(63 days)
The Rüsch Urodynamic Rectal Balloon 2-way Catheter is intended to provide a fluid conduit for urodynamic studies, where the detrusor pressure is to be calculated from rectal pressure.
The Rusch Urodynamic Rectal Balloon 2-way Catheter consists of a double lumen polyvinyl chloride tube upon which is affixed a latex balloon, with a radiopaque stripe.
To use, the balloon is inflated with sterile water using a luer taper syringe. The catheter is then connected to a transducer, and can be used in conjunction with equipment for calculating the detrusor pressure necessary to open the urinary sphincter).
The provided text describes a 510(k) summary for the Rüsch Urodynamic Rectal Balloon 2-way Catheter. However, it does not contain information about acceptance criteria or specific study results involving a device's performance against such criteria in the manner requested. Instead, it focuses on the device's characteristics, comparison to predicate devices, and a general statement about biocompatibility and bench testing without numerical performance data or detailed study methodology.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text.
The closest information available that might be interpreted in the context of "performance" is the statement:
"The device's performance in these tests [Tensile Testing, Balloon Burst Testing] is comparable with that of the Rüsch Urodynamic Rectal Balloon Catheter (K952573)."
This indicates that some form of performance evaluation was done through bench testing, and the outcome was "comparable" to a predicate device. However, it does not provide the specific numerical acceptance criteria for these tests or the reported numerical performance of the device.
§ 876.1620 Urodynamics measurement system.
(a)
Identification. A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.