(101 days)
Intermittent Catheters are indicated for routine transient intermittent drainage of the bladder. The cather is inserted through the urethra.
A hydrophilic urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. The tip/distal end of the tube are inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. The device is made using Polyolefin Based Synthetic Thermoplastic Elastomer (TPE) as base material with the addition of an additive material is hydrophilic and makes the surface slippery when wetted with water. The products are designed for transient use only and are available in male and female lengths. The products are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH14, CH16, CH18. An increasing Charrière corresponds to a larger external diameter. The male catheter range also consists of variants with a bent (Tiemann) catheter tip shape.
The provided document is a 510(k) summary for the ConvaTec GentleCath™ Glide Intermittent Urinary Catheter. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices based on performance testing and comparison of characteristics.
Here's an analysis of the acceptance criteria and study in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a medical device's clinical performance (e.g., sensitivity, specificity for diagnostic devices). Instead, it demonstrates "substantial equivalence" to predicate devices through a series of bench tests and comparison of device characteristics. The acceptance criteria are implicitly that the subject device's performance in these tests is "similar or superior" to the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Similar or Superior Flow Rate to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Catheter Tensile Properties to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Coefficient of Friction to predicate devices. | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Similar or Superior Angle of Coudé (Tiemann) Tip to predicate devices (for relevant variants). | "All the parameters are similar or superior for the GentleCath Glide Intermittent Urinary Catheter." (Page 6) |
| Compliance with ISO 10993-1, 10993-3, 10993-5, 10993-7, 10993-10, 10993-11 for biocompatibility for surface devices in contact with mucosal membrane for a limited time. | The subject device was tested in compliance with these ISO standards and "Biocompatibility studies of the device conclude that the material compound is safe for the intended use." (Pages 8-9) |
| Compliance with EN1616:1997 Sterile Urethral Catheters for Single Use, Table 1. Shaft dimensions for catheter length. | "All devices are in compliance with EN1616:1997 Sterile Urethral Catheters for Single Use, Table 1. Shaft dimensions." (Page 10) |
| Compliance with ISO 8836:2014 Suction catheters for use in the respiratory tract for connector color coding. | "Connector colour coding all comply with ISO 8836:2014 Suction catheters for use in the respiratory tract" (Page 11) |
| Compliance with EN1616:1997 Sterile Urethral Catheters for Single Use for catheter outer diameter. | "Catheter outer diameters all comply with the requirements of EN1616:1997 Sterile Urethral Catheters for Single Use." (Page 11) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the bench tests (flow rate, tensile properties, coefficient of friction, angle of Coudé tip).
The data provenance is from laboratory testing performed by ConvaTec Limited (UK-based company). It is implicitly retrospective as it compares the new device to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. Given that the testing consisted of bench tests, the "ground truth" would likely be established by validated test methods and instrumentation, rather than expert review of clinical cases.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as the document describes bench testing, not a clinical study involving human judgment that would require an adjudication method.
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
An MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a physical medical device (intermittent urinary catheter), not an AI-assisted diagnostic tool. Therefore, effects on human readers or AI assistance are not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation mostly relies on bench test measurements against established engineering and material science standards (e.g., ISO and EN standards) and comparative performance against legally marketed predicate devices. For biocompatibility, the ground truth is established by the results of specific ISO-standardized biological evaluations (e.g., cytotoxicity, sensitization, irritation reports).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device (catheter); there is no "training set" in the context of machine learning or AI models. The design and manufacturing process are based on engineering principles and materials science.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as point 8.
§ 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.