(62 days)
The Cefaly® Dual is indicated for:
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The acute treatment of migraine with or without aura in patients 18 years of age or older.
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The prophylactic treatment of episodic migraine in patients 18 years of age or older.
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.
This document does not contain the detailed information necessary to complete the requested table and provide answers for all points. The provided text is a 510(k) summary for the Cefaly® Dual device, making a claim of substantial equivalence to two predicate devices (Cefaly® Acute and Cefaly®). While it describes the device's technical specifications and indications for use, it does not include the results of a clinical study or performance testing against specific acceptance criteria for efficacy or safety.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and reported device performance:
This information is not available in the provided text. The document focuses on showing the Cefaly® Dual is technically equivalent to its predicates. It does not present clinical performance data or acceptance criteria for that data in this summary.
2. Sample size used for the test set and the data provenance:
This information is not available as no clinical test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not available as no clinical test set or ground truth establishment is described.
4. Adjudication method for the test set:
This information is not available.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not available. The Cefaly® Dual is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The Cefaly® Dual is a medical device, not an algorithm.
7. The type of ground truth used:
This information is not available.
8. The sample size for the training set:
This information is not available as no training set for a machine learning algorithm is mentioned.
9. How the ground truth for the training set was established:
This information is not available.
Summary of what the document does provide:
- Device: Cefaly® Dual, a supraorbital transcutaneous electrical nerve stimulator.
- Indications for Use:
- Acute treatment of migraine with or without aura in patients 18 years of age or older.
- Prophylactic treatment of episodic migraine in patients 18 years of age or older.
- Mechanism of Action: Transmits electrical impulses via a supraorbital electrode to excite supratrochlearis and supraorbitalis nerves (external trigeminal nerve stimulation) to generate an analgesic effect.
- Substantial Equivalence: Claimed against Cefaly® Acute (K171446) and Cefaly® (K160237). The Cefaly® Dual combines the stimulation programs and indications of these two predicate devices.
- Technical Characteristics: Detailed comparison of Cefaly® Dual with its predicates, showing identical physical dimensions, weight, housing materials, electrodes, power source, pulse width, waveform, and net charge per pulse. The key difference is that Cefaly® Dual includes two fixed programs (one for acute treatment at 100 Hz, one for prophylactic at 60 Hz), whereas each predicate only had one.
- Non-Clinical Performance Testing: Cefaly® Dual is compliant with the same international standards (IEC 60601-1, -1-2, -1-6, -1-11, -2-10, IEC 62366) as the predicate devices. This indicates electrical safety, electromagnetic compatibility, usability, and specific requirements for nerve stimulators.
The provided text is a regulatory submission for substantial equivalence based on technical and performance similarities to previously cleared devices, rather than a report on a clinical trial with specific acceptance criteria and outcome measurements for the new device.
§ 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.