Therefore, many of the requested points regarding AI/ML acceptance criteria, performance metrics (like sensitivity, specificity, AUC), ground truth establishment, training sets, and MRMC studies are not applicable to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to demonstrating the device's equivalent performance and safety to its predicate, particularly for its proposed OTC use.

Here's a breakdown based on the document:

Acceptance Criteria for Cefaly® Dual (for OTC use):

The acceptance criteria are implicitly tied to demonstrating the substantial equivalence to the predicate device (Cefaly® Dual K173006) and showing that the device is safe and effective for over-the-counter use without requiring a prescription.

The document highlights the following as crucial for demonstrating equivalence/acceptance:

Identical Technological Characteristics: The device must be technologically identical to the predicate device in design, materials, energy source, electrical impulse parameters (pulse width, frequency, current, waveform), and software.
Identical Intended Use/Clinical Application: The clinical application and intended users (patients 18 years or older for acute treatment of migraine with or without aura, and prophylactic treatment of episodic migraine) must remain the same as the predicate.
Safety and Effectiveness for OTC Use: The primary additional "acceptance criterion" for the OTC claim is demonstrating that the device can be used safely and effectively by lay users without professional guidance. This is addressed through a Human Factors validation study.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the (implicit) acceptance criteria for OTC marketing is primarily a Non-Clinical Human Factors Validation Study.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Acceptance Criterion (Implicit)	Reported Device Performance and Evidence from Submission
Technological Equivalence to Predicate Device	Met: The Subject Device (Cefaly® Dual for OTC) is stated to be "identical to the legally marketed Predicate Cefaly® Dual (K173006) in terms of technological characteristics (design, material, and energy source)." Specific parameters like power source, channels, software, maximum output current, pulse width, frequency, session duration, waveform, shape, net charge per pulse, current density, and power density are listed as "Equivalent" to the Predicate.
Identical Clinical Application and Intended Users	Met: The indications for use for acute and prophylactic treatment of migraine in patients 18 years or older are explicitly stated to be the same as the predicate device. The document explicitly says, "While the clinical application, the intended users and use remains identical..."
Safety and Effectiveness for Over-The-Counter (OTC) Use	Met: A "Human Factors validation study was conducted with the Cefaly® Dual (Subject Device)" to support the change in indications for use from Rx to OTC. The successful completion of this study implied the device is safe and effective for use by lay users. The FDA's clearance (K201895) further confirms this.
Compliance with International Standards	Met: The Subject Device is stated to be "compliant to the same international standards as the legally marketed Predicate (K173006)."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: The document only mentions a "Human Factors validation study" but does not specify the sample size for this study.
Data Provenance: Not explicitly stated, but Human Factors studies are typically prospective tests conducted in a simulated or real-world use environment. The manufacturer is CEFALY Technology, based in Belgium, so participants could be from Europe or the US, but this is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This question is not applicable in the context of this device. A TENS device does not generate data that requires expert labeling or ground truth establishment in the way an AI/ML algorithm for medical image analysis would.
For Human Factors studies, "experts" are typically human factors specialists, usability engineers, and potentially clinicians who understand the device's use environment, rather than experts establishing "ground truth" in clinical data. The document does not detail the expertise of those involved in the human factors study design or evaluation.

4. Adjudication Method for the Test Set:

Not applicable for this type of device and study. Human Factors studies involve observing user interactions, identifying use errors, and assessing user comprehension, rather than adjudicating clinical findings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, this was not done. The device cleared via a 510(k) pathway by demonstrating substantial equivalence to a predicate. The document explicitly states: "Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device."
MRMC studies are typically for AI/ML algorithms where human performance with and without AI assistance is being compared. This device is a direct-to-patient TENS.

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

Not applicable. This device is hardware with simple embedded software. It is not an AI/ML algorithm that operates in a "standalone" analytical capacity. Its performance is tied directly to its hardware function and user interaction.

7. The Type of Ground Truth Used:

Not applicable for clinical efficacy. As noted, clinical performance testing was not performed for this submission. The "ground truth" for the Human Factors study would be the identification of all potential use errors and the successful demonstration that lay users can safely and effectively operate the device according to its instructions for use. This isn't "ground truth" in the diagnostic or prognostic sense.

8. The Sample Size for the Training Set:

Not applicable. This device does not use an AI/ML algorithm that is "trained" on a dataset in the conventional sense. The software functions are fixed programs (Program 1 for acute treatment, Program 2 for prophylactic treatment) identical to the predicate device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary

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Image /page/0/Picture/2 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

9/29/2020

CEFALY Technology % Parul Chansoria CEO & Founder, Regulatory Consultant Elexes Medical Consulting 6494 Tralee Village Dr Dublin, California 94568

Re: K201895

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: July 2, 2020 Received: July 8, 2020

Dear Parul Chansoria:

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

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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) 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 (QS) 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 medical devices and radiation-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.

Xiaorui Tang, Ph.D. Interim Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201895

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)	Registration Use (Part 21 CFR 201.321 Subpart D) On The Container (21 CFR 201.321 Subpart C)
-------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------

__ Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of a red curved line above the words "CEFALY" and "TECHNOLOGY", which are stacked on top of each other. The text is in a sans-serif font and is gray in color.

Rue Louis Plescia, 34
4102 Seraing - BELGIUM
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
www.cefaly-technology.com

5.1 SUBMITTER

CEFALY Technology, LIEGE Science Park, Rue Louis Plescia, 34, 4102 Seraing, BELGIUM

Contact Person:

Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: + 408-475-8091 E-mail: parul@elexes.com

Summary Prepared: June 25, 2020

5.2 DEVICE

Common/Usual name/Regulation Description: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulatory Class: Class II Classification Panel: Neurology Product Code: PCC Regulation Number: 21 CFR 882.5891

5.3 PREDICATE DEVICE

Cefaly® Dual is substantially equivalent to the following cleared device:

Company	Product	510(k) Number
CEFALY Technology	Cefaly® Dual	K173006

5.4 DEVICE DESCRIPTION

The Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A

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Image /page/4/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of the word "CEFALY" in a serif font, with the word "TECHNOLOGY" in a smaller sans-serif font underneath. Above the word "CEFALY" is a red graphic that resembles two curved lines meeting in the middle.

Rue Louis Plescia, 34
4102 Seraing - BELGIUM

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

www.cefaly-technology.com

self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.

The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically.

The electrical impulses generated by the Subject 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 (V1). 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.

5.5 INDICATIONS FOR USE

The indications for use of the Cefaly® Dual for an over-the-counter use 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 TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Subject Device is identical to the legally marketed Predicate Cefaly® Dual (K173006) in terms of technological characteristics (design, material, and energy source).

The Subject Device is made of a plastic casing identical to that of the Predicate. It works with the same electrode as the Predicate Device. It is powered by the same battery. The electronics inside the device are also the same. The Subject Device delivers biphasic impulses of the same pulse shape and width (250 us) as the Predicate Device. The repetition frequency of the impulses of the Subject Device depends on the selected stimulation program. The frequencies delivered by the Subject Device for the treatment of Migraine is the same as that of the Predicate.

Parameter	Subject DeviceCefaly® Dual(indicated for OTC)	PredicateCefaly® Dual(indicated for Rx)	Equivalence
Manufacturer	CEFALYTechnology	CEFALYTechnology	-
Device Name	Cefaly® Dual	Cefaly® Dual	-
510(k) number	-	K173006	-
Product Code	PCC	PCC	Equivalent
RegulationNumber	882.5891	882.5891	Equivalent
RegulatoryClass	II	II	Equivalent
Indicationsfor use	The indications for useof the Cefaly® Dual foran over-the-counteruse are:-The acute treatment ofmigraine with orwithout aura in patients18 years of age orolder.-The prophylactictreatment of episodicmigraine in patients 18years of age or older.	The indications foruse of the Cefaly®Dual for an Rx useare:- The acute treatmentof migraine with orwithout aura inpatients 18 years ofage or older.- The prophylactictreatment of episodicmigraine in patients18 years of age orolder.	DifferentWhile the clinicalapplication, theintended users anduse remainsidentical, thedifference is only interms of labellingchange where theSubject Device is tobe indicated for anOTC use instead ofRx.
Power Source	1 rechargeable LiPo3.7 Vbattery	1 rechargeable LiPo3.7 Vbattery	Equivalent
Channels	1	1	Equivalent
Software provided	2 fixed programs:- 1 fixed program forthe acute treatment ofmigraine attacks(Program 1)- 1 fixed program for	2 fixed programs:- 1 fixed program forthe acute treatment ofmigraine attacks(Program 1)- 1 fixed program for	Equivalent
	prophylactic treatmentof migraine(Program 2)	prophylactictreatment of migraine(Program 2)
Program 1:Max. outputcurrentPulse widthPulse frequencySession duration	16 mA250 µs,fixed 100 Hz,fixed 60 minutes	16 mA250 µs,fixed 100 Hz,fixed 60 minutes	Equivalent
Program 2:Max. outputcurrent PulsewidthPulse frequencySession duration	16 mA250 µs,fixed 60 Hz,fixed 20 minutes	16 mA250 µs,fixed 60 Hz,fixed 20 minutes	Equivalent
Waveform	Biphasic	Biphasic	Equivalent
Shape	RectangularFull compensatedSymmetrical	RectangularFull compensatedSymmetrical	Equivalent
Net charge (µC)per pulse	0	0	Equivalent
Maximum outputcurrent (mA):At 500 ohmsAt 2,000 ohmsAt 10,000 ohms	16166	16166	Equivalent
Maximum currentdensity (mA/cm2,r.m.s) at 500 ohms	2.37	2.37	Equivalent
Maximumaverage powerdensity (W/cm2,	0.000047	0.000047	Equivalent

Table 1: An overview of the Subiect Device w.r.t. thePredicate Device

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Image /page/5/Picture/0 description: The image contains the logo for "CEFALY Technology". The logo consists of the text "CEFALY" in a larger, bolder font above the word "TECHNOLOGY" in a smaller font. Above the text is a stylized red graphic element that resembles a curved line or roof-like shape.

Rue Louis Plescia, 34
4102 Seraing - BELGIUM

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

www.cefaly-technology.com

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Image /page/6/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of the word "CEFALY" in large, bold, sans-serif font, with the word "TECHNOLOGY" in a smaller font size underneath. Above the word "CEFALY" is a red, stylized graphic that resembles two curved lines meeting in the middle, forming a shape similar to a stylized roof or eyebrow. The overall design is clean and modern, with a focus on the company name.

4102 S

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Image /page/7/Picture/0 description: The image contains the logo for "CEFALY TECHNOLOGY". The word "CEFALY" is in a larger font size than the word "TECHNOLOGY", and both words are in a sans-serif font. Above the words is a red graphic that looks like two curved lines meeting in the middle. The background is white.

Rue Louis Plescia, 34
4102 Seraing - BELGIUM

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

www.cefaly-technology.com

r.m.s) at 500 ohms
--------------------	--

Differences

While the clinical application, the intended users and use remains identical, the difference is only in terms of labelling change where the Subject Device is to be indicated for an OTC use instead of Rx.

5.7 NON-CLINICAL STUDY

The Subject Device is compliant to the same international standards as the legally marketed Predicate (K173006). To support the change in the indications for use from an Rx to an OTC use, a Human Factors validation study was conducted with the Cefaly® Dual (Subject Device).

5.8 SOFTWARE

The Subject Device software is identical to the software used in the Predicate Device.

5.9 CLINICAL STUDY

Not Applicable. Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device.

5.10 CONCLUSION

The Subject Device is substantially equivalent to the Predicate Device in terms of technological characteristics, system operating ranges, and intended use. The Subject Device is as safe and effective as the Predicate Device (K173006).

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.