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aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney. The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney. The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components. Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.

The Single-Use Flexible Cystoscope is designed to be used with the Vathin Display Unit, endotherapy accessories and other auxiliary device for endoscopy and treatment of adult bladder. The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The devices are for use in professional Healthcare Facility Environment.

The device consists of a Single-use Flexible Cystoscope and a Digital Video Monitor for endoscopic image processing and displaying. They are used in conjunction with other accessories for the endoscopy and treatment of adult bladder.

The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.

This Special 510(k) discloses the modifications to the steps to carry out surface disinfection of the model 4500 handle that was reviewed and cleared in K232837. The Uro-G HD Flexible Cystoscope is a handheld, battery- operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. When fully assembled, the Uro-G HD Flexible Cystoscope- cannula and handle-has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.

aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2. Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder. The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 5 Cysto HD shall be disposed of as infected medical device with electronic components. Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design. The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables. The Ambu® aBox™ 2 has the following physical and performance characteristics: - Can process and display live imaging data from Ambu® aScope™ 5 Cysto HD to a monitor - Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD - Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

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.

Endoscopic Video Image Processor This device is used in conjunction with the video endoscopes produced by our company to process the images collected by the video endoscopes and send them to the display, and provide power for the endoscope. Single-Use Video Flexible Cysto-Nephroscope This product shall be used in conjunction with the Endoscopic Video Image Processor and other peripheral equipment for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The device is suitable for professional healthcare facility environments such as hospitals and clinics. This product shall not be used for other purposes.

The proposed device, Cysto-Nephroscope System, which includes a Single-Use Video Flexible Cysto-Nephroscope and an Endoscopic Video Image Processor is intended for observation, diagnosis, photography and treatment within the bladder, urethra, and kidney. The Single-Use Video Flexible Cysto-Nephroscope is available in two models with the different position of "U" and "D" mark on the handle and different deflection, RP-U-C01F, RP-U-C01F5. The Endoscopic Video Image Processor has only one model, RP-IPD-V2000EF. The Single-Use Video Flexible Cysto-Nephroscope is sterile and single-patient-use device. The Endoscopic Video Image Processor is nonsterile and multi-patient-use device, and it will be cleaned and disinfected before first use and after each use.

The BubbleView™ Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleView™ is intended to provide visualization via ViewHub® video processor and can be used with endoscopic accessories. BubbleView™ is intended for use in a hospital environment or medical office environment. BubbleView™ is designed for use in adults. ViewHub® is designed to display live imaging data from compatible MACROLUX™ endoscopes.

The Single-Use Digital Flexible Cystoscope System consists of BubbleView™ Single-Use Digital Flexible Cystoscope (consists of a handle with control lever, endoscope cable and access port for accessories, and a flexible body portion) and ViewHub® Video Processor with itsaccessories including power cables. The BubbleView™ is provided sterile (sterilized by EQ) and intended to be single-use. The ViewHub® is a reusable multi-patient use device. The built-in LED at the Distal tip of the BubbleView™ Single-Use Digital Flexible Cystoscope provides a light source, the lens module captures the light signal, then the CMOS module converts the light signal into an electrical signal: the endoscope cable connects the BubbleView™ to the ViewHub®, which provides power and processes video signal from the endoscope; the control lever on the handleconnected to the controllable portion by a wire rope controls the bending direction and angle of the controllable portion: the instrument channel delivers water and other instruments. The ViewHub® Video Processor is a video imaging system that receives video signals from the connected endoscope, controls the lightat the endoscope tip and outputs this signal including a graphical user interface to a connected external video monitor.

The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra. Generally recognized indications for cystoscopy include: • Symptomatic voiding dysfunction • Hematuria • Bladder tumor surveillance • Recurrent lower urinary tract infections • Pelvic pain syndromes

The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope System—cannula and handle—has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.