(529 days)
Cefaly Dual Connected - OTC and Cefaly Dual Enhanced with RFID - OTC are indicated for:
- Acute treatment of migraine with or without aura in patients 18 years of age or older
- Preventative treatment of migraine in patients 18 years of age or older
Cefaly Dual Connected - Rx and Cefaly Dual Enhanced With RFID - Rx are indicated for:
- Acute treatment of migraine with or without aura in patients 18 years of age or older
- Prophylactic treatment of migraine in patients 18 years of age or older
The Cefaly® Dual Series of devices are small, non-invasive, and portable devices meant to be worn on the forehead using a self-adhesive electrode to treat migraine similar to Cefaly® Dual (K201895 OTC and K173006 R.). The devices are similar in construction and materials and use the same components (electronics and electrical components, and firmware), including the component that comes into patient contact which is the CEFALY® Electrode. The notable differences between the Subject and Predicate devices are Bluetooth technology and mobile application for the purpose of displaying device data, the new docking station, RFID for electrode detection, audio/visual indicators, and the dimensions and the weight of the electrode.
The provided text is a 510(k) premarket notification for the Cefaly Dual Series devices. It details the device's characteristics and compares them to predicate devices to demonstrate substantial equivalence. Crucially, this document does not contain information about a study that proves the device meets specific acceptance criteria in the format typically used for demonstrating the performance of a novel AI/ML-based medical device.
The document states:
- "No animal testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
- "No clinical testing was required to justify the differences with the corresponding Predicate Devices." (page 40)
This indicates that the submission relies on demonstrating substantial equivalence to existing devices through bench testing and comparison of technological characteristics, rather than new clinical performance data to prove efficacy. The changes made to the device (e.g., Bluetooth, RFID, audio/visual indicators, charging system, weight, dimensions, electrode thickness, packaging) are assessed against safety and electrical standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and adhesion performance.
Therefore, I cannot provide the requested information for a study proving acceptance criteria for an AI/ML device because:
- No acceptance criteria for an AI/ML device are listed. The document pertains to a Transcutaneous Electrical Nerve Stimulator, not a device incorporating AI/ML for diagnostic or therapeutic decision-making.
- No study proving device performance against such criteria is presented. The "Performance Testing - Bench" section (Table 5.7.1) lists general electrical and EMC safety standards, and adhesion testing for electrodes, but not performance metrics related to migraine treatment outcomes that would typically be evaluated in a clinical trial.
Without a study described as such in the provided text, I cannot fill in the requested table or additional details. The information provided heavily focuses on hardware changes and their compliance with general safety standards, and substantiates that the functionality of the device (e.g., electrical stimulation parameters) remains equivalent to the cleared predicate devices, thus not requiring new clinical evidence of effectiveness for migraine treatment.
§ 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.