Cefaly Dual

K173006 · Cefaly Technology · PCC · Nov 28, 2017 · Neurology

Device Facts

• Record ID: K173006
• Device Name: Cefaly Dual
• Applicant: Cefaly Technology
• Product Code: PCC · Neurology
• Decision Date: Nov 28, 2017
• 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 the forehead via a self-adhesive electrode with two conductive zones. Device is powered by a rechargeable LiPo 3.7V battery and operated by a single button to select and start automated stimulation programs. It delivers biphasic electrical impulses to the supratrochlear and supraorbital nerves (upper branch of the trigeminal nerve) to generate an analgesic effect for migraine treatment. The device combines two stimulation programs: Program 1 (100 Hz, 60 minutes) for acute migraine treatment and Program 2 (60 Hz, 20 minutes) for migraine prophylaxis. It is intended for use by patients 18 years or older. The device provides non-invasive neurostimulation, potentially reducing migraine frequency and severity, thereby benefiting patients by offering an alternative to pharmacological interventions.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics, design, and performance testing (bench testing) against established international standards (IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10, and IEC 62366).

Technological Characteristics

Supraorbital transcutaneous electrical nerve stimulator; plastic PC housing; rechargeable 3.7V LiPo battery; biphasic, fully compensated, symmetrical rectangular waveform; 250 us pulse width; 16 mA max output current; 100 Hz (acute) or 60 Hz (prophylactic) frequency. Compliant with IEC 60601-1, 60601-1-2, 60601-1-6, 60601-1-11, 60601-2-10, and IEC 62366.

Indications for Use

Indicated for acute treatment of migraine (with/without aura) and prophylactic treatment of episodic migraine in patients 18 years 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® Acute (K171446)
• Cefaly® (K160237)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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.

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 ([e-mail]) or phone [phone] 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) | |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/0 description: The image contains the logo for "CEFALY Technology". The logo features a stylized red graphic above the text. The text is in a gray sans-serif font, with "CEFALY" on the top line and "TECHNOLOGY" on the bottom line.

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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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Image /page/4/Picture/0 description: The image shows the logo for "CEFALY Technology". The logo consists of a red graphic element above the text. The graphic element is composed of two curved lines that meet in the middle, resembling a stylized roof or arch. Below the graphic element, the word "CEFALY" is written in a gray, sans-serif font, with each letter capitalized. Underneath "CEFALY", the word "TECHNOLOGY" is written in a smaller, gray, sans-serif font, also with each letter capitalized.

ww.cefalv-technology.com

### 5.4. Description of the device

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.

#### 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.: [phone] Fax: [phone] 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 acute<br>treatment of migraine attacks<br>(Program 1) | 1 fixed program for the<br>prophylactic treatment of<br>migraine (Program 2) | 2 fixed programs:<br>- 1 fixed program for the<br>acute treatment of migraine<br>attacks (Program 1)<br>- 1 fixed program for<br>prophylactic treatment of<br>migraine (Program 2) |
| Program 1:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | 16 mA<br>250 us, fixed<br>100 Hz, fixed<br>60 minutes | Not included | 16 mA<br>250 us, fixed<br>100 Hz, fixed<br>60 minutes |
| Program 2:<br>Max. output current<br>Pulse width<br>Pulse frequency<br>Session duration | Not included | 16 mA<br>250 us, fixed<br>60 Hz, fixed<br>20 minutes | 16 mA<br>250 us, fixed<br>60 Hz, fixed<br>20 minutes |
| Waveform | Biphasic | Biphasic | Biphasic |
| Shape | Rectangular<br>Full compensated<br>Symmetrical | Rectangular<br>Full compensated<br>Symmetrical | Rectangular<br>Full compensated<br>Symmetrical |
| Net charge (µC) per<br>pulse | 0 | 0 | 0 |
| Maximum output<br>current (mA):<br>At 500 ohms<br>At 2,000 ohms<br>At 10,000 ohms | 16<br>1 Q<br>6 | ા ર<br>16<br>6 | 16<br>16<br>6 |
| Maximum current<br>density (mA/cm2,<br>r.m.s) at 500 ohms | 2.37 | 2.37 | 2.37 |

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Image /page/6/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 gray sans-serif font.

| Maximum average<br>power density<br>(W/cm2, r.m.s) at<br>500 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.