(77 days)
The Bardex®, Lubri-Sil® and Lubri-Sil® IC Ail-Silicone Foley Catheters are intended for use in the drainage and/or collection and/or measurement of urine.
The Bardex®, Lubri-Sil® and Lubri-Sil® I.C. All-Silicone Foley Catheters 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 nephrostomy tract.
The Bard® all-silicone Foley catheter is a two-way all silicone 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.
I am sorry, but based on the provided document, I cannot answer the request as the document does not contain the specific information required to describe the acceptance criteria and the study that proves the device meets those criteria.
Specifically, the document is a 510(k) summary for a Foley catheter, which confirms substantial equivalence to a predicate device based on similar intended use, design, and fundamental scientific technology. While it states that the device was tested for "function and biocompatibility" in accordance with relevant standards, it does not provide any details about:
- Specific acceptance criteria (e.g., performance metrics, thresholds).
- Any performance results or data that would allow a table of "reported device performance."
- Details about a "study" (e.g., type of study, sample sizes, data provenance, ground truth establishment, expert involvement, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance).
The document is a regulatory submission for premarket notification, not a detailed technical report of performance studies.
§ 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.