Cefaly Dual

K201895 · Cefaly Technology · PCC · Sep 29, 2020 · Neurology

Device Facts

• Record ID: K201895
• Device Name: Cefaly Dual
• Applicant: Cefaly Technology
• Product Code: PCC · Neurology
• Decision Date: Sep 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Cefaly Dual is a supraorbital transcutaneous electrical nerve stimulator; applied to forehead via self-adhesive electrode with 2 conductive zones. Device powered by rechargeable LiPo battery; operated by single button to select/start automatic stimulation programs. Electrical impulses excite supratrochlearis and supraorbitalis nerves (upper branch of trigeminal nerve/V1) to generate analgesic effect for migraine treatment. Used by patients in home/non-clinical settings (OTC). Provider/patient uses device to manage migraine symptoms; output is electrical stimulation; intended to reduce migraine frequency/severity.

Clinical Evidence

No clinical performance testing performed. Substantial equivalence supported by identical technological characteristics and a human factors validation study for OTC use.

Technological Characteristics

Plastic casing; supraorbital electrode; rechargeable 3.7V LiPo battery. Biphasic, rectangular, fully compensated, symmetrical waveforms. Pulse width 250 µs. Program 1: 100 Hz, 60 min. Program 2: 60 Hz, 20 min. Max output 16 mA. Fixed program software.

Indications for Use

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

Regulatory Classification

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.

Special Controls

*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.

In combination with the general controls of the Food Drug & Cosmetic Act, the Transcutaneous Electrical Nerve Stimulator to Treat Headache is subject to the following special controls:

Predicate Devices

• Cefaly® Dual (K173006)

Submission Summary (Full Text)

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

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

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

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 ([e-mail]) or phone [phone] 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

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

# 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) | <input type="checkbox"/> Registration Use (Part 21 CFR 201.321 Subpart D) <input checked="" type="checkbox"/> 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)

#### 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 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.: [phone]
Fax: [phone]
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: [e-mail]

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

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

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.: [phone]
Fax: [phone]

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 Device<br>Cefaly® Dual<br>(indicated for OTC) | Predicate<br>Cefaly® Dual<br>(indicated for Rx) | Equivalence |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CEFALY<br>Technology | CEFALY<br>Technology | - |
| Device Name | Cefaly® Dual | Cefaly® Dual | - |
| 510(k) number | - | K173006 | - |
| Product Code | PCC | PCC | Equivalent |
| Regulation<br>Number | 882.5891 | 882.5891 | Equivalent |
| Regulatory<br>Class | II | II | Equivalent |
| Indications<br>for use | The indications for use<br>of the Cefaly® Dual for<br>an over-the-counter<br>use are:<br>-The acute treatment of<br>migraine with or<br>without aura in patients<br>18 years of age or<br>older.<br>-The prophylactic<br>treatment of episodic<br>migraine in patients 18<br>years of age or older. | The indications for<br>use of the Cefaly®<br>Dual for an Rx use<br>are:<br>- The acute treatment<br>of migraine with or<br>without aura in<br>patients 18 years of<br>age or older.<br>- The prophylactic<br>treatment of episodic<br>migraine in patients<br>18 years of age or<br>older. | Different<br>While the clinical<br>application, the<br>intended users and<br>use remains<br>identical, the<br>difference is only in<br>terms of labelling<br>change where the<br>Subject Device is to<br>be indicated for an<br>OTC use instead of<br>Rx. |
| Power Source | 1 rechargeable LiPo<br>3.7 V<br>battery | 1 rechargeable LiPo<br>3.7 V<br>battery | Equivalent |
| Channels | 1 | 1 | Equivalent |
| Software provided | 2 fixed programs:<br>- 1 fixed program for<br>the acute treatment of<br>migraine attacks<br>(Program 1)<br>- 1 fixed program for | 2 fixed programs:<br>- 1 fixed program for<br>the acute treatment of<br>migraine attacks<br>(Program 1)<br>- 1 fixed program for | Equivalent |
| | prophylactic treatment<br>of migraine<br>(Program 2) | prophylactic<br>treatment of migraine<br>(Program 2) | |
| Program 1:<br>Max. output<br>current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 µs,<br>fixed 100 Hz,<br>fixed 60 minutes | 16 mA<br>250 µs,<br>fixed 100 Hz,<br>fixed 60 minutes | Equivalent |
| Program 2:<br>Max. output<br>current Pulse<br>width<br>Pulse frequency<br>Session duration | 16 mA<br>250 µs,<br>fixed 60 Hz,<br>fixed 20 minutes | 16 mA<br>250 µs,<br>fixed 60 Hz,<br>fixed 20 minutes | Equivalent |
| Waveform | Biphasic | Biphasic | Equivalent |
| Shape | Rectangular<br>Full compensated<br>Symmetrical | Rectangular<br>Full compensated<br>Symmetrical | Equivalent |
| Net charge (µC)<br>per pulse | 0 | 0 | Equivalent |
| Maximum output<br>current (mA):<br>At 500 ohms<br>At 2,000 ohms<br>At 10,000 ohms | 16<br>16<br>6 | 16<br>16<br>6 | Equivalent |
| Maximum current<br>density (mA/cm2,<br>r.m.s) at 500 ohms | 2.37 | 2.37 | Equivalent |
| Maximum<br>average power<br>density (W/cm2, | 0.000047 | 0.000047 | Equivalent |

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

{5}------------------------------------------------

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.: [phone]
Fax: [phone]

www.cefaly-technology.com

{6}------------------------------------------------

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

{7}------------------------------------------------

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.: [phone]
Fax: [phone]

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).