(224 days)
URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney. The instrument enables delivery and use of accessories such as biopsy forceps, laser fibers, graspers and retrieval baskets at a surgical site.
The URUS System is a software-controlled single-use digital flexible ureteroscope system. That consist of the single-use digital flexible ureteroscope (DMG-SU100R) and a video processing unit (VP-100). The URUS System is intended to be used by physicians to access, visualize, and perform procedures in the urinary tract and the kidney.
The provided text is a 510(k) summary for the URUS System, a digital flexible ureteroscope. This document outlines the device's characteristics and its substantial equivalence to a predicate device, but it does not contain details about a clinical study comparing the device's performance to specific acceptance criteria in a human cohort.
Instead, the performance data section primarily discusses bench testing, compliance with standards, and software validation. There is an explicit statement: "The subject of this premarket submission did not require clinical studies were considered necessary and performed." This means there won't be information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies that typically derive from clinical trials.
Therefore, I cannot fulfill all parts of your request as the provided document lacks a description of a clinical study that proves the device meets acceptance criteria defined by performance metrics like sensitivity, specificity, or reader improvement.
However, I can extract information related to the bench testing and other validations performed, which can be presented in a modified format to address the parts that are available.
Here's a summary based on the provided document:
Acceptance Criteria and Device Performance Study for the URUS System
The URUS System, a single-use digital flexible ureteroscope, underwent various types of testing, primarily bench testing, to demonstrate its performance and substantial equivalence to a predicate device (WiScope™ Digital Endoscope System, K181977). A clinical study was not considered necessary or performed for this premarket submission.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" for clinical performance (like sensitivity, specificity) and "reported device performance" against those in a clinical setting are not available from the provided document, I will present the performance items tested in bench studies, which serve as a form of acceptance criteria for engineering and optical performance.
| Performance Item (Acceptance Criteria per ISO 8600-1) | Reported Device Performance (Implied as "Passed" or "Complies") |
|---|---|
| Optical Performance Bench Testing | |
| Field of View | Tested and Complies (Specific value: 85° diagonal, compared to 100° for predicate) |
| Depth of Field | Tested and Complies (Specific value: 3 - 50 mm, compared to 2 - 50 mm for predicate) |
| Resolution | Tested and Complies |
| Distortion | Tested and Complies |
| IIU (Image Intensity Uniformity) | Tested and Complies |
| SNR/DR | Tested and Complies |
| Mechanical Performance Bench Testing | |
| Outer Shaft Diameter | Tested and Complies (Specific value: 9.5F, compared to 8.6Fr for predicate) |
| Overall length | Tested and Complies (Specific value: 948 mm, compared to 905 mm for predicate) |
| Working length | Tested and Complies (Specific value: 680 mm, compared to 670 mm for predicate) |
| Working Channel Diameter | Tested and Complies (Specific value: 3.6Fr (1.2mm), same as predicate) |
| Up/Down Deflection | Tested and Complies (Specific value: UP: 270°, DOWN: 270°, compared to UP: 275°, DOWN: 275° for predicate) |
| Direction of View | Tested and Complies (Specific value: 0°, same as predicate) |
| Tip Column Strength | Tested and Complies |
| Lever Force | Tested and Complies |
| Tip to Shaft Tensile Strength | Tested and Complies |
| Accessory port | Tested and Complies |
| Brightness Control | Tested and Complies (Same as predicate) |
| White balance | Tested and Complies (Same as predicate) |
| Connections tensile strength | Tested and Complies |
| Torque and Leakage | Tested and Complies |
| Flow rate and pressure | Tested and Complies |
| Torque strength | Tested and Complies |
| Fatigue | Tested and Complies |
| Bending path | Tested and Complies |
| Leakage | Tested and Complies |
| Other Performance/Safety Data | |
| Electrical, Mechanical and Thermal Safety | Complies with IEC 60601-1:2005/AMD2:2020 |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2:2014+A1:2020 and IEC TS 60601-4-2:2024 |
| Usability | Complies with IEC 60601-1-6:2010/AMD2:2020 |
| Endoscopic Equipment Safety | Complies with IEC 60601-2-18: 2009 |
| Sterilization | Validated to ISO 11135:2014 with EO/ECH residual test per ISO 10993-7:2008 (SAL: 10^-6) |
| Shelf-Life | 3 years, determined by stability study including accelerated aging test per ASTM F1980-16 for the Single-Use Digital Flexible Ureteroscope. |
| Package Validation | Conducted according to ISO 11607-1:2019, ISO 11607-2:2019, ASTM F1886, F88/F88M-21, F1929-15, and ASTM D4169-22. |
| Software Validation & Verification | Designed according to IEC 62304; evaluated for Basic level documentation (June 2023 FDA guidance) |
| Cybersecurity | Provided in accordance with FDA guidance |
| Biocompatibility | Evaluated for patient contacting components per ISO 10993-1:2018 and FDA Guidance for "externally communicating device contacting tissue/bone/dentin" with contact duration " |
§ 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.