(190 days)
SpeediCath Soft 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 cather is inserted into the bladder allowing urine to drain.
The product is for adult male patients only.
The SpeediCath Soft is a sterile, single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by adult males with missing or reduced bladder control. The catheter has a grip which serves as protection from the user's touch and aids the user during insertion.
The provided text details the 510(k) submission for the Coloplast SpeediCath Soft urological catheter. Based on this document, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document lists a comprehensive set of performance tests conducted for the SpeediCath Soft, implying that for each test, pre-determined acceptance criteria were established. The general statement made is that "All tests met the pre-determined acceptance criteria." While specific numerical acceptance criteria and detailed performance results for each test are not explicitly provided in a table within this document, the following table summarizes the types of tests conducted (which serve as the basis for acceptance) and the general performance statement provided.
| Acceptance Criteria (Test Type) | Reported Device Performance |
|---|---|
| Real Time and Accelerated Aging shelf life testing (ASTM F1980-16) | Complies (met pre-determined acceptance criteria) |
| Biocompatibility (ISO 10993-1, FDA Guidance) | Complies (met pre-determined acceptance criteria) |
| Proof of packing seal strength and integrity | Complies (met pre-determined acceptance criteria) |
| Peel force test of packaging material | Complies (met pre-determined acceptance criteria) |
| Transportation testing (ASTM D4169) followed by coating assessment and damage inspection | Complies (met pre-determined acceptance criteria) |
| Detach and re-attach force of the grip | Complies (met pre-determined acceptance criteria) |
| Flow rate (ASTM F623-99:2013 and ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Coefficient of friction (ASTM D1894:2014) | Complies (met pre-determined acceptance criteria) |
| Catheter coating friction | Complies (met pre-determined acceptance criteria) |
| pH | Complies (met pre-determined acceptance criteria) |
| Osmolality | Complies (met pre-determined acceptance criteria) |
| Surface Finish (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Outer Diameter (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Effective Shaft Length (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Catheter Strength (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Connector Security (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Kink Stability (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Catheter Stiffness (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Peak Tensile Force (ISO 20696:2018) | Complies (met pre-determined acceptance criteria) |
| Usability (EN 62366:2008, ISO 62366-1:2015, AAMI HE 75:2009, FDA Guidance) | Complies (met pre-determined acceptance criteria) |
2. Sample sizes used for the test set and the data provenance
The document does not specify the sample sizes used for each of the non-clinical tests listed. It states that "Performance testing for SpeediCath Soft was conducted according to applicable sections of non-recognized and recognized voluntary consensus standards." These standards typically define appropriate sample sizes for testing.
The data provenance is for a medical device (urological catheter) and the tests conducted are non-clinical, likely in a laboratory setting by the manufacturer, Coloplast. There is no indication of country of origin of the data beyond the manufacturer being based in Humlebaek, Denmark. The studies are described as "Performance testing," implying they were specifically conducted for this submission, making them prospective in nature for regulatory purposes, although the underlying methods might be well-established.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The tests conducted are non-clinical engineering and performance tests on the catheter itself (e.g., flow rate, tensile strength, biocompatibility), not tests involving human "readings" or interpretations that would require expert consensus for ground truth. Usability testing, which might involve human subjects, is mentioned, but details on "experts establishing ground truth" are not provided.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for medical image analysis or clinical trials where multiple human readers interpret data, and a consensus mechanism is needed for the ground truth. The tests performed are objective, quantitative measurements or qualitative assessments against defined standards.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any element of AI assistance in this submission. This is a 510(k) for a physical medical device (catheter), not a diagnostic AI system.
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 urological catheter, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests, the "ground truth" is defined by the acceptance criteria specified in the referenced ASTM and ISO standards. For example, a flow rate test would have a pre-defined minimum or range of acceptable flow rates. Biocompatibility would be assessed against established criteria for cytotoxicity, irritation, etc., as per ISO 10993 standards. These are objective measures against a standard, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as the device is a physical product and not an AI or machine learning algorithm that requires a "training set" with established ground truth.
§ 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.