(63 days)
The In-Probe II Urodynamic System is indicated as an aid in the diagnosis of voiding dysfunction in males and females. In females, the In-Probe II Urodynamic System is also indicated for measuring urethral angle during straining.
The In-Probe II Urodynamic System is a compact and portable urodynamic system capable of performing cystometrography (CMG) for both men and women. In addition, for women, the device can provide objective measurement of the changes in urethral angle that occur during patient straining.
The provided text states that the In-Probe II Urodynamics System is "substantially equivalent" to two predicate devices: Influence, Inc.'s In-Probe Urodynamics System and Andronic Devices, Ltd.'s Insight electronic alignment indicator. The document also mentions "Performance testing and information in the application demonstrated that the In-Probe II system is biocompatible and provides equivalent performance to the original In-Probe Urodynamics System."
However, the provided text does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It mainly focuses on the FDA 510(k) clearance process based on substantial equivalence to predicate devices. Therefore, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies, as these details are not present in the provided document.
To properly answer your request, more detailed performance study reports or technical specifications for the In-Probe II Urodynamics System would be required.
§ 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.