(131 days)
The ThinkMed Intermittent Catheter with/without Hydrophilic Coating is indicated for intermittent catheterization of the urethra 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 catheter is inserted into urethra to reach the bladder allowing urine to drain.
ThinkMed Intermittent Catheter is sterile, single use device to be designed as an intermittent pathway for drainage of the bladder. It is available for male and female, in uncoated and coated variants and in two different tip configurations of Nelaton (straight and rounded) and Tiemann (curved and tapered) respectively. There are two polished drainage eyelets on the catheter in various configurations and types.
The uncoated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. it is consists of a tubular catheter shaft with attached a drainage funnel.
The catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemann-tip.
The coated catheter is manufactured with conventional medical grade, latex-free, biocompatible materials. Coated with a hydrophilic low-friction coating, with attached a drainage funnel. The surface of coated catheter is hydrophilic and when the coated catheter is activated with the sterile water, it becomes slippery and thus reduces friction against the urethra. This allows the coated catheter to slide in and out of the urethra in the most comfortable way. The coated catheter is available in sizes 6Fr to 22Fr for Nelaton-tip and sizes 8Fr to 22Fr for Tiemann-tip.
This document is a 510(k) premarket notification for a medical device (ThinkMed Intermittent Catheter with/without Hydrophilic Coating). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be found in this document. This submission is about showing that the new device is as safe and effective as a previously approved device, not about proving groundbreaking performance through a new clinical trial.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table of explicit acceptance criteria or reported device performance metrics in the way one would see for a new clinical study. Instead, it relies on demonstrating equivalence to existing standards and a predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance | Source/Method |
|---|---|---|
| Intended Use (Same as predicate) | Indicated for intermittent catheterization of the urethra for individuals unable to promote natural urine flow or with significant residual urine. | Comparison Table |
| Condition of Use (Same as predicate) | Single Use | Comparison Table |
| Principle of Operation (Same as predicate) | Intermittent catheterization | Comparison Table |
| Biocompatibility (Conform to ISO10993) | Conforms to ISO10993; Cytotoxicity and Sensitization tests passed. | Comparison Table, Biocompatibility Test section |
| Labeling (Meet 21 CFR Part 801) | Meets the requirements of 21 CFR Part 801 | Comparison Table |
| Material Composition (Similar to predicate) | Conventional medical grade, latex-free, biocompatible materials (e.g., polyvinylpyrollid for hydrophilic coating). | Device Description, Comparison Table |
| Design Characteristics (Similar to predicate) | Nelaton & Tiemann tip designs, drainage funnel, various sizes (6Fr-22Fr). | Device Description, Comparison Table |
| Sterilization Method (Similar to predicate) | EtO Gas | Comparison Table |
| Dimensional, Design, Material, Sterility, Packaging (Conform to ASTM F 623) | Conformed with ASTM F 623. | Non-Clinical Test Conclusion |
Missing Information:
- Specific quantitative acceptance criteria (e.g., "flexibility must be X N/mm," "flow rate must be Y mL/sec").
- Quantitative device performance data against such criteria. The document only states that it conforms or meets standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any performance testing. The ASTM F 623 and ISO 10993 tests would have involved samples, but the number is not provided.
- Data Provenance: The document does not describe the origin of data in terms of country or retrospective/prospective for clinical outcomes. It refers to non-clinical tests conducted to verify compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable and not provided in the document. The "tests" mentioned are non-clinical, laboratory-based tests (e.g., biocompatibility) against established standards rather than clinical studies requiring expert ground truth or assessment of outcomes.
4. Adjudication Method for the Test Set
- Not applicable and not provided. There was no clinical study described that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this document. This type of study is typically for evaluating diagnostic accuracy of imaging or AI systems with human readers, which is not relevant to an intermittent catheter.
- Therefore, an effect size for human readers improving with/without AI assistance is not applicable.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
- Not applicable. This device is an intermittent catheter, not an algorithm or AI system.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is primarily compliance with established international standards (ISO 10993 for biocompatibility) and national standards (ASTM F 623 for performance specification for foley catheter), along with demonstrating substantial equivalence to a predicate device.
- There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as it's a 510(k) focused on equivalence and non-clinical testing.
8. Sample Size for the Training Set
- Not applicable. This document describes a medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this device.
§ 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.