(192 days)
Folysil catheters are intended for use up to 30 days in adult and pediatric populations for:
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Bladder drainage by urethral catheterization,
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Bladder drainage by suprapubic catheter replacement only (for non-grooved, straight 2-way Folysil catheters with a maximum balloon volume of 15mL).
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Bladder instillation of physiological saline solution.
Folysil catheters are thin, hollow tubes equipped with a balloon, funnel and valve, to be inserted into the bladder by the urethral or supra-pubic approach to drain urine into a urine collection bag. Folysil catheters are held in place within the bladder by the balloon, which is filled with sterile water or with aqua-glycerin solution.
The provided text describes a medical device, the Folysil® Silicone Catheter, seeking 510(k) clearance from the FDA. The submission focuses on demonstrating substantial equivalence to predicate devices through biocompatibility and bench testing. However, it does not include information about clinical studies involving human patients, multi-reader multi-case (MRMC) studies, or the use of AI. Therefore, most of the requested information regarding human-in-the-loop performance, expert consensus, and training/test set details cannot be extracted from this document.
Here's the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "All pre-determined acceptance criteria were met for 14-24 Fr. catheters" for the bench tests conducted according to FDA recognized standards and guidance. For catheter sizes 6-12 Fr., "the protocol and acceptance criteria for these tests were scientifically adequate and clinically relevant, and the acceptance criteria were met for these tests as well."
The text lists the following bench tests performed:
| Acceptance Criteria (Test) | Reported Device Performance (Met/Not Met) |
|---|---|
| Visual tests | Met |
| Catheter integrity test | Met |
| Balloon size and shaft size | Met |
| Flow rate through drainage lumen | Met |
| Balloon integrity (resistance to rupture) | Met |
| Inflated balloon response to traction | Met |
| Balloon volume maintenance | Met |
| Deflation reliability test (failure to deflate) | Met |
| Funnel security of fit test | Met |
| Tensile test on funnel junction | Met |
| Tensile test on tip | Met |
| Simulation of use test | Met |
| Kink resistance test | Met |
| Radiopacity test | Met |
| Tensile test on valve junction | Met |
Additionally, for biocompatibility testing:
| Acceptance Criteria (Test) | Reported Device Performance (Met/Not Met) |
|---|---|
| Cytotoxicity | Met (demonstrates biocompatibility) |
| Irritation | Met (demonstrates biocompatibility) |
| Sensitization | Met (demonstrates biocompatibility) |
| Acute Systemic Toxicity | Met (demonstrates biocompatibility) |
| Material-mediated Pyrogenicity | Met (demonstrates biocompatibility) |
| Genotoxicity Ames and Mouse Lymphoma | Met (demonstrates biocompatibility) |
| Implantation 4 and 13 weeks | Met (demonstrates biocompatibility) |
| Systemic toxicity 13 weeks | Met (demonstrates biocompatibility) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact sample sizes (number of devices) used for each individual test or for the overall test set. It refers to "14-24 Fr. catheters" and "6-12 Fr. catheter sizes."
- Data Provenance: The testing was presented by Coloplast, an international company with its legal manufacturer address in Humlebaek, Denmark. The testing appears to be internal company testing based on recognized standards and guidance documents. The data is retrospective in the sense that it's data collected from internal testing for the purpose of this submission, not a prospective clinical trial.
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 as the evaluation mentioned is based on objective bench tests and biocompatibility testing, not on human interpretation or clinical data requiring expert ground truth in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for objective bench and biocompatibility testing. The "ground truth" for these tests is defined by the physical or biological measurement outcomes against pre-defined quantitative or qualitative acceptance limits.
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 information is not present in the document. The submission pertains to a physical medical device (catheter) and its substantial equivalence, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present in the document. The device is a physical catheter, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is established by:
- Physical measurements and performance criteria defined in recognized standards (ASTM F623-19, ISO 20696:2018) and FDA guidance documents for bench testing.
- Biological responses and cytotoxicity assessments defined in recognized standards (ISO 10993-1 and relevant sub-standards) for biocompatibility testing.
8. The sample size for the training set:
This information is not applicable. This is a submission for a physical medical device (catheter) based on bench and biocompatibility testing, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated above.
§ 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.