(256 days)
The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.
The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.
Here's a breakdown of the acceptance criteria and study information for the Rochester Medical Corporation Silicone Antibacterial Foley Catheter, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reduction in incidence of catheter-acquired bacterial urinary tract infection (CAUTI) | - Statistically significant reduction in CAUTI during the first 5 days of catheterization. (2.4% incidence vs. 6.9%incidence for conventional catheter group). |
- Statistically significant difference in actuarial survival curves for time until CAUTI between the two groups (p = 0.007, Kaplan-Meier survival, Breslow logrank statistic) for the first 5 days of use. |
| Material Biocompatibility | Passed Cytotoxicity, USP Systemic Toxicity, Subchronic Toxicity, Intracutaneous Injection, Muscle Implant Study, Sensitization Study, Pyrogenicity, and Hemolysis. |
| Mutagenicity | Some mutagenic changes indicated (Note: This is a reported finding, not explicitly stated as an "acceptance criterion" that was passed, but part of the testing results). |
| Antibacterial Activity (In-vitro) | Nitrofurazone-impregnated catheter segments showed antibacterial activity against clinical isolates of uro-pathogens including Coagulase-negative staphylococci, S. aureus, Enterococcus spp., C. Minutissimum, E. Coli, Enterobacter spp., and Klebstella spp. |
| Conformity to Standards | Meets the requirements of ASTM 623-89 Standard Specification for Foley Catheters. |
| Elution Profile & Bacteriocidal Levels | Elution profile reproducible, and antibacterial agent released at bacteriocidal levels. |
| Material Degradation with Aging | No evidence of degradation with aging. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: A total of 344 patients were enrolled in the clinical trial.
- Data Provenance: The study was a "single site randomized, double-blind, controlled clinical trial." This indicates it was a prospective study. The country of origin is not explicitly stated, but given the 510(k) submission to the FDA (USA), it is highly probable the study was conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document does not explicitly state the number of experts or their qualifications used to establish the ground truth (diagnosis of CAUTI) for the clinical trial. Clinical trials usually rely on defined diagnostic criteria and sometimes independent clinical adjudication committees, but this specific detail is not provided.
4. Adjudication Method for the Test Set
- The document does not explicitly describe an adjudication method for the diagnosis of CAUTI in the clinical trial. It was a "double-blind" study, meaning neither the patients nor the clinicians administering the treatment knew which type of catheter was being used, which helps reduce bias in assessing outcomes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This study was a clinical trial comparing the device to a conventional catheter in human patients, not a study evaluating human readers' diagnostic performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done, in the sense that the device itself (the catheter) was tested for its inherent antibacterial properties in an in-vitro capacity and its clinical effectiveness without direct human interaction. The "algorithm" in this context is the inherent antibacterial mechanism of the device.
- In-vitro studies specifically showed the antibacterial activity of the nitrofurazone-impregnated catheter segments against various uro-pathogens. This is a standalone performance assessment of the device's mechanism.
7. The Type of Ground Truth Used
- For the clinical trial, the ground truth was clinical outcomes data, specifically the "incidence of catheter associated urinary tract infection (CAUTI)." This would have been determined through clinical diagnosis based on established medical criteria (e.g., urine culture results, clinical symptoms).
8. The Sample Size for the Training Set
- This device is a physical medical device (catheter) with an antibacterial coating, not an AI or software-based device that explicitly requires a "training set" in the machine learning sense. Therefore, the concept of a "training set" is not applicable to this submission. The "training" for the device's performance is embedded in its manufacturing process and design, not in a data-driven training regimen.
9. How the Ground Truth for the Training Set was Established
- As explained above, the concept of a "training set" for an AI algorithm is not applicable to this physical medical 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.