(77 days)
Luja Coudé 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 male patients only (adults and pediatric above the age of 1 years).
The Luja Coude is a single-use, sterile, hydrophilic coated 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.
The 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.
The provided FDA 510(k) clearance letter and supporting Traditional 510(k) summary pertain to a urological catheter (Luja Coudé) and its substantial equivalence to a predicate device. This document focuses on the mechanical and material properties of the catheter, not on an AI/software as a medical device (SaMD) or diagnostic imaging device.
Therefore, many of the requested details, such as MRMC comparative effectiveness studies, standalone algorithm performance, AI training/test sets, expert ground truth establishment, and complex adjudication methods, are not applicable to this type of medical device submission. These elements are typically required for AI/ML-based diagnostic devices where performance is measured in terms of diagnostic accuracy (e.g., sensitivity, specificity, AUC) and reader improvement.
The provided information focuses on bench testing (non-clinical performance) to demonstrate the device's physical and biological properties meet established standards and are equivalent to the predicate.
Here's an analysis of the provided text in relation to your questions, highlighting what is available and what is not:
Analysis of Acceptance Criteria and Study Proof for Luja Coudé Catheter
Based on the provided FDA 510(k) clearance letter and Traditional 510(k) summary, the Luja Coudé catheter demonstrates its performance through non-clinical (bench) testing and biocompatibility assessments, rather than clinical studies or AI/ML performance evaluations involving human readers.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "Biocompatibility and bench performance testing were conducted to verify the proposed subject devices with modified hydrophilic coating met the pre-determined acceptance criteria per specified requirements." It also states, "The subject devices met the pre-determined acceptance criteria after simulated shipping distribution and aging cycle per specified performance requirements."
However, the specific numerical acceptance criteria or the exact reported performance values are not detailed in this public summary. Instead, the summary lists the tests conducted and confirms that the device met the criteria.
| Category | Test Performed / Standard Applied | Acceptance Criteria (Implied: Met) | Reported Device Performance (Implied: Met Criteria) |
|---|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (General Evaluation) | Safe for intended use | Biologically compatible |
| ISO 10993-5:2009 (Cytotoxicity) | Non-cytotoxic | Non-cytotoxic | |
| ISO 10993-10:2021 (Irritation & Sensitization) | Non-irritating, Non-sensitizing | Non-irritating, Non-sensitizing | |
| ISO 10993-11:2017 (Systemic Toxicity) | No systemic toxicity | No systemic toxicity | |
| ISO 10993-12:2021 (Sample Prep) | (Methodology Standard) | (Methodology Standard) | |
| ISO 10993-23:2021 (Irritation) | Non-irritating | Non-irritating | |
| USP (Pyrogen Test) | Non-pyrogenic | Non-pyrogenic | |
| Catheter Performance | ISO 20696:2018 (Sterile urethral catheters for single use) | Meets ISO performance reqs | Meets ISO performance reqs |
| Coloplast TM6030 (Friction at T=0 minutes) | (Proprietary Criteria) | Met proprietary criteria | |
| Coloplast TM6058 (Friction after 5 minutes) | (Proprietary Criteria) | Met proprietary criteria | |
| Coloplast TM6129 (Kink of catheter tubes) | (Proprietary Criteria) | Met proprietary criteria | |
| Coloplast TM0507 & TM6032 (pH and Osmolality) | (Proprietary Criteria) | Met proprietary criteria | |
| Shipping & Aging | ASTM D4169-22 (Simulated shipping distribution) | Performance retained | Performance retained |
| ASTM F1980-21 (Accelerated aging) | Performance retained, 2-year shelf life | Performance retained, 2-year shelf life | |
| Sterility | SAL 10⁻⁶ | Achieved | Achieved |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify exact sample sizes for each non-clinical test (e.g., number of catheters tested for friction, kink, etc.). It only states that "Testing was performed on final, finished, and sterilized devices." This is typical for bench testing where the number of units tested is governed by standard protocols (e.g., ISO, ASTM, internal methods) to achieve statistical confidence for manufacturing and design verification, but individual numbers are not usually disclosed in 510(k) summaries unless a specific, novel statistical method for performance testing is employed.
- Data Provenance: The studies are "non-clinical" (bench testing). Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies do not apply in the context of human subject data. The device is manufactured by Coloplast A/S in Humlebæk, Denmark, and the tests would have been performed in a controlled laboratory environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. For this type of device (a physical urological catheter), "ground truth" is established through physical measurements, chemical analysis, and standardized biological assessments in a lab setting, not by human experts interpreting clinical data (like radiologists interpreting images). The "experts" involved would be engineers, material scientists, and microbiologists conducting the tests.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (e.g., 2+1, 3+1) are used to resolve discrepancies among human readers/experts in diagnostic studies, typically for AI/ML device validation. This is not relevant for the bench testing of a physical catheter.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is relevant for AI/ML-driven diagnostic devices where the AI assists human readers. This device is a physical medical instrument, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This question applies to AI algorithms. The Luja Coudé is a physical catheter designed for direct patient use via insertion, not an algorithm.
7. The Type of Ground Truth Used
- For this device, the "ground truth" is based on:
- Standardized Bench Test Measurements: Objective physical properties (e.g., friction coefficients, kink resistance, dimensions, pH, osmolality) measured against international and proprietary Coloplast standards (ISO 20696, Coloplast TMs).
- Biocompatibility Testing: Laboratory assays and in-vivo animal models (for systemic toxicity, irritation, sensitization) that demonstrate the material's safety in a biological environment, conforming to ISO 10993 standards.
- Sterility Assurance Level (SAL): Defined by microbial inactivation standards (SAL 10⁻⁶).
8. The Sample Size for the Training Set
- Not Applicable. The concept of a "training set" is for AI/ML models. This device does not use an AI/ML model. The design and manufacturing process for the catheter would involve extensive development and testing, but not in the sense of an "AI training set."
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no AI training set, there is no ground truth to establish for it. The development of the catheter relies on established engineering principles, material science, and manufacturing quality control.
Summary: The provided document is a 510(k) summary for a physical medical device (catheter) that relies on non-clinical bench testing and biocompatibility assessments to demonstrate substantial equivalence and safety/effectiveness. It does not involve AI/ML technology or human reader studies. Therefore, many of the questions related to AI/ML device validation are not applicable.
§ 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.