(28 days)
The LithoVue Elite Digital Flexible Ureteroscope System is intended to by 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 LithoVue Elite Digital Flexible Ureteroscope System is a software-controlled digital flexible ureteroscope system that consists of the StoneSmart Connect Console and the Single-Use Digital Flexible Ureteroscope. The LithoVue Elite Digital Flexible Ureteroscope System is designed to allow the physician to access, visualize and perform procedures in the urinary tract.
The proposed devices within the scope of this Special 510(k) premarket notification are the StoneSmart Connect Console and the LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
Changes to the StoneSmart Connect Console (cleared under K221515 on 02-FEB-2023) include software changes to introduce a new user control feature (referred to as "Aiming Beam Mode") that is designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system and implement software bug fixes and enhancements.
The proposed LithoVue Elite Single-Use Digital Flexible Ureteroscope is the same as the predicate LithoVue Elite Sinqle-Use Digital Flexible Ureteroscope with pressure monitoring (K221515) with respect to its design, performance, intended use, operating principle, and fundamental technology, except that it does not possess the pressure monitoring capability.
This document is a 510(k) summary for the StoneSmart Connect Console and LithoVue Elite Single-Use Digital Flexible Ureteroscope. It details the device's characteristics and its substantial equivalence to a predicate device (K221515).
Based on the provided text, the device is an endoscope system used to visualize the urinary tract and perform diagnostic/therapeutic procedures. The core of the submission revolves around software changes to the console and the removal of the pressure monitoring capability from the ureteroscope.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly present a table of acceptance criteria in the way one might see for an AI/ML device (e.g., predefined sensitivity/specificity thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device (K221515) by comparing technological and performance characteristics. The acceptance criterion is implicitly that the changes do not negatively impact safety or effectiveness, and the device performs similarly or better than the predicate.
Here's a table based on the "Comparison of Key Technological/Performance Characteristics" section, which serves as the evidence for meeting the implicit acceptance criterion of substantial equivalence:
| Characteristic | Proposed Device Performance | Predicate Device Performance (K221515) | Substantial Equivalence Discussion |
|---|---|---|---|
| Reusability | Ureteroscope: Single Use; Console: Reusable | Ureteroscope: Single Use; Console: Reusable | Same |
| Ureteroscope Type | Flexible | Flexible | Same |
| Ureteroscope is Provided | Sterile | Sterile | Same |
| Sterilization Agent | Ethylene Oxide (EO) | Ethylene Oxide (EO) | Same |
| Power Input (Workstation) | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz | Same |
| Imager Type | CMOS | CMOS | Same |
| Imager Location | Distal | Distal | Same |
| Illumination Source | LED | LED | Same |
| Ureteroscope supports real-time intraluminal pressure monitoring | No | Yes | The proposed ureteroscope does not support real-time intraluminal pressure monitoring. (This is a difference, but the submission argues it doesn't alter suitability for intended use, likely because pressure monitoring is not a core "vision" function and its absence is not considered a safety/effectiveness concern for the primary indication). |
| Aiming Beam Mode | Yes | No | Aiming beam mode is a new feature introduced with the proposed console. It is an optional (user-activated) feature designed to provide the physician with more options to reduce interference from high intensity laser aiming beams within the live image displayed by the LithoVue Elite ureteroscope system. (This is an improvement/addition that is argued to not impact substantial equivalence negatively, but rather enhance user experience). |
| Shaft Working Length | 68 cm | 68 cm | Same |
| Shaft OD | 9.5F | 9.5F | Same |
| Insertion Portion Width (Distal Face) | 7.7 F | 7.7 F | Same |
| Working Channel Size | 3.6 F (1.15mm MIN ABS) | 3.6 F (1.15mm MIN ABS) | Same |
| Working Length | 82 cm | 82 cm | Same |
| Deflection | Active and Passive | Active and Passive | Same |
| Degree of Active Deflection | 270° in both directions | 270° in both directions | Same |
| Field of View (in air) | 120° (diagonal) | 120° (diagonal) | Same |
| Working Distance | 2 - 50 mm | 2 - 50 mm | Same |
| Direction of View | 0° (forward viewing) | 0° (forward viewing) | Same |
| Resolution | Typical (5mm Distance): >9.81 lp/mm | Typical (5mm Distance): >9.81 lp/mm | Same |
| Video Latency (Max.) | 155 ms | 155 ms | Same |
2. Sample size used for the test set and the data provenance:
The document states: "Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope. Changes to the cleared console (K221515) are limited to software changes only. The existing bench testing information/data reviewed by the FDA for the predicate console (reference K221515) remains valid for the proposed console."
This indicates that a new clinical test set was not used for this submission. The "test set" for performance evaluation is effectively the data that supported the previous K221515 clearance. The document focuses on demonstrating that the changes (software update and removal of pressure monitoring) do not invalidate the prior testing.
- Sample size for test set: Not explicitly mentioned for this submission. It relies on the testing performed for K221515.
- Data provenance: Not specified for K221515's data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. Given that this is largely a performance and software change submission for an existing device, and not an AI/ML diagnostic system with new clinical claims requiring interpretation of images by experts, such details are generally not included. The "ground truth" for a ureteroscope is its ability to visualize and manipulate within the urinary tract, which is assessed through bench testing and, for prior clearances, likely clinical use data (though not detailed here).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. Not applicable for bench testing or performance verification of an endoscope system.
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:
No. An MRMC study is typically for evaluating the diagnostic performance of software, especially AI, in assisting human readers. This submission is for an endoscope system (hardware and software for visualization and procedure) and not specifically an AI-based diagnostic aid that assists human readers in interpreting images for a specific diagnostic outcome. The "Aiming Beam Mode" is a user control feature for image quality, not an AI interpretation feature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML algorithm that operates standalone to provide a diagnostic output. The "algorithm" here refers to the software controlling the endoscope system and processing the live video feed. Its performance is intrinsically tied to the human operator using the device for visualization and intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For this type of device and submission, the "ground truth" relates to the functional performance of the device:
- Visualization Quality: Resolution, field of view, working distance (bench tested, as shown in the table).
- Mechanical Performance: Deflection, shaft dimensions.
- Safety: Biocompatibility, electrical safety, EMC, sterility (tested or demonstrated as equivalent to previously tested predicate).
- Software Functionality: Verification and validation of software changes (e.g., Aiming Beam Mode) against specifications.
The document states: "Design verification (bench) testing for visualization, mechanical performance, and durability, conducted by utilizing the predicate ureteroscope (K221515), remains valid for the proposed ureteroscope." This implies the ground truth for these aspects comes from bench test standards and measurements.
For software, the "ground truth" is adherence to software requirements and specifications through V&V activities. "Software testing was completed. The software documentation stipulated in FDA guidance document... was included in this premarket submission."
8. The sample size for the training set:
Not applicable. This submission is not for an AI/ML model that would have a "training set" in the traditional sense. The software changes are bug fixes and a new user control feature, which are typically developed and tested using standard software engineering practices (unit testing, integration testing, system testing) rather than a machine learning training dataset.
9. How the ground truth for the training set was established:
Not applicable. As above, there's no "training set" in the context of machine learning. The "ground truth" for software development would be the documented requirements and design specifications, against which the software's functionality is verified and validated.
§ 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.