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510(k) Data Aggregation
K Number
K241895Device Name
Cannulated PsiFGuard
Manufacturer
Date Cleared
2024-09-26
(90 days)
Product Code
Regulation Number
888.3040Why did this record match?
Product Code :
SCY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Cannulated PsiFGuard is an accessory to systems intended for sacroiliac joint fusion for conditions including sacrolliac joint disruptions and degenerative sacroilitis. It is indicated for use during sacroiliac joint guidewire placement to provide feedback to the surgeon via visual and audible alerts that indicate a change in conductivity at the tip of the probe and may indicate contact of the tip with bone and possible cortex perforation.
Device Description
The Cannulated PsiFGuard is a device that assists surgeons to place a guidewire in the sacroiliac joint during posterior sacroiliac fusion surgery. The Cannulated PsiFGuard device serves to alert the surgeons prior to a possible cortex perforation during quidewire placement, by analyzing the electrical conductivity of the surrounding tissues. The Cannulated PsiFGuard consists of a stainless steel needle component and electronic handle (DSG Handle or the DSG Connect Handle).
The Cannulated PsiFGuard has exactly the same principles of operation as the previously cleared systems, i.e. the tip of the instrument simultaneously penetrates the tissue for guidewire placement and senses possible cortex perforation or contact with bone. The devices then provide a visual and audible feedback to the surgeon to indicate changes in conductivity associated with possible bone perforation. If the DSG Connect handle is used, the device also allows for the signal generated by the device to be transferred to a tablet, to visually reproduce the audio signal over time.
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