Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101

Q: Who is the manufacturer of Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101?

STERIS Corporation filed the 510(k) submission for Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101 (K223466).

Q: What is the FDA product code for Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101?

FGB. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

Q: What is the regulatory pathway for Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101?

510(k) clearance (submission type: Special).

Q: What are the predicate devices for Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101?

Uretero1 Ureteroscope System (K211347).

Q: Who can help prepare an FDA 510(k) submission like Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K223466 · STERIS Corporation · FGB · Feb 17, 2023 · Gastroenterology, Urology

Device Facts

Record ID	K223466
Device Name	Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101; Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101; Vision1 Imaging Console and Display System, PN VIS101
Applicant	STERIS Corporation
Product Code	FGB · Gastroenterology, Urology
Decision Date	Feb 17, 2023
Decision	SESE
Submission Type	Special
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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.

Device Story

Uretero1 Ureteroscope System consists of a single-use, flexible digital ureteroscope and a Vision1 Imaging Console and Display System (CCU). Ureteroscope features articulation lever for tip steering, working channel for instruments/irrigation, and camera/illumination at distal tip. CCU processes video from ureteroscope for display on integrated touchscreen or external monitor via HDMI. System used in clinical settings by physicians for urinary tract visualization and procedures. Ureteroscope has 4-hour usage limit with on-screen countdown notifications. CCU provides GUI for image management, photo/video capture to encrypted USB, and printer connectivity. No ePHI storage; no network connectivity. System aids clinical decision-making by providing real-time visualization of urinary anatomy and diagnostic/therapeutic access.

Clinical Evidence

Bench testing only. Performance verified via functional and regression testing (IEC 62304), optical performance (ISO 8600-3/5, ISO 12233, ISO 9039, ISO 15739), biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), and packaging integrity (ASTM F1886, F2096, F88).

Technological Characteristics

Single-use flexible ureteroscope; CCU utilizes NXP i.MX8MQ processor and LATTICE ECP5 FPGA. Software built on Linux (YOCTO) with QT5 GUI and g-streamer video pipeline. Connectivity: HDMI, USB. Sterilization: Ethylene Oxide (SAL 10^-6). Materials include various medical-grade adhesives (Loctite series, Dymax).

Indications for Use

Indicated for patients undergoing urological endoscopic procedures requiring visualization of the urinary tract (urethra, bladder, ureter, calyces, renal papillae) and performance of diagnostic or therapeutic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

Uretero1 Ureteroscope System (K211347)

Related Devices

K231878 — Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 · STERIS Corporation · Jul 25, 2023
K211347 — Uretero1 Ureteroscope System · STERIS Corporation · Nov 23, 2021
K242699 — Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US); Flexible Ureteroscope (U-Scope)(2.5/1.2) (OMI161-2F25-CH12-US); Images Systems (Camera-Controlled Unit) (OMI01M12) · Opcom Medical, Inc. · May 28, 2025
K233275 — RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard); RenaFlex Single-use Flexible Ureteroscope (SUURF-VR Reverse); Video System Center for Single-use Endoscopes (CV-S1) · Gyrus Acmi, Inc. · Mar 25, 2024
K233645 — StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection · Boston Scientific Corporation - · Dec 12, 2023

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 17, 2023 STERIS Corporation Carroll L. Martin Regulatory Affairs Director 5976 Heislev Road Mentor, OH 44060 Re: K223466 > Trade/Device Name: Uretero1TM Ureteroscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: January 13, 2023 Received: January 19, 2023 Dear Carroll L. Martin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. {1}------------------------------------------------ You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark J. Antonino -S Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223466 Device Name Uretero1TM Ureteroscope System ## Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for STERIS. The word STERIS is in all capital letters and in a bold, sans-serif font. Below the word STERIS is a graphic of several horizontal, wavy lines in a light blue color. The registered trademark symbol is to the right of the word STERIS. K223466 Page 1 of 11 # 510(k) Summary for the Uretero1™ Ureteroscope System STERIS Corporation 5960 Heisley Road Mentor, OH 44060 | Contact: | Carroll Martin | |----------|----------------------------------| | | Regulatory Affairs Director | | | Tel: 440-358-6259 | | | Email: Carroll_Martin@steris.com | February 6, 2023 Submission Date: STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600 {4}------------------------------------------------ #### 1. Device Name | Trade Name: | Uretero1TM Ureteroscope System | |--------------------|--------------------------------| | Device Class: | Class II | | Regulation Name: | Endoscope and Accessories | | Common/usual Name: | Ureteroscope | | Regulation Number: | 21 CFR 876.1500 | | Product Code: | FGB | #### 2. Predicate Device Uretero1 Ureteroscope System, K211347 Class II (21 CFR 876.1500), product code FGB #### Device Description 3. 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 Uretero1TM 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 {5}------------------------------------------------ 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 UreterolTM 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. #### 4. Indications for Use The single use Uretero1™ Ureteroscope System is intended to be used 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. {6}------------------------------------------------ #### Comparison of Technological Characteristics with the Predicate Device 5. A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1. | Features | Uretero1™ Ureteroscope System K211347 | Uretero1™ Ureteroscope System (Modified Device) | Comparison | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The single use Uretero1™ Ureteroscope System is intended to be used 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 single use Uretero1™ Ureteroscope System is intended to be used 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. | Identical | | Ureteroscope Construction / Components | Handle Articulation Lever Handle Button Accessory Port Irrigation Port Connector Cable Connector Cable Plug Flexible Shaft Articulation Section Distal Tip (camera, illumination optics, and the working channel, video signal cables, articulation wires and light fiber) Instrument Channel Light (illumination fiber) Camera | Handle Articulation Lever Handle Button Accessory Port Irrigation Port Connector Cable Connector Cable Plug Flexible Shaft Articulation Section Distal Tip (camera, illumination optics, and the working channel, video signal cables, articulation wires and light fiber) Instrument Channel Light (illumination fiber) Camera | Identical | | Monitor Components | Frame Touchscreen with Antiglare USB Ports Scope Connector Power Button HDMI In HDMI Out USB Type B Port AD/DC Power Cable | Frame Touchscreen with Antiglare USB Ports Scope Connector Power Button HDMI In HDMI Out USB Type B Port AD/DC Power Cable | Identical | | Sterile/Non-sterile | Sterile | Sterile | Identical | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical | | Sterilization Assurance Level | 10-6 | 10-6 | Identical | | Usage | Single use, disposable | Single use, disposable | Identical | | Features | Uretero1TM Ureteroscope System K211347 | Uretero1TM Ureteroscope System (Modified Device) | Comparison | | Page 3 of 1 | | | | | Functionality | Irrigation capability through irrigation port Ability to use endoscopic tools through instrument port Ability to record images (picture and video) Ability to record to external media (USB flash) Audio (notifications to the user) | Irrigation capability through irrigation port Ability to use endoscopic tools through instrument port Ability to record images (picture and video) Ability to record to external media (USB flash) Audio (notifications to the user) | Identical | | Ureteroscope Working Distance | 2mm – 50mm | 2mm – 50mm | Identical | | Dimensions | Tip Diameter: 6.6F (2.2mm) Outer Diameter: 9.5F (3.2mm) Instrument Channel internal diameter: 3.6F (1.2mm) | Tip Diameter: 6.6F (2.2mm) Outer Diameter: 9.5F (3.2mm) Instrument Channel internal diameter: 3.6F (1.2mm) | Identical | | Ureteroscope Tip Deflection | 270° in both directions | 270° in both directions | Identical | | Target Population | Patients undergoing a urological endoscopic procedure | Patients undergoing a urological endoscopic procedure | Identical | | Energy Used/Delivered | None | None | Identical | | Accessories Provided | Accessory port cover | Accessory port cover | Identical | | Method of Application | Manual | Manual | Identical | | Software System | The Uretero1TM 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 Uretero1TM 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 a streamer | Identical | | Features | Uretero1™ Ureteroscope System | Uretero1™ Ureteroscope System (Modified Device) | Comparison | | | K211347 | | | | Software Update: Allow unlimited addresses for scope detection. | Has finite number of addresses for scope detection. | Has unlimited addresses for scope detection. | Similar. No impact on safety, effectiveness or how the device is used. This software change is a convenience feature for the user. | | Software Update: Synchronization check on incoming video frame. | Synchronization check not performed on incoming video. | Synchronization check performed on incoming video. | Similar. No impact on safety, effectiveness or how the device is used by the user. Change is intended to increase manufacturability. | | Software Update: Modification in Image Signal Processing (ISP) | Image Signal Processing (ISP) utilizes an external clock source as a root clock. | Image Signal Processing (ISP) utilizes an internal clock source as a root clock | Similar. No impact on safety, effectiveness or how the device is used by the user. Change is intended to increase manufacturability. | | Software Update: Modification in behavior of HDMI output to external monitors | Use of an incompatible monitor causes a "stutter" effect. | Use of an incompatible monitor results in no video from the ureteroscope. | Different. No impact on safety, effectiveness or how the device is used by the user. The Uretero1 System allows a user to connect a monitor other than the Vision1. The change is for the convenience of the user. | | Software Update: Turn off scope LED drive when the scope is not connected. | LED drive remains on when scope is disconnected. | LED drive is turned off when the scope is disconnected. | Different. No impact on safety, effectiveness or how the device is used by the user. This change is to extend the life of the LED driver chip. | | Software Update: Update initialization for Hardware Chip | Error checks performed only at boot up | Additional error checks performed at boot up and screen transitions. | Similar. No impact on safety, effectiveness or how the device is used by the user. This change improves the boot up performance of the system. | | Software Update: Remove dormant software class objects from memory | Dormant software class objects remain in memory. | Dormant software class objects removed from memory. | Different. No impact on safety, effectiveness or how the device is used by the user. This change improves memory usage of the system. | | Software Update: Update the Uretero1 System application to eliminate the digital artifact | Sensor registers are not monitored once they are set. | Sensor registers are constantly monitored once they are set. | Different. No impact on safety, effectiveness or how the device is used by the user. This change returns the device to its original specifications. | | Features | Uretero1TM Ureteroscope System K211347 | Uretero1TM Ureteroscope System (Modified Device) | Comparison | | Software Update: Provide the user the ability to disable the scope buttons in the Settings menu of the console. | Scope button is always enabled. | Option given to the user to disable the scope button. | Different. This change does not impact safety or effectiveness. This change is for the convenience of the user. | | Software Update: Implement on-screen annotation of Left vs. Right kidney. | No ability to annotate left and right kidney. | Ability for user to annotate left and right kidney. | Different. This change does not impact safety or effectiveness. This change is to aid the user | | Software Update: Change email address listed in HELP menu from vision1@steris.com to urology@steris.com. | Email address is vision1@steris.com | Email address is urology@steris.com | Different. This change does not impact safety, effectiveness or how the device is used. The change is for the convenience of the user | | Software Update: Remove the red static text "Insert Thumb drive to take photos or videos" in the patient data box. | Red static text remains regardless of whether or not the thumb drive has been inserted. | The red static text is removed. | Different. This change does not impact safety, effectiveness or how the device is used. The change is for the convenience of the user. | | Software Update: Make the pop-up message "Photo or video not saved, insert USB drive" disappear after 5 seconds, without requiring user intervention. | User intervention is required to remove the pop-up message. | User intervention is not required to remove the pop-up message. | Different. This change does not impact safety, effectiveness or how the device is used. The change is for the convenience of the user. | | Software Update: Grey out all languages except English. | All languages appear available. | Only English appears available. | Different. This change does not impact safety, effectiveness or how the device is used. The change is for the convenience of the user. | | Software Update: Refactor device power board software code and GUI software code. | Unoptimized code structure and memory usage. | Improved code structure and memory usage. | Different. This change does not impact safety, effectiveness or how the device is used. | | Features | Uretero1TM Ureteroscope System K211347 | Uretero1TM Ureteroscope System (Modified Device) | Comparison | | Software Update: Lock the HDMI output resolution to 1080p/60. | HDMI output capable of 720p and 1080p | HDMI output capable of 1080p/60 | Different. This change does not impact safety, effectiveness or how the device is used. This change is to ensure monitor compatibility. | | Software Update: Provide a selection button on the monitor that allows the user to print a snapshot of the live view during a procedure to a printer. | No printer functionality available. | Printer functionality available.…