(57 days)
Intermittent Catheters are indicated for routine short term drainage of the bladder. The catheter is inserted through the urethra.
The GentleCath™ Intermittent Urinary Catheter is labelled as a single use, sterile device and is sterilized by Ethylene Oxide to a Sterility Assurance Level of 10-6 A urological catheter is a flexible tubular device that is inserted through the urethra and used to pass fluids from the bladder. tip/distal end of the tube is inserted into the urethra and the funnel/connector end is used to drain the urine or can be connected to a urine drainage bag. Both components of the device are made using Polyvinyl chloride (PVC) as base material and bonded with Cyclohexanone. The products are designed for transient use only and are available in various diameters; Six FR/CH sizes: CH08, CH10, CH12, CH16, CH18. An increasing Charrière corresponds to a larger external diameter.
This document is a 510(k) premarket notification for a medical device and therefore does not contain acceptance criteria for an AI/ML device. It is for a physical medical device, the GentleCath™ Intermittent Urinary Catheter.
The acceptance criteria typically found in such a document would relate to the physical and functional properties of the device, rather than performance metrics of an AI algorithm. The study details included focus on demonstrating substantial equivalence to predicate physical devices.
Based on the provided text, here's what can be extracted regarding the device performance and comparative studies:
The document describes performance testing for the GentleCath™ Intermittent Urinary Catheter to demonstrate its substantial equivalence to two predicate devices:
- Primary Predicate: GentleCath™ Male Coudé Olive Tip Intermittent Urinary Catheter (K140953)
- Secondary Predicate: Self-Cath® Intermittent Urinary Catheter (K100878)
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the format of a requirement with a "pass" or "fail" threshold. Instead, it presents a comparison of various parameters between the subject device and the predicate devices to demonstrate equivalence. The "reported device performance" is given as quantitative measurements for each parameter.
| Parameter | Subject Device (GentleCath™ Intermittent Urological Catheter) | Primary Predicate (K140953) | Secondary Predicate (K100878) | Performance/Outcome |
|---|---|---|---|---|
| Flow Rate (ml/min) | 150.5 to 1403.8 ml/min | 148.7 to 1321.5 ml/min | 115.1 to 1380.7 ml/min | Similarities: All products comply with ASTM F623-99. |
| Differences: Subject device demonstrated a slightly higher flow rate. | ||||
| Catheter Tensile Properties (N) | 67.7 to 207.1 N | 60.7 to 203.3 N | 60.1 to 152.5 N | Similarities: Tensile properties comparable for strength of tube and connector attachment. |
| Differences: Slightly greater force is needed for disconnection of tube and connector in the subject device. | ||||
| K Dimension (mm) | 4.7 to 8.4 mm | 5 to 7.9 mm | 5 to 8.1 mm | Similarities: Coudé tip angle comparable to predicate devices. |
| Differences: K Dimension of subject device and predicate devices are considered substantially equivalent. (This reads like a similarity despite being listed under "Differences" column, indicating slight numerical variations that are not clinically significant enough to deem non-equivalent). | ||||
| Catheter tube - outer diameter (mm) | Varies by CH size (e.g., CH08 - 2.6, CH18 - 6.00) | Varies by CH size (e.g., CH08 - 2.67, CH18 - 6.00) | Varies by CH size (e.g., CH08 - 2.66, CH18 - 5.99) | Similarities: Subject device and primary predicate diameters are the same. |
| Differences: Secondary predicate diameters are considered substantially equivalent to GentleCath™ products. | ||||
| Catheter tube - inner diameter (mm) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Similarities: Subject device and primary predicate diameters are the same. |
| Differences: Secondary predicate diameters are considered substantially equivalent to GentleCath™ products. | ||||
| Eyelet size - width (mm) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 1.65, CH18 - 4.30) | Varies by CH size (e.g., CH08 - 0.97, CH18 - 2.67) | Similarities: Subject device and primary predicate eyelets are the same. |
| Differences: Secondary predicate eyelet dimensions are slightly smaller. | ||||
| Eyelet size - length (mm) | Varies by CH size (e.g., CH08 - 2.50, CH18 - 5.90) | Varies by CH size (e.g., CH08 - 2.50, CH18 - 5.90) | Varies by CH size (e.g., CH08 - 2.01, CH18 - 5.03) | Similarities: Subject device and primary predicate eyelets are the same. |
| Differences: Secondary predicate eyelet dimensions are slightly smaller. |
The overarching "acceptance criterion" for this type of submission is to demonstrate substantial equivalence to legally marketed predicate devices, meaning that "the device performs similarly to the predicate devices" and that "all the results are similar or superior for the GentleCath™ Intermittent Urinary Catheter."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "Details relating to performance testing of the subject device and the two predicate devices can be found in section 18 of this submission." However, Section 18 is not included in the provided text. Therefore, the specific sample sizes for the test sets are not available in this extract. The data provenance is also not available from the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of device and study. The testing described is bench testing of physical properties (flow rate, tensile strength, dimensions), not clinical evaluation requiring expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device and study. Bench testing of physical properties does not involve human adjudication in the way clinical studies with AI/ML devices might.
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 is not applicable. This document is for a physical medical device (urinary catheter), not an AI/ML device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This document is for a physical medical device (urinary catheter), not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance testing mentioned (Flow Rate, Catheter Tensile Properties, K Dimension), the "ground truth" would be the measurement results obtained through standardized laboratory test methods. This is not "expert consensus, pathology, or outcomes data" in the typical sense. The standard for flow rate is mentioned as ASTM F623-99.
8. The sample size for the training set
This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. This submission is for a physical medical device, not an AI/ML device that requires a training set.
§ 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.