(204 days)
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 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 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.
The provided text describes the 510(k) summary for the STERIS Corporation's Uretero1™ Ureteroscope System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It is not a study that provides clinical performance data (e.g., diagnostic accuracy, patient outcomes with human readers, or standalone AI performance). Therefore, many of the requested elements for describing a study are not present in the provided text.
Here is an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance
The document lists various non-clinical tests performed, and for each, the reported device performance is "Pass." The acceptance criteria for each specific test are not explicitly detailed (e.g., what constitutes a "Pass" for "Image Latency" in terms of milliseconds). However, the general acceptance criterion for all listed tests is that the device passed them.
| Testing Category | Reported Device Performance |
|---|---|
| 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) | Pass |
| Aspiration Flow/Working Channel Collapse (Scope and Accessory Cap) | Pass |
| Working Channel Freedom from Leakage (Scope and Accessory Cap) (repeated entry) | 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 |
| Maximum Width of Insertion Portion (Overall Shaft Diameter and Size) – after aging | Pass |
| Image Latency - after aging | Pass |
| Lumen Output - after aging | Pass |
| Maximum Angle of Deflection - after aging | Pass |
| Bend Radius - after aging | Pass |
| Lever Deflection Force - after aging | Pass |
| SUD Working Channel Freedom from Leakage (Scope and Accessory Cap) - after aging | Pass |
| Shaft to Handle Tensile Strength - after aging | Pass |
| Umbilicus to Handle Tensile Strength - after aging | Pass |
| Umbilicus to Connector Tensile Strength - after aging | Pass |
| Connector Retention Strength - after aging | Pass |
| Tip to Shaft Tensile Strength - after 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 (repeated entry) | Pass |
| Radiopacity Testing (repeated entry) | Pass |
| Working Channel Connection Compatibility | Pass |
| Packaging Integrity (repeated entry) | Pass |
| Package Seal Strength (repeated entry) | Pass |
| Biocompatibility (Cytotoxicity, Irritation, USP Physiochemical ) | All evaluation acceptance criteria were met |
| Electrical Safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-18) | All evaluation acceptance criteria were met |
| Software verification and validation | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes non-clinical engineering and laboratory testing, not a clinical study with a "test set" of patient data. Therefore, this information is not applicable in the context of clinical data. The tests are performed on the device itself and its components. No information on data provenance relating to patient data is provided as patient data was not used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable as the document describes non-clinical performance testing of a medical device, not a study evaluating diagnostic or interpretive capabilities that would require expert ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of clinical findings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not a study assessing the effectiveness of human readers with or without AI assistance. The Uretero1™ Ureteroscope System is a visualization and procedural device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Uretero1™ Ureteroscope System is a medical device, not an algorithm, and its performance is inherently human-in-the-loop during medical procedures.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For biocompatibility, the "ground truth" was defined by the acceptance criteria specified in ISO 10993-1:2018 for cytotoxicity, irritation, and USP Physiochemical . For electrical safety, the "ground truth" was defined by the acceptance criteria in the listed IEC standards (IEC 60601-1, etc.). For the numerous physical and mechanical performance tests, the "ground truth" or acceptance criteria are inherent in the engineering specifications for each test (e.g., a specific bend radius must be achievable, leakage must not occur, etc.). These are engineering and safety standards, not clinical ground truth.
8. The sample size for the training set
Not applicable. The document describes testing of a physical medical device. It does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.