(201 days)
The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as nephrostomy tract.
The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
The provided 510(k) summary for the Bardex® I.C. Latex Foley Catheter focuses on substantial equivalence to a predicate device based on its intended use, general design, and fundamental scientific technology. It does not present a study with specific acceptance criteria and detailed device performance metrics in the manner typically associated with studies for a medical imaging AI/ML device.
Instead, the submission states:
1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document mentions "The Bardex® IC latex Foley catheter was tested in accordance with the relevant standards for function and biocompatibility." but does not elaborate on these standards, acceptance criteria, or specific performance outcomes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no such test set or study details are provided.
3. 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, as no ground truth establishment for a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable, as this is a medical device for drainage/collection, not an AI/ML imaging device requiring human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) pertains to a physical medical device (Foley catheter) and its clearance is based on demonstrating substantial equivalence to a predicate device through adherence to relevant standards for "function and biocompatibility." It does not involve the type of performance study (with acceptance criteria, test sets, ground truth establishment, etc.) that would be conducted for an AI/ML diagnostic or prognostic 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.