(80 days)
The Conveen® EasiCath Set is indicated for use by patients for intermittent catheterization for the purpose of bladder drainage.
The Conveen® EasiCath Set is a single use, disposable system that consists of a sterile polyvinylchloride intermittent catheter, coated with polyvinvlovrrolidone, and a sterile saline solution ampoule all sealed in a urine collection bag. The user twists open the saline ampoule inside the bag and soaks the catheter for 30 seconds. Once wet, the polyvinylpyrrolidone layer binds water molecules to the surface of the catheter creating a smooth lubricating film. The bag is opened and the catheter is inserted into the patent's urethra. The catheter itself is the same design and materials as our current non-coated Conveen® Intermittent Catheters, K896729.
Here's a breakdown of the acceptance criteria and study information for the Conveen® EasiCath Set, derived from the provided 510(k) summary:
This device appears to be primarily a catheter system and the "acceptance criteria" and "studies" are focused on biocompatibility and safety of its components, rather than a performance study measuring clinical outcomes or diagnostic accuracy which would typically involve human readers or ground truth as seen in AI/imaging devices.
Therefore, many of the requested fields regarding AI/human reader performance, ground truth establishment, and sample sizes for training/test sets are not applicable to this type of device and its submission.
Acceptance Criteria and Reported Device Performance
| Test/Criteria | Acceptance Criteria (Implied by USB XXII Requirements) | Reported Device Performance |
|---|---|---|
| Intracutaneous Test | No significant difference in skin reaction between extract and control solutions. | Conclusion: "No difference in skin reaction was observed at the injection sites of the extracts or the control solutions. Passed the Intracutaneous Test according to USP XXII requirements." |
| Systemic Injection Test | No signs of toxicity in treated animals compared to controls. | Conclusion: "No signs of toxicity were observed in the mice treated with the extract or the control solution. Passed the Systemic Injection Test according to USP XXII requirements." |
| Mutagenicity Ames Test | No increase in the number of revertants compared to controls, indicating no mutagenic activity. | Conclusion: "The extracts induced no increase in the number of revertants as compared to the controls. Thus, no detectable mutagenic activity was found of the extracts in the Ames test." |
| Sensitization Guinea Pig Maximization Test | No evidence of delayed contact hypersensitivity. | Conclusion: "No evidence of delayed contact hypersensitivity was seen after treatment with the extract or the control solution." |
| Cytotoxicity Elution Test (L 929 cells) | Cytotoxicity grade |
§ 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.