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510(k) Data Aggregation
K Number
K202087Device Name
DIXI Medical Microdeep Micro-Macro Depth Electrodes
Manufacturer
Dixi Medical
Date Cleared
2021-11-18
(478 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
Dixi Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIXI Medical Microdeep® Micro-Macro 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 epileptogenic foci and brain mapping.
Device Description
The Microdeep® Micro-Macro Depth Electrode is a single patient use, sterile and disposable device. The Microdeep® Micro-Macro Depth Electrode is invasive as it is placed in contact with nerve tissue (brain) and must only be used during an SEEG procedure with Anchor Bolts. The Microdeen® Micro-Macro Depth Electrode is intended to connect to the user's recording. monitoring and stimulation equipment using the Connection System. This product is intended to be used only by physicians in the area of biopotential recording, monitoring and stimulation / response studies who are trained in intracranial neurophysiology. The DIXI Medical Microdeep® Micro-Macro Depth Electrode is comprised of the following components: Macro-contacts, Micro-contacts, Microdrive for micro-contacts, Cap, Connectors for micro and macro-contacts.
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K Number
K201931Device Name
Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids)
Manufacturer
Dixi Medical
Date Cleared
2021-10-02
(446 days)
Product Code
GYC
Regulation Number
882.1310Why did this record match?
Applicant Name (Manufacturer) :
Dixi Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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K Number
K170959Device Name
DIXI Medical Microdeep Depth Electrode
Manufacturer
DIXI Medical
Date Cleared
2017-11-24
(238 days)
Product Code
GZL
Regulation Number
882.1330Why did this record match?
Applicant Name (Manufacturer) :
DIXI Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DIXI Medical Microdeep Depth Electrodes are intended for temporary (<30 day) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.
Device Description
The DIXI Medical Microdeep Depth Electrode ("Microdeep Depth Electrode" or "Electrode") is a smooth electrode that is 0.8 mm in diameter with a rounded (hemispherical) tip. The electrode has multiple platinum/iridium contacts that are 2 mm long, with a total exploration length varying from 16 mm to 80.5 mm according to the electrode reference. Microdeep Depth Electrodes are intended for temporary use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Microdeep Depth Electrodes are used under the supervision of a physician (physicians in the areas of biopotential recording, monitoring and stimulation/response studies understand the use of depth electrodes) and are intended to connect to the user's recording, monitoring and stimulation equipment. This information is then used for defining the location of epileptogenic foci and brain mapping.
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