(24 days)
The LithoVue System is intended to be 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™ System is a software-controlled digital flexible ureteroscope system that consists of the LithoVue System Workstation (Touch PC with installed Interface Box and Cart) and the Litho Vue Single-Use Digital Flexible Ureteroscope (sterile, single-use disposable).
The LithoVue System is designed to allow physicians to access, visualize, and perform procedures in the urinary tract, using appropriate accessory devices (e.g., baskets, laser fibers, forceps).
This FDA 510(k) summary describes the Boston Scientific LithoVue System, a digital flexible ureteroscope for visualizing and performing procedures in the urinary tract. The document primarily focuses on demonstrating substantial equivalence to predicate devices through performance testing.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance testing conducted but does not explicitly provide a table of acceptance criteria alongside the reported device performance. It only states that "All evaluation acceptance criteria were met" for various tests.
However, based on the types of tests performed, we can infer some general acceptance criteria categories and the claimed performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Optical Performance | All acceptance criteria met for: |
| - Working Distance Resolution in Air (Near, Typical, Far) | - Good image resolution at various distances |
| - Field of View in Air | - Appropriate field of view |
| - Direction of View | - Correct viewing direction |
| - Image Orientation | - Correct image orientation |
| - Contrast Sensitivity | - Sufficient contrast for visualization |
| - Image Signal to Noise | - Clear images with low noise |
| - Uniformity of Image Brightness | - Even illumination |
| - Total Flux Available at Tip | - Adequate illumination at the tip |
| - Automatic Light Control (ALC) | - Effective automatic brightness adjustment |
| - ALC Response Time | - Fast response to light changes |
| Mechanical Performance | All acceptance criteria met for: |
| - Width of Insertion Portion Distal Tip | - Appropriate tip size |
| - Maximum Width of Insertion Portion (Overall Shaft Diameter and Size Designation) | - Appropriate shaft diameter |
| - Working Length (Shaft Length) | - Correct working length |
| - Minimum Instrument Channel Width | - Sufficient channel width for accessories |
| - Tortuous Path Ability | - Ability to navigate curved paths |
| - Surface and Edges | - Smooth surfaces and edges |
| - SUD Working Channel Freedom from Leakage | - Channel integrity |
| - SUD Shaft Leakage | - Shaft integrity |
| - Torsional Resistance of Tip | - Good tip stability |
| - Tip Column Strength | - Strong tip |
| - Shaft Flexural Resistance | - Resistant to bending |
| - Maximum Angle of Deflection | - Sufficient deflection range |
| - Bend Radius | - Appropriate bend radius |
| - Secondary Deflection | - Good secondary deflection capability |
| - Deflection Life Cycling | - Durable deflection mechanism |
| - Shaft to Handle Tensile Strength | - Strong connection |
| - Tip to Shaft Tensile Strength | - Strong connection |
| - Handle to Active Deflection Torque Angle at Break | - Durable handle connection |
| - Umbilicus to Handle Tensile Strength | - Strong connection |
| - Umbilicus to Connector Tensile Strength | - Strong connection |
| - Critical Shaft Bend Radius | - Resistant to critical bends |
| - Shaft Bend Fatigue | - Durable under bending stress |
| - SUD Durability (Procedure Duration) | - Durable for intended procedure duration |
| - SUD Mechanical Durability | - Good overall mechanical durability |
| - Neutral Position Marking | - Clear marking |
| - Deflection Direction Marking | - Clear marking |
| - Lever Force | - Appropriate force for operation |
| - Connector Retention Strength | - Secure connection |
| Compatibility & Safety | All acceptance criteria met for: |
| - Laser Aiming Beam Compatibility | - Compatible with laser aiming beams |
| - Laser Lithotripsy Compatibility | - Compatible with laser lithotripsy |
| - Radiopacity | - Visible under X-ray |
| - Working Channel Connection Compatibility | - Compatible with accessories |
| - Maximum Endotherapy Tool Blind Insertion Distance | - Safe insertion distance |
| - Working Channel Length | - Correct channel length |
| - Monitor and Switcher Compatibility | - Compatible with external displays |
| - SUD Packaging Integrity | - Intact packaging |
| - SUD Package Seal Strength | - Secure seal |
| - Photobiologic Safety per IEC 62471 | - No photobiologic hazards |
| - Software verification and validation | - Software functions as intended |
| - Biocompatibility (ISO 10993-1) | - Demonstrates biocompatibility |
| - Electrical Safety (IEC 60601-1, -1-2, -1-4, -2-18) | - Meets electrical safety standards |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions "LithoVue Flexscope samples aged at T=0 and T=3 months accelerated aged" for performance testing. It does not provide specific numerical sample sizes for each test.
- Data Provenance: The testing was conducted by Boston Scientific Corporation. This implies the data is internal (manufacturer-generated) and likely prospective, specifically designed to demonstrate device performance for regulatory submission. There is no mention of country of origin for the data or whether it was retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of experts being used to establish ground truth for the performance testing described. The tests are bench evaluations (e.g., measuring resolution, strength, dimensions) and safety standards (biocompatibility, electrical safety), which are typically assessed against predefined engineering specifications and international standards, not expert consensus on clinical cases.
4. Adjudication Method for the Test Set
Not applicable. As noted in point 3, the described tests are bench and safety evaluations against specifications, not clinical assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in this 510(k) summary. The document focuses on demonstrating substantial equivalence through bench testing to predicate devices, not on comparing reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The LithoVue System is a physical medical device (a ureteroscope), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not applicable in this context. The device itself performs visual acquisition, and its performance characteristics (optical, mechanical, safety) are what were evaluated. The "software verification and validation" mentioned refers to the functionality of the device's control software, not an AI for diagnosis or interpretation.
7. The Type of Ground Truth Used
The ground truth for the reported tests primarily consists of:
- Engineering Specifications: For mechanical and optical properties (e.g., width, length, resolution, field of view).
- International Standards: For biocompatibility (ISO 10993-1) and electrical safety (IEC 60601 series).
- Functional Requirements: For aspects like ALC response, tortuous path ability, and compatibility.
There is no mention of pathology, outcomes data, or expert consensus in a clinical sense as ground truth for these engineering and safety evaluations.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm that requires a "training set" in the machine learning sense. The "samples" referred to in the document are physical units of the device used for engineering and safety testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no AI 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.