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510(k) Data Aggregation
K Number
K233472Device Name
CVAC Aspiration System + CVAC Image Processor
Manufacturer
Date Cleared
2024-02-02
(100 days)
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
Calyxo, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The CVAC Aspiration System and CVAC Image Processor consists of a sterile single use, steerable ureteral catheter and a reusable software-controlled image processor. It is intended to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). It employs flexible ureteroscopy within the urinary tract for endoscopic examination of the urinary tract and the interior of the kidney.
The steerable ureteral catheter is used for irrigation of kidney stones and stone dust with dedicated irrigation and vacuum channels under ureteroscopy. The CVAC Aspiration System and CVAC Image Processor can be used with additional accessories to perform various diagnostic and therapeutic procedures.
Device Description
The single use CVAC Aspiration System and the reusable CVAC Image Processor are specialized devices designed to allow physicians to locate kidney stones and to establish a conduit during endoscopic urological procedures for the treatment and removal of urinary stones (kidney stones, fragments, and dust). The devices are used in a surgical suite and are compatible with standard hospital monitors, vacuum sources, and irrigation sources.
The CVAC Aspiration System is a sterile single-use steerable ureteral catheter employing ureteroscopy with built-in irrigation and vacuum functionality. Accessories provided with the CVAC Aspiration System include an introducer, a laser bridge, a trigger tie, a 3-way stopcock, and a vacuum port cap. The CVAC Aspiration System catheter is compatible with commercially available accessories for stone removal such as appropriately sized single-use laser fibers and stone baskets, which are inserted and used in the vacuum channel. The CVAC Aspiration System connects to the CVAC Image Processor via an attached video cable.
The CVAC Image Processor is a software-controlled, reusable and electrical image processor. The CVAC Image Processor is connected to a standard 110V hospital electrical outlet via a provided power cord. The internal carrier board inside the CVAC Image Processor houses the LED control circuit, the display interface, and supports electrical interconnect between the image signal processing module and the System-on-Module (SOM). This allows the CVAC Image Processor to generate a video signal compatible with standard hospital grade external monitors. Accessories provided with the CVAC Image Processor include a HDMI-to-DVI adapter, a HDMI cable, and a power cable.
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