(217 days)
The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra.
The Uro-G cystoscope is a handheld, battery-operated portable cystoscope consisting of a sterile, disposable steerable endoscopic cannula and a reusable handle with a video monitor. The disposable cannula contains a miniature CMOS camera and a light-emitting diode (LED) illumination module at its tip and one channel for infusion of irrigating fluid. The handle is lightweight and ergonomically designed. It has a connector and locking mechanism for attaching and detaching the disposable cannula. The handle contains the remaining electronics, including a power on/off button, a button to adjust the brightness of the LED, a button to allow capture of single images or to start/stop video of the procedure, a video processor, a display unit (LCD display), a rechargeable battery, management electronics, microcontrollers, and firmware.
The provided text describes the 510(k) summary for the Uro-G Cystoscope. This document primarily focuses on establishing substantial equivalence to a predicate device (Uro-V Cystoscope) rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for an AI/ML device.
The "acceptance criteria" for a medical device like a cystoscope typically refer to the performance standards and safety requirements it must meet to be considered safe and effective, often demonstrated through engineering bench testing, biocompatibility, and electrical safety. The "study that proves the device meets the acceptance criteria" in this context refers to these non-clinical tests.
There is no mention of AI/ML components in the Uro-G Cystoscope from the provided text, nor are there any acceptance criteria, sample sizes, or ground truth establishment relevant to AI/ML or comparative effectiveness studies with human readers. The device is a physical endoscope.
Therefore, I will interpret "acceptance criteria" and "study" in the context of a medical device submission focused on equivalence for a non-AI physical device.
Here's the breakdown based on the provided document:
Acceptance Criteria and Study for Uro-G Cystoscope (Non-AI Device)
The Uro-G Cystoscope is a physical medical device. The "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device (Uro-V Cystoscope) and compliance with relevant safety and performance standards through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance/Comparison |
|---|---|---|
| Predicate Equivalence | Intended Use: "The Uro-G flexible cystoscope has been designed for endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra." | EXACTLY THE SAME as predicate (Uro-V Cystoscope). |
| Indications for Use: Symptomatic voiding dysfunction, Hematuria, Bladder tumor surveillance, Recurrent lower urinary tract infection, Pelvic pain syndromes. | EXACTLY THE SAME as predicate. | |
| Route of Advancement: Advanced to the bladder via the urethra. | SAME as predicate. | |
| Site of Use: Hospitals and physician offices. | SAME as predicate. | |
| Components: Reusable handle with video screen; Attachable cannula with working channel, illumination source, and camera at tip. | **SAME** as predicate (handle is identical, cannula has modifications but core components are the same). | |
| Image Transmission/Display: Image transmitted from video camera at tip to video monitor on handle; 3.5-inch LCD Display. | SAME as predicate. | |
| Field of View: 140 degrees. | SAME as predicate. | |
| Direction of View: 0 degrees (forward viewing). | SAME as predicate. | |
| Operational Characteristics: Adjustable illumination brightness, capture still images/video, cleaning/disinfection protocol, frequency/duration of use. | SAME as predicate for these operational aspects. | |
| Tissue Contact Materials: Compliant with ISO 10993. | SAME as predicate, and cannula materials passed all applicable biocompatibility tests (see details below). | |
| Differences and Rationale: Changes in Outer Diameter (5.5mm vs 4.2mm); Working Length (380mm vs 254mm); Working Channel ID (2.2mm); Flexible Tip Deflection (up to 210° up and 130° down); Focal Length (5-50mm vs 3-50mm). Rationale provided for each difference to demonstrate no new safety/effectiveness issues. | Acceptable; Differences are addressed and do not raise new issues of safety or effectiveness. For example, increased OD is still within anatomical limits for patients, increased working length allows better access, improved tip deflection enhances ease of use without compromising safety due to continuous imaging. | |
| Performance Data (Bench/Non-Clinical) | Design Verification & Validation: Ensure device performs as intended and meets specifications. | Conducted with successful results. |
| Packaging & Shelf-Life: Maintain sterility and integrity over time. | Conducted for the sterile cannula, confirming labeled shelf life compliance. | |
| Biocompatibility: Meet ISO 10993 Part 1 requirements for short-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.