(267 days)
The Uro-G HD Flexible Cystoscope is intended for endoscopic diagnosis and infusion of irrigating fluids within the bladder and urethra.
Generally recognized indications for cystoscopy include:
• Symptomatic voiding dysfunction
• Hematuria
• Bladder tumor surveillance
• Recurrent lower urinary tract infections
• Pelvic pain syndromes
The Uro-G HD Flexible Cystoscope System is a handheld, battery-operated portable cystoscope consisting of a disposable steerable endoscopic cannula with a 2.2 mm channel for fluid infusion and instrument advancement, and a reusable handle with a video monitor. The fully assembled Uro-G HD Cystoscope System—cannula and handle—has an overall length of 630 mm (approximately 25 inches). The disposable cannula's working length is 380.2 mm (approx. 15 inches) and a total length of 406 mm, from tip to connector. The cannula's maximum width is 5.6 mm and it has a connector for attaching and detaching to the handle.
This document is a 510(k) Premarket Notification for the Uro-G HD Flexible Cystoscope, seeking to prove substantial equivalence to a predicate device (Uro-G Flexible Cystoscope, K202921). As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the demonstration that the modified device (Uro-G HD) is as safe and effective as the predicate device, not necessarily a performance study against a specific clinical endpoint. The primary method for proving this is through comparative testing and analysis of technological characteristics.
Here's an analysis of the provided text in the context of acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative targets in a table format within the provided text. Instead, the document uses a comparative approach against a predicate device. The "reported device performance" is essentially the Uro-G HD's characteristics, and "meeting acceptance criteria" means demonstrating that these characteristics are equivalent to or improve upon the predicate without introducing new risks.
Here’s a table summarizing the key characteristics and the comparison to the predicate device, highlighting what could be implicitly considered an "acceptance criterion" (i.e., equivalence or improvement):
| Characteristic | Predicate Device (Uro-G, K202921) Performance | Subject Device (Uro-G HD) Performance | Acceptance Criteria (Implicit) | Met? |
|---|---|---|---|---|
| Cannula | ||||
| Working length | 380.2 mm | 380.2 mm | Not Changed (Equivalent) | Yes |
| Total length (tip to connector) | 406 mm | 406 mm | Not Changed (Equivalent) | Yes |
| Number of ports | 2 | 2 | Not Changed (Equivalent) | Yes |
| Working channel minimum width | 2.2 mm | 2.2 mm | Not Changed (Equivalent) | Yes |
| Maximum insertion width (OD) | 5.5 mm | 5.6 mm | Equivalent (Increased by 0.1mm, deemed not to introduce new risk, as human urethral diameter is larger) | Yes |
| Tip OD | 4 mm | 4 mm | Not Changed (Equivalent) | Yes |
| Camera | ||||
| CMOS module pixels | 0.3 million pixels | 0.7 million pixels | Equivalent (Higher pixels for HD imaging, does not introduce new risk) | Yes |
| Focal length | 5 mm to 50 mm | 5 mm to 50 mm | Not Changed (Equivalent) | Yes |
| Field of view (in air) | 120 ° ± 5 ° | 100 ° ± 5 ° | Equivalent (Smaller FOV but sufficient for HD imaging in confined spaces, does not introduce new risk) | Yes |
| Direction of view from center axis | 0 ° (Forward Viewing) | 0 ° (Forward Viewing) | Not Changed (Equivalent) | Yes |
| Image resolution | 3 lp/mm on 1551 USAF test chart in air | 3 lp/mm on 1551 USAF test chart in air | Not Changed (Equivalent) | Yes |
| Image distortion | 120 mL/min | > 120 mL/min | Not Changed (Equivalent) | Yes |
| Light source | LED, 520 lumens at 25 mm focal length | LED, 520 lumens at 25 mm focal length | Not Changed (Equivalent) | Yes |
| Tip temperature when LEDs are on |
§ 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.