(132 days)
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Jimushi Sterile Urethral Catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. This product is supplied in three slightly different forms: 1) Common model (conventional uncoated type), 2) Hydrophilic coated model, 3) Hydrophilic coated with water pocket model. The catheter body is made of polyvinyl chloride (PVC) with or without hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel shaped connector at the proximal end can be connected to a urine collection container. The catheter body is sterilized by EO, where the water pocket in some models is pre-sterilized by radiation.
The provided text is a 510(k) premarket notification for a medical device (Jimushi Sterile Urethral Catheter for single use). This type of document is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.
It does not describe a study involving an AI-powered device or an algorithm's performance. Instead, it focuses on the physical and performance characteristics of a traditional medical catheter. Therefore, it does not contain the information requested in your prompt regarding AI model acceptance criteria, test sets, expert ground truth, MRMC studies, or standalone algorithm performance.
The document primarily covers:
- Device Description: Jimushi Sterile Urethral Catheter for single use, its materials (PVC, hydrophilic coating), and its intended use (intermittent urinary catheterization).
- Predicate Device: Teleflex Medical Rusch FloCath Quick Urological Catheter.
- Similarities and Differences: A detailed table comparing the subject device to the predicate device across various parameters like indications for use, contraindications, population, size range, materials, and sterilization methods.
- Non-clinical Performance Data (Bench Testing): A list of physical and performance tests conducted on the subject device (e.g., visual inspection, flow rate, strength, biocompatibility, sterilization validation) and their "Pass" results, indicating the device meets established standards.
In summary, this document is entirely irrelevant to your prompt about an AI-powered device and its acceptance criteria due to the nature and purpose of the 510(k) submission described.
§ 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.