(22 days)
VaPro™ Pocket 40cm intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
VaPro™ Pocket 20cm 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 VaPro Pocket intermittent catheter is a single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter has the following elements:
∑ hydrophilic-coated PVC catheter (phthalate free)
∑ 2 smooth catheter eyelets
∑ protective sleeve
∑ protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion
∑ color coded funnel
The packaging contains a sealed water compartment chamber of which the water migrates to the catheter compartment and lubricates the catheter. The outer packaging was designed to be discreet, easy to store, easy to open and facilitate access to the catheter.
This product does not utilize a collection bag.
The provided document is a 510(k) premarket notification for a medical device called "VaPro™ Pocket intermittent catheter." It does not contain information about an AI-powered device or a study involving acceptance criteria and device performance as typically understood for AI/ML medical devices.
The document describes a urological catheter and its packaging. The "performance testing" section refers to:
- Biocompatibility testing: Performed on the new packaging (not the device itself, as no change to the device was made).
- Sterility testing: Performed using Gamma Irradiation.
- Package integrity testing: To verify maintenance of the sterile barrier through shelf life.
- Transportation testing: To verify no impact on catheter safety or efficacy.
These are standard engineering and quality control tests for a physical medical device, not performance metrics for an AI algorithm.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI-powered device because the provided text describes a physical, non-AI medical device and its packaging.
§ 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.