(224 days)
Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.
The Actreen Mini Intermittent Urinary Catheters include the Actreen Mini Cath and the Actreen Mini Set. The Actreen Mini Set is identical to the Actreen Mini Cath, except that the Actreen Mini Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are available in one length of 3.5 in with a straight tip, and offered in gauges 10 FR, 12 FR, 14 FR.
This document is a 510(k) Premarket Notification from the FDA regarding the Actreen® Mini Intermittent Urinary Catheters. It does not describe a study that uses AI or machine learning algorithms, nor does it provide detailed acceptance criteria and performance data in the context of such studies.
Therefore, I cannot provide a description of acceptance criteria and a study proving device performance as requested, because the provided text does not contain information about an AI/ML powered device, acceptance criteria or performance studies of the type requested in the prompt.
The document states that biocompatibility and performance testing were performed in accordance with ISO 10993-1 and EN 1616 to support substantial equivalence to predicate devices, but it does not specify the details of these tests, acceptance criteria, or the results.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.