CURRENT REGULATORY PATHWAY
In EU countries, Cranial Electrotherapy Stimulator (CES) devices is reviewed through Medical Device Directive MDD 93/42/EEC. According to the Medical Device Directive MDD 93/42/EEC, the NeuroCes™ is an active medical device (Class IIa medical device in accordance with MDD Annex IX – “Classification Criteria” Rule 9). NeuroCes™ has been CE Certified by the Notified Body 1304 Slovenian Institute of Quality and Metrology (SIQ).
In USA, these devices are currently reviewed through the 510(k) pathway, and are allowed onto the market if their indications for use and technological characteristics are determined to be “substantially equivalent” to a legally marketed predicate device.
Cranial Electrotherapy Stimulation is defined by FDA in its regulation (21 CFR 882.5800) as “a device that applies electrical current to a patient's head to treat insomnia, depression, or anxiety”.
NeuroCes™ is indicated for the treatment of anxiety, insomnia and depression. NeuroCes™ CES treatment has been available in doctor’s offices, clinics, and hospitals, and for home use.
NeuroCes™ who draws advantages from the wealth of knowledge established over time has been designed to combine state-of-the-art technologies with advanced Cranial Electrotherapy Stimulation technique. The NeuroCes™ is a small and portable handheld battery powered medical device with a 1.8” LCD display, wire with touch proof socket for connecting to the ear clip electrodes and five control buttons.
NeuroCes™ has three basic components. The first is the main unit that houses the electronics. This is responsible for generating the electrical stimulation that is delivered to the patient. This contains the controls with which the patient or physician can select the session time and adjust the stimulation intensity.
The second and third components are the Ear Clip Electrodes, which are clipped on the ear lobes and the Lead wire.
NeuroCes™ Main Unit
Ear Clip Electrode
Sizes : 115 x 68 x 22 mm
Weight : 155 g (with batteries)
Software : NeuroCes™ Embedded Software, Version 1.0.0
Device Common Name : Cranial Electrotherapy Stimulator (CES)
Batteries : 3 x AA 1.5 Volt Alkaline Batteries
Timer : 20, 40 or 60 minute countdown timers.
Current : 0 to 500 microamperes (μA) adjustable in 50 μA increments.
Frequency : 0.5 Hz (pulses per second).
Waveform : Square
NeuroCes™ fulfilled the requirements of the following standard(s) or normative document(s):
EN ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes.
EN ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
EN ISO 14971: Medical devices - Application of risk management to medical devices
EN 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
EN 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
EN 62304: Medical device software - Software life-cycle processes.