CEFALY Connected - OTC, CEFALY Connected - Rx

K234029 · Cefaly Technology · PCC · Jul 18, 2024 · Neurology

Device Facts

• Record ID: K234029
• Device Name: CEFALY Connected - OTC, CEFALY Connected - Rx
• Applicant: Cefaly Technology
• Product Code: PCC · Neurology
• Decision Date: Jul 18, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5891
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cefaly Connected - OTC is indicated for: 1. 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 Connected - Rx is indicated for: 1. Acute treatment of migraine with or without aura in patients 18 years of age or older 2. Prophylactic treatment of migraine in patients 18 years of age or older

Device Story

CEFALY Connected (OTC/Rx) is a non-invasive, portable transcutaneous electrical nerve stimulator worn on the forehead via self-adhesive electrode to treat migraines. Device consists of a neurostimulator and the 'CeCe Migraine Management App' on a personal smartphone/tablet. The neurostimulator delivers biphasic, rectangular, fully compensated, symmetrical electrical pulses (100Hz for acute, 60Hz for prevent). The mobile app communicates via Bluetooth to allow users to start/stop sessions, control intensity, and monitor progress. The app also logs migraine triggers, symptoms, and treatment history to generate trends/insights. The neurostimulator functions independently of the app; app controls are supplementary and can be overridden by physical buttons on the device. Used in home environments by patients. Benefits include migraine management and tracking. Healthcare providers can review exported PDF reports of patient-logged data to inform clinical decision-making.

Clinical Evidence

No clinical studies have been conducted for the subject device. Substantial equivalence is supported by bench testing, software verification, and validation.

Technological Characteristics

Neurostimulator: 1-channel, 3.7V LiPo battery, 25g, 66x47x17mm. Waveform: Biphasic, rectangular, fully compensated, symmetrical. Output: 0-16mA amplitude, 505µs pulse duration. Electrodes: Acrylic hydrogel, 94x20mm. Connectivity: Bluetooth. Software: Mobile application (iOS/Android) for remote control and data logging. Sterilization: Not specified.

Indications for Use

Indicated for acute and preventative/prophylactic treatment of migraine with or without aura 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 Series (Cefaly® Dual Enhanced with RFID - Rx, Cefaly® Dual Enhanced with RFID - OTC, Cefaly® Dual Connected - Rx and Cefaly® Dual Connected - OTC) (K212071)

Submission Summary (Full Text)

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July 18, 2024

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

Re: K234029

Trade/Device Name: CEFALY Connected - OTC, CEFALY 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: June 18, 2024 Received: June 18, 2024

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Jitendra V. Virani -S

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

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#### Indications for Use

Submission Number (if known)

K234029

Device Name

CEFALY Connected - OTC, CEFALY Connected - Rx

Indications for Use (Describe)

Cefaly Connected - OTC is indicated for:

- 1. 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 Connected - Rx is indicated for:

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

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Image /page/3/Picture/0 description: The image contains the logo for "CEFALY Technology". The word "CEFALY" is in large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font, inside of a rounded rectangle. The logo is in a dark gray color, and the background is white. There is a registered trademark symbol next to the "Y" in "CEFALY".

#### 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: [e-mail] Summary Prepared: Jul 18, 2024

#### DEVICE INFORMATION 2.

Common/Usual name: Transcutaneous electrical nerve stimulator to treat headache

Trade Name: CEFALY Connected - OTC, and CEFALY Connected - Rx

Regulation Name: Transcutaneous electrical nerve stimulator to treat headache

Regulation Number: 21 CFR Part 882.5891

Regulatory Class: Class II

Classification Panel: Neurology

Product Code: PCC

#### 3. PREDICATE DEVICE INFORMATION

The Predicate Device is listed in Table 1

#### Table 1 - Predicate Device

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| Predicate Device Name | Manufacturer | Predicate Priority | 510K Number | Regulatory Information |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|--------------------|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cefaly® Dual Series<br>(Cefaly® Dual<br>Enhanced with RFID -<br>Rx, Cefaly® Dual<br>Enhanced with RFID -<br>OTC, Cefaly® Dual<br>Connected - Rx and<br>Cefaly® Dual<br>Connected - OTC) | CEFALY<br>Technology | Primary | K212071 | Regulation Name:<br>Transcutaneous<br>electrical nerve<br>stimulator to treat<br>headache<br><br>Regulation<br>Number: 21 CFR<br>Part 882.5891<br><br>Regulatory Class:<br>Class II<br><br>Classification<br>Panel: Neurology<br><br>Product Code:<br>PCC |

The Predicate Device is not subject to recall by the FDA.

For this submission, the subject device has been compared with the Cefaly® Dual Connected - Rx and the Cefaly® Dual Connected - OTC of K212071, to demonstrate substantial equivalence.

#### DEVICE DESCRIPTION 4.

CEFALY Connected - Rx and CEFALY Connected - OTC consists of neurostimulators, Cefaly Electrodes, and mobile application. The neurostimulators are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraines similar to Cefaly® Dual Connected - Rx, and Cefaly® Dual Connected - OTC of K212071.

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Image /page/5/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, bold, gray letters. Below that, the word "TECHNOLOGY" is in smaller, white letters on a gray rounded rectangle.

The mobile application, CeCe Miqraine Management App, is a two-way communicatinq, mobile application, installed and run on users' personal mobile devices such as smartphone or tablet. The app is compatible with neurostimulators of CEFALY Connected devices (Rx and OTC). The mobile application communicates with the neurostimulator through Bluetooth and allows users to track the treatments.

This application software allows the users:

- to select a treatment mode (Acute/Prevent)
- to start or stop a treatment session
- to control treatment intensity ●
- to monitor treatment sessions in real-time including time elapsed, the neurostimulator's battery level, Bluetooth connection status
- to log preventative treatment data such as time/date, duration, and treatment intensity
- to maintain (log or record) migraine diary (information), where user can log migraine triggers and symptoms
- to view device status such as the device's battery level, connection state, and user notifications such as the following push notifications
- O reminders scheduled by the user to do a PREVENT treatment, track the treatment session, log a migraine episode
- informs users when the intensity is ramping up and the intensity is o stabilized.

All the above functions are available only to registered users who have successfully paired their neurostimulator.

The above functions are further elaborated below:

- 1. Selecting treatment mode

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Image /page/6/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif font. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif font, set against a gray, rounded rectangle. A registered trademark symbol is located to the right of the letter "Y" in "CEFALY".

## 510(k) Summ K234029

This feature allows the user to select the preferred treatment mode such as Acute or Preventative.

- 2. Starting/Stopping treatment
This feature allows the user to initiate ACUTE or PREVENT treatment sessions alternatively, using the app user interface. Treatment sessions once initiated using the app can run and terminate independently of the app. The app also sends push notifications of treatment activity.

- 3. Controlling treatment intensity
This function allows the user to, as an alternative to the control button on the neurostimulator, increase or stabilize treatment intensity and displays a real-time variation of the intensity level on the app user interface. The treatment control buttons operate exactly the same manner as the control button on the neurostimulator.

- 4. Monitoring Treatment session
During a treatment session, users can view the treatment intensity graphically, the time remaining for the treatment session, the battery status of the CEFALY Connected Device paired with the smartphone, and the status of the Bluetooth Connection between the smartphone and the neurostimulator. The mobile application sends push notifications to the smartphone to inform them about active treatment sessions when the app is running in the background.

- ട്. Logging Treatment information
Users of the mobile application can record information about treatments undergone using both CEFALY Connected devices and other modes such as drugs. This information is used to create data points for visuals on migraine treatment information.

- 6. Logging Migraine information
Users of the mobile application can record information related to

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Image /page/7/Picture/0 description: The image shows the logo for CEFALY Technology. The word "CEFALY" is in large, gray, sans-serif font. Below it, the word "TECHNOLOGY" is in smaller, white, sans-serif font on a gray, rounded rectangle. The registered trademark symbol is next to the Y in CEFALY.

migraines experienced, such as symptoms, maximum pain intensity, migraine triggers, Location of pain, medication or non-drug treatments taken, overall treatment effectiveness, and additional notes about the treatment(s). This information is used to create data points for visuals on trends and patterns in the user's migraine journey.

- 7. Generating Insights/Trends
This feature displays the graphical data that includes:

- The three most common triggers over set time .
- Intensity of migraine over set time .
- . Maximum intensity reached during preventative CEFALY sessions over a set time
- . Migraine frequency over set time
- The average duration of migraine attacks over a set time
- Treatment intensities over set time ●
- . Type of drug and non-drug treatment information logged by the user corresponding to the historical migraine attacks
- . Average effectiveness based on user-provided ratings each time they log historical migraine attacks

The graphical data is generated based solely on user inputs, i.e., when users fill out the migraine logs and/or the preventative treatment logs.

- 8. Export to PDF
This feature allows the following information regarding the health condition (based on user inputs)to be reported:

- . Patient-specific statistics related to existing migraine based on information collected during user registration on the application

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- Trends based on Migraine triggers, location of pain, symptoms, . frequency per day of the week, and intensity based on information collected during user registration on the application.
- . Trends of Acute and Preventative treatments used during migraine attacks
- . Evolution of the symptoms based on Migraine Frequency, Intensity, Average Duration, Acute and preventative Treatments, Average treatment Effectiveness over time
- . Evolution of migraine treatments, triggers, and symptoms, based on categories such as top 3 Acute and Preventative treatments of migraine

Most of the device functions are the same as the device functions cleared in K212071. The changes made include adding more functions to the mobile application. The differences between the mobile application of the Subject Device and the version submitted in K212071 are as follows:

- . The mobile application of the Subject Device has 2-way communication allowing the app to start/stop treatment sessions, and control (increase/stabilize) intensity as an alternative to the control button on the neurostimulator.
- Push notifications to users, suggesting them to undertake . Prevent Treatment as scheduled by them and inform users when the intensity is ramping up and the intensity is stabilized
- Log historical preventative treatment data using the Cefaly . device, namely time, date, duration, and treatment intensity, in addition to the acute treatment data using the Cefaly device

#### INDICATIONS FOR USE 5.

Cefaly Connected - OTC is indicated for:

- 1. Acute treatment of migraine with or without aura in patients 18 years of

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age or older

- 2. Preventative treatment of migraine in patients 18 years of age or older
Cefaly Connected - Rx is indicated for:

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

#### TECHNOLOGICAL CHARACTERISTICS 6.

| 6.1. Comparison of Technological Characteristics between Subject | | |
|------------------------------------------------------------------|--|--|
| and Predicate Devices | | |

| Comparison for the mobile application component | | | |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Parameters | Subject Device | Primary Predicate Device:<br>Cefaly® Dual Connected -<br>OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence |
| Device Physical<br>status | Mobile Application | Mobile Application | Equivalent |
| Major app<br>functionalities | Remote treatment session control of hardware through Bluetooth interface Treatment log Migraine log | Treatment log Migraine log PDF Download of trends and patterns | Different |
| Comparison for the mobile application component | | | |
| Parameters | Subject Device | Primary Predicate Device:<br>Cefaly® Dual Connected -<br>OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence |
| | PDF Download of<br>trends and patterns | | |
| User Interface:<br>Treatment<br>Session Controls | Start/stop treatment<br>sessions Increase intensity Stabilize intensity | No Treatment session controls<br>available | Different |
| Monitoring<br>treatment<br>progress | Visually Monitor progress of<br>treatment sessions through<br>app user-interface in<br>addition to the audio-visual<br>indications on the hardware | Visually monitor progress of<br>treatment sessions through<br>app user-interface in addition<br>to the audio-visual indications<br>on the hardware | Equivalent |
| Treatment Logs | Patient-reported | Patient-reported | Equivalent |
| Migraine logs | Patient-reported | Patient-reported | Equivalent |
| Migraine report | PDF report consisting of<br>trends and patient-specific<br>statistics based on user | PDF report consisting of trends<br>and patient-specific statistics<br>based on user reported | Equivalent |
| Comparison for the mobile application component | | | |
| Parameters | Subject Device | Primary Predicate Device:<br>Cefaly® Dual Connected -<br>OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence |
| | reported migraine<br>information, acute and<br>preventative treatments,<br>which can be saved and<br>shared with a healthcare<br>provider | migraine information, acute<br>and preventative treatments,<br>which can be saved and<br>shared with a healthcare<br>provider | |
| User<br>authentication | User authentication via<br>account creation and login<br>process | User authentication via<br>account creation and login<br>process | Equivalent |
| Graphical Data | Data graphs displaying<br>number of migraines<br>experienced, migraine pain<br>intensity, location,<br>symptoms, triggers, drug/<br>non-drug treatments,<br>frequency of treatments,<br>distribution of migraines<br>across a specified timeframe<br>(months, weeks, etc.),<br>trends in triggers,<br>medications reported, and<br>treatment intensity of | Data graphs displaying number<br>of migraines experienced,<br>migraine pain intensity,<br>location, symptoms, triggers,<br>drug/ non-drug treatments,<br>frequency of treatments,<br>distribution of migraines across<br>a specified timeframe (months,<br>weeks, etc.), trends in triggers,<br>medications reported, and<br>treatment intensity of CEFALY<br>treatment sessions | Equivalent |
| Comparison for the mobile application component | | | |
| Parameters | Subject Device | Primary Predicate Device:<br>Cefaly® Dual Connected -<br>OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence |
| | CEFALY treatment sessions | | |
| Indicators on<br>app interface | Visual (textual indicators in<br>form of pop-ups, banners,<br>push notifications,<br>information display)<br>indicators for:<br>1. On/off status<br>2. Battery charge status in<br>terms of remaining<br>charge<br>3. Bluetooth Connection<br>state<br>4. Type of treatment<br>program selected during<br>initial selection<br>5. Time remaining for a<br>treatment session to end | Visual (textual indicators in the<br>form of pop-ups, banners,<br>push notifications, information<br>display) indicators for:<br>1. On/off status<br>2. Battery charge status<br>in terms of remaining<br>charge<br>3. Bluetooth Connection<br>state<br>4. Type of treatment<br>program selected<br>throughout treatment<br>session<br>5. Time remaining for a<br>treatment session to<br>end<br>6. When the treatment is | Different |
| Comparison for the mobile application component | | | |
| Parameters | Subject Device | Primary Predicate Device:<br>Cefaly® Dual Connected -<br>OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence |
| | 6. Intensity stabilized | in session | |
| | 7. Intensity ramp-up | | |
| | 8. Intensity at 10 mA | | |
| | 9. Intensity at maximum<br>value | | |
| | 10. Reminders to do Prevent<br>Treatment as scheduled<br>by user | | |
| Option to Log<br>historical<br>preventative<br>treatment data<br>using the Cefaly<br>Device | Available | Unavailable | Different |

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Image /page/13/Picture/0 description: The image shows the logo for CEFALY. The word "CEFALY" is in large, gray, sans-serif font. Below that, the word "TECHNOLOGY" is in a smaller, white, sans-serif font, set against a gray rounded rectangle.

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Image /page/14/Picture/0 description: The image contains the logo for "CEFALY TECHNOLOGY". The word "CEFALY" is in a large, bold, sans-serif font, and the word "TECHNOLOGY" is in a smaller, sans-serif font and is set within a gray rounded rectangle. The registered trademark symbol is present to the right of the word "CEFALY".

| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------|--|
| Parameters | Subject Device | Primary Predicate<br>Device:<br>Cefaly® Dual Connected<br>- OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence | |
| Device button functions | Start treatment sessions Increase intensity Stabilize intensity Initiate Bluetooth connection | Start Treatment sessions Increase intensity Stabilize intensity Initiate Bluetooth connection | Equivalent | |
| Bluetooth | Yes | Yes | Equivalent | |
| Charging System | Charging dock,<br>Power adapter and<br>USB Cable. | Charging dock,<br>Power adapter and<br>USB Cable. | Equivalent | |
| Power Source | 1 rechargeable LiPo | 1 rechargeable LiPo | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
| Parameters | Subject Device | Primary Predicate<br>Device: | Equivalence | |
| | | Cefaly® Dual Connected<br>- OTC, and,<br>Cefaly® Dual Connected<br>-Rx | | |
| | 3.7 V battery | 3.7 V battery | | |
| Weight | 25 grams | 25 grams | Equivalent | |
| Dimensions | 66 mm x 47 mm x 17<br>mm | 66 mm x 47 mm x 17 mm | Equivalent | |
| Channels | 1 | 1 | Equivalent | |
| Treatment | 2 programs: | 2 programs: | Equivalent | |
| Programs | • Program 1 - | • Program 1 - | | |
| | The acute treatment of<br>Migraine attacks | The acute treatment of<br>Migraine attacks | | |
| | • Program 2 - | • Program 2 - | | |
| | The prevent treatment of | The prevent treatment of | | |
| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
| Parameters | Subject Device | Primary Predicate<br>Device:<br>Cefaly® Dual Connected<br>- OTC, and,<br>Cefaly® Dual Connected<br>-Rx | Equivalence | |
| | migraine | migraine | | |
| Waveform | Biphasic | Biphasic | Equivalent | |
| Shape | Rectangular | Rectangular | Equivalent | |
| | Full compensated | Full compensated | Equivalent | |
| | Symmetrical | Symmetrical | Equivalent | |
| Net charge (µC)<br>per pulse | 0 | 0 | Equivalent | |
| Maximum output<br>voltage (V): | | | | |
| At 500 ohms | 8 | 8 | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
| Parameters | Subject Device | Primary Predicate<br>Device: | Equivalence | |
| | | Cefaly® Dual Connected<br>- OTC, and,<br>Cefaly® Dual Connected<br>-Rx | | |
| At 2,000 ohms | 32 | 32 | | |
| At 10,000 ohms | 60 | 60 | | |
| Maximum output<br>current (mA): | | | | |
| At 500 ohms | 16 | 16 | Equivalent | |
| At 2,000 ohms | 16 | 16 | Equivalent | |
| At 10,000 ohms | 6 | 6 | Equivalent | |
| Pulse duration<br>(μs) | 505 | 505 | Equivalent | |
| Maximum Phase<br>Charge (μC) @<br>500 Ohms | 4 | 4 | Equivalent | |
| Type of<br>impedance<br>monitoring<br>system | Electrical | Electrical | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
| Parameters | Subject Device | Primary Predicate<br>Device: | Equivalence | |
| | | Cefaly® Dual Connected<br>- OTC, and,<br>Cefaly® Dual Connected<br>-Rx | | |
| Maximum<br>current density<br>(mA/cm2<br>, r.m.s.)<br>at 500 ohms | 2.37 | 2.37 | Equivalent | |
| Treatment Programs output specifications - Program 1 | | | | |
| Amplitude | 0 - 16 mA | 0 - 16 mA | Equivalent | |
| Pulse width | 250 µs, fixed | 250 µs, fixed | Equivalent | |
| Pulse frequency | 100 Hz, fixed | 100 Hz, fixed | Equivalent | |
| Session duration | 60 minutes | 60 minutes | Equivalent | |
| Maximum<br>average current<br>(average absolute<br>value, mA) at<br>500 ohms | 0.8 | 0.8 | Equivalent | |
| Maximum<br>average power<br>density (W/cm2) | 0.000047 | 0.000047 | Equivalent | |
| Comparison for the neurostimulator used with the Subject Device and the Predicate<br>Device | | | | |
| Parameters | Subje…