(253 days)
The LithoVue Elite Digital Flexible 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 LithoVue Elite System is a software-controlled digital flexible ureteroscope system that consists of the Workstation (to be marketed as StoneSmart Connect Console) and the Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue Elite System is designed to allow the physician to access, visualize and perform procedures in the urinary tract, and to provide real-time intraluminal pressure monitoring in the kidney and ureter during ureteroscopy.
The provided text is a 510(k) summary for the LithoVue Elite Digital Flexible Ureteroscope System. Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with quantitative targets alongside reported device performance for all aspects. Instead, it discusses performance testing and successful outcomes against design specifications. However, we can infer some criteria and reported performance from the "Comparison of Key Technological/Performance Characteristics" table and the "Performance Testing" section.
| Feature/Criterion | Acceptance Metric/Target (Inferred) | Reported Device Performance |
|---|---|---|
| General | ||
| Reusability (Ureteroscope) | Single Use | Single Use |
| Reusability (Workstation) | Reusable | Reusable |
| Ureteroscope Type | Flexible | Flexible |
| Ureteroscope Provided Status | Sterile | Sterile |
| Sterilization Agent | Ethylene Oxide (EO) | Ethylene Oxide (EO) |
| Power Input (Workstation) | 100-240 VAC, 50-60 Hz | 100-240 VAC, 50-60 Hz |
| Imager Type | CMOS | CMOS |
| Imager Location | Distal | Distal |
| Illumination Source | LED | LED |
| Ureteroscope Mechanical Specifications | ||
| 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 | ||
| 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 | >5.04 lp/mm at 5mm distance (predicate) | >9.81 lp/mm at 5mm distance (proposed) |
| Video Latency | 155 ms | 155 ms |
| Pressure Measurement Capability | ||
| Gauge Pressure Accuracy in Water | Meets design specifications | Evaluated, met design specifications |
| Pressure Sensor Bandwidth | Meets design specifications | Evaluated, met design specifications |
| Pressure Measurement Durability | Meets design specifications | Evaluated, met design specifications |
| Pressure Measurement Zero Point Drift | Meets design specifications | Evaluated, met design specifications |
| Pressure Measurement Accuracy | Meets design specifications | Evaluated, met design specifications |
| Pressure Measurement Latency | Meets design specifications | Evaluated, met design specifications |
| Biocompatibility | ||
| Cytotoxicity | Biocompatible | Biocompatible |
| Irritation | Biocompatible | Biocompatible |
| Sensitization | Biocompatible | Biocompatible |
| Acute Systemic Toxicity | Biocompatible | Biocompatible |
| Pyrogen | Biocompatible | Biocompatible |
| EMC & Electrical Safety | ||
| Compliance with ANSI AAMI ES60601-1 | Meets requirements | Demonstrates compliance |
| Compliance with IEC 60601-2-18 | Meets requirements | Demonstrates compliance |
| Compliance with IEC 60601-1-2 | Meets requirements | Demonstrates compliance |
| Software | ||
| Software Verification and Validation | Completed, meets FDA guidance | Completed |
| Intraluminal Pressure Monitoring Accuracy (in vivo) | Accurate | Demonstrated in GLP Animal Study |
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing" and a "GLP Animal Study."
- Bench Testing: The sample size for bench testing is not specified. The provenance is internal to the manufacturer (Boston Scientific Corporation). Nature of the data is not applicable (bench tests, not patient data).
- GLP Animal Study: The specific sample size (number of animals) for the GLP Animal Study is not provided. The provenance is internal to the manufacturer, conducted under Good Laboratory Practice (GLP) standards, which implies a controlled, prospective study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported performance testing primarily involved objective measurements against design specifications and recognized standards (e.g., electrical safety, biocompatibility) and an animal study for pressure accuracy. There is no indication of human experts establishing ground truth for perception or diagnostic accuracy.
4. Adjudication method for the test set
Not applicable. The testing described does not involve expert adjudication for decision-making or image interpretation.
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 MRMC study was done. The device does not involve AI assistance for human readers; it is a diagnostic/therapeutic tool for visualization and pressure monitoring. Clinical testing was explicitly stated as not required to demonstrate substantial equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was conducted for the device's components and overall system. This includes bench testing for mechanical, optical, and pressure sensor characteristics, as well as an animal study for in-vivo pressure monitoring accuracy. The device itself (image capture and pressure sensing) operates in a standalone manner, providing data to the human user.
7. The type of ground truth used
- Bench Testing: Engineering specifications, physical measurements, and compliance with industry standards (e.g., for resolution, field of view, electrical safety).
- Biocompatibility: Results of standardized chemical and biological tests defined in ISO 10993-1.
- GLP Animal Study: Direct physiological measurements of intraluminal pressure in an animal model were used as ground truth for the device's pressure monitoring accuracy. The report of this study was included in the submission.
8. The sample size for the training set
Not applicable. This device is a hardware system for visualization and pressure monitoring, not a machine learning or AI-driven diagnostic device that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
§ 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.