(75 days)
The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.
The provided 510(k) summary for the CareVent device does not contain the detailed information requested for acceptance criteria and the study proving it meets those criteria. The document is a regulatory submission for premarket notification, not a full study report.
Here's a breakdown of what is and is not in the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document mentions "conformance to product specification" but doesn't define those specifications.
- Reported Device Performance:
- Qualitative: "All testing was successful."
- Specific tests mentioned: "general operation, valve operation, and fluid leak." No quantitative results (e.g., specific leak rates, operational pressures, durability cycles) are provided.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). It's implied the testing was conducted in-house by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the testing described ("general operation, valve operation, and fluid leak") does not involve expert interpretation or ground truth establishment in the clinical sense. These are engineering/performance verification tests.
4. Adjudication method for the test set
- Not applicable as no expert adjudication was involved.
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 device is a mechanical component (a valve for a Foley catheter), not an AI-powered diagnostic or decision-support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a mechanical device, not an algorithm.
7. The type of ground truth used
- Not applicable in the clinical sense. The "ground truth" for the tests performed would be adherence to internal engineering specifications for general operation, valve function, and absence of fluid leaks.
8. The sample size for the training set
- Not applicable as this is a mechanical device, not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Information from the Document:
| Category | Information from Document |
|---|---|
| Acceptance Criteria & Device Performance | |
| Acceptance Criteria: | Not explicitly defined with quantifiable metrics. Stated as "conformance to product specification." |
| Reported Device Performance: | "All testing was successful." Specific tests included "general operation, valve operation, and fluid leak." No quantitative results or specific performance values are provided. |
| Study Details | |
| Sample Size (Test Set): | Not mentioned. |
| Data Provenance (Test Set): | Not mentioned (implied in-house testing). |
| Number of Experts & Qualifications (Ground Truth - Test Set): | Not applicable (testing involved device function, not expert interpretation). |
| Adjudication Method (Test Set): | Not applicable. |
| MRMC Comparative Effectiveness Study: | Not applicable (mechanical device, not AI). |
| Standalone Performance (Algorithm Only): | Not applicable (mechanical device). |
| Type of Ground Truth Used (Clinical Context): | Not applicable for the described tests (ground truth relates to engineering specifications for functionality). |
| Sample Size (Training Set): | Not applicable (mechanical device). |
| How Ground Truth for Training Set was Established: | Not applicable. |
| Overall Study Description: | "Product testing was conducted to evaluate conformance to product specification. Testing included general operation, valve operation, and fluid leak. All testing was successful." This indicates internal verification/validation, not a clinical study. |
§ 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.