(283 days)
The Bardex® Lubri-Sil® All-Silicone Foley Catheter, and the Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter are 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 hemostatis following surgery such as transurethral resection of the prostate.
The subject device three-way Foley catheter is composed of a trifurcated silicone tube, a silicone balloon and a two-way valve (a valve that upon activation permits flow in either of two directions, i.e., for inflation of the balloon). The three-way designation of the catheter refers to the number of lumens in the catheter tubing. The tube has three lumens, one lumen for urinary drainage which is to be connected to a urine collection container (drainage bag or urine meter), one lumen with a two-way valve for inflation/deflation of the Foley balloon, and one lumen for irrigation of the bladder. Catheters with either a 5cc or 30cc balloon will be available with 16 through 24 Fr. shafts (i.e., 16, 18, 20, 22, and 24).
The provided text describes a 510(k) premarket notification for a medical device, specifically the Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the device performance information is presented differently than for a new, innovative AI device.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document does not explicitly present a discrete table of "acceptance criteria" for novel performance metrics with corresponding numerical "reported device performance" values in the way one might expect for a new AI diagnostic device. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device by meeting the same design, manufacturing, and performance specifications.
The relevant section states:
"The Bardex® Lubri-Sil® 3-Way Foley Catheter and Bardex® Lubri-Sil® I.C. 3-Way Foley Catheter referenced in this submission are held to the same design, manufacture, and performance specifications as the predicate (#K002868). Performance and functional testing standards are based on the FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" dated September 12, 1994. ISO 10993-1, "Biological Evaluation of Medical Devices," and ASTM F623-99, "Standard Performance Specification for Foley Catheter.""
Interpretation:
The "acceptance criteria" for this device are that it must comply with:
- The same design, manufacture, and performance specifications as the predicate device (Bard® Lubri-Sil™ 3-Way Foley Catheter, Bard® Lubri-Sil™ I.C. 3-Way Foley Catheter).
- FDA Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters (1994).
- ISO 10993-1: Biological Evaluation of Medical Devices.
- ASTM F623-99: Standard Performance Specification for Foley Catheter.
The "reported device performance" is essentially that the device met these specifications and standards, allowing the FDA to determine substantial equivalence. The document doesn't provide specific numerical results of these tests, but rather states that the device "is held to" these standards. The FDA's letter of clearance indicates that based on the submission, the device was found substantially equivalent, implying it met these underlying performance requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a sample size for a "test set" in the context of clinical performance data as we might see for an AI algorithm. The performance evaluation here refers to engineering and biocompatibility testing against established standards. These tests would involve a certain number of catheter units, but it's not a "test set" in the sense of patient data.
- Data Provenance: The document does not provide information on data provenance (e.g., country of origin, retrospective/prospective) because it's not a study based on patient data analysis like an AI diagnostic algorithm would require. The "data" refers to the results of engineering and biocompatibility tests.
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 to this 510(k) submission. The ground truth for a Foley catheter's performance is established by its adherence to physical design specifications, material properties, sterility, and functional tests (e.g., balloon inflation, flow rates, lack of leakage), and biocompatibility, as outlined in the referenced standards (FDA, ISO, ASTM). These are objective engineering and biological assessments, not subjective expert interpretations of images or clinical outcomes.
4. Adjudication method for the test set:
This is not applicable. There is no "adjudication method" in the context of expert consensus as there would be for subjective clinical assessments. The performance tests are objectively measured against defined criteria within the standards.
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:
This is not applicable. This device is a physical medical device (Foley catheter), not an AI-powered diagnostic tool, and therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This is not applicable. This device is not an algorithm. It's a physical medical device.
7. The type of ground truth used:
The "ground truth" for this device, in the context of its safety and effectiveness, is established by:
- Compliance with recognized standards: FDA guidance, ISO 10993-1 (biological evaluation), and ASTM F623-99 (physical performance standards).
- Demonstration of substantial equivalence to a predicate device in terms of intended use, design, and fundamental scientific technology.
- Objective engineering tests (e.g., burst strength, flow rates, sterility) and biocompatibility testing (e.g., cytotoxicity, sensitization) as required by the referenced standards.
8. The sample size for the training set:
This is not applicable. This device does not use a "training set" as it is not an AI algorithm.
9. How the ground truth for the training set was established:
This is not applicable. There is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a conventional medical device (Foley catheter). The "acceptance criteria" and "study" described are focused on demonstrating substantial equivalence to a predicate device and compliance with established engineering and biocompatibility standards, rather than evaluating the performance of an AI algorithm against a clinical ground truth. Many of the requested details (like sample sizes for test/training sets, expert qualifications, MRMC studies, and ground truth types) are specific to AI/diagnostic device evaluation and are not relevant to this type of medical 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.