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510(k) Data Aggregation
K Number
K221123Device Name
WISE Cortical Strip (WCS)
Manufacturer
WISE S.r.l.
Date Cleared
2022-11-22
(218 days)
Product Code
GYC
Regulation Number
882.1310Why did this record match?
Applicant Name (Manufacturer) :
WISE S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
Device Description
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.
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