(245 days)
For urological use only. Intended for use by patients for bladder management including urine drainage, collection and measurement. The devices are passed to the urinary bladder via the urethra.
The Hydrophilic Intermittent Urinary Catheter is made from silicone elastomer with a hydrophilic coating. The device is for urological use only. It is intended for use by patients for bladder management including urine drainage, collection, and measurement. The device consists of an all silicone elastomer single lumen catheter and includes a silicone handle. The catheter has drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has a hydrophilic coating which binds water molecules to the surface creating a smooth lubricating film. The handle provides the patient-user an ergonomically designed area for a secure grip and notouch area when inserting the catheter.
The provided text describes a 510(k) premarket notification for a Urological Catheter, focusing on its substantial equivalence to predicate devices. The information primarily covers device description, intended use, technological characteristics, and non-clinical performance data. It does not contain the specific details required to complete your request for acceptance criteria and the study that proves the device meets those criteria, particularly regarding AI/algorithm performance, human readers, or detailed test set characteristics.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer questions about sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/algorithm-based device, as this documentation pertains to a physical medical device.
The document discusses non-clinical performance data which includes:
- Design Qualification:
- Included dimensional analysis, appearance, and functional testing according to EN 1616.
- Lubricity testing according to modified ASTM D1894.
- Long Term Stability/Shelf Life:
- Included dimensional analysis, appearance, and functional testing according to EN 1616.
- Biocompatibility:
- ISO 10993-5, Cytotoxicity
- ISO 10993-10, Sensitization GPMT (Klingman), 2 extracts
- ISO 10993-10, Vaginal Irritation w/Histopathology, 2 extracts
However, these are performance metrics for a physical device, not an AI or algorithm.
§ 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.