(264 days)
Intermittent drainage of the urinary bladder of Adults who need assistance with drainage due to conditions causing urinary retention or dysfunction of the urinary system.
The target population for GC Air for Men is male adults and includes Transitional Adolescents B (18 year old to less than 22 years old but treated like adult).
GC Air for Men is a sterile, single use, disposable, hydrophilic, intermittent, urethral catheter. It is designed for portability, ease of use and discreet disposal, with FeelClean™ technology for superior comfort and less sticky residue. The catheter comprises of a flexible tube and color-coded funnel, both made from plastic materials (Polyvinyl Chloride; PVC). The catheter tube is made using thermoplastic elastomer (TPE) with a hydrophilic additive in the base material which when wetted activates and lubricates the catheter. Catheters are individually packed into a sealed foil primary pouch along with a sterile (E-Beam) water sachet and handling sleeve, prior to secondary and tertiary packing and sterilization by X-Ray irradiation. The water sachet is provided for wetting of the hydrophilic surface and is burst at the point of use. The handling sleeve is provided to minimize touching the catheter shaft directly during insertion and retraction.
The provided document describes the Convatec GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter and its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
The document is a 510(k) summary for a medical device (a urinary catheter), not an AI/ML diagnostic or predictive system. Therefore, the typical acceptance criteria and study designs relevant to AI/ML device performance (e.g., sensitivity, specificity, AUC, MRMC studies, ground truth establishment by experts) are not applicable or present in this document.
The "Performance Testing" section on page 5 refers to standard testing for physical medical devices and their materials, sterilization, and packaging, not clinical performance metrics related to AI/ML.
Therefore, an answer formatted as requested cannot be provided from this document.
If you have a document pertaining to an AI/ML medical device, please provide that.
§ 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.