(83 days)
Not Found
No
The description focuses on electrical nerve stimulation and does not mention any AI/ML components or algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for the acute treatment and prophylactic treatment of migraine, which are therapeutic uses.
No
The device description and intended use clearly state that the Cefaly® Dual is a therapeutic device for the treatment and prophylaxis of migraine, not for diagnosis. It stimulates nerves to create an analgesic effect, rather than to identify a condition.
No
The device description explicitly states it is a "supraorbital transcutaneous electrical nerve stimulator device" and describes hardware components like electrodes, a rechargeable battery, and a button.
Based on the provided information, the Cefaly® Dual device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Cefaly® Dual Function: The description clearly states that the Cefaly® Dual is a "supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead." It works by transmitting electrical impulses to nerves on the forehead to treat migraine headaches.
- No Specimen Analysis: There is no mention of the device analyzing any biological specimens from the patient. Its function is based on external electrical stimulation.
Therefore, the Cefaly® Dual falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
PCC
Device Description
The Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.
The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically.
The electrical impulses generated by the Subject Device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.
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
Over-The-Counter Use
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)
Not Applicable. Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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9/29/2020
CEFALY Technology % Parul Chansoria CEO & Founder, Regulatory Consultant Elexes Medical Consulting 6494 Tralee Village Dr Dublin, California 94568
Re: K201895
Trade/Device Name: Cefaly Dual Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator to Treat Headache Regulatory Class: Class II Product Code: PCC Dated: July 2, 2020 Received: July 8, 2020
Dear Parul Chansoria:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Xiaorui Tang, Ph.D. Interim Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201895
Device Name Cefaly® Dual
Indications for Use (Describe)
The Cefaly® Dual is indicated for
-
The acute treatment of migraine with or without aura in patients 18 years of age or older.
-
The prophylactic treatment of episodic migraine in patients 18 years of age or older.
| Type of Use (Select one or both, as applicable) | Registration Use (Part 21 CFR 201.321 Subpart D) On The Container (21 CFR 201.321 Subpart C) |
|---|---|
| ------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Rue Louis Plescia, 34
4102 Seraing - BELGIUM
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
www.cefaly-technology.com
5.1 SUBMITTER
CEFALY Technology, LIEGE Science Park, Rue Louis Plescia, 34, 4102 Seraing, BELGIUM
Contact Person:
Parul Chansoria, MS, RAC, CQA CEO & Founder, Elexes Medical Consulting Telephone: + 408-475-8091 E-mail: parul@elexes.com
Summary Prepared: June 25, 2020
5.2 DEVICE
Common/Usual name/Regulation Description: Transcutaneous electrical nerve stimulator to treat headache Trade Name: Cefaly® Dual Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine Regulatory Class: Class II Classification Panel: Neurology Product Code: PCC Regulation Number: 21 CFR 882.5891
5.3 PREDICATE DEVICE
Cefaly® Dual is substantially equivalent to the following cleared device:
| Company | Product | 510(k) Number |
|---|---|---|
| CEFALY Technology | Cefaly® Dual | K173006 |
5.4 DEVICE DESCRIPTION
The Cefaly® Dual device indicated for an OTC (also referred to as the Subject Device) is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A
4
Image /page/4/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of the word "CEFALY" in a serif font, with the word "TECHNOLOGY" in a smaller sans-serif font underneath. Above the word "CEFALY" is a red graphic that resembles two curved lines meeting in the middle.
Rue Louis Plescia, 34
4102 Seraing - BELGIUM
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.
The Subject Device is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically.
The electrical impulses generated by the Subject Device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.
5.5 INDICATIONS FOR USE
The indications for use of the Cefaly® Dual for an over-the-counter use are:
- The acute treatment of migraine with or without aura in patients 18 years of age or older; ●
- The prophylactic treatment of episodic migraine in patients 18 years of age or older. ●
5.6 TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Subject Device is identical to the legally marketed Predicate Cefaly® Dual (K173006) in terms of technological characteristics (design, material, and energy source).
The Subject Device is made of a plastic casing identical to that of the Predicate. It works with the same electrode as the Predicate Device. It is powered by the same battery. The electronics inside the device are also the same. The Subject Device delivers biphasic impulses of the same pulse shape and width (250 us) as the Predicate Device. The repetition frequency of the impulses of the Subject Device depends on the selected stimulation program. The frequencies delivered by the Subject Device for the treatment of Migraine is the same as that of the Predicate.
| Parameter | Subject Device
Cefaly® Dual
(indicated for OTC) | Predicate
Cefaly® Dual
(indicated for Rx) | Equivalence |
|--------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | CEFALY
Technology | CEFALY
Technology | - |
| Device Name | Cefaly® Dual | Cefaly® Dual | - |
| 510(k) number | - | K173006 | - |
| Product Code | PCC | PCC | Equivalent |
| Regulation
Number | 882.5891 | 882.5891 | Equivalent |
| Regulatory
Class | II | II | Equivalent |
| Indications
for use | The indications for use
of the Cefaly® Dual for
an over-the-counter
use are:
-The acute treatment of
migraine with or
without aura in patients
18 years of age or
older.
-The prophylactic
treatment of episodic
migraine in patients 18
years of age or older. | The indications for
use of the 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 in patients
18 years of age or
older. | Different
While the clinical
application, the
intended users and
use remains
identical, the
difference is only in
terms of labelling
change where the
Subject Device is to
be indicated for an
OTC use instead of
Rx. |
| Power Source | 1 rechargeable LiPo
3.7 V
battery | 1 rechargeable LiPo
3.7 V
battery | Equivalent |
| Channels | 1 | 1 | Equivalent |
| Software provided | 2 fixed programs: - 1 fixed program for
the acute treatment of
migraine attacks
(Program 1) - 1 fixed program for | 2 fixed programs:
- 1 fixed program for
the acute treatment of
migraine attacks
(Program 1) - 1 fixed program for | Equivalent |
| | prophylactic treatment
of migraine
(Program 2) | prophylactic
treatment of migraine
(Program 2) | |
| Program 1:
Max. output
current
Pulse width
Pulse frequency
Session duration | 16 mA
250 µs,
fixed 100 Hz,
fixed 60 minutes | 16 mA
250 µs,
fixed 100 Hz,
fixed 60 minutes | Equivalent |
| Program 2:
Max. output
current Pulse
width
Pulse frequency
Session duration | 16 mA
250 µs,
fixed 60 Hz,
fixed 20 minutes | 16 mA
250 µs,
fixed 60 Hz,
fixed 20 minutes | 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
current (mA):
At 500 ohms
At 2,000 ohms
At 10,000 ohms | 16
16
6 | 16
16
6 | Equivalent |
| Maximum current
density (mA/cm2,
r.m.s) at 500 ohms | 2.37 | 2.37 | Equivalent |
| Maximum
average power
density (W/cm2, | 0.000047 | 0.000047 | Equivalent |
Table 1: An overview of the Subiect Device w.r.t. thePredicate Device
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Rue Louis Plescia, 34
4102 Seraing - BELGIUM
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
6
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4102 S
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Rue Louis Plescia, 34
4102 Seraing - BELGIUM
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
| r.m.s) at 500 ohms | |
|---|---|
| -------------------- | -- |
Differences
While the clinical application, the intended users and use remains identical, the difference is only in terms of labelling change where the Subject Device is to be indicated for an OTC use instead of Rx.
5.7 NON-CLINICAL STUDY
The Subject Device is compliant to the same international standards as the legally marketed Predicate (K173006). To support the change in the indications for use from an Rx to an OTC use, a Human Factors validation study was conducted with the Cefaly® Dual (Subject Device).
5.8 SOFTWARE
The Subject Device software is identical to the software used in the Predicate Device.
5.9 CLINICAL STUDY
Not Applicable. Clinical performance testing was not performed with the Subject Device to support equivalence, as there are no differences between the Subject Device and the Predicate Device.
5.10 CONCLUSION
The Subject Device is substantially equivalent to the Predicate Device in terms of technological characteristics, system operating ranges, and intended use. The Subject Device is as safe and effective as the Predicate Device (K173006).