(39 days)
Both devices are indicated for use in the collection of free flowing urinary drainage. Both devices function in the same manner: they collect and contain urine.
ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each stèrile bag is fitted with a permanently welded 55 inch inlet tube containing a universal connector which connects to an indwelling or external catheter. The Bedside Drainage Bag (Sterile) has a T-tap drainage valve. The inlet tube contains an anti-reflux valve to reduce the risk of urine backflow and infection and, a sample port used for urine sampling is integrated into the universal connecter.
The provided text is a 510(k) summary for a medical device called the "ProSys™ Bedside Drainage Bag (Sterile)". It describes the device, its intended use, and claims substantial equivalence to a predicate device.
However, the information required to answer your specific questions about acceptance criteria, device performance, and study details (sample size, experts, ground truth, MRMC, standalone performance, training set details) is not present in this document.
This 510(k) summary focuses on general device description, biocompatibility, and process validation testing, but it does not provide the detailed study results or specific quantitative performance metrics that would be typically found in a clinical study report or a more comprehensive technical document.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor can I answer your specific questions about sample sizes, experts, ground truth, or MRMC/standalone studies, as this information is not available in the provided text.
The document mentions "Process validation testing performed on ProSys™ Bedside Drainage Bag (Sterile) included tests for resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve, tensile strength and outline weld integrity were also tested. All components performed at an acceptable level and the test results appear in Item 5a."
This indicates that some testing was done, and that the results were deemed "acceptable," but it does not provide the quantitative acceptance criteria or the reported performance values. It also refers to "Item 5a" for the test results, which is not included in the provided text.
§ 876.5250 Urine collector and accessories.
(a)
Identification. A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:(1) A urine collector and accessories intended to be connected to an indwelling catheter, which includes the urinary drainage collection kit and the closed urine drainage system and drainage bag; and
(2) A urine collector and accessories not intended to be connected to an indwelling catheter, which includes the corrugated rubber sheath, pediatric urine collector, leg bag for external use, urosheath type incontinence device, and the paste-on device for incontinence.
(b)
Classification —(1)Class II (special controls) for a urine collector and accessories intended to be connected to an indwelling catheter. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2)
Class I (general controls). For a urine collector and accessories not intended to be connected to an indwelling catheter, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.