(114 days)
Coude Foley catheter / or Tiemann Foley Catheter/ is all silicone Foley catheter 2-way intended for urological use only. Indicated for routine drainage of the urinary bladder.
Maximum recommended indwelling time is not more than 30 days.
Prescription Use ONLY (Part 21 CFR 801 Subpart D)
Coude Foley catheter / or Tiemann Foley catheter is all silicone Foley catheter 2-way.
This document is a 510(k) summary for a medical device (Coude Foley catheter / or Tiemann Foley catheter). It primarily focuses on the regulatory clearance process, specifically demonstrating substantial equivalence to a predicate device.
Therefore, the provided text does not contain information about acceptance criteria, device performance metrics, study designs (sample sizes, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies as requested in the prompt.
The document states the "Indications for Use" for the device, which is "for routine drainage of the urinary bladder" with a "Maximum recommended indwelling time is not more than 30 days." However, these are indications, not performance metrics or acceptance criteria.
To answer your request, I would need a different type of document, such as a clinical study report, a performance testing report, or a detailed technical specification for the 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.