(119 days)
The Quick Disconnect Plug is Intended to stop the flow of urine from the urinary catheter to the drainage bag. It is intended for use on a short term basis of no longer than two weeks (14 days) duration. The dally disconnection schedule should not exceed two hours. This device is available sterile for one-time use by physician's prescription.
The Quick Disconnect Plug is designed to facilitate a speedy, comfortable, and safe rehabilitation for patients requiring use of a urinary catheter. The use of a urinary catheter to facilitate drainage from the bladder is usual and customary following most surgery. In using a catheter, it is connected to a collection bag, which becomes a potential physical hazard and a source of discomfort to the patient in attempting to do rehabilitative exercise. The Quick Disconnect Plug allows the patient and/or attending nurse or physician to quickly disconnect the catheter from the drainage bag, leaving one half of the Quick Disconnect Device, which has a shut-off valve built in, in the open end of the catheter and seals off the flow of urine until such time as it is reconnected and the flow is once again resumed between the catheter and the collection bag.
This document describes a 510(k) summary for a "Quick Disconnect Plug" catheter connector. As such, it does not contain the acceptance criteria or study details typical for AI/ML-driven medical device performance evaluations.
The device is a simple mechanical connector and the approval is based on substantial equivalence to a predicate device, rather than a performance study demonstrating accuracy, sensitivity, specificity, or other typical AI/ML metrics.
Therefore, I cannot provide the requested information in the format requested, as it is not applicable to this type of device submission.
Here's why each of the requested points is not available in the provided text for this specific device:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission states "Performance Standards: None established." The device is cleared based on substantial equivalence to an existing predicate device, not through demonstrating performance against specific quantitative criteria in a study. The "performance" described is its function (stopping urine flow) and material specifications.
- Sample size used for the test set and the data provenance: Not applicable. This is a mechanical device, not an AI/ML algorithm. There's no "test set" in the sense of data used for evaluating an algorithm's performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. As above, there's no "test set" requiring expert ground truth for an AI/ML algorithm.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI/ML.
- 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 mechanical device, not an AI system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. There is no ground truth needed for an AI/ML algorithm in this submission.
- The sample size for the training set: Not applicable. No AI/ML algorithm is involved.
- How the ground truth for the training set was established: Not applicable. No AI/ML algorithm is involved.
The provided text focuses on:
- Substantial Equivalence: Comparing the device to a pre-amendment predicate device.
- Device Description: Explaining its function and components.
- Technical Characteristics: Material (USP Class VI), size (up to size 26 catheters), intended use (short-duration, one-time use, 2-hour disconnection limit).
- Sterilization: ETO sterilization, packaging, and shelf-life testing (5 years).
- Biocompatibility: Stating it's made of USP Class VI material, implying low bioincompatibility.
- Safety and Effectiveness: General statement about government-regulated manufacturing and sterilization.
The core of the submission for this type of device is demonstrating that it is as safe and effective as a legally marketed predicate device, primarily through material specifications, design, and manufacturing controls, rather than clinical performance studies against specific endpoints.
§ 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.