Search Results
Found 1 results
510(k) Data Aggregation
(30 days)
Luja Coude (20108 Male CH18 - large packaging)
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 urethra to reach 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, 16 Fr, and 18 Fr. Luja Coudé CH/FR 18 differs from the predicate device in the catheter size variants. Luja Coudé (predicate) includes French size 8 (CH8) through French size 16 (CH16) variants compared to the subject device which is a line extension to the Luja Coudé. The reference device supports the inclusion of the 18 Fr size variant.
The provided text describes the non-clinical performance testing for the Luja Coude (20108 Male CH18 - large packaging) device. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance values for each test. Instead, it lists the types of tests conducted and generally states that the "properties meet the acceptance criteria" or "proposed subject devices met the pre-determined acceptance criteria."
Here's an inferred table based on the information provided:
| Test Category | Specific Test / Standard | Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|---|---|
| Aging/Stability | ASTM F1980-21, Standard guide for accelerated aging of sterile barrier systems and medical devices | Not explicitly detailed, but implied to demonstrate stability over defined shelf life. | "The properties meet the acceptance criteria after the aging cycle, the device is therefore deemed to be stable for the defined shelf life." (Planned 2 years shelf life mentioned) |
| Biocompatibility | ISO 10993-1:2018, -5:2009, -10:2021, -11:2017, -18:2020, -23:2021 (Cytotoxicity, irritation or intracutaneous reactivity, sensitization, material mediated pyrogenicity, acute systemic toxicity, subacute toxicity, chemical characterization) | Not explicitly detailed, but implied to ensure biological safety and compatibility with human tissue. | Testing was conducted "to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." (Leveraged from K230165, where "the 18 fr size was included in analysis for all worst-case scenarios and included in testing.") |
| Catheter Performance | ISO 20696: 2018 (Sterile urethral catheters for single use) | Not explicitly detailed, but implied to meet performance characteristics for urethral catheters (e.g., kink resistance, coude measurement, friction, opening torque, sleeve collapse force, drainage characteristics). | Bench performance testing "was conducted to verify the proposed subject devices met the pre-determined acceptance criteria per specified requirements." (Leveraged from K230165, where "the 18 fr size was included in analysis for all worst-case scenarios and included in testing.") |
| ASTM F623-19 (Standard performance specification for Foley Catheter) | Not explicitly detailed. | ||
| ASTM D1894: 2014 (Static and kinetic coefficients of friction of plastic film and sheeting) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6058 (Friction after 5 minutes) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6059 (Opening torque) | Not explicitly detailed. | ||
| Coloplast Test Method TM 6100 (Sleeve collapse force) | Not explicitly detailed. | ||
| Coloplast Test Method TM6129 (Kink and Coude measurement) | Not explicitly detailed. | ||
| Packaging | ISO 11607-1 :2019 (Packaging for terminally sterilized medical devices) | Not explicitly detailed, but implied to maintain sterile barrier, prevent leaks, and withstand transportation. | Packaging integrity testing "was conducted to verify the maintenance of the sterile barrier through shelf life." Transportation testing "was conducted to verify that there is no impact to the device safety or efficacy of the catheter performance due to the hazards associated with the transportation environment." |
| ASTM F2096 (Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)) | Not explicitly detailed. | ||
| EN 868-5 (Packaging for terminally sterilized medical devices Sealable pouches and reels) | Not explicitly detailed. | ||
| ASTM F88/FM88 (Seal Strength of Flexible Barrier Materials) | Not explicitly detailed. | ||
| ASTM D4169-22 (Performance Testing of Shipping Containers and Systems) | Not explicitly detailed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each test conducted. It generally states that "the 18 fr size was included in analysis for all worst-case scenarios and included in testing." This implies that a sufficient number of 18 Fr devices were tested to represent the product.
- Data Provenance: The data is from non-clinical in vitro and bench testing conducted by Coloplast A/S (Denmark), with the contact person based in Minneapolis, MN, USA. The studies are retrospective in the sense that they are internal corporate testing used for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are non-clinical bench and lab tests for a medical device (urological catheter). There are no human subjects, images, or diagnostic outputs that would require expert consensus or ground truth establishment by medical professionals like radiologists. The "ground truth" for these tests comes from established engineering and regulatory standards (e.g., ISO, ASTM, Coloplast internal methods).
4. Adjudication Method for the Test Set
This information is not applicable for non-clinical bench testing. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., by multiple readers).
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
This information is not applicable. The submission describes non-clinical performance testing for a urological catheter, not an AI or imaging diagnostic device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical urological catheter, not an algorithm or software.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical tests described is based on:
- Established international and national standards (e.g., ISO, ASTM).
- Internal Coloplast test methods and specifications, which are themselves derived from engineering principles and regulatory requirements for safe and effective medical devices.
- The physical and chemical properties of the device materials and design.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI algorithm that requires a training set. The "training" for the device's design and manufacturing comes from engineering and material science principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm and therefore does not have a "training set" in that context.
Ask a specific question about this device
Page 1 of 1