Who is the manufacturer of PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

Bristol-Myers Squibb filed the 510(k) submission for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167 (K960949).

What is the FDA product code for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

KNX. It is classified under 21 CFR 876.5250 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167

K960949 · Bristol-Myers Squibb · KNX · Apr 19, 1996 · Gastroenterology, Urology

Device Facts

Record ID	K960949
Device Name	PROSYS BEDSIDE DRAINAGE BAG (STERILE) MODEL 650167
Applicant	Bristol-Myers Squibb
Product Code	KNX · Gastroenterology, Urology
Decision Date	Apr 19, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.5250
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for patients requiring collection of free flowing urinary drainage via indwelling or external catheters.

Regulatory Classification

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™

Related Devices

K971764 — WELCON HUE-VU URINARY DRAINAGE BAG · Welcon, Inc. · Jul 29, 1997
K962604 — PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING · Convatec, A Division of E.R. Squibb & Sons · Jul 18, 1996
K971929 — AMSINO URINARY LEG BAG · Amsino Intl., Inc. · Aug 6, 1997
K080881 — CURE CATHETER CLOSED SYSTEM · Cure Medical, LLC · Jun 11, 2008
K990428 — DRAINAGE BAG · Remington Medical, Inc. · Aug 12, 1999

Submission Summary (Full Text)

{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.