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510(k) Data Aggregation

    K Number
    K171358
    Device Name
    Emprint SX Ablation Platform and Accessories
    Manufacturer
    Coviden llc
    Date Cleared
    2017-09-01

    (115 days)

    Product Code
    NEY
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Coviden llc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint SX™ Ablation Platform is not intended for use in cardiac procedures. The system's optional, 3-D navigation feature assists in the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted ablation zone relative to the position of the antenna is displayed on the enhanced ultrasound image.
    Device Description
    The Emprint™ SX Ablation Platform with Thermosphere™ Technology is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) a defined tissue volume. The Emprint™ SX Ablation Platform utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The platform is software-controlled and a touchscreen Graphical User Interface is used to select the desired ablation time (up to 10 minutes) and power (5 to 100W) settings. Using an optional temperature probe, the ablation platform can be set to monitor the temperature of a desired target and to automatically turn the generator off, when the target reaches a pre-set temperature. The ablation platform uses circulating, room-temperature, normal saline to cool the non-radiating portion of the antenna shaft and to provide a consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system. Using an optional/selectable navigation feature, the Emprint™ SX Ablation Platform assists physicians in the accurate placement of the trackable Emprint™ SX Navigation Antenna into a target anatomical structure by overlaying the image of the antenna and its trajectory onto an ultrasound image in real time. Sensors are attached to platform-compatible, open and laparoscopic ultrasound probes and to the platform's trackable antenna. These sensors detect fluctuations in an electromagnetic field emitted from the system's Table Top Field Generator (TTFG). The TTFG is placed underneath the patient and transmits positional information that is processed by the system's navigation hardware and interpreted by its software. The platform's software allows the surgeon to see a representation of the ablation zone on an auxiliary display and the system's operator to control the ablation system via the touchscreen interface.
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