(453 days)
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No
The description details a TENS device with electrical circuits controlled by firmware, but there is no mention of AI or ML capabilities for data analysis, pattern recognition, or adaptive learning. The device's functionality appears to be based on pre-programmed electrical stimulation protocols.
Yes
The device is indicated for the prophylactic treatment of episodic migraine and intends to stimulate nerves to reduce the frequency of migraine attacks, which is a therapeutic purpose.
No
The device is described as a transcutaneous electrical nerve stimulator (TENS) indicated for the prophylactic treatment of episodic migraine, meaning it is used to prevent or reduce the frequency of migraine attacks, not to diagnose them.
No
The device description clearly states that the Cefaly device consists of two distinct hardware components: an electrical pulse generator (EPG) and a self-adhesive electrode. It describes the materials, power source, and physical connection of these components.
Based on the provided information, the Cefaly device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Cefaly device is a transcutaneous electrical nerve stimulator that is applied to the forehead. It does not analyze any biological samples (like blood, urine, tissue, etc.).
- The intended use is for prophylactic treatment of migraine. This is a therapeutic use, not a diagnostic one. IVDs are used to diagnose, monitor, or screen for diseases or conditions.
- The device description details electrical stimulation. The mechanism of action involves applying electrical pulses to the trigeminal nerve, not analyzing biological markers.
Therefore, the Cefaly device falls under the category of a therapeutic medical device, specifically a nerve stimulator, rather than an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
PCC
Device Description
The Cefaly device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead (Fig. 1A) using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally (Fig. 1B). It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attacks.
The Cefaly device consists of two distinct components: an electrical pulse generator (EPG) and a self-adhesive electrode (Fig. 1). The Cefaly EPG (Fig. 1A) is made of ABS plastic and consists of electrical circuits controlled by firmware and powered by two 1.5V batteries. The front of the Cefaly EPG has a single button that is used to turn the device on/off and also to adjust the intensity of the electrical stimulus during a treatment session. Visual and auditory indicators inform the user when the device is on vs. off and help them troubleshoot if it is not working properly (e.g., device indicates if batteries need replacing and if electrical connection between device and skin is unacceptable). The back of the Cefaly EPG has two metal blades that serve to electrically connect it to the Cefaly electrode.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Cranium, Forehead, over the upper branches of the trigeminal nerve
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study 1: PREvention of MIgraine using the STS CEfaly (PREMICE study)
Methods:
Study type: Prospective, multicenter, double blinded, randomized, and sham-controlled trial.
Sample size: 67 subjects randomized (34 verum group, 33 sham group); 59 completed the study (30 verum group, 29 sham group) for per protocol analysis.
Data source: Conducted in 5 Belgian tertiary headache clinics run by members of the Belgian Headache Society.
Annotation protocol: Subjects filled in diaries recording headache occurrence and its severity on a 4-point scale (0, no pain; 1, mild-not interfering with normal daily activities; 2, moderate-interfering with daily activities; 3, severe pain-prohibiting daily activities), presence of an aura, nausea/vomiting, phonophobia or photophobia, and acute antimigraine drug intake. A migraine day was defined as a day with headache fulfilling ICHD-II criteria for migraine, except for duration if treated. Migraine days not separated by at least one headache-free day were considered to belong to the same migraine attack. A headache of grade 1 severity without associated symptoms and not treated with an acute medication was recorded as "headache," not migraine.
Results:
Co-Primary Endpoints:
- Responder rate (at least 50% reduction of monthly migraine days): 38.2% in the verum group vs. 12.1% in the sham group (p
§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR CEFALY DEVICE
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Transcutaneous Electrical Nerve Stimulator to Treat Headache. 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.
NEW REGULATION NUMBER: 882.5891
CLASSIFICATION: CLASS II
PRODUCT CODE: PCC
BACKGROUND
DEVICE NAME: CEFALY
SUBMISSION NUMBER: K122566
DATE OF DE NOVO: DECEMBER 13, 2012
CONTACT: STX-MED SPRL JEAN-YVES MIGNOLET, RESEARCH AND DEVELOPMENT MANAGER ZI DES HAUNTS SARTS 4E AVENUE 5 HERSTAL, LIEGE BELGIUM, 4040
REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II
INDICATIONS FOR USE
The Cefaly device is indicated for the prophylactic treatment of episodic migraine in patients 18 years of age or older.
LIMITATIONS
For prescription use only.
The Cefaly device cannot be used by an individual who has a cardiac pacemaker or an implanted or wearable defibrillator.
1
The Cefaly device cannot be used by an individual who has an implanted metallic or electronic device in their head.
The Cefaly device should not be used by an individual with chronic migraine, refractory migraine, medication overuse headache, or chronic tension-type headaches. The safety and effectiveness of the device has not been demonstrated for individuals with these conditions.
The Cefaly device should not be applied on the neck or chest, and it should not be used in the presence of electronic monitoring equipment (e.g., cardiac monitors), in the bath or shower, while sleeping, while driving, or while operating machinery.
The long-term effects of using the Cefaly device are unknown.
PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
2
DEVICE DESCRIPTION
The Cefaly device is a transcutaneous electrical nerve stimulator (TENS) that is applied to the forehead (Fig. 1A) using a self-adhesive electrode positioned over the upper branches of the trigeminal nerve bilaterally (Fig. 1B). It is intended to stimulate the upper branches of the trigeminal nerve in order to reduce the frequency of migraine attacks.
Fig. 1 The components of the Cefaly device and how they are meant to be worn during a treatment session. (A) A subject demonstrating the proper location of the Cefaly device in the middle of the forehead. The Cefaly electrical pulse generator (EPG) is shown and the on/off button can be seen in the middle of the EPG. (B) A drawing that illustrates the proper position of the Cefaly self-adhesive electrode over the supratrochlear and supraorbital branches of the trigeminal nerve. A plastic pin in the middle of the electrode slips into a receptacle on the back of the Cefaly EPG. This attachment is designed to mate the metal contact blades in the back of the Cefaly EPG to the conductive surface of the electrode, and thus transfer the electrical stimulus to the subject during a treatment session.
The Cefaly device consists of two distinct components: an electrical pulse generator (EPG) and a self-adhesive electrode (Fig. 1). The Cefaly EPG (Fig. 1A) is made of ABS plastic and consists of electrical circuits controlled by firmware and powered by two 1.5V batteries. The front of the Cefaly EPG has a single button that is used to turn the device on/off and also to adjust the intensity of the electrical stimulus during a treatment session. Visual and auditory indicators inform the user when the device is on vs. off and help them troubleshoot if it is not working properly (e.g., device indicates if batteries need replacing and if electrical connection between device and skin is unacceptable). The back of the Cefaly EPG has two metal blades that serve to electrically connect it to the Cefaly electrode.
3
The Cefaly electrode (Fig. 1B) consists of a patient-contacting layer of gel, a layer of silvercoated carbon, and a layer of cotton. An ABS plastic pin in the middle of the electrode fits securely inside a receptacle in the back of the Cefaly EPG in order to maintain a secure electrical connection during a treatment session. The Cefaly electrode is meant to be used only with the Cefaly EPG, and vice versa. It can be reused a maximum of 20 times.
A treatment session begins by attaching the Cefaly electrode to the middle of the forehead and attaching the Cefaly EPG to the electrode. When the on/off button is depressed, a pulsatile electrical stimulus is applied for 20 minutes. During the first 14 minutes, the intensity of the stimulus gradually increases until it reaches a maximum. At any time while the stimulus intensity is increasing, the user can press the button on the front of the device to select an intensity that is lower than the maximum, and it will remain constant at this lower value for the remainder of the treatment session. The device turns the stimulus off automatically after 20 minutes, or alternatively, the user can stop a treatment session by pressing the button twice or simply removing the device from their forehead. The technical characteristics of the Cefaly device are summarized in Tables 1 and 2.
| Power Source | 2 AAA alkaline batteries, 1.5V each |
|---|---|
| Channels | 1 |
| Software-controlled | Yes, 1 fixed program |
| Constant Current | Yes |
| Automatic overload trip voltage level | Yes |
| Patient override control method | On/Off button on front of device |
| Indicator displays: | |
| Unit functioning | Yes |
| Low battery | Yes |
| Electrical connection | Yes |
| Timer Setting | Yes |
| Weight | 30 g |
| Dimensions | 160 x 170 x 40 mm |
Table 1: Features of the Cefaly device
| Table 2: Output Specifications for the Cefaly device |
|---|
| ------------------------------------------------------ |
| Waveform | Biphasic, rectangular, symmetrical |
|---|---|
| Phase Duration (µsec) | 250 |
| Duration between the two phases (µsec) | 5 |
| Pulse Duration (µsec) | 505 |
| Frequency (Hz) | 60 |
| Net Charge (µC) per pulse | 0 |
| Maximum output voltage (V): | |
| @500 ohms | 8 |
4
| @2000 ohms | 32 |
|---|---|
| @10000 ohms | 60 |
| Maximum output current (mA): | |
| @500 ohms | 16 |
| @2000 ohms | 16 |
| @10000 ohms | 6 |
| Maximum phase charge (µC) @500Ω | 4 |
| Maximum Current Density, (mA/cm², r.m.s.) @500Ω | 2.37 |
| Maximum Average Power Density, (W/cm²) @500Ω | 0.000017 |
| Maximum Average Current (average absolute value, mA) @500Ω | 0.48 |
BIOCOMPATIBILITY/MATERIALS
The patient-contacting surface of the Cefaly electrode is Comfort gel A hydrogel - M807 from R&D Medical. The electrode has limited duration contact (