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510(k) Data Aggregation
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The Vanquish Water Vapor Ablation System is indicated for the thermal ablation of targeted prostate tissue via a transurethral approach.
The Vanquish Water Vapor Ablation System provides a method of focal thermal ablation that utilizes the high energy stored in water vapor to target prostate tissue. In a minimally invasive transurethral outpatient procedure performed under transrectal ultrasound (TRUS) guidance, sterile water is heated within the system and converted into vapor. This vapor is then delivered through small emitter holes at the distal end of a transurethral needle into the prostate tissue.
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(267 days)
FEops HEARTguide™ Simulation Application is indicated for patient-specific simulation of transcatheter left atrial appendage occlusion (LAAO) device implantation during procedural planning.
The software performs computer simulation to predict implant frame deformation to support the evaluation for LAAO device size and placement.
FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
FEops HEARTguide™ Simulation Application is not intended to replace the simulated device instructions for use for final LAAO device selection and placement.
FEops HEARTguide™ Simulation Application is prescription use only.
FEops HEARTguide™ Simulation Application predicts implant frame deformation after percutaneous LAAO device implantation through computer simulation. The predicted deformation provides additional information during LAAO procedural planning.
The information provided by FEops HEARTguide™ Simulation Application is intended to be used by qualified clinicians in conjunction with the simulated device instructions for use, the patient's clinical history, symptoms, and other preprocedural evaluations, as well as the clinician's professional judgment.
The customer (clinician) does not interact with the simulation software directly. The simulations are performed by trained FEops case analysts through an established workflow. Based on a patient-specific 3D model of the anatomy, a computational model of the anatomy is generated and combined with a predefined computational model of the device.
The simulation results are delivered to the customer through the medical device FEops HEARTguide™ ALPACA (FEops - K223855) in the form of 3D model visualizations and a PDF report. All results are accessible through a standard web browser. The customer cannot modify the simulation results nor run additional simulations.
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