(263 days)
The YiKang Latex Foley Catheter is intended to be placed in the bladder, through the urethra, to drain urine and other fluids from the urinary bladder.
The YiKang Latex Foley Catheter is a flexible tubular device that is passed through the urethra into the bladder to drain urine and other fluids from the urinary bladder. The catheter is manufactured from natural latex, consists of a shaft with eyelets near the tip, balloon, drainage funnel, inflation funnel, irrigation funnel (only for 3-way) and valve. The eyelets allow for drainage of urine from the tip of the catheter through the drainage lumen. The balloon once inflated with sterile water retains the catheter within the bladder. The valve allows for inflation and deflation of the balloon. The YiKang Latex Foley Catheter offers various balloon volumes and shaft sizes to accommodate pediatric and adult use, it is supplied in French size ranging from 6Fr to 30Fr and balloon size 3cc(ml), the 6Fr, 8Fr and 10Fr are for pediatric use, remaining size for adult use. The YiKang Latex Foley Catheter consists of two types (2-way & 3-way) of devices. Two-way catheters are used for urological bladder drainage only. Three-way Foley catheters offer the option of irrigating the bladder through a 3rd lumen. The catheter is coated with a silicone elastomer through a dipping process. The product is individually packaged with a sterile barrier pouch which is produced of plastic film plus paper through heat sealing. The product is ethylene oxide sterilized (per ISO11135), the catheter is for single use.
The provided text is a 510(k) summary for the YiKang Latex Foley Catheter and does not contain information about studies for an AI-powered device, nor does it provide details about acceptance criteria and performance for such a device.
The document describes the YiKang Latex Foley Catheter, which is a physical medical device (a urological catheter), and its substantial equivalence to a predicate latex Foley catheter. The performance data presented are for physical properties of the catheter itself, not for an AI algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI-powered device.
- Sample size and data provenance for a neural network test set.
- Details on experts establishing ground truth for a test set.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used for an AI.
- Sample size and ground truth establishment for a training set.
The document focuses on the following performance aspects for the physical catheter:
- Flow Rate through Drainage Lumen
- Balloon Integrity (Resistance to Rupture)
- Inflated Balloon Response to Traction
- Balloon Volume Maintenance
- Balloon Size and Shaft Size
- Deflation Reliability (Failure to Deflate)
- Biocompatibility (cytotoxicity, sensitization, irritation per ISO10993-1)
- Sterility (SAL=10^-6)
It states that "all the testing results meet requirements of ASTM F623-99 (Reapproved 2013) and defined acceptance criteria," but it does not list the specific numerical acceptance criteria or the numerical performance metrics achieved for each of these tests. It only confirms compliance with the ASTM standard.
§ 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.