(217 days)
Luja Coude is indicated for use by patients with urine retention and patients with post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the bladder allowing urine to drain. The product is for adult male patients only.
Luja Coude is a single-use, sterile catheter for intermittent urinary catheterization. The catheter has a flexible tip which contains several small holes (micro holes) by the tip creating a drainage zone which allows the urine to flow from the bladder through the catheter. The drainage end of the device has an outlet to which a urine bag with a suitable connector can be connected. The catheter also contains a hydrophilic-coating and is sterilized by irradiation. The primary packaging provides the sterile barrier and contains a proof of seal for identification of opened products. Luja Coude is available in one length (33cm) with a flexible tip and diameters of 8 Fr, 10 Fr, 12 Fr, 14 Fr, and 16 Fr. The reference device supports the inclusion of 8 Fr models.
The provided text describes the acceptance criteria and the studies performed for the Luja Coude urological catheter. However, it does not contain information relevant to AI/ML device performance, ground truth establishment for a training set, MRMC studies, or standalone algorithm performance. The device is a traditional medical device, not an AI/ML device.
Therefore, many of the requested fields cannot be answered from the provided document.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various non-clinical performance tests and associated standards. The general reported performance is that the "proposed subject devices met the pre-determined acceptance criteria per specified requirements" and "The performance testing demonstrates the subject device is as safe and effective as the predicate device." Specific numerical acceptance criteria and performance results are not provided in this summary.
| Test Category | Study/Standard | Acceptance Criteria (General) | Reported Performance (General) |
|---|---|---|---|
| Biocompatibility | ISO 10993-1, -5, -10, -11, -18, -23 | Not explicitly stated in detail, but implied compliance with these ISO standards. | Addressed cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, and subacute toxicity, implying meeting the requirements of these standards. |
| Catheter Performance | ISO 20696:2018, ASTM F623-19, ASTM D1894:2014, Coloplast Test Methods (TM 6058, TM 6059, TM 6100, TM6129), EN/IEC 62366-1:2015/A1:2020 | Not explicitly stated in detail, but implied compliance with these standards and internal test methods. | Bench performance testing and usability testing were conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements. These tests included friction, opening torque, sleeve collapse force, and kink/coude measurements. |
| Packaging | ISO 11607-1:2019, ASTM F2096, EN 868-5, ASTM F88/FM88, ASTM D4169-22 | Not explicitly stated in detail, but implied compliance with these standards. | Packaging integrity testing verified maintenance of the sterile barrier through shelf life. Transportation testing verified no impact to device safety or efficacy due to transportation hazards. |
| Aging/Stability | ASTM F1980-21 | Properties meet acceptance criteria after aging cycle. | The stability study investigated product properties over shelf-life. The properties met the acceptance criteria after the aging cycle, deeming the device stable for the defined shelf life (8 months at submission, planned 2 years). |
2. Sample size used for the test set and the data provenance:
Not applicable information for the provided device type. The device is a physical catheter, and the testing involves bench performance and biocompatibility rather than a "test set" of data in the AI/ML context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/ML device requiring expert-established ground truth for a test set.
4. Adjudication method for the test set:
Not applicable. This is not an AI/ML device requiring adjudication of a test set.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
Not applicable. The "ground truth" for this device's performance is established through physical and biological testing against established international and ASTM standards, as well as Coloplast's internal test methods.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
§ 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.