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The CONMED PlumeSafe® X5™ Smoke Management System is designed to remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

The PlumeSafe® X5™ Smoke Management System is a portable, stand-alone, capital unit, that when paired with a reusable filter and disposable accessories makes up a Smoke Management System. The smoke unit is accompanied by a reusable filter and is available in two different configurations, a 22mm or 25mm size. Each filter is designed to capture components of surgical smoke and return clean air to the environment and can connect to different accessories which include pencils, adapters, fluid traps, and tube sets. Each filter is a seff-contained device that is completely enclosed to protect health care personnels from potential contamination during filter changes. Each filter is comprised of filtration (gross particulate pre-filter, Ultra-Low Penetration Air (ULPA), coconutbased carbon, impregnated alumina, and carbon dust capture media) that produce capture efficiency ratings equal to or better than 99.999% for particles ranging in size from 0.01μm to 0.2μm. PlumeSafe® X5™ is comprised of a vacuum motor, aluminum, steel, and plastic components combined with sound reducing insulation. The vacuum motor is used to draw the surgical site, through an accessory, and into the PlumeSafe® X5™ filter. The PlumeSafe® X5™ Smoke Management System provides multiple modes (open, laparoscopic, and pencil) and settings to adjust the flow to the clinical need.

The Surnic Surclear Smoke Plume Evacuation System with accessories is intended to remove smoke created in surgical procedures at the surgical site.

The Surclear 8010 have been designed with a high suction, high flow rate vacuum motor. The ultra-quiet motor is used to draw the surgical smoke from the surgical site through the vacuum tubing and into the Surclear 8010 filter 8QF1 where the surgical smoke is processed by a series of filters. A single disposable filter is used to simplify the installation and removal during filter changes. The filter is completely enclosed to protect the healthcare personnel from potential contamination during filter changes. One 8QF1 filter contains four different stages within to capture the smoke plume.

Medline's Smoke Evacuation Shroud is a single use, sterile product. Its intended use is as an electrosurgical accessory to attach to a standard cautery pencil. The shroud removes surgical procedures. The product is used inside the sterile field.

Medline's Smoke Evacuation Shroud is a single use, sterile product.

To remove airborne particles generated by tissue combustion during laparoscopic surgery, via filtration of gaseous media contained within the distended pneumoperitoneum in order to improve visualization. NEBULAE® SRS may be used in any laparoscopic surgery, as appropriate.

This 510(k) submission for the NEBULAE® SRS Laparoscopic Surgical Smoke Removal System (henceforth referred to as NEBULAE® SRS) covers the following product codes: • NEBULAE® SRS Pump (7-700-00) • NEBULAE® SRS CO₂ Gas Filtration Tubing Sets (7-510-57) The NEBULAE® SRS is intended to recirculate CO2 gas in the pneumoperitoneum whilst removing surgical smoke during laparoscopic procedures. The system consists of two parts: a Pump and dedicated singleuse, sterile Tubing Sets. The NEBULAE® SRS Pump is a microprocessor driven, mains-powered device containing a DC motor. The single-use, disposable Tubing Set consists of an integrated cartridge, containing a diaphragm pump, an in-line ultra-low particulate air (ULPA) with activated carbon filter, fluid trap(s), 10 feet of DEHP-free PVC tubing and two connectors for connecting the tubing to the trocars. The NEBULAE® SRS Pump's DC motor drives the pump head in the Tubing Set's cartridge to create the flow of CO2 gas from the patient's pneumoperitoneum, through the fluid trap(s) and filter before re-entering the patient. The NEBULAE® SRS Pump can be positioned on a level surface (e.g. a surgical trolley in the operating room) or fixed to a vertical IV pole using a dedicated bracket, which is available as an accessory (See VOLUME 011 for further information). The re-circulating CO2 gas can also be warmed by the addition of an in-line gas warmer, also available as an optional accessory.

The Megadyne Smoke Evacuator with accessories is intended to remove smoke created in surgical procedures at the surgical site.

The Megadyne Smoke Evacuator is designed to provide smoke evacuation in open and Laparoscopic procedures for the removal of surgical smoke. Using a scroll pump and 4 stages of filtration, the Megadyne Smoke Evacuator is designed to evacuate surgical smoke both quietly and effectively. An intuitive front panel design allows users to customize both the rate of suction FLOW and the length of RUN TIME after the active electrode is deactivated. Push button selections for OPEN, LAP (laparoscopic), and MANUAL modes are also clearly marked and easily accessible. The Megadyne smoke evacuator provides evacuation of smoke plume via a smoke evacuation device and tubing (e.g. E-Z Clear Smoke Evacuation Electrosurgical Pencil under K141587 on February 18, 2015) connected to the face of the Filter.

To remove and filter smoke and aerosols from a surgical site produced during electrosurgical and laser procedures.

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The Megadyne Foot Switch is an accessory that is interface with compatible smoke evacuation systems to control on/off inputs for manual operation.

The Megadyne Foot Switch is used with a compatible smoke evaluation system to control on/off inputs for manual operation.

SafeAir Smoke Evacuator compact is designed to remove and filter smoke generated during electrosurgical and laser procedures.

SafeAir Smoke Evacuator compact is a device with a vacuum pump that aspirates the surgical smoke produced during cauterization. The main purpose of smoke evacuation systems is to remove surgical smoke plume as close as possible to the surgical site. The component of the system ensuring that this is achieved is a diathermy pencil with integrated smoke evacuation function or a click-on tubing set connected to a surgical smoke evacuator. SafeAir Smoke Evacuator compact is designed for use in the hospital/clinic environment. It is built around a vacuum pump with a replaceable filter at the entry point. A specially designed pump control is centrally placed in the machine. The SafeAir Smoke Evacuator compact is designed with a pump with different activation functions; manual activation on the front panel, footswitch activation through diathermy pencil with smoke evacuation tubing. Synchronization is possible with most of the electrosurgical units.

Smoklean is a passive smoke evacuation system which removes particles from surgical smoke generated in laparoscopic procedures while maintaining a clear field of vision.

During the laparoscopic surgery, the smoke generated by the electrocautery dims the surgeon's vision, affecting the operation and causing the smoke to have a negative effect on the surgeon. It is used in connection with a laparoscopic trocar body or a single port used to expand the surgical site during laparoscopic surgery. This product filters smoke generated when the tissue is cauterized through the laparoscopic trocar body and a single port. The connecting part of the Trocar body or single port is 4.25 * 5.04mm in diameter. The device is consisted of 35cm tubing, a body with filters and an adaptor.

The Crystal Vision Smoke Evacuator System with Accessories is intended to remove smoke created in surgical procedures.

The Crystal Vision Smoke Evacuator System with Accessories is designed to remove smoke created in surgical procedures. The Crystal Vision Smoke Evacuator System with Accessories can be used to remove smoke produced by lasers, electrosurgical devices, argon beam coagulators, LEEP devices, and other devices that create smoke during surgical procedures. During internal surgical procedures such as laparoscopy. it helps to maintain the desired internal pressure (pneumoperitoneum). The Crystal Vision Smoke Evacuator System with Accessories removes up to 20 litersper-minute of smoke produced. The Crystal Vision Smoke Evacuator System with Accessories automatically activates when active (smoke producing) devices that are coupled to the smoke evacuator, with special sensors, are turned on. The Crystal Vision Smoke Evacuator System with Accessories automatically turns off, at a time predetermined by the operator, after the active device turns off and automatically activates when the high pressure limit is exceeded in the pneumoperitoneum and it remains running to remove smoke, vapors, and gases until the internal pressure returns to levels below the preset maximum. The Crystal Vision Smoke Evacuator System with Accessories can be used to evacuate CO2 gas from the pneumoperitoneum at the end of laparoscopic procedures. The Crystal Vision Smoke Evacuator System with Accessories is intended to be used by trained professionals. The subject device (Crystal Vision Smoke Evacuator System with Accessories) operates under same technologies, same mechanism of actions as the predicate (Crystal Vision (Model 470) and Accessories) and will use same accessories as the predicate device. The modifications are: increase dimension of the product chassis to partially enclose the Input ULPA filter and the Output Charcoal filter; replace mechanical controls with push buttons; eliminate Stand By switch; replace flow set display, from bargraph display to 3 digits display; expand flow reading from 2 to 3 digits. Accessories description: The ULPA Filter & Water Trap: The ULPA Filter & Water Trap for the Crystal Vision Smoke Evacuator System with Accessories, like the filters for the predicate device, is a replaceable filter that is completely enclosed to protect health care personnel from potential contamination during filter change. The ULPA Filter & Water Trap has a ULPA (Ultra Low Penetration Air) media. Charcoal Output Filter: The Charcoal Output Filter for the Crystal Vision Smoke Evacuator System with Accessories, like the one for the predicate device, is a replaceable filter that is completely enclosed and installed on the back of the Crystal Vision Smoke Evacuator System. The filter contains Granular Activated Charcoal from coconut shell and its life is based on the ability of the charcoal to absorb odors. Sensor: The Sensor for the Crystal Vision Smoke Evacuator System with Accessories, like the sensor for the predicate device, is an accessory which activates the Crystal Vision Smoke Evacuator automatically, when a cutting, smoke producing device will activate. Foot Pedal: The foot pedal is used for end user convenience as to activate the smoke evacuator when needed. The foot pedal shall be connected through same input connector used by sensor(s). Intra-Abdominal Tubing Set, Sterile and Non-Sterile: The I/A tubing is used during laparoscopic procedures, to evacuate the smoke produced. It connects to the trocar at one end and to the smoke evacuator to the other end. Smoke Tubing, Sterile and Non-Sterile: The smoke tubing may be used during any surgical procedure where there are smoke producing devices that needs smoke evacuation. Smoke Tubing with In-Line Filter, Non-Sterile: The smoke tubing may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation. In addition, the smoke tubing has a HEPA filter Wand, Sterile and Non-Sterile: The wand is a hand held device that may be used during any surgical procedure where there is smoke producing devices that needs smoke evacuation.