(27 days)
This 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.
The VaPro 2 Plus and VaPro 2 Plus Pocket is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. VaPro 2 Plus and VaPro 2 Plus Pocket has the following features:
- Hydrophilic-coated PVC catheter (phthalate free)
- Two 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
- Available with a Firmer Style Catheter (Standard packaging only with packaging differentiated as F-Style)
- Urine Collection bag
The packaging contains a sealed water compartment chamber from which the water migrates to the catheter compartment and hydrates (lubricates) the catheter. The outer packaging is designed to facilitate access for those with limited dexterity. The Pocket version is designed to be discreet and easy to store.
The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
The provided text describes the regulatory clearance of a medical device, the VaPro 2 Plus and VaPro 2 Plus Pocket intermittent catheters, based on substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-based medical device.
The document is a 510(k) summary for a urological catheter, which is a physical medical device. The "brief description of non-clinical testing" mentions standards for physical performance (e.g., EN 1618, ISO 8669-2), biocompatibility (ISO 10993 series), and sterilization (ISO 11137 series). These are standard tests for physical medical devices to ensure safety and function, but they are not related to artificial intelligence performance, diagnostic accuracy, or human-algorithm interaction.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone performance.
- Type of ground truth used.
- Sample size for training set.
- How ground truth for the training set was established.
This document is focused on the regulatory clearance process for a physical medical device and asserts substantial equivalence, not the performance evaluation of an AI-powered diagnostic or assistive tool.
§ 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.