(117 days)
The FLUME catheter is intended for the drainage of the urinary tract.
The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethane-based polymers. The catheter has an inflatable retention balloon attached to the catheter has a dual lumen tube. The larger lumen is for draining urine from the urinary tract. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in size 14 Fr with a smooth shaft.
The provided text is a 510(k) summary for the FLUME catheter, which is a urological catheter. It discusses the device's indications for use, its comparison to a predicate device (Teleflex Rusch All-Silicone Foley Catheter K980870), and the non-clinical testing performed to demonstrate substantial equivalence.
However, the document does not contain any information about acceptance criteria and the study that proves the device meets those criteria for an AI/ML-driven medical device. Specifically, there is no mention of:
- AI/ML performance metrics (e.g., sensitivity, specificity, AUC)
- Sample sizes for test or training sets for an AI model
- Data provenance for AI/ML data
- Expert ground truth establishment for AI/ML models
- Adjudication methods for AI/ML ground truth
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies
- Standalone AI algorithm performance
- Types of ground truth for AI/ML (e.g., pathology, outcomes data)
- How ground truth for a training set was established for an AI model
The FLUME catheter is a physical medical device, and the testing described (Biocompatibility, Sterilization Validation, Transportation simulation/package integrity/shelf-life, and Performance/Functional testing per ASTM F623-19) are standard non-clinical tests for such devices to demonstrate physical and biological safety and performance, not AI/ML algorithm performance.
Therefore, I cannot extract the requested information based on the provided input. The document does not describe a study involving an AI/ML component.
§ 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.