(136 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 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 provided text is a 510(k) Summary for a medical device (VaPro™ Intermittent Catheter), which focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.
Therefore, many of the requested sections about acceptance criteria, detailed study design, ground truth, and AI performance metrics are not applicable to this type of submission.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense of a performance study with specific metrics. The provided document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use, rather than defining and meeting specific quantitative performance acceptance criteria in an AI/Software context.
- The "performance" described is primarily functional and safety-related for a physical catheter, evaluated through biocompatibility and product evaluation to support functionality.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a hardware device (catheter) submission. There is no "test set" of data in the context of an AI/Software algorithm. The testing would involve physical samples of the catheter for biocompatibility and functional evaluation. No details on sample sizes for these physical tests are provided in the summary.
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)
- Not Applicable. This is a hardware device. There is no ground truth established by experts in the context of diagnostic interpretation or AI model training/testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set is mentioned as this is not an AI/Software device requiring such a process.
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
- Not Applicable. This is a physical medical device (catheter), not an AI/Software system. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For this physical device, "ground truth" would relate to confirmed physical properties, material safety (biocompatibility), and functional performance (e.g., flow rates, lubrication effectiveness) validated against established standards, not diagnostic outcomes.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/Software system that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable. Same as above, no training set for a physical device.
Information that can be extracted or inferred regarding device evaluation:
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Device Performance Reported (for a physical device):
- Biocompatibility: "Biocompatibility testing was performed based on Performance Testing the United States Food and Drug Administration Office of Conclusions: Device Evaluation General program Memorandum #G95-1 and ISO 10993 biocompatibility testing standards. Results indicate compliance to the standard."
- Device Functionality: "Product evaluation also supports device functionality."
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Predicate Device Equivalence (which implies the new device also meets foundational criteria present in predicates):
- Intended Use: Matches or is highly similar to predicates.
- Condition of Use: Single Use (matches predicates).
- Prelubricated: Yes - by water vapor hydration (similar mechanism to predicates).
- Ready to Use: Yes (similar to Speedicath and Incare, different from Lofric).
- End Design: Funnel (matches predicates).
- Sterile: Yes (matches predicates).
- No-touch design: Yes - contains sleeve (similar to Lofric and Incare, different from Speedicath).
- Lubricant: PVP Based (similar to Lofric and Speedicath, different from Incare).
- Protective Tip: Yes (similar to Incare, different from Lofric and Speedicath).
Conclusion:
The provided 510(k) summary is for a physical medical device (intermittent catheter). The evaluation criteria and "proof" of performance are based on standard engineering tests for physical properties, materials, and biocompatibility, as well as demonstrating substantial equivalence to other legally marketed devices. It does not contain information related to acceptance criteria, study sizes, ground truth establishment, or performance metrics typically associated with AI/Software medical devices.
§ 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.