Uretero1 Ureteroscope System

K211347 · STERIS Corporation · FGB · Nov 23, 2021 · Gastroenterology, Urology

Device Facts

• Record ID: K211347
• Device Name: Uretero1 Ureteroscope System
• Applicant: STERIS Corporation
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Nov 23, 2021
• Decision: SESE
• Submission Type: Traditional
• 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 is a single-use, sterile, flexible digital ureteroscope used with a Vision1 Imaging Console and Display System (CCU). The system captures video from the ureteroscope distal tip and displays it on an external monitor. The clinician steers the distal tip via an articulation lever on the handle; a working channel allows for endoscopic accessory use and irrigation. The CCU features a 4-hour usage timer with automated on-screen notifications at 60, 30, and 5 minutes, after which the device ceases operation. The system supports image/video capture via handle buttons, with data export to an encrypted USB drive. Used in clinical settings by urologists for diagnostic and therapeutic urinary tract procedures. The device provides real-time visualization, aiding clinical decision-making during minimally invasive urological interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by extensive non-clinical bench testing, including mechanical integrity (tensile strength, deflection, torque), electrical safety (IEC 60601-1, 60601-2-18), biocompatibility (ISO 10993-1), and software verification/validation. All performance tests met acceptance criteria.

Technological Characteristics

Single-use flexible digital ureteroscope; NXP i.MX8MQ processor and LATTICE ECP5 FPGA-based CCU; Linux-based software (YOCTO); HDMI video output; USB data export; Ethylene Oxide sterilization; 270-degree tip deflection; 2mm-50mm working distance; 1.12mm minimum instrument channel width.

Indications for Use

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

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

• LithoVue System (K153049)

Submission Summary (Full Text)

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November 23, 2021

STERIS Corporation Caroll Martin Director, Regulatory Affairs 5976 Heisley Road Mentor, Ohio 44060

Re: K211347

> Trade/Device Name: Ureterol Ureteroscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: II Product Code: FGB Dated: October 25, 2021 Received: October 27, 2021

Dear Caroll 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. You must comply with all the Act's

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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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K211347

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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K211347 Page 1 of 7

# 510(k) Summary for the Uretero1TM Ureteroscope System

STERIS Corporation 5960 Heisley Road Mentor, OH 44060

Contact: Carroll Martin Regulatory Affairs Director Tel: [phone] Email: [e-mail]

April 30, 2021 Submission Date:

STERIS Corporation ■ 5960 Heisley Road ■ Mentor, OH 44060-1834 USA ■ 440-354-2600

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#### 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

LithoVue System, K153049

#### 3. Device Description

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 to 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 OT5. 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

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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 ther 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: Uretero1TM 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.

#### 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.

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#### 5. Technological Characteristics Comparison Table

A comparison of technical characteristics between the proposed and predicate devices is summarized in Table 1.

| Features | LithoVue System<br>Predicate Device<br>K153049 | Uretero1™ Ureteroscope<br>System (Proposed<br>Device) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The LithoVue System is<br>intended to be used to<br>visualize organs,<br>cavities and canals in<br>the urinary tract<br>(urethra, bladder,<br>ureter, calyces and renal<br>papillae) via<br>transurethral or<br>percutaneous access<br>routes. It can also be<br>used in conjunction with<br>endoscopic accessories<br>to perform various<br>diagnostic and<br>therapeutic procedures<br>in the urinary tract. | The single use<br>Uretero1™ Ureteroscope<br>System is intended to be<br>used to visualize organs,<br>cavities and canals in the<br>urinary tract (urethra,<br>bladder,<br>ureter, calyces and renal<br>papillae) via transurethral<br>or percutaneous access<br>routes. It can also be used<br>in conjunction with<br>endoscopic accessories to<br>perform various<br>diagnostic and therapeutic<br>procedures in the urinary<br>tract. | Identical |
| Ureteroscope<br>Construction/Components | Handle<br>Articulation Lever<br>Accessory Port<br>Irrigation Port<br>Connector Cable<br>Connector Cable Plug<br>Flexible Shaft<br>Articulation Section<br>Distal Tip (camera,<br>illumination optics, and<br>the working channel,<br>video signal cables,<br>articulation wires and<br>light fiber)<br>Instrument Channel<br>Light (illumination fiber)<br>Camera | Handle<br>Articulation Lever<br>Handle Button<br>Accessory Port<br>Irrigation Port<br>Connector Cable<br>Connector Cable Plug<br>Flexible Shaft<br>Articulation Section<br>Distal Tip (camera,<br>illumination optics, and<br>the working channel,<br>video signal cables,<br>articulation wires and light<br>fiber)<br>Instrument Channel<br>Light (illumination fiber)<br>Camera | Similar. The predicate<br>device does not have a<br>handle button to allow<br>the user to take photos,<br>record video or zoom<br>in/out. This does not<br>affect safety and<br>effectiveness in that this<br>feature in the proposed<br>device gives the user<br>options to capture data. |
| Monitor Components | Frame<br>Touchscreen<br>Scope Connector<br>AD/DC Power Cable<br>DVI Input | Frame<br>Touchscreen with<br>Antiglare<br>USB Ports<br>Scope Connector<br>Power Button<br>HDMI In<br>HDMI Out<br>USB Type B Port<br>AD/DC Power Cable | Similar. The DVI<br>Digital Visual Interface<br>of the predicate is<br>similar to the HDMI<br>Output of Uretero1 as<br>they both allow transfer<br>of video signal to an<br>external display. The<br>HDMI input allows a<br>user to display image<br>from an external display |
| Features | LithoVue System<br>Predicate Device<br>K153049 | Uretero1™ Ureteroscope<br>System (Proposed<br>Device) | Comparison |
| Sterile/Non-sterile | Sterile | Sterile | Identical |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Identical |
| Sterilization Assurance<br>Level | 106 | 106 | Identical |
| Usage | Single use, disposable | Single use, disposable | Identical |
| Functionality | Irrigation capability<br>through irrigation port<br>Ability to use endoscopic<br>tools through instrument<br>port. | Irrigation capability<br>through irrigation port<br>Ability to use endoscopic<br>tools through instrument<br>port<br>Ability to record images<br>(picture and video)<br>Ability to record to<br>external media (USB<br>flash)<br>Audio (notifications to the<br>user) | Similar. The listed<br>differences between the<br>proposed and predicate<br>devices do not impact<br>safety/effectiveness of<br>the device in that the<br>additional functionality<br>of the proposed device is<br>a convenience to the<br>user. |
| Ureteroscope Working<br>Distance | 2mm - 50mm | 2mm - 50mm | Identical |
| Dimensions | Max. Width of Insertion<br>Portion (Distal Face): ≤2.6<br>mm<br>Max. Width of Insertion<br>Portion: ≤3.23 mm<br>Working Length: 680 ± 2<br>mm<br>Minimum Instrument<br>Channel Width: ≥1.12 mm | Max. Width of Insertion<br>Portion (Distal Tip): ≤2.6<br>mm<br>Max. Width of Insertion<br>Portion: ≤3.23 mm<br>Working Length: 680 ± 2<br>mm<br>Minimum Instrument<br>Channel Width: ≥1.12 mm | Identical. |
| Ureteroscope Tip<br>Deflection | 270° in both directions | 270° in both directions | Identical |
| Target Population | Patients undergoing a<br>urological endoscopic<br>procedure | Patients undergoing a<br>urological endoscopic<br>procedure | Identical |
| Energy Used/Delivered | None | None | Identical |
| Accessories Provided | None | Accessory port cover | Different. The proposed<br>device offers an<br>accessory port cover for<br>the convenience of the<br>user. The cover<br>facilitates the passage of<br>instruments during a<br>procedure. |

## Table 1. Technological Characteristics Comparison Table

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#### 6. Summary of Non-Clinical Performance Testing

Non-clinical testing consisted of the following:

| Testing | Results |
|-----------------------------------------------------------------------------------------------------------------------------|---------|
| Width of Insertion Portion (Distal Face) | Pass |
| Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) | Pass |
| Working Length | Pass |
| Working Channel Length | Pass |
| Deflection Direction Marking (Visual test) | Pass |
| Printing Legibility (Visual test) | Pass |
| Ink Integrity (Handle Print Adhesion/Legibility – Visual test) | Pass |
| Surface and Edges (Visual test) | Pass |
| Maximum Angle of Deflection | Pass |
| Bend Radius | Pass |
| Direction of View | Pass |
| Image Orientation | Pass |
| Image Latency | Pass |
| Lumen Output | Pass |
| Lever Deflection Force | Pass |
| Working Channel Freedom from Leakage | Pass |
| Aspiration Flow/Working Channel Collapse | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) | Pass |
| Aspiration Flow/Working Channel Collapse (Scope and Accessory Cap (accessory port cover)) | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory Cap (accessory port cover)) | Pass |
| Button Resistance after Conditioning | Pass |
| Minimum Working Distance after Conditioning | Pass |
| Image Latency after Conditioning | Pass |
| Lumen Output after Conditioning | Pass |
| Lever Deflection Force after Conditioning | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory) after Conditioning | Pass |
| Torsional Resistance at Tip | Pass |
| Tip Column Strength | Pass |
| Shaft to Handle Tensile Strength | Pass |
| Umbilicus to Handle Tensile Strength | Pass |
| Umbilicus to Connector Tensile Strength | Pass |
| Tip to Shaft Tensile Strength | Pass |
| Critical Shaft Bend Radius | Pass |
| 3-Point Bend (Shaft Flexural Resistance) | Pass |
| Single Use Device Handle Temp. During Procedure | Pass |
| Control Body must be able to change the axis of tip deflection | Pass |
| Single Use Device Use Time Tracking/ Single Use Device Remaining Use Time | Pass |
| Button Functions | Pass |
| Laser Aiming Beam/Laser Lithotripsy Compatibility | Pass |
| Testing | Results |
| Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) –<br>Testing conducted after 3-month accelerated aging | Pass |
| Image Latency - Testing conducted after 3-month accelerated aging | Pass |
| Lumen Output - Testing conducted after 3-month accelerated aging | Pass |
| Maximum Angle of Deflection - Testing conducted after 3-month<br>accelerated aging | Pass |
| Bend Radius - Testing conducted after 3-month accelerated aging | Pass |
| Lever Deflection Force - Testing conducted after 3-month accelerated aging | Pass |
| SUD Working Channel Freedom from Leakage (Scope and Accessory Cap) -<br>Testing conducted after 3-month accelerated aging | Pass |
| Shaft to Handle Tensile Strength - Testing conducted after 3-month<br>accelerated aging | Pass |
| Umbilicus to Handle Tensile Strength - Testing conducted after 3-month<br>accelerated aging | Pass |
| Umbilicus to Connector Tensile Strength - Testing conducted after 3-month<br>accelerated aging | Pass |
| Connector Retention Strength - Testing conducted after 3-month accelerated<br>aging | Pass |
| Tip to Shaft Tensile Strength - Testing conducted after 3-month accelerated<br>aging | Pass |
| Shaft Leakage conducted after 3-month accelerated aging | Pass |
| Radiopacity Testing | Pass |
| Luer Testing | Pass |
| Accessory Channel Minimum Width Assessment | Pass |
| Handle to Active Deflection Torque Angle at Break | Pass |
| Packaging Age Testing (Integrity and Seal Strength) | Pass |
| Software verification and validation | Pass |
| Radiopacity Testing | Pass |
| Working Channel Connection Compatibility | Pass |
| Packaging Integrity | Pass |
| Package Seal Strength | Pass |
| Software verification and validation | Pass |

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Biocompatibility of the Uretero1 Ureteroscope was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface – Mucosal Membrane" with a contact duration of "Limited (< 24 hours)". The following tests were performed: Cytotoxicity, Irritation, and USP Physiochemical <661>. All evaluation acceptance criteria were met.

Electrical safety testing of the System was evaluated in accordance with IEC 60601-1 (2005) Edition 3.1, IEC 60601-1-2 (2014) Edition 4, IEC 60601-1-6 (2010), Edition 3.1 and IEC 60601-2-18:2009 Edition 3. All evaluation acceptance criteria were met.

#### 7. Conclusion

Based on the intended use, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs as well or better than the legally marketed predicate device (K153049), Class II (21 CFR 876.1500), product code FGB.