(77 days)
The Bardex® Lubri-Sil™ Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.
Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
The Bardex® Lubri-Sil™ Foley Catheter is a two-way all-silicone Foley catheter with a lubricious hydrophilic coating.
The Bard Lubri-Sil Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a two-lumen catheter with a drainage lumen and an inflation lumen with two-way valve. A hydrophilic polymeric coating is applied to the finished catheter. This coating becomes very slippery when wet. The Lubri-Sil Foley Catheter is available in shaft sizes 8 and 10 Fr. with a 3cc balloon, in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.
The provided text describes the Bardex® Lubri-Sil™ Foley Catheter, its intended use, and performance data, but it does not describe a study involving an AI device or software. Therefore, many of the requested sections about AI-specific criteria, sample sizes for AI models, expert adjudication, or MRMC studies cannot be answered from the provided document as they are not applicable.
The document focuses on the physical and biocompatibility performance of a medical device (a Foley catheter) against established standards and internal criteria.
Here's a breakdown of the information that can be extracted from the provided text, adapted to the questions where possible:
Acceptance Criteria and Device Performance for Bardex® Lubri-Sil™ Foley Catheter
The Bardex® Lubri-Sil™ Foley Catheter is a medical device, not an AI or software device. The acceptance criteria and performance data pertain to its physical and biological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Bard Lubri-Sil Foley Catheter "meets the following performance requirements per testing conducted according to ASTM F 623-89, when appropriate, and/or Bard testing/acceptance criteria." Specific numerical performance results or explicit acceptance thresholds are not provided in the document for each criterion, only that the device "meets" them.
| Acceptance Criterion (Based on ASTM F 623-89 and/or Bard criteria) | Reported Device Performance |
|---|---|
| Flow rate through the drainage lumen | Meets requirements |
| Resistance of the balloon to rupture (7 days at claimed volume) | Meets requirements |
| Resistance of inflated balloon to distortion/pull-through | Meets requirements |
| Maintenance of balloon inflation over extended time | Meets requirements |
| Manufacturing tolerances (tip, balloon, shaft diameters) | Meets requirements |
| Ability of inflated catheter to deflate reliably (within 4 Fr. sizes, incl. deflation time) after 7 days | Meets requirements |
| Coefficient of friction | Meets requirements |
| Shaft tensile strength and tip adherence | Meets requirements |
| Balloon burst | Meets requirements |
| Application of coating has no adverse effect on base material (shaft/balloon) after aging | Meets requirements |
| Biocompatibility per ISO 10993-1 (cytotoxicity, systemic toxicity, mucosal irritation, sensitization, implantation) | Passes testing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify sample sizes for each test conducted for the catheter's physical performance or biocompatibility. The tests are described as "Bard testing/acceptance criteria" and "testing conducted according to ASTM F 623-89" and "biocompatibility testing per ISO 10993-1." The provenance of the data is implicitly internal testing conducted by C. R. Bard, Inc. (USA). The data would be prospective in the sense that the tests were performed to evaluate the manufactured device against specified criteria.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical medical device, not an AI or diagnostic tool requiring expert ground truth for its performance evaluation in the context described. Its performance is evaluated through engineering and biocompatibility tests.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI or diagnostic study, an adjudication method in the sense of resolving conflicting expert opinions is not relevant. Performance is determined by meeting objective engineering and biological test specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic systems where human readers interpret medical images or data. This document describes a physical medical device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For the physical and performance tests (e.g., flow rate, balloon integrity, tensile strength), the "ground truth" would be the objective measurement against established engineering standards (ASTM F 623-89) and internal Bard specifications. For biocompatibility, the "ground truth" is determined by established biological safety standards (ISO 10993-1) for cytotoxicity, systemic toxicity, etc. There is no "expert consensus" or "pathology" in the typical sense for these types of device performance evaluations.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI or machine learning model.
§ 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.