(92 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 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 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.
The provided FDA 510(k) summary for the Uretero1™ Ureteroscope System (K223466) describes a device that is substantially equivalent to a previously cleared device (K211347). As such, the submission primarily focuses on comparing the modified device to its predicate and demonstrating that the changes do not raise new questions of safety or effectiveness. This type of submission generally does not include extensive clinical study data with acceptance criteria for a novel AI algorithm's performance with ground truth. Instead, it relies on non-clinical performance testing to ensure that the modified device continues to meet established standards and functions as intended.
Therefore, the requested information about acceptance criteria and a study that proves the device meets them, particularly regarding AI performance metrics, sample sizes, expert qualifications, and ground truth establishment, is largely not applicable in the context of this 510(k) summary. The document does not describe the device as incorporating an AI algorithm that would require such performance evaluation.
However, I can extract the information that is present regarding the non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or numerical reported performance values. Instead, it states that various tests "Pass" or that changes have "No impact on safety, effectiveness or how the device is used."
| Change Type | Testing Type | Acceptance Criteria Implicit (e.g., "Pass") | Reported Device Performance |
|---|---|---|---|
| Software | Functional and Regression Testing | Pass | Pass |
| Optical Color Performance Testing | Pass | Pass | |
| White Balance Testing | Pass | Pass | |
| Hardware Changes | Optical Performance Testing | Pass | Pass |
| Review of Prior Testing | Pass | Pass | |
| Software Regression Testing | Pass | Pass | |
| Material Change (Adhesive) | Workmanship, functionality and performance | Pass | Pass |
| Biocompatibility | Pass | Pass | |
| Dimensional Changes | Device passage, lumen output and tensile testing | Pass | Pass |
| Electrical Testing | Pass | Pass | |
| Labeling Changes | Labeling Review | Pass | Pass |
| Extension of Expiration Date | Functional/performance testing | Pass | Pass |
| Packaging testing | Pass | Pass | |
| Software Update (various changes) | "No impact on safety, effectiveness or how the device is used." | No new safety/effectiveness concerns | No new safety/effectiveness concerns |
| Hardware Changes (connector, sensor, adhesive, dimensions) | "No impact on safety, effectiveness or how the device is used." | No new safety/effectiveness concerns | No new safety/effectiveness concerns |
2. Sample size used for the test set and the data provenance
Not explicitly stated in the provided document. The testing described is non-clinical performance testing (e.g., electrical, optical, mechanical, software functionality), which typically involves testing of the device hardware and software rather than a clinical dataset. Thus, concepts like country of origin for patient data are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an endoscope system, and the testing described is non-clinical performance testing. The "ground truth" here would be objective engineering specifications and functional requirements rather than expert interpretation of medical images or patient outcomes.
4. Adjudication method for the test set
Not applicable. As described above, the testing is non-clinical performance testing.
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. The document does not mention the inclusion of any AI assistance features in the Uretero1™ Ureteroscope System, nor does it present any MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The document describes an endoscope system and its modifications; it does not present a standalone algorithm.
7. The type of ground truth used
For the non-clinical performance tests, the "ground truth" would be established engineering standards, specifications, and functional requirements as outlined in the referenced ISO standards (e.g., ISO 8600-3:2019, ISO 8600-5:2020, ISO 12233:2017, ISO 9039:2008, ISO 15739:2017, IEC 62304:2006/A1:2016, IEC 60601-1:2012, ISO 10993-1:2018, ISO 15223-1, ASTM F1886, ASTM F2096, ASTM F88).
8. The sample size for the training set
Not applicable. There is no mention of a machine learning or AI algorithm requiring a training set in this 510(k) submission.
9. How the ground truth for the training set was established
Not applicable. As there is no mention of a training set for an AI algorithm, this question is not relevant to the provided document.
§ 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.