(109 days)
Intermittent catheters are single use devices indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
The intermittent urinary catheter is a thin hollow tube, fitted with a connector at one end and an olive tip (ball) at the other, which is inserted intermittently through the urethra and up to the bladder so that urine can drain. Both components are prepared from plastic materials and are bonded by cyclohexanone. The products are designed for transient use only and are available in various diameters; six FR (CH) sizes: FR08, FR10, FR12, FR14, FR16 and FR18. An increasing French size corresponds to a larger external diameter.
The catheter is primary packaged in a paper/film peelpack and is sterilized by Ethylene Oxide.
The catheter tube has a smooth, clear surface with two lateral eyelets and closed angled tip with small ball called an olive. Eyelets are placed on the left and right site of the catheter and the angled portion of the catheter tip is oriented upward.
This document describes the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter and its substantial equivalence to predicate devices, focusing on performance testing.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Predicate) | Reported Device Performance (GentleCath) |
|---|---|---|
| 1) Catheter Flow Rate | (Implied: similar to predicate) | Similar or superior |
| 2) Strength of Tube and Connector Attachment | (Implied: similar to predicate) | Similar or superior |
| 3) Angle of Coudé Tip | (Implied: similar to predicate) | Similar or superior |
| 4) Diameter of Ball | (Implied: similar to predicate) | Similar or superior |
Note: The document states "All the parameters are similar or superior for the GentleCath Male Coudé Olive Tip Intermittent Urinary Catheter" compared to the predicate devices. Specific quantitative acceptance criteria are not explicitly listed in this summary but are referenced as being in Section 18 of the submission.
2. Sample Size Used for the Test Set and Data Provenance:
The document summarizes performance testing ("Bench Performance Testing") and states that "Details relating to performance testing of the subject device and the 2 predicate devices can be found in section 18 of this submission." This summary does not provide the specific sample sizes used for each test.
The data provenance is not explicitly stated as "country of origin." However, the applicant is ConvaTec Ltd. which has an address in Deeside, Flintshire, UK. The tests are described as "laboratory testing," suggesting they were conducted in a controlled environment, likely by the manufacturer. The study is retrospective in the sense that it compares features of a new device to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes bench testing of a medical device (catheter) and not a study involving human interpretation of data where "experts" would establish ground truth in the traditional sense. The "ground truth" here is based on quantifiable physical properties and performance metrics of the catheters themselves, as measured by standard laboratory methods. Therefore, this section is not applicable in the context of this submission. Device performance is measured against established engineering and regulatory standards and predicate device characteristics.
4. Adjudication Method for the Test Set:
Not applicable, as this is a bench testing study of a physical device, not an interpretation-based study requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study is focused on the physical and functional equivalence of a medical device through bench testing, not on the effectiveness of human readers using the device or interpreting associated data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, this can be considered a standalone study in the sense that the device's physical and functional performance was tested independently of human interaction during the actual measurement process. The tests evaluate the intrinsic properties of the catheter itself (flow rate, strength, tip angle, ball diameter). There is no "algorithm" involved in this type of device.
7. Type of Ground Truth Used:
The ground truth used for this study is based on measurable physical properties and functional performance characteristics of the catheters. These include:
- Catheter flow rate
- Strength of tube and connector attachment
- Angle of Coudé tip
- Diameter of the ball
These are objective, quantitative measurements determined by laboratory testing, often against established standards for medical devices of this type, or established performance of the predicate devices.
8. Sample Size for the Training Set:
This document describes performance testing for substantial equivalence, which primarily relies on comparison to predicate devices and established standards. There is no explicit "training set" mentioned, as this is bench testing of a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of this physical device testing.
§ 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.