(15 days)
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr 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 nephrostomy tract.
The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is a single use, sterile, 2-way, latex-free, hydrogel-coated Foley catheter and represents a product line extension to the current Bard Medical Division product line range of silicone Foley catheters found substantially equivalent in K984084 and K002868.
Here's a breakdown of the acceptance criteria and study information for the Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Dimensional Requirements | Meet C.R. Bard Inc. dimensional requirements | Met C.R. Bard Inc. dimensional requirements |
| Friction | Coefficient of friction test | Passed coefficient of friction test |
| Flow Rate | ASTM F623-99 Standard Performance Specification for flow rate | Met ASTM F623-99 Standard Performance Specification for flow rate |
| Balloon Integrity | ASTM F623-99 Standard Performance Specification for balloon integrity | Met ASTM F623-99 Standard Performance Specification for balloon integrity |
| Balloon Pull-out Response | ASTM F623-99 Standard Performance Specification for inflated balloon response to pull out | Met ASTM F623-99 Standard Performance Specification for inflated balloon response to pull out |
| Balloon Volume Maintenance | ASTM F623-99 Standard Performance Specification for balloon volume maintenance | Met ASTM F623-99 Standard Performance Specification for balloon volume maintenance |
| Balloon/Shaft Size | ASTM F623-99 Standard Performance Specification for balloon and shaft size | Met ASTM F623-99 Standard Performance Specification for balloon and shaft size |
| Balloon Deflation | ASTM F623-99 Standard Performance Specification for balloon deflation reliability | Met ASTM F623-99 Standard Performance Specification for balloon deflation reliability |
| Biocompatibility | Biocompatibility testing | Performed successfully |
| Pediatric Catheter Specific | Additional testing established by C.R. Bard Inc. for a silicone-coated pediatric catheter | Additional testing for a silicone-coated pediatric catheter (details not specified in the provided text but stated as "provided within this 510(k)") |
Study Details
The provided text describes a submission for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a de novo clinical study with a focus on comparative effectiveness against human readers or extensive ground truth establishment as might be seen with AI/ML devices.
Therefore, many of the requested points are not applicable or explicitly mentioned in the context of this type of submission.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document does not specify sample sizes for any "test set" in the context of clinical data. The testing mentioned (dimensional, friction, ASTM standards, biocompatibility) are laboratory/bench tests, not clinical evaluations with patient data.
- Data provenance is not applicable for the described bench testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. "Ground truth" in the clinical sense (e.g., for diagnostic accuracy) is not established or discussed for this device. The evaluations are against engineering specifications and industry standards.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This device's evaluation doesn't involve subjective interpretation that would require an adjudication method.
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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:
- No. This is a medical device (Foley catheter), not an AI/ML diagnostic tool. Therefore, MRMC studies and AI assistance metrics are not relevant or performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the performance tests, the "ground truth" or reference is established by engineering specifications, C.R. Bard Inc. internal requirements, and recognized industry standards (ASTM F623-99). For biocompatibility, it would be established by relevant ISO standards or FDA guidance for biological evaluation of medical devices.
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The sample size for the training set:
- Not applicable. This device's development does not involve a "training set" in the context of machine learning. Product design and testing are based on engineering principles and regulatory standards.
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How the ground truth for the training set was established:
- Not applicable, as no "training set" is involved.
§ 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.