(94 days)
Urological catheter intended for drainage/irrigation of the urinary tract. Catheterization is accomplished through the urinary tract, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
The subject device is a single-use, latex-free, 3-way Foley catheter that is constructed of medical grade silicone. It incorporates three (3) lumens, one for inflation/deflation of the balloon, another for drainage, and the remainder for irrigation of the urinary tract. The balloon, at the distal end of the catheter, is inflated to fill volume between 10-30 ml and remains inflated via the incorporated two-way valve in the connector at the proximal end of the inflation lumen. The connector engages with slip/taper luer connection that is standard on syringes. With the balloon inflated, the catheter maintains position in the urinary tract for the duration of the clinical application. Prior to removal, the balloon is deflated via the two-way valve connection. The drainage inlet is located distal to the catheter's balloon. The urinary bag is a standard non-interconnectable connector. The irrigation outlet is located just proximal of the catheter's balloon. It is positioned underneath a sleeve, which directs fluid in the proximal direction towards the 3-way connection. The purpose of the sleeve is to disperse the irrigation fluids gently down the urinary tract. The connector for the irrigation lumen is a standard non-interconnectable connector.
The provided document is a 510(k) Premarket Notification for a medical device, specifically a PSM 3-Way Silicone Foley Catheter. As such, it is not a study proving the device meets acceptance criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device based on similar technological characteristics and performance standards.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, sample size for training set) are not applicable to this type of regulatory submission for a traditional medical device (not an AI/ML device).
However, I can extract the acceptance criteria and reported device performance related to the physical and functional attributes of the Foley catheter based on the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" values in a table format with corresponding "reported performance." Instead, it highlights that testing was performed "in accordance to FDA guidance and recognized performance states" and that "Successful results were achieved with all evaluations conducted." This implies that the device met the standards for these tests. The "performance standards" column in the comparison table indirectly serves as acceptance criteria.
| Acceptance Criteria (Performance Standard) | Reported Device Performance |
|---|---|
| ASTM F623 | Successful; Met standard |
| Biocompatibility | Successful |
| Sterilization | Successful |
| Packaging Integrity (Sterile Barrier) | Successful |
| Transportation | Successful |
| Shelf-Life | Successful |
| Performance/Functionality | Successful |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified. This is a regulatory submission, not a clinical study report. The tests are likely performed by the manufacturer or their contracted labs.
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)
- Not Applicable. This is not an AI/ML device. "Ground truth" in this context would refer to the standards applied in the physical and functional tests, not expert interpretation of medical images or data. Testing is based on established engineering and material standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Not an AI/ML device.
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
- Not Applicable. This is not an AI/ML device, so no MRMC study would be performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device, so no algorithm standalone performance would be done.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device would be adherence to recognized engineering and material standards (e.g., ASTM F623 for catheters, ISO standards for biocompatibility and sterilization), and the device's functional performance against its design specifications. It's based on objective measurements and established scientific test methods, not expert consensus in a diagnostic sense.
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.