← Product Code [KNX](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNX) · K960949 # PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (K960949) _Bristol-Myers Squibb · KNX · Apr 19, 1996 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNX/K960949 ## Device Facts - **Applicant:** Bristol-Myers Squibb - **Product Code:** [KNX](/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNX.md) - **Decision Date:** Apr 19, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.5250 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology ## Indications for Use The ProSys™ Bedside Drainage Bag (Sterile) is indicated for use in the collection of free flowing urinary drainage. ## Device Story Sterile bedside urinary drainage bag; 2000 ml capacity; 55-inch inlet tube with universal connector; integrated anti-reflux valve to prevent urine backflow; integrated sample port for urine collection; T-tap drainage valve. Used in clinical settings for urine containment. Device collects urine via gravity drainage from indwelling or external catheters. Benefits include infection risk reduction via anti-reflux mechanism and ease of sampling. ## Clinical Evidence Bench testing only. No clinical data. Testing included biocompatibility (non-irritating, non-sensitizing, non-cytotoxic), resistance to bursting, resistance to impact, leakage, anti-reflux valve performance, tensile strength, and weld integrity. ## Technological Characteristics 2000 ml capacity sterile drainage bag; PVC/plastic construction; gravity-fed drainage; T-tap valve; anti-reflux valve; universal connector; integrated sample port. Sterilized product. ## Regulatory 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. ## Special Controls *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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter. ## Predicate Devices - Bard® Urinary Drainage Bag with Anti-reflux Chamber ## Reference Devices - ProSys™ - Bard® Dispoz-A-Bag® - Flip-Flo™ ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K960949 510(k) Premarket Notification ProSys™ Bedside Drainage Bag (Sterile) APR 19 1996 # ITEM 8: 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ Bedside Drainage Bag (Sterile). ProSys™ Bedside Drainage Bag (Sterile) is available with a 2000 ml volume capacity. Each sterile 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 connector. ProSys™ Bedside Drainage Bag (Sterile) is substantially equivalent to Bard® Urinary Drainage Bag with Anti-reflux Chamber. 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. The components of ProSys™ Bedside Drainage Bag (Sterile) have been subjected to extensive biocompatibility testing with results which demonstrate that the components are acceptable for use. All testing indicates that the components are non-irritating, non-sensitizing and non-cytotoxic. 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. A comparison of the indication for use, the components, functions and characteristics of ProSys™ Bedside Drainage Bag (Sterile) and the Bard® Urinary Drainage Bag with Anti-reflux Chamber indicates that these products are substantially equivalent. ProSys™ Bard®Dispoz-A-Bag® Flip-Flo™ - Trademark of E. R. Squibb & Sons, Inc. - Registered Trademark of C.R. Bard, Inc. - Registered Trademark of C.R. Bard, Inc. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNX/K960949](https://fda.innolitics.com/submissions/GU/subpart-f%E2%80%94therapeutic-devices/KNX/K960949) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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