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The Brain Biopsy Needles are used during guided procedures and by methods deemed safe by the physician/surgeon to remove a targeted tissue for biopsy.

Brain Biopsy Needles are used to remove a targeted sample of brain tissue for analysis. These Brain Biopsy Needles are side-cutting needles. Side-cutting needles can extract several tissue samples without requiring a new trajectory. Biopsy needles are used to sample brain tissue or to extract brain tissue samples to determine tissue abnormality or any deviation from healthy brain tissue. These Brain Biopsy Needles substantially consist of two cannulae that fit inside one another. Both cannulas have a sampling window opening in the distal tip. The inner cannula window opening has a sharp edge. The Brain Biopsy Needle is placed into tissue to the desired depth. An aspiration syringe may be attached to the brain biopsy to support aspiration of a small amount of tissue into the sampling window. The inner cannula is rotated such that the sampling window removes a tissue sample. The inner cannula is removed. The tissue sample from the inner cannula is removed for analysis. The inner cannula may be passed back through the outer cannula and additional biopsies can be taken as directed by the surgeon.

The AD-TECH Subdural Electrodes (Dual-Sided Interhemispheric, Grid, Intraoperative, Strip, Wyler) 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 the location of epileptogenic foci and brain mapping.

Subdural electrodes described in this application are single patient use, disposable, sterile and non-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 physician.

The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue (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 physician.

The Macro-Micro Depth Electrodes are intended for use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue. 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 depth electrodes. The main components of the depth electrodes are: 1. Contract strip with macro depth electrode contacts and connector contacts; 2. Stylet; Inner lumen: 3. 4. Micro wire electrode(s) for insertion and placement through the macro electrode inner lumen. The lead wires terminate in a safety connector that cannot be connected to an AC power outlet. The materials are the same as used in the predicate devices and/or are common to depth electrodes.

The foramen ovale electrode is designed for monitoring brain electrical activity (eeg) or defining the location of epileptogenic foci in patients with intractable epilepsy. The foramen ovale electrode is intended for "Surgical Use Only" and "Not Intended for Implantation" This product should only be used by a physician/surgeon trained in the use of foramen ovate electrodes.

Ad-Tech's Foramen Ovale Electrode has similar intended uses, naterials, technological characteristics, sterilization procedures, and packaging as the commercially available Ad-Tech Depth Electrode (K 891920B). The Foramen Ovale Electrodes are used for intraoperative monitoring ( for surgical use only / not for implantation) and recording of electrical brain signals for epilepsy monitoring on the surface and sub-surface of the brain.

The use of the Model CMU Cortical Mapping Unit is indicated where intraoperative, short-term recording of cortical surface EEG activity is required.

AD-TECH's Model CMU Cortical Mapping Unit has similar intended uses, materials and technological characteristics as the predicate device. There are only three differences of note: (1) Our electrode plates are made of clear Lexan plastic while theirs are stainless steel. We maintain that the clear plates are a marketing feature. (2) Our electrodes are made of stainless steel; theirs use cotton wicks. (3) Our device is sterilized via EtO: theirs may be autoclaved.

Ad-Tech's Spinal Electrode is intended for measurement of muscle MEP (Motor Evoked Potential) type monitoring during spinal surgery.

The Ad-Tech Spinal Electrode addressed in this premarket notification has identical materials, technological characteristics, sterilization procedures and packaging as the commercially available Ad-Tech Depth Electrode (K891920B). The device has similar intended use, materials and technological characteristics to the commercially available Nicolet Epidural Spinal Electrode (K882053). Like this device, the Ad-Tech Spinal Electrode is to be placed epidurally for monitoring evoked potentials.