(151 days)
The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode
The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.
The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.
The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.
The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its path to FDA clearance via a 510(k) submission (K050008). However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically used for diagnostic or AI-based devices.
This submission focuses on substantial equivalence to predicate devices and biocompatibility testing rather than performance in terms of diagnostic effectiveness or clinical outcome improvement through a P-value or specific statistical analysis commonly found in clinical trials. As such, many of the requested fields cannot be filled from the provided text.
Here's a breakdown based on the given information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO Method) | Catheter portion: Did not induce cytotoxicity. |
| Introducer tip portion: Did introduce cytotoxicity, but reactivity was less than Grade 2 (mild reactivity). | |
| Guinea Pig Maximization (Saline & Vegetable Oil Extracts) | No signs of sensitization observed. |
| Systemic Toxicity (Acute Systemic Injection with Saline & Vegetable Oil Extracts) | Met the requirements of the systemic injection test. |
| Acute Vaginal Irritation | Met the requirements of the vaginal irritation test. |
| Genotoxicity (Ames Test) | Extracts were not mutagenic for any tester strain, with or without S9 activation. |
| Substantial Equivalence: | The device is considered substantially equivalent in form and function to the Mentor's Self-Cath Plus Catheter (K003874) and the Self-Cath Closed System (K003873). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for biocompatibility tests (e.g., number of units tested, number of animals). This information is usually detailed in the full test reports, which are not included in this summary.
- Data Provenance: Not specified. The tests are general biocompatibility tests, not clinical studies in humans or specific geographical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This submission concerns the biocompatibility and substantial equivalence of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This type of adjudication is typically used for image-based diagnostics or clinical studies where subjective interpretation is involved.
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
- No MRMC study was done. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility, the "ground truth" is established by the results of standardized biological tests (e.g., observation of cellular reactions, animal responses to extracts, genotoxicity assays) and comparison against acceptance criteria defined by relevant ISO standards or regulatory guidelines.
- For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.