Search Results

The single use Uretero1™ Ureteroscope System is intended to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.

The Uretero1™ Ureteroscope System contains an all-in-one camera control unit (CCU) for image processing and display. The CCU operates at 110 V - 230V ~ 50 - 60 Hz and has a simple graphical user interface that prompts the clinician through actions to get a live view via the Ureteroscope. After unpackaging the sterile, single-use ureteroscope, the user is required to plug in the single-use ureteroscope device via a 16-pin male connector inserted into the CCU to obtain a live image. There is a process of authentication, in which the CCU recognizes the firmware of the inserted product, and the image from the ureteroscope is displayed on live view. The Uretero1™ CCU software platform is based on i.MX8MQ processor from NXP and LATTICE ECP5 FPGA. The ECP5 provides the camera interface plus ISP functionality. The CCU software is based on Linux board support package provided by NXP. The board support package and Linux distribution are configured and built using YOCTO. The main functionality of the system is to capture the video from an external camera and display it to an external display. Graphical user interface is developed using QT5. Video pipeline is implemented through g-streamer.

The ureteroscope is disposable and can be utilized for up to 4 hours. The ureteroscope possesses a 4-hour countdown timer and after 4 hours of usage, the ureteroscope will no longer produce a live image and a use notification message will be displayed on the screen informing the user that the ureteroscope usage time has expired. The ureteroscope has 3 use notification messages. One occurs at 60 minutes left on the timer and appears on the side menu bar of the display screen on the CCU. A second occurs with 30 minutes left on the timer and also appears on the side menu bar. The final notification message appears with 5 minutes of time remaining on the ureteroscope and it is in the middle of the screen and requires user interaction to acknowledge the use notification message by pressing OK. When the duration of time has elapsed, the ureteroscope will no longer produce a live image and the user will be directed to a screen that states the ureteroscope no longer has any usable time remaining and to insert new ureteroscope.

Once the flexible shaft is inserted into the patient, the distal tip is steered via the articulation lever on the ureteroscope handle. The flexible shaft allows for passive secondary deflection while accessing the patient's urinary tract. The flexible shaft contains a working channel to allow surgical accessories and procedural solutions to be delivered through the distal tip to the surgical field. The handle button allows the user to take photos, record video and zoom in and out. In addition to the articulation lever and the handle button, the handle contains an accessory access port and a connection port for procedural solutions. An irrigation system (irrigation tubing and an irrigation source) can be attached to one port and the biopsy port cover can be attached to the other port. In this way, the user can use endoscopic instruments through the biopsy port cover and irrigate at the same time. The Uretero1TM Single-Use Digital Flexible Ureteroscope must be used in conjunction with the Vision1™ Imaging Console and Display System (CCU).

In addition to image processing, the CCU supports video connectivity in two additional ways. The user is allowed to mirror image from the CCU to an external display which produces the same image the user sees on the CCU screen on any other compatible display system that accepts HDMI input. In addition, the CCU can accept an HDMI input signal from an external HDMI output and the CCU can act as a dummy display panel for the external HDMI imaging source. There are two USB data ports to provide data export (photos and video taken during procedure) or allow connection of selected accessories (printer). No data, including Electronic Protected Health Information (ePHI) data is stored on this device (e.g., last name, SSN, DOB, MRN) and there is no ethernet, Wi-Fi or Blue Tooth capability.

The ureteroscope will be offered in two different models: UreterolTM Ureteroscope (Standard Deflection) and Uretero1TM Ureteroscope (Reverse Deflection). To save procedural photo or video, a proprietary system encrypted USB drive is provided to Customers with the purchase of the CCU. The Vision1™ Imaging Console and Display System communicate with the encrypted USB drive, the Uretero1TM Single-Use Digital Flexible Ureteroscope, and the external printer.

The Uretero1 Ureteroscope System comes packaged with single-use, disposable accessory port cover. The accessory port cover is adjustable and is intended to resist the backflow of fluid around an instrument inserted through the working channel of the ureteroscope. It is designed to facilitate the passage of instruments during a procedure. It has a cap feature to allow instruments to be inserted and secured. A clicking mechanism is used to facilitate the open, semi-closed and closed position of the valve. It also has a side arm y-port with a luer cap to allow for irrigation or other procedural solutions, if needed. This accessory attaches to the instrument port of the Uretero1 Ureteroscope via a distal luer connection.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is primarily an FDA 510(k) clearance letter and a summary of the device's technical characteristics and comparison to a predicate device.

The "Summary of Non-Clinical Performance Testing" table on page 9 mentions "Functional and Regression Testing," "Optical Color Performance Testing," and "White Balance Testing" all with "Pass" results, but it does not provide:

• Specific quantifiable acceptance criteria (e.g., "accuracy greater than 90%").
• Reported device performance values that can be compared against such criteria.
• Details on the study methodology (e.g., sample size, data provenance, expert involvement, ground truth methods, MRMC studies, or training set information).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as the necessary information is not present in the provided text.

Ask a specific question about this device