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The LiNA CystoVu HD is intended for use in visualization via LiNA displaying unit of adult male and female urethra and bladder cavity during diagnostic and therapeutic cystoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals. The LiNA ScopeVu is intended for visualization from compatible LiNA endoscopes for female and male patients of all ages during diagnostic and therapeutic endoscopy procedures. It is intended for hospital- or medical office environment use and is operated by medical professionals.

The LiNA CystoVu™ HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. Visualization will be achieved by LiNA Scope Vu™ full HD display and light source. The LiNA Cysto Vu™ HD is intended to be used with a reusable LiNA ScopeVu™ to visualize the urethra and the bladder. The LiNA CystoVu™ HD can be operated by the left or right hand. The optical module in the distal tip consists of a camera housing containing camera and LED light sources.

The SafeAir Combi is an electrosurgical generator containing an integrated surgical smoke evacuator. The unit is intended to deliver high frequency energy for cutting and/or coagulating tissues using monopolar and bipolar tools in surgical procedures. When used with an electrosurgical pencil capable of surgical smoke evacuation, the console is also intended to remove and filtrate smoke generated during electrosurgical procedures.

SafeAir Combi (model: SFR-Combi-US) is an electrosurgical generator with the added functionality of smoke evacuation. This device is a non-sterile medical device, indicated to be used in operating theatres for use during general surgical procedures. SafeAir Combi uses 5 different output modes: 2 cut modes (Pure and Blend), 2 coagulation modes (Fulguration and Spray) and 1 mode for bipolar accessories. The device operates with a power range of 5-200 Watts for cut modes, 5-120 Watts for coagulation modes and 5-100 Watts for the bipolar mode. The device is intended to be used as a system together with monopolar or bipolar active accessories with a neutral electrode, however this submission is only intended to cover the electrosurgical generator and smoke evacuation feature and dedicated footswitch, without any active surgical accessories. Device is intended to be operated by healthcare professionals in hospitals and clinics where electrosurgical procedures are typically performed.

LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

LiNA OperaScope™ Needle is delivered as a sterile, single-use device designed to be used specifically with the LiNA OperaScope for hysteroscopic and cystoscopic injections. The device consists of a handle, a shaft and an injection needle, which is pointed at the distal end and has a luer-lock connection at the proximal end. Devices are packed in Tyvek pouches, with 6 units packed in a box.

The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the LiNA OperaScope could offer visualization include: - Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram - Assessment of infertility and pregnancy wastage - Confirmation of the presence of intrauterine foreign body - Assist in locating submucosal fibroids and polyps targeted for removal - Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine adhesions and septa. The LiNA OperaScope can also be used to permit viewing of the adult female urinary bladder through minimally invasive approach by utilizing natural orifices for the purpose of performing diagnostic and therapeutic procedures.

The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The LiNA OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission. The LiNA OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a non- sterile reusable unit. The LiNA OperaScope contains a miniature Complimentary Medical Oxide Semiconductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the LiNA OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

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.

SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

SafeAir Telescopic Smoke Pencil is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. SafeAir Telescopic Smoke Pencil has got telescopic function which allows to extend the length of pencil by up to 120 mm. Extension is possible after twisting the green lock-ring.

The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures. The types of procedures where the OperaScope could offer visualization include: · Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram; - · Assessment of infertility and pregnancy wastage; · Confirmation of the presence of intrauterine foreign body; · Assist in locating submucosal fibroids and polyps targeted for removal; · Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine and septa.

The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission. The OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a nonsterile reusable unit. The OperaScope contains a miniature Complimentary Medical Oxide Semi-conductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display unit (LCD display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.

The SafeAir Smoke Pencil is designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The SafeAir Smoke Pencil is a sterile, single-use, integrated electrosurgical pencil and smoke evacuation handpiece. The device is designed for general electrosurgical applications and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture smoke plume simultaneously. The SafeAir Smoke Pencil is available in two activation switch configurations, a rocker style and push-button style, which activate monopolar cut or coagulate functions. The pencil is connected to smoke evacuation tubing which features a dual connector (8 and 22 mm) to allow the user to connect to a variety of smoke evacuation systems including filtration or central vacuum systems, thus minimizing exposure of personnel to surgical smoke plume. Electrodes are available in either 70 mm blade or 70 mm coated blade configurations.

The LiNA PowerBlade Plus™ HC is intended for use in open and laparoscopic surgery where grasping, coagulating and transecting is indicated

The PowerBlade Plus HC is a sterile 5 mm single use instrument available in one 330mm length version with a 10mm jaw opening. The proposed device is a bipolar forceps device that grasps and coagulates utilizing electrical current. Transecting is done with a mechanical sharp blade. The LiNA PowerBlade Plus HC includes a rotation wheel on the handle that rotates the grasper jaws at the tip to improve positioning and ergonomics during the surgical procedure. The device is single use ethylene oxide sterilized and is compatible with most standard electrosurgical generators that provide a bipolar outlet. Two types of connectors are provided: the two pin connector is for use with most standard electrosurgical generators with a bipolar outlet, and a 3-pin connector that is attached to the cable of the LiNA PowerBlade Plus HC for use with ValleyLab™ generators with a LigaSure™ outlet. When the 3-pin connector is used, the control button on the hand piece can be used to activate the coagulation. When using the 2pin connector the coagulation function of the PowerBlade Plus HC is foot pedal controlled.

The LiNA SafeAir Smoke Pencil is designed for general electrosurgical applications, including cutting and coagulation, and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The SafeAir Smoke Pencil is a sterile single use integrated electrosurgical pencil and smoke evacuation hand piece that is packaged with an electrode blade. The device is designed for general electrosurgical applications including cutting and coagulating and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The integration of the electrosurgical pencil and smoke evacuation enables the operator to activate an electrosurgical current as well as capture the smoke plume simultaneously. The proposed device is the same as the predicate SafeAir Smoke Pencil. The only modification is a change to the labeling to allow the use of the Stryker® Colorado MicroDissection Needle electrodes in addition to the electrode that is packaged with the hand piece.