(375 days)
The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.
The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.
The provided document is a 510(k) summary for the Uropower device, a urine flow and volume measuring system. It describes the device, its intended use, and its classification. However, it does not contain details about specific acceptance criteria or a study proving the device meets those criteria, and therefore I am unable to populate the table and other requested information.
The document primarily focuses on establishing substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against predefined acceptance criteria. This is common for 510(k) submissions, which often rely on comparison to existing legally marketed devices rather than de novo clinical trials with explicit acceptance criteria.
§ 876.1800 Urine flow or volume measuring system.
(a)
Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.(b)
Classification. (1) 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.