(84 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 Intermittent Catheter 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 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)
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, (Standard and Pocket), was designed to facilitate access for those with limited dexterity. The Pocket version was designed to be discreet and easy to store.
This document is a 510(k) premarket notification for a medical device called the "Vapro 2 Intermittent Catheter." It is a request to the FDA to determine if the new device is substantially equivalent to legally marketed predicate devices.
The information provided here concerns the performance of a physical medical device (a catheter), not a software or AI-driven device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/software performance (e.g., accuracy, sensitivity, specificity, human reader improvement) is not applicable here.
The document discusses non-clinical testing to demonstrate performance and safety, which is standard for physical medical devices but doesn't align with the detailed AI/software performance metrics requested in the prompt.
Therefore, I cannot provide the requested information regarding AI/software performance metrics from this document because it is about a physical medical device and not an AI/software device.
However, I can extract information about the non-clinical testing performed for this physical device:
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Acceptance Criteria & Reported Performance (Non-Clinical Physical Properties):
- Physical Performance Properties: VaPro 2 "met all applicable requirements of EN 1618, EN 1616 and EN 13868." (Specific thresholds not detailed in this summary).
- Biocompatibility Testing: VaPro 2 "met the requirements of ISO 10993-1, 10993-11 and 10993-12." (Specific thresholds not detailed in this summary).
- Sterilization: VaPro 2 "met all requirements of ISO 11137-1, ISO 11137-2, AAMI/ANSI/ISO 11737-1 and AAMI/ANSI/ISO 11737-2." (Specific thresholds not detailed in this summary).
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Sample Size Used for Test Set and Data Provenance: Not applicable in the AI/software context. For physical device testing, sample sizes would be determined by the specific ISO/EN standards cited, but these details are not provided in this summary.
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Number of Experts, Qualifications, Adjudication Method, MRMC Study, Standalone Performance, Type of Ground Truth, Training Set Sample Size, Training Set Ground Truth: These questions are specifically tailored to AI/software performance evaluation and are not relevant or described in this document about a physical medical device. The "ground truth" for a physical catheter's performance is typically established by laboratory testing against engineering specifications and international standards.
§ 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.