(32 days)
Not Found
No
The summary describes a nerve stimulator with a fixed program and does not mention any adaptive or learning capabilities.
Yes
The device is indicated for the prophylactic treatment of episodic migraine, which is a therapeutic purpose.
No
The device is described as a stimulator for prophylactic treatment of migraine, not for diagnosing any condition.
No
The device description clearly states it is a "supraorbital transcutaneous nerve stimulator device to be applied on the forehead" and includes components like a self-adhesive electrode, a rechargeable battery, and a switch, indicating it is a hardware device that delivers electrical impulses.
Based on the provided information, the Cefaly® 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 about a person's health.
- Cefaly® Description: The description clearly states that the Cefaly® device is a supraorbital transcutaneous nerve stimulator applied to the forehead. It works by transmitting electrical impulses through the skin to stimulate nerves.
- Intended Use: The intended use is for the prophylactic treatment of episodic migraine, which is a therapeutic application, not a diagnostic one based on analyzing biological samples.
The device's mechanism of action and intended use are entirely external and therapeutic, not involving the analysis of in vitro samples.
N/A
Intended Use / Indications for Use
The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Product codes
PCC
Device Description
Cefaly® device is a supraorbital transcutaneous 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.
Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.
The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) 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 a sedative 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
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 4, 2016
CEFALY Technologies Jean-Yves Mignolet R&D Manager ZI des Hauts Sarts 4eme Avenue 5 Herstal, Liege, 4040 Belgium
Re: K160237
Trade/Device Name: CEFALY® Regulation Number: 21 CFR 882.5891 Regulation Name: Transcutaneous electrical nerve stimulator to treat headache Regulatory Class: Class II Product Code: PCC Dated: January 29, 2016 Received: February 1, 2016
Dear Mr. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael J. Hoffmann -A
for Carlos L. Peña, Ph.D., M.S. 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) K160237
Device Name Cefaly®
Indications for Use (Describe)
The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for "CEFALY Technology". The word "CEFALY" is in a larger font than the word "TECHNOLOGY", and the registered trademark symbol is next to the "Y" in "CEFALY". Above the text is a maroon-colored design that looks like two curved lines meeting in the middle.
ZI des Hauts-Sarts
4ème AVENUE N° 5-6
4040 Herstal
BELGIQUE
Tél.: +32 4 367 67 22
Fax: +32 4 367 67 02
Section 6
510(k) Summary
| Submitter Name: | CEFALY Technology |
|---|---|
| Address: | Zoning Industriel des Hauts Sarts, 4e avenue, 5 |
| HERSTAL | |
| B 4040 | |
| BELGIUM | |
| Phone: | + 32 4 367 67 22 |
| Fax: | + 32 4 367 67 02 |
| Contact Person: | Jean-Yves MIGNOLET (R&D Manager) |
| This summary was prepared on: | January 2016 |
Device Trade or Proprietary Name: Cefaly® Device Common or usual name: Supraorbital transcutaneous nerve stimulator
Device Classification Name: Stimulator, Nerve. Electrical, Transcutaneous, For Migraine Classification Product Code: PCC
Substantial Equivalency is claimed against the following legally marketed device: Cefaly®. The De Novo Number is DEN120019 and the 510(k) Number is K122566.
Description of the device:
Cefaly® device is a supraorbital transcutaneous 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.
Cefaly® is operated by a rechargeable battery. A pressure on the single switch starts a program, which runs automatically for 20 minutes.
The electrical impulses generated by the Cefaly® device are transmitted transcutaneously via the supraorbital electrode to excite (trigger action potentials) 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 a sedative effect and is intended to treat migraine headaches.
4
Image /page/4/Picture/0 description: The image shows the logo for CEFALY Technology. The logo consists of the word "CEFALY" in a gray sans-serif font, with the word "TECHNOLOGY" in a smaller font below it. Above the word "CEFALY" are two curved lines that meet in the middle, forming a shape that resembles a roof. The lines are a dark red color.
ww.cefalv-technology.com
Intended use of the device:
The Cefaly® device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
Comparison between the original and the modified, improved version of the Cefaly®:
The intended use and the scientific technology of the modified Cefaly® device are identical to those of the original version of the Cefaly® device. The modified version of the Cefaly® has exactly the same output stimulation parameters than the legally marketed Cefaly®. The device modifications concern the power supply, the dimensional specifications, and the fixing system between the device and the electrode. The risk analysis did not show any unacceptable risk resulting from these device modifications (see Section 15). The modified version of the Cefaly® is therefore as safe and as effective than the legally marketed Cefaly®.