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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):

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