(62 days)
Not Found
No
The description focuses on electrical nerve stimulation and does not mention any AI/ML components or algorithms.
Yes
The device is indicated for the acute and prophylactic treatment of migraine, and its description explicitly states that it "generates an analgesic effect and is intended to treat migraine headaches."
No
The device description indicates it is a transcutaneous electrical nerve stimulator for treating migraine, not for diagnosing it. It "generates an analgesic effect and is intended to treat migraine headaches."
No
The device description explicitly states it is a "supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead" and describes physical components like a self-adhesive electrode, a rechargeable battery, and a button, indicating it is a hardware device.
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. It works by applying electrical impulses to the forehead to stimulate nerves and treat migraine headaches. It does not involve the analysis of any biological specimens.
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 is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.
The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically.
The electrical impulses generated by the Cefaly® Dual device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (VI). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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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November 28, 2017
CEFALY Technology Jean-Yves Mignolet R&D Manager Rue Louis Plescia, 34 Seraing, BE 4102 Liege
Re: K173006
Trade/Device Name: Cefaly® Dual Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous Electrical Nerve Stimulator To Treat Headache Regulatory Class: Class II Product Code: PCC Dated: September 25, 2017 Received: September 27, 2017
Dear Jean-Yves Mignolet:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
William J. Heetderks -S 2017.11.28 12:38:40 -05'00'
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173006
Device Name Cefaly® Dual
Indications for Use (Describe)
The Cefaly® Dual is indicated for:
-
The acute treatment of migraine with or without aura in patients 18 years of age or older.
-
The prophylactic treatment of episodic migraine in patients 18 years of age or older.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5
510(k) Summary
5.1. Submitter information
Submitter Name: CEFALY Technology Address: Rue Louis Plescia, 34 4102 Seraing BELGIUM + 32 4 367 67 22 Phone: + 32 4 367 67 02 Fax: Contact Person: Jean-Yves MIGNOLET (R&D Manager) This summary was prepared on: September 25, 2017
5.2. Device information
Device Trade or Proprietary Name: Cefalv® Dual Device Common or Usual Name (Regulation Description): Transcutaneous electrical nerve stimulator to treat headache Device Classification Name: Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (21 CRF 882.5891. Product Code PCC) Device Class: Class II
5.3. Substantial equivalency
Substantial Equivalency is claimed against the following legally marketed devices:
In particular, while the Cefaly® Acute has one stimulation program indicated for the acute treatment of migraine with or without aura and the Cefaly® has one stimulation program indicated for the prophylactic treatment of episodic migraine, the Cefaly® Dual device combines the output modes (stimulation programs) of the two predicate devices. Consequently, the Cefaly® Dual combines the indications for use of the two predicate devices (see Section 5.5).
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ww.cefalv-technology.com
5.4. Description of the device
The Cefaly® Dual device is a supraorbital transcutaneous electrical nerve stimulator device to be applied on the forehead. A self-adhesive electrode with 2 conductive zones is placed on the forehead. This double electrode is directly connected to the device.
The Cefaly® Dual is operated by a rechargeable battery. A pressure on the single button allows selecting and starting a stimulation program, which runs automatically.
The electrical impulses generated by the Cefaly® Dual device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials on) the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (VI). Therefore, the supraorbital neurostimulation is also known as external trigeminal nerve stimulation. The supraorbital neurostimulation generates an analgesic effect and is intended to treat migraine headaches.
5.5. Indications for use of the device
The indications for use of the Cefaly® Dual are:
- The acute treatment of migraine with or without aura in patients 18 years of age or older,
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
5.6. Summary of the technological characteristics of the Cefaly® Dual in comparison with the predicate Cefaly® Acute and Cefaly® devices
The Cefaly® Dual device is significantly equivalent to the legally marketed devices Cefaly® Acute (K171446) and Cefaly® (K160237) in terms of technological characteristics (design, material, energy source), except for the button color, and it combines the output modes of the two predicate devices. In particular, while each predicate device offers a single stimulation program for given indications for use, the Cefaly® Dual offers these two different stimulation programs in a single device, and each stimulation program is associated with its specific FDA-approved indications for use.
The Cefaly® Dual device is made of a plastic casing identical to that of the predicate Cefaly® Acute and Cefaly® devices. Only the button color is changed to easily differentiate three devices. It works with the same electrode as the predicate devices. It is powered by the same battery. The electronics inside the device is also the software has been adapted. The Cefaly® Dual device delivers biphasic impulses of the same pulse shape and width (250 us)
5
Rue Louis Plescia. 3 4102 Seraing - BELGIUM Tél.: +32 4 367 67 22 Fax: +32 4 367 67 02 www.cefaly-technology.com
than the predicate devices. The repetition frequency of the Cefaly® Dual device depends on the selected stimulation program. For the program indicated for the acute treatment of migraine (Program 1), the frequency is 100 Hz, as for the Cefaly® Acute. For the program indicated for the prophylactic treatment of episodic migraine (Program 2), the frequency is 60 Hz, as for the Cefaly®.
| Cefaly® Acute | Cefaly® | Cefaly® Dual | |
|---|---|---|---|
| 510 (k) Number | K171446 | K160237 | K173006 |
| Manufacturer | CEFALY Technology | CEFALY Technology | CEFALY Technology |
| Weight | 12 g | 12 g | 12 g |
| Dimensions | 55 mm x 40 mm x 15 mm | 55 mm x 40 mm x 15 mm | 55 mm x 40 mm x 15 mm |
| Housing materials | Plastic PC | Plastic PC | Plastic PC |
| Electrodes | Cefaly® electrode | Cefaly® electrode | Cefaly® electrode |
| Power Source | 1 rechargeable LiPo 3.7 V | 1 rechargeable LiPo 3.7 V | 1 rechargeable LiPo 3.7 V |
| battery | battery | battery | |
| Software provided | 1 fixed program for the acute | ||
| treatment of migraine attacks | |||
| (Program 1) | 1 fixed program for the | ||
| prophylactic treatment of | |||
| migraine (Program 2) | 2 fixed programs: |
- 1 fixed program for the
acute treatment of migraine
attacks (Program 1) - 1 fixed program for
prophylactic treatment of
migraine (Program 2) |
| Program 1:
Max. output current
Pulse width
Pulse frequency
Session duration | 16 mA
250 us, fixed
100 Hz, fixed
60 minutes | Not included | 16 mA
250 us, fixed
100 Hz, fixed
60 minutes |
| Program 2:
Max. output current
Pulse width
Pulse frequency
Session duration | Not included | 16 mA
250 us, fixed
60 Hz, fixed
20 minutes | 16 mA
250 us, fixed
60 Hz, fixed
20 minutes |
| Waveform | Biphasic | Biphasic | Biphasic |
| Shape | Rectangular
Full compensated
Symmetrical | Rectangular
Full compensated
Symmetrical | Rectangular
Full compensated
Symmetrical |
| Net charge (µC) per
pulse | 0 | 0 | 0 |
| Maximum output
current (mA):
At 500 ohms
At 2,000 ohms
At 10,000 ohms | 16
1 Q
6 | ા ર
16
6 | 16
16
6 |
| Maximum current
density (mA/cm2,
r.m.s) at 500 ohms | 2.37 | 2.37 | 2.37 |
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| Maximum average
power density
(W/cm2, r.m.s) at
| 500 ohms | 0.000047 | 0.000017 | 0.000047 |
|---|---|---|---|
| ------------------------------------------------------------------- | ---------- | ---------- | ---------- |
5.7. Non-Clinical Performance Testing
The Cefaly® Dual device is compliant to the same international standards as the legally marketed Cefaly® Acute device (K171446) and Cefaly® device (K160237).
| Standards | Cefaly® Acute | Cefaly® | Cefaly® Dual |
|---|---|---|---|
| IEC 60601-1 | Yes | Yes | Yes |
| IEC 60601-1-2 | Yes | Yes | Yes |
| IEC 60601-1-6 | Yes | Yes | Yes |
| IEC 60601-1-11 | Yes | Yes | Yes |
| IEC 60601-2-10 | Yes | Yes | Yes |
| IEC 62366 | Yes | Yes | Yes |
5.8. Conclusion
The subject device is significantly equivalent to the legally marketed predicate Cefaly® Acute and Cefaly® devices.