(281 days)
The Bardex® Temperature-Sensing Foley Catheter, when connected to a Bard CritiCore® or Urotrack 224 monitor, or other 400-series Temperature Monitors, is intended for use in the drainage and/or collection and/or measurement of urine and in conjunction with an electronic urine monitor for the monitoring of core body temperature, in degrees Fahrenheit and degrees Celsius.
The Bardex® Temperature-Sensing Foley Catheter is a two-way silicone Foley Catheter with a thermistor embedded in the third lumen. The catheters will be available uncoated, with a lubricious coating or with a silver and lubricious coating.
The provided text is a 510(k) summary for the Bardex® Temperature-Sensing Foley Catheter. This type of submission is for medical devices, which typically do not involve the same kind of performance studies (e.g., studies with human readers, training and test sets, ground truth established by experts) as AI/ML software. Instead, the focus is on demonstrating substantial equivalence to a predicate device through engineering and functional testing.
Based on the provided text, here's a breakdown of the requested information, noting where it is not applicable or not provided for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "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 and ASTM F623-99, "Standard Performance Specification for Foley Catheter.""
However, the specific acceptance criteria and detailed reported device performance (e.g., pass/fail for each standard) are not explicitly listed in the provided summary. The summary simply states that the new device "is held to the same design, manufacture, and performance specifications as the predicate (#K003289)."
| Acceptance Criteria (Based on FDA Guidance / ASTM F623-99) | Reported Device Performance |
|---|---|
| Specific criteria not detailed in submission | Not explicitly reported in this summary |
| Adheres to design, manufacture, and performance specifications of predicate device | Device meets same specifications as predicate K003289 |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not applicable in the context of an AI/ML device where "test sets" typically refer to data used to evaluate algorithm performance. For a physical medical device like a Foley catheter, testing involves engineering and functional tests on manufactured units. The sample size for these specific tests (e.g., how many catheters were tested for flow rate, balloon integrity, or temperature sensing accuracy) is not provided in this summary. Data provenance is also not relevant in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This is not applicable. The "ground truth" concept, especially established by experts, is primarily relevant for AI/ML diagnostic or prognostic devices that interpret complex data (like medical images). For a temperature-sensing catheter, accuracy is typically verified against calibrated measurement standards, not expert consensus.
4. Adjudication Method for the Test Set:
This is not applicable for the same reasons as #3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
This is not applicable. MRMC studies are used to evaluate human reader performance with and without AI assistance, which is irrelevant for a physical medical device like a Foley catheter.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is not applicable. There is no "algorithm" in the sense of AI/ML software for this device to be evaluated in a standalone manner. The device itself performs the temperature sensing and urine drainage.
7. The Type of Ground Truth Used:
For a temperature-sensing Foley catheter, the "ground truth" for its temperature sensing function would be established through calibration against recognized temperature standards using laboratory equipment, not expert consensus, pathology, or outcomes data. The summary does not detail the specific method for establishing the performance specifications, but it references ASTM F623-99, which would include such calibration and verification procedures.
8. The Sample Size for the Training Set:
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable. There is no "training set" for this device.
Summary for the Bardex® Temperature-Sensing Foley Catheter:
The submission for the Bardex® Temperature-Sensing Foley Catheter is a 510(k) for a physical medical device, not an AI/ML software device. Therefore, many of the requested categories related to AI/ML software performance studies (e.g., test sets, training sets, expert ground truth, MRMC studies) are not applicable.
The core of the study described (implicitly) is demonstrating substantial equivalence to a predicate device (K003289). This is achieved by showing that the new device meets the same design, manufacturing, and performance specifications as the predicate. These specifications are, in turn, based on:
- FDA "Guidance for the Content of Premarket Notifications for Conventional and Antimicrobial Foley Catheters" (September 12, 1994)
- ASTM F623-99, "Standard Performance Specification for Foley Catheter"
While the specific acceptance criteria (e.g., exact temperature accuracy tolerance, flow rates, balloon inflation characteristics) and the detailed results of the functional and engineering tests are not provided in this summary, the FDA's clearance indicates that C.R. Bard, Inc. successfully demonstrated that the device met these established standards through their testing process. The "study" here refers to the engineering and functional verification processes conducted to ensure the device met the relevant industry standards and performed equivalently to the predicate.
§ 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.