(120 days)
The GRIOUFS is intended to be used to measure urinary flow rates.
Urine flowrate meter used for determining urine flow rate from patients performing normal micturition. The device functions by weighing the voided urine, the weight in grans approximates to the volume in ml the specific gravity of urine varies between 1.002 and 1.006 in infants and 1.025 in adults (95% ranges) and any inaccuracy is therefore no more than 2.5%. The urine is weighed as the urine flows using a straingauged load cell, the signal nutput from which is digitised. The flow volume is differentiated digitally to give the flow rate, which is printed on a paper chart recorder. The flowmeter uses algorithms to calculate the following parameters.
- Total voided volume Volume at maximum flow Maximum Now rate Mcan flow rate Flow time Time of maximum flow
The recorder is a table-top device connected to the load coll which supports a jug and which fits under either a commode chair or stand.
This document is a 510(k) summary for the Albyn Medical Ltd. GR100F Urine Flowmeter, dated September 19, 1997. It describes the device, its intended use, and claims substantial equivalence to a predicate device, the Browne Medical Systems Inc. "UroFlo".
However, the provided text does not contain any information regarding acceptance criteria, study details, or performance results of the GR100F Urine Flowmeter. The document is a regulatory submission for premarket notification, outlining the device's characteristics and its equivalence claim, but it does not include the results of a study to prove it meets specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence to a predicate device, not on a detailed performance study with 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.