(27 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 (cleared under K221515 on 02-FEB-2023 and K233645 on 12-DEC-2023) consists of the StoneSmart Connect Console, LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring, and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring). The proposed devices within the scope of this Special 510(k) premarket notification are the LithoVue Elite Single-Use Digital Flexible Ureteroscope with pressure monitoring and LithoVue Elite Single-Use Digital Flexible Ureteroscope (without pressure monitoring).
The proposed ureteroscope with pressure monitoring contains a redesigned distal tip to improve its durability during a ureteroscopy procedure. To maintain congruence between the two marketed configurations of the ureteroscope, the distal tip of the ureteroscope (without pressure monitoring) is also modified to match the one used in the ureteroscope with pressure monitoring, with the exception that it does not contain the specific modifications intended for pressure monitoring. Furthermore, test methods are also modified to be more representative of "challenging" working conditions as well as for better alignment with the intent of the specifications.
This document is a 510(k) summary for the LithoVue Elite Single-Use Digital Flexible Ureteroscope. It details the device, its intended use, and a comparison to predicate devices, focusing on the substantial equivalence argument for regulatory clearance. Since this is a submission for the clearance of a device (a ureteroscope), and not for an AI/ML algorithm or a diagnostic test, the typical acceptance criteria and study designs that would apply to software are not present. The document focuses on the physical and functional aspects of the hardware.
Therefore, many of the questions regarding AI/ML-specific details, such as data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and training/test set ground truth, are not applicable to this document. The "device" in question is a physical endoscope.
However, I can extract the relevant performance testing information provided:
1. Table of acceptance criteria and the reported device performance:
The document implicitly defines acceptance criteria by stating that the proposed devices have the "Same" or "Identical" performance to the predicate devices across various characteristics. The specific numerical criteria mentioned are for "Pressure Measurement Accuracy" which applies to the ureteroscope with pressure monitoring.
| Characteristic | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Mechanical Specifications | Identical to Predicate | |
| Shaft Working Length | 68 cm | 68 cm |
| Shaft OD | 9.5F | 9.5F |
| Insertion Portion Width (Distal Face) | 7.7 F | 7.7 F |
| Working Channel Size | 3.6 F (1.15mm MIN ABS) | 3.6 F (1.15mm MIN ABS) |
| Working Length | 82 cm | 82 cm |
| Deflection | Active and Passive | Active and Passive |
| Degree of Active Deflection | 270° in both directions | 270° in both directions |
| Optical Specifications | Identical to Predicate | |
| Field of View (in air) | 120° (diagonal) | 120° (diagonal) |
| Working Distance | 2 - 50 mm | 2 - 50 mm |
| Direction of View | 0° (forward viewing) | 0° (forward viewing) |
| Resolution (Typical, 5mm Distance) | >9.81 lp/mm | >9.81 lp/mm |
| Pressure Measurement Accuracy (Pressure Monitoring version only) | Same as Predicate | |
| 0-60 minutes: 0-100 mmHg | +/- 10 mmHg | +/- 10 mmHg |
| 0-60 minutes: 100-300 mmHg | +/- 5 mmHg + 5 % of reading | +/- 5 mmHg + 5 % of reading |
| 60-120 minutes: 0-100 mmHg | +/- 13 mmHg | +/- 13 mmHg |
| 60-120 minutes: 100-300 mmHg | +/- 8 mmHg + 5 % of reading | +/- 8 mmHg + 5 % of reading |
Description of the Study:
The study performed was a "subset of the mechanical performance and durability testing (including pressure sensor durability testing) along with the 'Image Rotation Offset' testing." The purpose was to evaluate the "design changes" to the ureteroscopes, specifically a redesigned distal tip to improve durability. The document asserts that the proposed devices maintained the same performance characteristics as the predicate devices.
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 does not explicitly state the sample size for the mechanical performance and durability testing. It indicates that testing was performed on the "proposed ureteroscopes" to evaluate the design changes. The data provenance is not specified, but given it's for a medical device cleared in the US, it would generally be expected to be internal laboratory testing. It is a prospective evaluation of the new design.
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 information is not applicable and therefore not provided. The testing relates to the physical and functional performance of the device, not the interpretation of medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical or image-based studies where expert consensus is needed. The testing described is physical performance testing against engineering specifications.
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:
This information is not applicable. The device is a ureteroscope (hardware), not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. The device is a physical ureteroscope, not a standalone AI algorithm. It's a tool used by a human clinician.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device would be its adherence to established engineering specifications and performance benchmarks for mechanical durability, optical clarity, and pressure measurement accuracy. This is based on objective measurements rather than expert consensus or pathology in a clinical sense.
8. The sample size for the training set:
This information is not applicable. The device is hardware; there is no AI/ML training set.
9. How the ground truth for the training set was established:
This information is not applicable. There is no AI/ML training set.
§ 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.