(24 days)
The SpeediCath Flex Coudé Pro is indicated for use by patients with urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing the urine to drain. The product is for male patients only.
The SpeediCath Flex Coudé Pro catheter is a sterile single use hydrophilic coated polyurethane catheter for men. The catheter is to be used for intermittent drainage of the bladder through the urethra by males with missing or reduced bladder control. The catheter has a bended flexible tip that facilitates passage through the urethra to the bladder. The catheter is shielded by a sleeve, which serves as protection from the user's touch during insertion.
The provided text is a 510(k) premarket notification for a medical device, the SpeediCath Flex Coudé Pro. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical efficacy studies. Therefore, the document does not contain the information requested about acceptance criteria, clinical study details (like sample size, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/diagnostic device performance).
The "performance testing" mentioned in the document refers to non-clinical bench testing to ensure the physical properties and safety of the modified catheter are comparable to its predicate device. This is typical for a 510(k) submission where the device is a minor modification or a line extension of an already cleared device.
Specifically, the document states:
- "Performance testing for SpeediCath Flex Coude Pro was conducted according to applicable sections of voluntary standards in order to document the following properties of the SpeediCath Flex Coudé Pro catheter." It lists tests such as flow rate, coefficient of friction, tensile strength, connector security, and biocompatibility.
- "The proposed changes do not impact the performance testing." This implies the core performance (mechanical, material, biocompatibility) is expected to be the same as the predicate.
- "The following tests were completed to determine the impact of the modification based on assessment of the device risk documentation: Coating inspection at average and extreme temperatures according to internal test methods. Tip bend inspection at extreme temperature according to internal test methods. Biocompatibility assessment per ISO 10993-1: 2009 Accelerated Aged (per ISO F1980-16) shelf life testing per internal test method assessments for coating and tip bend inspections."
- "All tests passed the pre-determined acceptance criteria."
Since this is a catheter and not a diagnostic device or an AI/ML algorithm-based device, the concepts of human reader improvement with AI, standalone algorithm performance, and expert ground truth establishment for diagnostic accuracy are not applicable to this 510(k) submission.
Therefore, I cannot populate the requested table and information as it pertains to a clinical efficacy study or AI/ML performance evaluation. The document focuses on demonstrating physical and material equivalence through non-clinical testing.
§ 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.