(30 days)
This intermittent catheter is a flexible tubular device that is inserted through the urethra by female patients who need to drain urine from the bladder.
The Infyna Chic is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. Infyna Chic has the following features:
- Hydrophilic-coated PVC catheter (phthalate free)
- Two smooth catheter eyelets
- Color-coded funnel
The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The primary packaging is designed to be easy to open, close and dispose of, with a discrete consumer design. The outer packaging also contains a 'first use label' that indicates to the end user if the product was previously opened.
This document is a 510(k) premarket notification for a medical device, specifically an intermittent catheter called "Infyna Chic." It's not a study proving the device meets acceptance criteria for an AI/ML product, but rather a regulatory submission demonstrating substantial equivalence to a predicate device based on technological characteristics and non-clinical performance testing.
Therefore, the requested information regarding acceptance criteria and studies for an AI/ML device is not present in this document. The document details the device's physical and material properties, sterilization methods, and packaging integrity tests, along with a comparison to a predicate device.
To directly answer your prompt, based only on the provided text, the answer is that this document does not contain the information you requested about AI/ML device performance and testing. It's for a traditional medical device (catheter).
§ 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.