(56 days)
The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.
The Magic3 Go® Intermittent Urinary Catheter is a ready-to-use silicone intermittent catheter with a self-hydrating over a hydrophilic coating. The device is provided sterile and is for single use.
The device consists of an all silicone single lumen catheter with a polyethylene insertion sleeve (Sure-Grip™) which is not made from natural rubber latex, DEHP and/or other phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The catheter will be offered in multiple French sizes (6 – 20Fr), multiple lengths (10" & 16") and two tip designs (straight and coudé).
The outer surface of the catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating coating is applied. The additional coating does not require activation with water prior to use. The Sure-Grip™ insertion sleeve provides the user with an ergonomically designed area for a secure grip and notouch area with which to insert the catheter.
This document is a 510(k) summary for the Magic3 Go® Intermittent Urinary Catheter and focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might see for a novel AI device or a device requiring extensive clinical trials for efficacy.
However, I can extract the information related to performance testing that serves as the "study" to demonstrate equivalence.
Here's the breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: In accordance with ISO 10993-1, 10993-5, 10993-10 | Device passed testing for: |
- Cytotoxicity
- Sensitization
- Vaginal Mucosal Irritation |
| Non-clinical functional performance: In accordance with BS EN 1616:1997 + A1:1999 | Device met the requirements of BS EN 1616:1997 + A1:1999. |
| Lubricity: Equivalent to predicate device K150345 | Lubricity of the subject device is determined to be equivalent to predicate device K150345. |
| Substantial Equivalence: Same intended use, similar indications for use, similar technological characteristics, and performance data as predicate devices. | The device was determined to be substantially equivalent. |
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: The document does not specify the exact sample sizes for the biocompatibility or non-clinical functional performance tests. It mentions "The battery of testing included the following:" for biocompatibility and "Non-clinical functional performance testing of the subject device was performed..." without giving numbers of units tested.
- Data Provenance: Not specified. Standard medical device testing is typically conducted in controlled laboratory environments, and the country of origin of the data is not mentioned. The tests are likely prospective for the specific device being submitted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable or not provided in the context of this 510(k) submission. For mechanical and biocompatibility testing of a medical device like a catheter, "ground truth" is established by adherence to recognized international standards and laboratory test methods, not by expert consensus on clinical interpretation. The experts are typically laboratory technicians, toxicologists, and engineers who conduct and interpret the results according to the specified standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This is not applicable for the type of testing described (biocompatibility and non-clinical functional performance). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where human reviewers independently assess outcomes and disagreeing results need resolution.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intermittent urinary catheter, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical medical device (catheter), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For biocompatibility: Ground truth is established by the results of standardized biological tests evaluated against the acceptance criteria defined in ISO 10993 series and regulatory guidelines.
- For non-clinical functional performance: Ground truth is established by the device meeting the specified parameters and ranges defined in the technical standard BS EN 1616:1997 + A1:1999.
- For lubricity: Ground truth is a comparison to the established lubricity of the predicate device (K150345), as the subject device is identical in material and coatings.
8. The sample size for the training set
- This is not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- This is not applicable as there is no training set mentioned for this type of device submission.
§ 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.