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Microwave Ablation Generator is indicated for the coagulation (ablation) of soft tissue. The device is not intended for cardiac use.

Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Generator consists of microwave source, pump, foot pedal etc. It is a software-controlled microwave generator that delivers the microwave energy at a working frequency of 2450 MHz and can meet various clinical needs of soft tissue ablation therapy. Microwave Ablation Generator delivers microwave energy to Microwave Ablation Antennas into the target tissue through Microwave Ablation Cable(sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged, leading to irreversible necrosis. The Microwave Ablation Temperature Probe is applied to monitor the temperature of the target location and to protect important organs and tissues in the periphery of the lesion from unexpected damage by microwave energy. Coagulated zones are monitored during treatment using appropriate imaging techniques.

Microwave Ablation Antennas, in conjunction with the compatible Microwave Ablation Generator, is intended for coagulation (ablation) of soft tissue. This device is not intended for cardiac use.

Microwave ablation is a kind of thermal ablation technology used in the treatment of soft tissue, utilizing electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) to produce tissue-heating effects. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis. Microwave Ablation Antennas generally consist of the Microwave Ablation Antennas, Microwave Ablation Cable. This device is single-use and sterilized by EO. During ablation, Microwave Ablation Antennas will be punctured into the target tissue of the patients. In order to achieve the intended use, Microwave Ablation Antennas shall be connected with Microwave Ablation Generator which deliver microwave energy to Microwave Ablation Antennas through Microwave Ablation Cable (sterile or non-sterile cable). When reaching the target temperature, the soft tissue will be damaged leading to irreversible necrosis. Coagulated zones are monitored during treatment using appropriate monitoring techniques.

IntelliBlate Microwave Ablation System: The IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Microwave Ablation System is not intended for use in cardiac procedures. IntelliBlate Ximitry Probe Assembly: The IntelliBlate Ximitry Probe Assembly, used with the IntelliBlate Microwave Ablation System is intended for coagulation (ablation) of soft tissue. The IntelliBlate Ximitry Probe Assembly is not intended for use in cardiac procedures.

The IntelliBlate Microwave Ablation System is a software-controlled microwave therapy delivery system with graphical user interface and hardware to control and monitor the therapy delivered to the target tissues. The system consists of a 2.45 GHz microwave generator (console) with an integrated peristaltic pump assembly for coolant fluid delivery, a coolant Fluid Mount and an optional mobile cart for the console. Accessories for the system include IntelliBlate Ximitry Probe Assembly - a sterile, single-use disposable microwave ablation assembly with ablation probes and a cassette for coolant fluid tubing (closed cooling circuit).

The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.

Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include: - Needle - Handle - Lead cable and connector

The swiftPro™ System is a surface-based device intended for the coagulation of soft tissue during non-invasive procedures. The swiftPro™ System is not indicated for use in cardiac procedures.

The core swiftPro™ System, comprising the hand-held microwave generator (SWF-HAN01), DC power cable (SWF-DCA01), cradle (SWF-CRA01), and applicator tips (SWF-AT03), has previously received FDA clearance under K222388. This new 510(k) application has been submitted to incorporate optional accessories: the Battery Pack (SWF-BAT01), Charqing Dock (SWF-CHA01), and Charging Dock DC power adaptor (SWF-DCA02) for cordless operation. The clinical functionality of delivering treatment via the swiftPro™ System remains unchanged. The only distinction is the introduction of an additional potential energy source. The power is supplied to swiftPro™ system by either a (external) medical-grade AC-DC adaptor with direct connection to the rear panel of the hand-held microwave generator or via a removable, rechargeable (optional) battery pack. There haven't been any alterations to the design, or the material used in the swiftPro™ hand-held microwave generator. The operation of the subject device follows the same steps as the predicate device. The addition of the accessories does not have any effect on the mode of operation.

The Emprint™ ablation system is intended for use in percutaneous, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The Emprint™ ablation system is not intended for use in cardiac procedures. The Emprint™ ablation system overlapping technique is only intended for use in the liver.

The Emprint™ Ablation System with Thermosphere™ Technology, Covidien's microwave ablation system, was released for commercial distribution in the United States in April 2014. The Emprint™ Ablation System is a microwave-based ablation system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablating) a defined volume of that tissue. The Emprint™ Ablation System utilizes a 2450 MHz 100W, or 150W generator to deliver power to a single microwave ablation antenna. The Emprint™ Ablation 100W Generator is composed of analog and digital circuits with no software or firmware. The Emprint™ Ablation 150W Generator utilizes software and firmware, however both generators' settings are controlled in the same fashion. Emprint™ Ablation Generators provide for user setting of ablation time (0-10 minutes) and ablation power (5 to 150W). With an optional temperature probe, the ablation generators can be set to monitor the temperature of a desired target and to automatically shut the generator off when the target reaches a pre-set temperature. The Emprint™ Ablation System uses circulating room temperature normal saline to cool the non-radiating portion of the antenna shaft and to provide a more 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. No saline is in contact with the patient. The 510(k) Cleared Emprint™ Ablation System consists of the following components: - Emprint™ Ablation Generator (2450 MHz) ● - Emprint™ HP Ablation Generator (2450 MHz) . - EmprintTM Percutaneous Antenna (sterile, single use) ● - Emprint™ Ablation Reusable Cable ● - Emprint™ Ablation Pump ● The system also includes the following optional equipment/accessories: - . Emprint™ Ablation Cart (with Isolation Transformer) - Emprint™ HP Ablation Cart (with Isolation Transformer) - Ablation Footswitch ● - Remote Temperature Probe (sterile, single use) ● The system must be used with a standard IV bag of sterile normal saline (not provided with the system).

The microwave ablation system is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Microwave ablation system is not intended for cardiac use. Sterile Microwave Ablation Probe is used with Microwave Ablation Device, which is indicated for soft tissue coagulation (ablation) by healthcare professionals in healthcare facilities. Sterile Microwave Ablation Probe is not intended for cardiac use.

The Microwave Ablation Device with Sterile Microwave Ablation Probe is a device system which is intended for soft tissue coagulation. The Microwave Ablation Device consists of power supply, microwave power source, control system, temperature measurement system, RF connection cable, foot switch, and temperature probe. The Sterile Microwave Ablation Probe is a single-use sterile product, consisting of a handle, RF connector, RF coaxial cable, needle bar, inner tube, pinhead, temperature sensor and coolant tube. The Microwave Ablation Device also contains a single use Sterile Temperature Probe.

The NEUWAVE™ Microwave Ablation System and Accessories are indicated for the ablation (coagulation) of soft tissue in percutaneous, open surgical and in conjunction with laparoscopic surgical settings, including the partial or complete ablation of non-resectable liver tumors. The NEUWAVE Microwave Ablation System is not indicated for use in cardiac procedures.

The NEUWAVE Microwave Ablation System is a self-contained stand-alone system of hardware and software designed for the ablation of soft tissue, including the partial or complete ablation of non-resectable liver tumors, via applying microwave energy to produce tissue heating effects generating tissue necrosis. The system consists of three major components: - (1) The system cart which contains the components necessary to deliver microwave power to the microwave ablation probes, monitor and control system functions, a graphical user interface for the user to interact with the system and a CO2 based cooling system. - (2) Power Distribution Module (PDM), which allows power to be transferred from the system generator to the ablation probes. - (3) Range of microwave ablation probe accessories for energy delivery. The system cart has a single 2.45 GHz signal microwave source with three 140W microwave power amplifiers, a touch-screen graphical user interface, and a CO2 based cooling system for limiting the temperature of the ablation probe, handle, and cable. The CO2 cooling system enables the Tissu-Loc™ function, which involves formation of an ice ball to adhere the probe in place prior to starting ablation therapy. This helps eliminate probe migration during imaging (CT scans, ultrasounds, etc.) and additional probe placement. The cooling system is responsible for controlling the pressure of the incoming CO2 gas from two Esized CO2 cylinders located on the back of the cart. The graphical user interface allows the user to set, adjust and activate the power setting per probe, time setting for each probe, ability to synchronize ablation initiation on probes, ablation activation, cauterization activation, audible volume, probe temperature, and Tissu-Loc™ function. Up to three (3) NEUWAVE Ablation Probes can connect to the PDM at once and the PDM allows power to be transferred from the system cart to the ablation probes. The microwave ablation probes are accessories which transfer microwave energy from the system cart to the target tissue to create regions of thermal necrosis. Each probe contains thermocouples that monitor the temperature of the probe. The probes can be used for Surgical Mode or Ablation Mode with various limits of maximum selectable power based on the probe type. The antenna of the NEUWAVE PR probe family is designed to limit the length of the ablation for instances when a shorter ablation zone is desired. NEUWAVE PR Probes were developed to provide physicians with an additional ablation probe option with a different ablation burn pattern compared with NEUWAVE LK/LN/SR probes. The NEUWAVE PR probes are designed to produce ablations that quickly encompass the tip of the probe while limiting the overall length of the ablation compared with other NEUWAVE ablation probes. There are 2 changes covered by this 510(k) submission: - 1. A new Microwave Ablation Probe, the Surgical PR Probe (PRS35), available for use with the NEUWAVE System. - 2. Updates to the NEUWAVE System software to accommodate the new PRS35 probe and to implement various enhancements to the user experience and correct minor software anomalies that do not impact safety or effectiveness. The new NEUWAVE Surgical PR Ablation Probe (PRS35) has a 11/13-gauge and 35cm length cannula with a 2.9m cable in length. The proposed PRS35 probe uses a similar cannula and antenna design to the predicate probes PRS15 & NWSR25, and the ablation pattern also closely resembles the above stated predicate. The longer cannula length is a primary purpose of the new probe to enable access to targets farther from the skin surface due to insufflation in laparoscopic procedures. The subject embedded software utilizes the existing firmware and software architecture design, technological characteristics and functions but incorporates enhancements and features as described below: - Procedure Profiles - PRS35 Probe Support ● - Planning: Time and Power Guide available without probe ● - Cybersecurity - Misc. Bug fixes ● - Additional Languages to support country specific registration globally (Finnish, Norwegian, Turkish) No changes were made to the currently marketed family of NEUWAVE Ablation Probes nor to any hardware aspects of the currently marketed NEUWAVE system cleared under K220472. The selection of available ablation probes provides physicians with the opportunity to select the length, stiffness, burn pattern and number of probes to use to create a wide variety of ablation zone sizes and shapes.

The Microwave Ablation System is indicated for the coagulation (ablation) of soft tissue. The Microwave Ablation System is not intended for cardiac use.

The Microwave Ablation System is a microwave power (energy) source that can meet the needs of clinical soft tissue microwave thermal ablation therapy. The microwave energy is transmitted to the disposable microwave ablation needle through coaxial transmission cable, and the disposable microwave ablation needle is directly inserted into the targeted soft tissue, and the electromagnetic wave (microwave) is radiated from the front end of the disposable microwave ablation needle to cause the soft tissue to produce heat and rise. When it reaches the temperature of tissue coagulation and necrosis, in-situ inactivation is formed, that is, the purpose of microwave ablation therapy is achieved. The Disposable Thermometer Needle and Foot Switch are accessories for the proposed device. And the proposed device is used in conjunction with the Disposable Microwave Ablation Needle made by our company.

Disposable Microwave Ablation Needle is used with the Microwave Ablation System. which is indicated for the ablation of soft tissue during open procedures. The Disposable Microwave Ablation Needle is not intended for cardiac use.

Disposable Microwave Ablation Needle is a puncture needle with microwave energy transmission. It is inserted into the human body through puncture, and the tissue is ablated by the thermal energy transformed by the needle tip. The Disposable Microwave Ablation Needle is composed of an inlet pipe, an outlet pipe, a handle, a needle rod, a medium tube, a radiation pole, and a coaxial transmission cable. It is a sterile disposable product. The coaxial transmission cable connect the Microwave Ablation System to transmit microwaves to the ablation needle (radiator), a handle is set at the connection between the microwave cable and the ablation needle to facilitate the operation of the operator. The Disposable Microwave Ablation Needle is provided sterile, for single use.