Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and connectivity features, not AI/ML algorithms.

Therapeutic

Yes
The device is indicated for the acute treatment and preventative treatment of migraine, which are therapeutic uses.

Diagnostic

No

The device description and intended use clearly state that it is for the "treatment" and "prophylactic treatment" of migraine, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a small, non-invasive, and portable device worn on the forehead using a self-adhesive electrode, and mentions electronics, electrical components, and firmware, indicating it is a hardware device with software components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The Cefaly Dual Series is described as a "small, non-invasive, and portable device meant to be worn on the forehead using a self-adhesive electrode." It delivers electrical stimulation to treat migraines.
Intended Use: The intended use is for the "acute treatment of migraine with or without aura" and "preventative treatment of migraine." This is a therapeutic treatment, not a diagnostic test performed on a sample.
Lack of Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.

The device is a therapeutic medical device that uses electrical stimulation for the treatment and prevention of migraines.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:

Acute treatment of migraine with or without aura in patients 18 years of age or older
Preventative treatment of migraine in patients 18 years of age or older

Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for:

Acute treatment of migraine with or without aura in patients 18 years of age or older
Prophylactic treatment of migraine in patients 18 years of age or older

Product codes (comma separated list FDA assigned to the subject device)

PCC

Device Description

CefalyDual Series by CEFALY Technology consists of Cefaly Dual Enhanced with RFID - R., Cefaly Dual Enhanced with RFID - OTC. Cefaly Dual Connected - R. and CefalyDual Connected - OTC. The Cefaly Dual Series of devices are identical to the Predicate Devices CefalyDual - Rx (K173006) and Cefaly Dual - OTC (K201895).

The submission includes CEFALY Dual Enhanced with RFID and CEFALY Dual Connected which are indicated for Ry, are identical to the Predicate Devices CEFALY Dual - Rx (K173006) and CEFALY Dual Enhanced with RFID and CEFALY Dual Connected, which are indicated for OTC, are identical to the Predicate Devices CEFALY Dual - OTC (K201895). Additionally, all the devices in the CEFALYDual Series are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.

The CefalyDual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly Dual (K201895 OTC and K173006 R.).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

forehead

Indicated Patient Age Range

18 years of age or older

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following bench performance testing was carried out for the devices in the Cefaly Dual series to evaluate the safety and efficacy of the devices due to the changes made over the Predicate Device:

Table 5.7.1 : List of Tests Performed - Cefaly Dual Series
Testing Type: Electrical Safety and Electromagnetic Compatibility Testing
Test Description: IEC 60601-1:2005+ AMD 1 Edition 3.1, 2012-08 IEC 60601-1-2 Edition 4.0 2014-02 - IEC 60601-1-11 Edition 2.0 2015-01 - IEC 60601-2-10 Edition 2.1 2016-04
Test Result: Electrical safety and EMC evaluation were performed on the Cefaly Dual Series according to following FDA-recognized and other international standards.

Adhesion testing was carried out to evaluate the adhesion performance of the Cefaly electrodes when used with the Subject Devices. The test results demonstrated that the electrodes function as intended when used and replaced in accordance with the IFU, and that there are no new or different questions related to safety and efficacy of the Subject Device.

No animal testing was required to justify the differences with the corresponding Predicate Devices.

No clinical testing was required to justify the differences with the corresponding Predicate Devices.

Compliance with Special Controls:

The patient-contacting components of the device must be demonstrated to be biocompatible - The material and manufacturing methods remain the same to that of the Predicate Devices, therefore the biocompatibility continues to be met as per K201895.
Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety - Electrical safety and Electromagnetic compatibility testing for Cefaly Dual Series was conducted in compliance with IEC 60601-1 and IEC 60601-1-2 standards and the results were found to be satisfactory.
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 (uC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system must be fully characterized - The Cefaly Dual Series devices have an electrical impedance monitoring system. Characterization of all the required technical parameters of the device was provided, and verification and validation tests were performed in accordance with IEC 60601-2-10 for Cefaly Dual Series devices.
Electrical performance, adhesive integrity, shelf life, reusability, and current distribution testing of the electrodes must be conducted - Electrical performance, adhesive integrity, reusability, and current distribution testing was conducted for Cefaly Dual Series and the results were found to be satisfactory. Nothing that affects the shelf life of the Cefaly Dual Series was changed, and the shelf life continues to be the same as that of the Predicate Devices.
Appropriate software verification, validation, and hazard analysis must be performed - Device Hazard Analysis and Software V&V were conducted for Cefaly Dual Series and the results were found to be satisfactory.
Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population -Indications for use, intended patient population, and technological characteristics of the Subject Device remain unchanged as compared to the Predicate Devices. The differences between the Subject and the Predicate Devices do not have an impact on the clinical performance and it continues to be the same as that of the Predicate Devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173006, K201895

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

December 13, 2022

CEFALY Technology % Parul Chansoria CEO and Founder Elexes Medical Consulting, LLC 30 N Gould St Ste R Sheridan, Wyoming 82801

Re: K212071

Trade/Device Name: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: January 6, 2022 Received: January 10, 2022

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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 (OS) 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 mediation-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,

Jitendra V. Virani -S

CDR Jitendra Virani, MS MBA Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212071

Device Name

Cefaly Dual Series (Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx)

Indications for Use (Describe) Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:

Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Preventative treatment of migraine in patients 18 years of age or older

Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for:

Acute treatment of migraine with or without aura in patients 18 years of age or older
Prophylactic treatment of 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)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. A small registration mark is present to the right of the letter "Y".

5.1. Submitter's information

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: December 12, 2022

5.2. Device Information

5.2.1. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected OTC Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation Number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
5.2.2. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Connected Rx Regulation name: Transcutaneous electrical nerve stimulator to treat headache Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC

CEFALY Technology K212071

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5.2.3. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - OTC Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC
5.2.4. Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Enhanced with RFID - Rs Classification name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulation number: 21 CFR 882.5891 Regulatory Class: Class II Classification panel: Neurology Product Code: PCC

5.3. Predicate Device Information

The following Predicate Devices are used:

| Company | Product | 510(k)
Number | Subject Device |
|----------------------|--------------|------------------|-------------------------------------------------------------------------------|
| CEFALY
Technology | Cefaly® Dual | K173006 | • Cefaly® Dual
Connected Rx,
• Cefaly® Dual
Enhanced with
RFID Rx |
| CEFALY
Technology | Cefaly® Dual | K201895 | • Cefaly® Dual
Connected
OTC,
• Cefaly® Dual |

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--	--	--	---------------------------

The Predicate Devices stated above are not subject to recall by the FDA.

5.4. Device Description

Cefaly® Dual Series by CEFALY Technology consists of Cefaly® Dual Enhanced with RFID - R., Cefaly® Dual Enhanced with RFID - OTC. Cefaly® Dual Connected - R. and Cefaly® Dual Connected - OTC. The Cefaly® Dual Series of devices are identical to the Predicate Devices Cefaly® Dual - Rx (K173006) and Cefaly® Dual - OTC (K201895).

The submission includes CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected which are indicated for Ry, are identical to the Predicate Devices CEFALY® Dual - Rx (K173006) and CEFALY® Dual Enhanced with RFID and CEFALY® Dual Connected, which are indicated for OTC, are identical to the Predicate Devices CEFALY® Dual - OTC (K201895). Additionally, all the devices in the CEFALY® Dual Series are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.

The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.).

ર.ડ. Indications for Use

Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID -OTC are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
1. Preventative treatment of migraine in patients 18 years of age or older

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Cefaly Dual Connected – Rx and Cefaly Dual Enhanced With RFID – Rx are indicated for:

1. Acute treatment of migraine with or without aura in patients 18 years of age or older
1. Prophylactic treatment of migraine in patients 18 years of age or older

5.6. Technological Characteristics

5.6.1. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:
Cefaly® Dual
Connected - OTC | Predicate
Device:
Cefaly® Dual | Equivalence | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Manufacturer | CEFALY
Technology | CEFALY
Technology | | |
| Device Name | CEFALY® Dual
Connected | CEFALY® Dual | - | |
| 510(k) Number | - | K201895 | - | |
| Product code | PCC | PCC | Equivalent | |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent | |
| Classification: | II | II | Equivalent | |
| Indications for
Use | The indications for
use of CEFALY®
Dual Connected for
an over-the-counter
use are: | The indications
for CEFALY®
Dual for an
over-the-counter
use are: | Equivalent | |
| | • Acute treatment
of migraine with
or without aura
in patients 18
years of age or
older

• Preventative
treatment of
migraine in
patients 18
years of age or
older | • The acute
treatment of
migraine with
or without aura
in patients 18
years of age or
older

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CEFALY Technology K212071

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CEFALY Technology K212071

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5.6.1.1. Similarities between Subject Device and Predicate Device

· The intended use is the same for the Subject and the Predicate Devices and both devices are meant for over-the-counter use.
Treatment Programs Waveform characteristics and output . specifications are same for both the Subject and Predicate Device.
The Channels are the same for both the Subject and . Predicate Devices.
Maximum output voltage is the same for both Subject and . Predicate Devices.
Maximum output current is the same for both Subject and . Predicate Devices.
The Power source (Battery) is the same for both Subject . and Predicate Devices.
. The Pulse duration, Maximum phase charge and Type of impedance monitoring system is the same for both Subject and Predicate devices.
. The dimensions and patient contacting material used in the electrode is same for both Subject and Predicate devices.

Differences between Subject Device and Predicate Device 5.6.1.2.

The usage of Mobile application and Bluetooth in Subject . Device is different from Predicate Device.
The RFID tag is added to electrode for Subject Device for ● electrode detection and, electrode metal plate thickness in

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Subject Device (1mm) is different from Predicate Device (0.4mm).

The weight and dimensions of the Subject device is ● different from Predicate Device.
The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.

5.6.2. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:
Cefaly® Dual
Connected - Rx | Predicate Device:
Cefaly® Dual | Equivalence |
|--------------|---------------------------------------------------|-----------------------------------|-------------|
| Manufacturer | CEFALY
Technology | CEFALY
Technology | |
| Device Name | CEFALY® Dual
Connected | CEFALY® Dual | - |

CEFALY Technology K212071

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510(k) Number	-	K173006	-
Product code	PCC	PCC	Equivalent
Regulation No.	21 CFR 882.5891	21 CFR 882.5891	Equivalent
Classification:	II	II	Equivalent
Indications for Use	The indications for use of CEFALY® Dual Connected for an Rx are:

• Acute treatment of migraine with or without aura in patients 18 years of age or older

• Prophylactic treatment of migraine in patients 18 years of age or older | The indications for CEFALY® Dual for an Rx use are:

• The acute treatment of migraine with or without aura in patients 18 years of age or older

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CEFALY Technology K212071

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Similarities between Subject Device and Predicate Device 5.6.2.1.

The intended use is the same for the Subject and the . Predicate Devices and both devices are meant for Prescription use.
Treatment Programs Waveform characteristics and output ● specifications are same for both the Subject and Predicate Device.
The Channels are the same for both the Subject and . Predicate Devices.
. Maximum output voltage is the same for both Subject and Predicate Devices.
Maximum output current is the same for both Subject and . Predicate Devices.
The Power source (Battery) is the same for both Subject . and Predicate Devices.
The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
. The dimensions and patient contacting material used in the electrode is same for both Subject and Predicate devices.

5.6.2.2. Differences between Subject Device and Predicate Device

The usage of Mobile application and Bluetooth in Subject Device is different from Predicate Device.
The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in

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Subject Device (1mm) is different from Predicate Device (0.4mm).

The weight and dimensions of the Subject device is ● different from Predicate Device.
The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.

5.6.3. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:
Cefaly® Dual
Enhanced with RFID

OTC | Predicate Device:
Cefaly® Dual | Equivalence |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manufacturer | CEFALY Technology | CEFALY
Technology | |
| Device Name | CEFALY® Dual
Enhanced with RFID | CEFALY® Dual | - |
| 510(k) Number | - | K201895 | - |
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications for
Use | The indications for
use of CEFALY® Dual
Enhanced with RFID
for an
over-the-counter use
are:
Acute treatment of
migraine with
or without aura
in patients 18
years of age or
older Preventative
treatment of
migraine in
patients 18
years of age or
older | The indications
for 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 | Equivalent |
| Mobile
Application | No | No | Equivalent |
| Bluetooth | No | No | Equivalent |
| RFID for
electrode
detection | Yes | No | Different |
| Charging
System | Charging dock, Power
adapter and USB
Cable | Power adapter and
USB Cable | Different |
| Power Source | 1 rechargeable LiPo
3.7 V battery | 1 rechargeable
LiPo 3.7 V battery | Equivalent |
| Electrode Metal
Plate Thickness | 1 mm | 0.4 mm | Different |
| Weight | 25 grams | 12 grams | Different |
| Dimensions | 66 mm x 47 mm x 17
mm | 55 mm x 40 mm x
15 mm | Different |
| Channels | 1 | 1 | Equivalent |
| Treatment
Programs | 2 programs:
Program 1 - The acute treatment of migraine attacksProgram 2 - The prevent treatment of migraine | 2 programs:
Program 1 - The acute treatment of migraine attacksProgram 2 - The prophylactic treatment of episodic migraine | Equivalent |
| Waveform | Biphasic | Biphasic | Equivalent |
| Shape | Rectangular | Rectangular | Equivalent |
| | Full compensated | Full compensated | Equivalent |
| | Symmetrical | Symmetrical | Equivalent |
| | Net charge
(µC) per pulse | 0 | 0 |
| Maximum
output voltage
(V): | | | |
| | At 500 ohms
8 | 8 | Equivalent |
| | At 2,000 ohms
32 | 32 | |
| At 10,000 ohms
60 | 60 | | |
| Maximum
output current
(mA): | | | |
| | At 500 ohms
16 | 16 | Equivalent |
| | At 2,000 ohms
16 | 16 | |
| At 10,000 ohms
6 | 6 | | |
| Pulse duration
(μs) | 505 | 505 | Equivalent |
| Maximum
Phase Charge
(µC) @ 500
Ohms | 4 | 4 | Equivalent |
| Type of
impedance
monitoring
system | Electrical | Electrical | Equivalent |
| Maximum
current density
(mA/cm²,
r.m.s.) at 500
ohms | 2.37 | 2.37 | Equivalent |
| Treatment Programs output specifications - Program 1 | | | |
| Amplitude
Pulse width
Pulse frequency
Session
duration | 0 - 16 mA
250 µs, fixed
100 Hz, fixed
60 minutes | 0 - 16 mA
250 µs, fixed
100 Hz, fixed
60 minutes | Equivalent |
| Maximum
average current
(average
absolute value,
mA) at 500
ohms | 0.8 | 0.8 | Equivalent |
| Maximum
average power
density
(W/cm²) at 500
ohms | 0.000047 | 0.000047 | Equivalent |
| Amplitude
Pulse width
Pulse frequency
Session
duration | 0 - 16 mA
250 µs, fixed
60 Hz, fixed
20 minutes | 0 - 16 mA
250 µs, fixed
60 Hz, fixed
20 minutes | Equivalent |
| Maximum
average current
(average
absolute value,
mA) at 500
ohms | 0.48 | 0.48 | Equivalent |
| Maximum
average power
density
(W/cm²) at 500
ohms | 0.000017 | 0.000017 | Equivalent |
| Audio-visual Indications | | | |
| Audio
Indicators for
low battery,
Acute and
Prevent
Program (Low
Battery
Charge),
Intensity is
10mA, Increase
Intensity (For
Experienced
CEFALY
Users) and | Present | Absent | Different |
| electrode
detection | | | |
| Visual
Indicators for
low battery and
electrode
detection | Present | Absent | Different |
| | Electrode | | |
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent |
| RFID tag | Present | Not Present | Different |
| Electrode Metal
plate (tinplate)
thickness | 1 mm | 0.4 mm | Different |
| Electrode Gel
used | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent |
| Packaging Configuration | | | |
| Gift Box | Made of cardboard,
has a magnetic latch,
artwork, and label. | A white box made
of cardboard, no
magnetic latch and
no artwork. The
white box slides
inside a sleeve that
has artwork and
label. | Different |
| Storage Case | The storage case
contains a USB cable,
charging dock, device,
user manual,
Instruction guide, and
resealable bag
consisting of | The storage case
contains a USB,
charging adapter,
and electrode
inside.
The device is on a | Different |
| | electrodes | cardboard sheet on
top of the storage
case. User
manual(s) are
below the case. | |
| Number of
electrodes
provided with
the device | Three (3) | One (1) | Different |
| Electrode
storage | Resealable bag | Non- resealable
bag | Different |

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Image /page/23/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. There is a small circle to the right of the "Y" which is likely a trademark symbol. The background is white.

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Image /page/24/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a dark gray color. The word is all capitalized and there is a small circle to the right of the Y.

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Image /page/25/Picture/0 description: The image shows the word "CEFALY" in all capital letters. The letters are a dark gray color. The font is sans-serif and the letters are evenly spaced. There is a small registered trademark symbol to the right of the letter Y.

CEFALY Technology K212071

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Image /page/26/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. There is a small circle to the right of the letter "Y".

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Image /page/27/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and there is a trademark symbol after the Y. The background is white.

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Image /page/28/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The letters are evenly spaced and the word is centered in the image. There is a registered trademark symbol to the upper right of the letter Y.

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Image /page/29/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and has a small trademark symbol after the "Y".

Similarities between Subject Device and Predicate Device 5.6.3.1.

The intended use is the same for the Subject and Predicate Devices and both devices are meant for over-the-counter use.
Treatment Programs Waveform characteristics and output . specifications are same for both the Subject and Predicate Devices.
. The Channels are the same for both Subject and Predicate Devices.
Maximum output voltage is the same for both Subject and . Predicate Devices.
Maximum output current is the same for both Subject and . Predicate Devices.
The Power source (Battery) is the same for both Subject . and Predicate Devices.

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Image /page/30/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color, and the word is horizontally oriented. A small registration mark is present to the right of the letter "Y".

The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
The dimensions and patient contacting material used in the . electrode is same for both Subject and Predicate devices.

Differences between Subject Device and Predicate Device 5.6.3.2.

The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in Subject Device (1mm) is different from Predicate Device (0.4mm).
The weight and dimensions of the Subject device is ● different from Predicate Device.
The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
The packaging configuration of Subject and Predicate ● devices are different. However, it does not raise new questions about safety and efficacy.

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Image /page/31/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. A small registration mark is present to the right of the letter "Y".

5.6.4. Comparison of the Technological Characteristics between Subject Device and Predicate Device

| Parameters | Subject Device:
Cefaly® Dual
Enhanced with
RFID - Rₓ | Predicate Device:
Cefaly® Dual | Equivalence |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Manufacturer | CEFALY
Technology | CEFALY
Technology | |
| Device Name | CEFALY® Dual
Enhanced with RFID | CEFALY® Dual | - |
| 510(k) Number | - | K173006 | - |
| Product code | PCC | PCC | Equivalent |
| Regulation No. | 21 CFR 882.5891 | 21 CFR 882.5891 | Equivalent |
| Classification: | II | II | Equivalent |
| Indications for
Use | The indications for
use of CEFALY®
Dual Enhanced with
RFID for an Rₓ use
are: | The indications for
CEFALY® Dual for
an Rₓ 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 | Equivalent |
| | Acute treatment of migraine with or without aura in patients 18 years of age or older Prophylactic treatment of migraine in patients 18 years of age or older | in patients 18 years of age or older | |
| Mobile Application | No | No | Equivalent |
| Bluetooth | No | No | Equivalent |
| RFID for electrode detection | Yes | No | Different |
| Charging System | Charging dock, USB Cable. | Power adapter and USB Cable | Different |
| Power Source | 1 rechargeable LiPo 3.7 V battery | 1 rechargeable LiPo 3.7 V battery | Equivalent |
| Electrode Metal Plate (RFID tag) Thickness | 1 mm | 0.4 mm | Different |
| Weight | 25 grams | 12 grams | Different |
| Dimensions | 66 mm x 47 mm x 17 mm | 55 mm x 40 mm x 15 mm | Different |
| Channels | 1 | 1 | Equivalent |
| Treatment
Programs | 2 programs:
Program 1 - The acute treatment of migraine attacks Program 2 - The prevent treatment of migraine | 2 programs:
Program 1 - The acute treatment of migraine attacks Program 2 - The prophylactic treatment of episodic migraine | Equivalent |
| Waveform | Biphasic | Biphasic | Equivalent |
| Shape | Rectangular
Full compensated
Symmetrical | Rectangular
Full compensated
Symmetrical | Equivalent |
| Net charge (μC)
per pulse | 0 | 0 | Equivalent |
| Maximum
output voltage | | 8 | Equivalent |
| (V):
At 500 ohms
At 2,000 ohms
At 10,000 ohms | 8 | 32 | |
| Maximum
output current
(mA):
At 500 ohms | 16 | 16 | Equivalent |
| At 2,000 ohms
At 10,000 ohms | 16 | 16
6 | |
| Pulse duration
(μς) | 505 | 505 | Equivalent |
| Maximum
Phase Charge
(μC) @ 500
Ohms | 4 | 4 | Equivalent |
| Type of
impedance
monitoring
system | Electrical | Electrical | Equivalent |
| Maximum
current density
(mA/cm²,
r.m.s.) at 500
ohms | 2.37 | 2.37 | Equivalent |
| Treatment Programs output specifications - Program 1 | | | |
| Amplitude | 0 - 16 mA | 0 - 16 mA | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | Equivalent |
| Session duration | 60 minutes | 60 minutes | |
| Maximum average current
(average absolute value,
mA) at 500 ohms | 0.8 | 0.8 | Equivalent |
| Maximum average power
density (W/cm²)
at 500 ohms | 0.000047 | 0.000047 | Equivalent |
| Treatment Programs output specifications - Program 2 | | | |
| Amplitude | 0 - 16 mA | 0 - 16 mA | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | |
| Pulse frequency | 60 Hz, fixed | 60 Hz, fixed | Equivalent |
| Session duration | 20 minutes | 20 minutes | |
| Maximum average current
(average absolute value,
mA) at 500 ohms | 0.48 | 0.48 | Equivalent |
| Maximum
average power
density (W/cm²)
at 500 ohms | 0.000017 | 0.000017 | Equivalent |
| Audio-visual Indications | | | |
| Audio
Indicators for
low battery,
Acute and
Prevent
Program (Low
Battery
Charge),
Intensity is
10mA, Increase
Intensity (For
Experienced
CEFALY
Users) and
electrode
detection | Present | Absent | Different |
| Visual
Indicators for
low battery and
electrode
detection | Present | Absent | Different |
| Electrode | | | |
| Dimensions | 94 mm x 20 mm | 94 mm x 20 mm | Equivalent |
| RFID tag | Present | Not Present | Different |
| Electrode Metal
plate (tinplate)
thickness | 1 mm | 0.4 mm | Different |
| Electrode Gel
used | Acrylic Hydrogel | Acrylic Hydrogel | Equivalent |
| Packaging Configuration | | | |
| Gift Box | Made of cardboard,
has a magnetic latch,
artwork, and label. | A white box made
of cardboard, no
magnetic latch and
no artwork. The
white box slides
inside a sleeve that
has artwork and
label. | Different |
| Storage Case | The storage case
contains a USB
cable, charging
dock, device, user
manual, Instruction
guide, and resealable
bag consisting of
electrodes | The storage case
contains a USB,
charging adapter,
and electrode inside.
The device is on a
cardboard sheet on
top of the storage
case. User
manual(s) are below
the case. | Different |
| Number of
electrodes
provided with
the device | Three (3) | One (1) | Different |
| Electrode
storage | Resealable bag | Non- resealable bag | Different |

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Image /page/33/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a dark gray color. There is a small circle to the right of the letter Y, indicating that it is a registered trademark.

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Image /page/34/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is horizontally oriented and centered in the image. There is a small trademark symbol to the right of the letter Y.

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Image /page/35/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. A small trademark symbol is located to the right of the letter "Y".

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Image /page/36/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word appears to be a logo or brand name. There is a trademark symbol to the right of the letter Y.

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Image /page/37/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and there is a small circle to the right of the letter Y.

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Image /page/38/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and there is a trademark symbol to the right of the letter Y.

Similarities between Subject Device and Predicate Device 5.6.4.1.

The intended use is the same for the Subject and the . Predicate Devices and both devices are meant for Prescription use.
. Treatment Programs - Waveform characteristics and output specifications are same for both the Subject and Predicate Device.
The Channels are the same for both the Subject and ● Predicate Devices.
Maximum output voltage is the same for both Subject and . Predicate Devices.
Maximum output current is the same for both Subject and . Predicate Devices.
The Power source (Battery) is the same for both Subject . and Predicate Devices.
The Pulse duration, Maximum phase charge and Type of . impedance monitoring system is the same for both Subject and Predicate devices.
The dimensions and patient contacting material used in the ● electrode is same for both Subject and Predicate devices.

Differences between Subject Device and Predicate Device 5.6.4.2.

The RFID tag is added to electrode for Subject Device for . electrode detection and, electrode metal plate thickness in Subject Device (1mm) is different from Predicate Device (0.4mm).
The weight and dimensions of the Subject device is ● different from Predicate Device.

39

The Audio and Visual Indication for low battery, bluetooth ● and electrode detection in the Subject device is different from Predicate device.
The charging system in the Subject Device is different in ● terms of the design and the characteristics of input power. The Charging system of the Subject Device receives DC input from an AC/DC adapter while the charging system in the Predicate Device consists of an AC/DC adapter that receives AC input. However, both charging systems provide identical DC output voltage to the neurostimulator. The safety of the charging system in the Subject Device owing to the differences in design characteristics compared to that in the Predicate Device, is demonstrated by performance testing according to IEC 60601-1.
The packaging configuration of Subject and Predicate . devices are different. However, it does not raise new questions about safety and efficacy.

5.7. PERFORMANCE TESTING - BENCH

The following bench performance testing was carried out for the devices in the Cefaly® Dual series to evaluate the safety and efficacy of the devices due to the changes made over the Predicate Device:

Table 5.7.1 : List of Tests Performed - Cefaly® Dual Series
Testing Type	Test Description	Test Result
Electrical Safety and
Electromagnetic
Compatibility
Testing	IEC 60601-1:2005+
AMD 1 Edition 3.1, 2012-08 IEC 60601-1-2
Edition 4.0	Electrical safety and
EMC evaluation were
performed on the Cefaly®
Dual Series according to
following
FDA-recognized and
other international
standards.

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| | 2014-02

IEC 60601-1-11 Edition 2.0 2015-01
IEC 60601-2-10 Edition 2.1 2016-04 |
|--|-----------------------------------------------------------------------------------------|
|--|-----------------------------------------------------------------------------------------|

Adhesion testing was carried out to evaluate the adhesion performance of the Cefaly electrodes when used with the Subject Devices. The test results demonstrated that the electrodes function as intended when used and replaced in accordance with the IFU, and that there are no new or different questions related to safety and efficacy of the Subject Device.

5.8. PERFORMANCE TESTING -ANIMAL

No animal testing was required to justify the differences with the corresponding Predicate Devices.

PERFORMANCE TESTING - CLINICAL 5.9.

No clinical testing was required to justify the differences with the corresponding Predicate Devices.

5.10. COMPLIANCE WITH SPECIAL CONTROLS

Cefaly Technology complies with all applicable special controls for 21 CFR 882.5891. The special controls and corresponding compliance are listed below:

1. The patient-contacting components of the device must be demonstrated to be biocompatible - The material and manufacturing methods remain the same to that of the Predicate Devices, therefore the biocompatibility continues to be met as per K201895.
1. Appropriate analysis/testing must validate electromagnetic compatibility and electrical, mechanical, and thermal safety - Electrical safety and Electromagnetic compatibility testing for Cefaly® Dual Series was

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Image /page/41/Picture/0 description: The image shows the word "CEFALY" in a sans-serif font. The letters are a muted gray color. The word is all capitalized and there is a trademark symbol after the letter Y.

conducted in compliance with IEC 60601-1 and IEC 60601-1-2 standards and the results were found to be satisfactory.

1. 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 (uC) per pulse, maximum phase charge at 500 ohms, maximum current density (mA/cm2, r.m.s.), maximum average current (mA), maximum average power density (W/cm2), and the type of impedance monitoring system must be fully characterized - The Cefaly® Dual Series devices have an electrical impedance monitoring system. Characterization of all the required technical parameters of the device was provided, and verification and validation tests were performed in accordance with IEC 60601-2-10 for Cefaly® Dual Series devices.
Electrical performance, adhesive integrity, shelf life, reusability, and 4. current distribution testing of the electrodes must be conducted - Electrical performance, adhesive integrity, reusability, and current distribution testing was conducted for Cefaly® Dual Series and the results were found to be satisfactory. Nothing that affects the shelf life of the Cefaly® Dual Series was changed, and the shelf life continues to be the same as that of the Predicate Devices.
1. Appropriate software verification, validation, and hazard analysis must be performed - Device Hazard Analysis and Software V&V were conducted for Cefaly® Dual Series and the results were found to be satisfactory.
1. Clinical performance data must demonstrate that the device is safe and effective as a treatment for headache in the indicated patient population -Indications for use, intended patient population, and technological characteristics of the Subject Device remain unchanged as compared to the Predicate Devices. The differences between the Subject and the Predicate Devices do not have an impact on the clinical performance and it continues to be the same as that of the Predicate Devices.
1. Labeling for Cefaly® Dual Series devices includes the following:

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Appropriate contraindications such as not for use in subjects with a. an implanted metallic or electronic device in the head, a cardiac pacemaker, or an implanted or wearable defibrillator.
b. 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
Appropriate precautions such as the long-term effects of chronic C. use of the device are unknown.
d. A summary of the expected risks and benefits of using the device.
A summary of the clinical performance data, including information e. on the patient population for which the device has and has not been demonstrated to be effective, and any adverse events and complications.
f. Information on how the device operates and the typical sensations experienced during treatment
A detailed summary of the device technical parameters . g.
h. An expiration date/shelf life for the electrodes and the number of times they can be reused.
1. Disposal instructions

For all the aforementioned (a through i) labeling requirements, appropriate information and instructions have been provided in the labeling of the Subject Device.

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CONCLUSION 5.11.

Cefaly® Dual Series is substantially equivalent to the Predicate Device Cefaly® Dual in terms of technological characteristics, system operating range and indications for use. CEFALY Technology has concluded that the performance data obtained by evaluation of the Subject Device to the international standards demonstrate the safety and effectiveness of the Subject Device and justify substantial equivalence with the corresponding Predicate Devices.

CEFALY Technology K212071