(64 days)
The Imager™ II Urology Torque Catheter is indicated for use in facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the infusion of radiopaque contrast material. The Imager™ II Urology Torque Catheter is also indicated for the infusion of gels, such as BackStop™, intended for use in the urinary tract.
The Imager TM II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a biocompatible polymer reinforced with a stainless steel braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter.
The provided text, K102527, is a 510(k) summary for a medical device (Imager™ II Urology Torque Catheter) seeking substantial equivalence to a predicate device. It explicitly states that no new clinical or non-clinical studies were performed. Instead, the submission relies on the concept of substantial equivalence by demonstrating that the proposed device has the same technological characteristics, intended use, and performance characteristics as its predicate device (K011965).
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document, as such studies were not conducted for this 510(k) submission.
The document states:
- "Utilizing FDA's Guidance for Industry and FDA Staff 'Format for Traditional and Abbreviated 510(k)s' a direct comparison of key characteristics demonstrates that the proposed urology catheter is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics tested."
- "The proposed Imager™ II Urology Torque Catheter is as safe, as effective, and performs as well as the predicate device."
This indicates that the "study" demonstrating adherence to "acceptance criteria" for the new device was a comparison to the predicate device based on existing data and prior approvals, rather than new, independent testing with explicit performance metrics and ground truth establishment.
Without a clinical or standalone performance study, no information can be provided for tables or sections that require data from such 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.