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The ATLAS Stim Headbox is a low power, constant current or voltage mode, bi-phasic stimulator intended for cortical or intracranial stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The ATLAS Stim Headbox itself is an accessory to the ATLAS Neurophysiology System and ATLAS STIM Headbox software. The stimulation parameters, the electrodes selection and the activation of the stimulation current are all set-up and controlled from these devices. The ATLAS Stim Headbox can operate only when so connected and with the Pegasus and ATLAS Stim Headbox software; it cannot serve as a stand-alone stimulator.

The ATLAS Stim Headbox (ASHB) is a clinical headbox that allows 3rd party Macro electrode contact electrode arrays (ECoG, depth electrodes, grid array, strip array, etc.) to interface with the Neuralynx ATLAS Neurophysiology System, previously cleared in 510(k) K110967, which includes the Pegasus Software. The ATLAS Stim Headbox is an accessory to the ATLAS Neurophysiology System (formerly known as SpikeTrax in K110967). The ATLAS Stim Headbox hardware consists of an encased amplifier and embedded firmware for generation and delivery of stimulation energy. The ATLAS Stim Headbox can deliver electrical stimulation current under the control of the associated ATLAS Stim Headbox Software which interfaces via a fiber optic ethernet communications connection.

Layer 7-T cortical electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT).

The Layer 7-T is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The electrodes may be placed in either open or burr hole procedures with the optional use of standard imaging techniques such as intraoperative x-ray, fluoroscopy, and computerized tomography (CT). The overall Layer 7-T consists of a sterile thin film 1024-electrode array connected to a more rigid PCB package (known as the headstage) with ribbon cables. Each ribbon cable connects to 64 channels from the electrode array. There are a total of 16 ribbon cables in the headstage, connecting 1024 electrodes on the array. The device is also provided with an intermediary yoke cable that connects the ribbon cables from the Layer 7-T headstage to standard EEG equipment via 64 standard DIN connectors. A yoke stand is also provided as an optional accessory that allows up to 16 yokes to be stacked. Surgical accessories are provided with the array and are intended to aid in deployment of the array. The system allows the surgeon to place electrode arrays on the surface of the brain through burr holes. The inserted portion of the device can be retrieved following use by pulling the electrode array through the burr hole. The thin film electrode array is designed to operate in a fashion identical to the currently used ECoG arrays, in that it is to be placed on the surface of the brain to interface with brain tissue through electrical recording and stimulation. The electrode array consists of a polyimide substrate with platinum electrodes and associated electrically connecting traces and another layer of polyimide on top. A polyimide pocket is adhered via silicone to the backside of the electrode array tip. The array also contains gold radiopaque markers embedded in the silicone pocket adhesive. A rigid stainless steel radiopaque stylet is temporarily placed in the pocket during electrode array deployment. The overall Layer 7-T system, including the yoke, is intended for single use only. The Layer 7-T is a passive device and only receives power from a connected FDA-cleared EEG system. It does not have any wireless capabilities and does not contain any software. It is not MRI-compatible. It is only intended for use in a professional healthcare environment.

The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.

The WISE Cortical Strip is medical device composed of: - A strip containing 4 electrodes that is positioned during surgery on the exposed surface of the brain - A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable. The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted. The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months. Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface. The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.

The Recording and stimulating for Central Nervous System electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for limited (≤24 hours) use with recording, monitoring, and stimulation equipment for electrical stimulation, monitoring of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci.

The Recording and stimulating for Central Nervous System electrodes are used for electrical stimulation, monitoring and recording of the signals on the surface of the brain for intraoperative monitoring, brain mapping and location of epileptogenic foci. The electrodes are multipole arrays of electrodes that are positioned on the surface of the brain. The electrode must be designed to follow the complex anatomy and they can assume different conformations in relation to the requests of clinical needs. The neurosurgeon is the person recommended for electrode placement. The electrodes have to be used under the direction of the neurosurgeon and other skilled physicians to support their clinical needs.

The DIXI Medical Intraoperative Subdural Electrodes (Strips and Grids) are intended for intraoperative use for less than or equal to 24 hours with recording and stimulation equipment for the recording and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports brain mapping.

The DIXI Medical Intraoperative Subdural Electrode (Strips and Grids) is an intra-cranial electrode used intraoperatively on the surface of the brain. The device is designed for electroencephalography (EEG) recording and brief stimulation for brain mapping purposes. The DIXI Medical Intraoperative Subdural Electrode consists of circular contacts sandwiched between two layers of silicone substrate. The brain contacting side of the silicone substrate body has material removed to expose an amount of contact surface area. Insulated wires extend from each contact through a flexible tube which terminates in connectors for direct connection to user's equipment.

Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Cortical Electrode (Per FDA Classification)

The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.

The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment. The family of Subdural Electrodes under review are used under the direction of neurosurgeons and other skilled physicians to support their clinical needs for subdural electrodes on the brain. Based upon the needs of their clinical practice and particular patients, various 2-dimensional geometric shapes (length and width) resulting in variations of Subdural Electrode body shapes and orientation configurations are necessary. All variations of Subdural Electrodes under review consist of the same materials and fundamental design as the predicate Subdural Electrodes. Either round discs or rectangular electrode contact material are sandwiched between two layers of silicone substrate electrode body material. The brain contacting side of the silicone substrate body has material removed to expose an amount of electrode contact surface area. The subdural electrode wires between the electrode contact and connector contacts at the most distal end of the subdural electrode tail pass through a tube for interface with the user's equipment.

The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (< 30 days) on the surface of the brain. The electrodes are designed to record and/or monitor the brain's electrical activity as well as stimulate the brain. It consists of a series of contacts mounted in thin plastic strips, or in a square/rectangular grid to cover larger surface areas. The device is connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other cortical electrodes, including the predicate device.

The °AirRay® Subdural Cortical Electrodes (Strips and Grids) are intended for temporary (<30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface level of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.

The ° AirRay® Subdural Cortical Electrodes Subdural electrodes are single patient use, disposable, sterile devices. The electrodes are invasive as they are placed in contact with the brain. The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of subdural electrodes.

The SD LTM STIM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation cortical or intracranial electrodes) and the resulting cortical or deep brain potentials themselves are recorded using third-party cortical or intracranial electrodes. The SD LTM STIM itself is an accessory to the SD LTM 64 EXPRESS Signal Acquisition System and SystemPlus EVOLUTION software. The stimulation parameters, the election and the activation of the stimulation current are all set-up and controlled from these devices. The SD LTM STIM can operate only when so connected and with the SystemPlus EVOLUTION software; it cannot serve as a stand-alone cortical stimulator.

The SD LTM is a low power, constant current, bi-phasic stimulator intended for cortical stimulation during electroencephalography examinations (i.e. stereoEEG). The stimulation is applied to the brain using third-party stimulation probes (including cortical or intraccanial electrodes) and the resulting cortical or deep brain potentials third-party cortical or intracranial electrodes. The use of these types of recordings can be related to the diagnosis/study of nervous system diseases.