(68 days)
The Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit is all intended for bladder neck suspension for female stress incontinence due to urethral hypermobility.
The Laparotomy Bladder Neck Suspension Kit is comprised of a template assembly, suture retriever, and suture cutter and suture placement system. The template assembly, suture retriever and suture cutter were cleared for marketing on April 4, 1997 under K963076, as part of the Louisville Laboratories Laparoscopic Bone Anchored Urethropexy Instrument Tray. The suture placement system that is offered is the Laurus Medical Disposable Suture Placement System.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Louisville Laboratories, Inc. Laparotomy Bladder Neck Suspension Kit.
Unfortunately, the provided document does not contain information about acceptance criteria or a study proving the device meets said criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, the requested table and the subsequent points about sample sizing, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information cannot be extracted from this document as they are not present.
The document primarily covers:
- Sponsor/Applicant information
- Device name
- Identification of predicate devices
- Device description
- Intended use
- Comparison of technological characteristics to predicate devices
- FDA's letter of clearance based on substantial equivalence.
Key takeaway: This 510(k) focuses on regulatory clearance via substantial equivalence, not on a detailed performance study with defined acceptance criteria.
§ 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.