FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The PORGES™ Silicone prostatectorny catheter is a balloon catheter of the retention type, commonly called THE FORGES " Silkone prosidioning outhere is a banetransparent silicone elastomer with a radiopaque a Toley datable is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate Shall. One laimer is for araning halas to anyth a third lumen, it is used in conjunction with the first lumen for the ballow with other water in used for inflation and deflation of the balloon. The distal end has opposite eye holes, which are used for drainage.
Nominal balloon inflation volumes are 15 to 30 cm³ or 30 to 50 cm³ with the 15 to 30 cm³ balloon being used Nominal banoon innation for normal usage, and 30 to 50 cm³ when a larger balloon is indicated.
to head of outher in place rehaft, are an connecting funnel and a Luer activated valve of which the colour varies according to the size of the catheter.
This product is available in sizes 18 Fr to 24 Fr, with DUFOUR, DELINOTTE, COUVELAIRE or standard tip. Total length of all catheters : 42 cm. One catheter has an open tip to fit over a guide wire.

AI/ML Overview

The provided document is a 510(k) summary for the PORGES™ Silicone prostatectomy catheter, which is a medical device and not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable.

However, I can extract the acceptance criteria for the device based on the provided text.

The device's performance requirements are assessed against the FDA "Guidance for the content of premarket notifications and functional testing of conventional and anti-reflux Foley catheters" dated September 12, 1994, and/or PORGES's own testing/acceptance criteria.

Here's a table based on the provided text, outlining the acceptance criteria (i.e., the performance requirements the device must meet) and what the document reports about the device performance regarding these criteria. It's important to note that the document generally states the device meets or passes these criteria, but it does not provide specific numerical outcomes or detailed results of the tests in this 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements from Section J.7)	Reported Device Performance
Flow rate through the drainage lumen.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Balloon to rupture when inflated to the claimed balloon volume and held under conditions approximating the usage environment for a period of seven days.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement. (Implied that the balloon does not rupture under these conditions).
Being distorted and pulled through the bladder outlet.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement. (Implied that the device performs adequately without problematic distortion).
Maintenance of balloon inflation to fill volume over an extended time.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Manufacturing tolerances for catheter tip, balloon and shaft diameters.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Deflate reliability (to within 4 Fr. sizes of the labelled shaft size, as applicable, including the time for such deflation) for a catheter submerged seven days.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Shaft tensile strength and tip adherence.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Balloon burst.	The PORGES™ Silicone prostatectomy catheter meets this performance requirement.
Biocompatibility testing per ISO 10993-1.	The PORGES™ Silicone prostatectomy catheter passes biocompatibility testing per ISO 10993-1.

Since this is a traditional medical device (catheter) and not an AI/ML product, the remaining questions are not directly applicable. However, I will address them to explicitly state why they are not relevant in this context.

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical, sterile, single-use medical device. Performance is evaluated through physical and material tests, not typically with "test sets" in the context of data. The document does not specify general "data provenance" but mentions testing according to FDA guidance and/or PORGES internal criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on image interpretation) is not relevant for the physical performance testing of a catheter. The "ground truth" here is compliance with established engineering and safety standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human reviewers in clinical data analysis for AI/ML. The performance of this device is assessed against predetermined physical and material specifications.

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 device is not an AI algorithm, so MRMC studies or human-with-AI vs. without-AI comparisons are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device, the "ground truth" is adherence to established mechanical, material, and biocompatibility standards (e.g., ASTM F 623-89, ISO 10993-1, and internal PORGES criteria).

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established: Not applicable. As there is no training set for an AI/ML model, "ground truth" for it is not established.

Summary

Regulation Number and Section

§ 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.