(64 days)
The VaPro™ 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 Plus™ 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 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. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity.
The VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.
This document describes a 510(k) premarket notification for the VaPro™ intermittent catheter and VaPro Plus™ intermittent catheter, submitted by Hollister Incorporated. The FDA determined the device is substantially equivalent to legally marketed predicate devices.
The information provided does not describe the acceptance criteria, reported device performance, or a study that specifically proves the device meets acceptance criteria in the manner typically presented for AI/ML devices outlining metrics like sensitivity, specificity, or AUC, as requested in your prompt. This document pertains to the regulatory clearance of a physical medical device (an intermittent catheter), not a software or AI/ML algorithm.
Therefore, many of the specific questions you asked are not applicable to the content of this regulatory submission. However, I can extract the relevant information regarding performance testing that was submitted to the FDA for this device.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria and reported device performance in the format of specific metrics (e.g., accuracy, sensitivity, specificity, etc.) typically associated with AI/ML systems. Instead, the performance evaluations are related to the safety and functionality of the physical catheter.
Summary of Performance Testing Conclusions:
- Biocompatibility: Complied with ISO 10993 standards based on the United States Food and Drug Administration Office of Device Evaluation General program Memorandum #G95-1.
- Product Evaluation: Supports device functionality.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing mentions "biocompatibility testing" and "product evaluation" but does not detail the sample sizes, data provenance, or specific methodologies (like retrospective or prospective studies) in the context of human data. The testing mentioned would likely involve laboratory tests on the device materials and components, not a "test set" of patient data for evaluating an algorithm's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not applicable/not provided. Ground truth establishment by experts, especially in the context of image interpretation or clinical outcomes, is relevant for AI/ML studies. For a physical medical device like a catheter, "ground truth" would relate to its physical properties, material safety, and functional performance, which are assessed through laboratory and possibly limited human user studies, not typically by expert consensus on a "test set" in the radiological or pathological sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. Adjudication methods are used to resolve discrepancies in expert interpretations when establishing ground truth for evaluating AI/ML algorithms. This concept does not apply to the biocompatibility and functionality testing of a physical medical device as described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not provided. MRMC studies are used to evaluate diagnostic imaging systems and AI/ML algorithms in a clinical setting by comparing human reader performance with and without AI assistance. This device is an intermittent catheter, not a diagnostic imaging system or an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. Standalone performance is relevant for AI/ML algorithms. This document concerns a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Performance Testing Conclusions" mentioned:
- Biocompatibility: The "ground truth" would be established by the ISO 10993 standards and FDA guidance (#G95-1), which define acceptable biological responses and material safety profiles. Compliance with these standards is determined through specific laboratory tests, not expert consensus in the clinical sense, pathology, or outcomes data in the usual context of AI/ML evaluation.
- Product evaluation: The "ground truth" for device functionality would be based on engineering specifications and performance requirements relevant to a medical catheter (e.g., flow rates, material tensile strength, durability, ease of use, lubricity).
8. The sample size for the training set
This information is not applicable/not provided. The concept of a "training set" belongs to AI/ML development. This document describes a physical medical device.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, "training set" and its ground truth are concepts for AI/ML.
In summary: The provided document is an FDA 510(k) clearance letter for a physical medical catheter. It describes the device, its intended use, and indicates that biocompatibility and product evaluation were performed to establish substantial equivalence to predicate devices. It does not contain the specific performance metrics or study designs typically requested for AI/ML device evaluations.
§ 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.