(89 days)
The Magic3 Go™ Intermittent Urinary Catheter is intended for urological use only. If is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
Magic3 Go™ Intermittent Urinary Catheter is a ready-to-use silicone intermittent urinary catheter with a self-hydrating coating over a hydrophilic coating.
The device consists of an all silicone single lumen catheter with a thermoplastic elastomer (TPE) handle which does not contain DEHP and/or phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating is applied. The additional coating does not require activation with water prior to use. The handle provides the user with an area for a secure grip and no-touch area with which to insert the catheter.
The provided document describes a 510(k) premarket notification for a medical device, the Magic3 Go™ Intermittent Urinary Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's effectiveness through clinical trials with specific acceptance criteria like those often seen for AI/ML devices or novel therapies.
Therefore, many of the requested elements (like a multi-reader multi-case study, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets) are not applicable to this type of regulatory submission for this particular device.
However, I can extract information related to the performance data provided to support substantial equivalence.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a urinary catheter, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device and meeting relevant industry standards. There are no numerical performance metrics (like sensitivity, specificity, accuracy) provided in the document for the device itself against a specific clinical outcome.
| Acceptance Criteria (Implied by Equivalence and Standards) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| - Cytotoxicity (ISO 10993-5) | Met standard (successfully passed) |
| - Sensitization (ISO 10993-10) | Met standard (successfully passed) |
| - Vaginal Mucosal Irritation (ISO 10993-10) | Met standard (successfully passed) |
| Nonclinical Functional Performance | |
| - Sterile urethral catheters for single use (BS EN 1616:1997 + A1:1999) | Met standard |
| - Coefficient of friction (low lubricity) | Low coefficient of friction, demonstrating low friction between catheter and urethral mucosa, demonstrating substantial equivalence to predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable/not specified for performance metrics in the context of clinical outcomes. The performance data refers to laboratory testing on device materials and function.
- Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for clinical data, as this is laboratory and material testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in this context, would be the results of the laboratory tests based on established ISO and BS EN standards, not expert clinical interpretation.
4. Adjudication method for the test set
- Not applicable. The "test set" here refers to physical/material performance tests, which are objective and do not require expert adjudication in the way clinical diagnostic interpretations would.
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. This is not an AI/ML device and therefore an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the performance data (biocompatibility and nonclinical functional performance) is based on established international and national standards (ISO 10993-5, ISO 10993-10, BS EN 1616:1997 + A1:1999) and quantitative measurements (e.g., coefficient of friction). For the substantial equivalence argument, the predicate device's established safety and effectiveness also serves as a "ground truth" reference.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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.