PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING

K962604 · Convatec, A Division of E.R. Squibb & Sons · FAQ · Jul 18, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K962604
• Device Name: PROSYS CUSTOM FIT LEG BAG WITH PREATTACHED ADJUSTABLE INLET TUBE FOR PATIENT SIZING
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: FAQ · Gastroenterology, Urology
• Decision Date: Jul 18, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 1

Intended Use

The ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing is indicated for the management of urinary incontinence.

Device Story

Device: ProSys™ Custom Fit Leg Bag; 500ml capacity. Input: Urine from external catheter via adjustable 600mm inlet tube. Operation: Passive collection/containment of urine; anti-reflux valve prevents backflow; integrated sample port for urine collection; T-tap drainage valve for emptying. Usage: Clinical or home setting; operated by patient or caregiver. Benefit: Manages urinary incontinence; reduces infection risk via anti-reflux mechanism; adjustable tube allows patient-specific sizing.

Clinical Evidence

Bench testing only. Tests included connector strength, burst resistance, impact resistance, leakage, and anti-reflux valve performance. Biocompatibility testing performed on all components; one cytotoxic result for fabric straps noted and addressed.

Technological Characteristics

Non-sterile leg bag; 500ml volume; 600mm adjustable inlet tube; T-tap drainage valve; anti-reflux valve; universal connector with integrated sample port; fabric leg straps.

Indications for Use

Indicated for patients with urinary incontinence requiring a leg bag for urine collection and containment.

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

• ProSys™ Leg Bag (Non-Sterile)

Submission Summary (Full Text)

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JUL 18 1996
K962604
510(k) Premarket Notification
ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing

# ITEM 8: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

The purpose of this 510(k) Premarket Notification is to request clearance to market ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing which is available in a volume capacity of 500ml. Each non-sterile bag is fitted with a permanently welded adjustable inlet tube with a self-packaged connector which connects to an external catheter. The inlet tube is available in one (1) size, 600mm to accommodate patient preference. Fabric straps are used to secure the leg bag in place. The leg bag 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™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing is substantially equivalent to ProSys™ Leg Bag (Non-Sterile). Both devices are indicated for the management of urinary incontinence. Both devices function in the same manner: they collect and contain urine. Both systems are reusable.

The components of ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing have been subjected to extensive biocompatibility testing with results which demonstrate that the components are acceptable for use. One cytotoxic result was noted for the fabric leg bag straps and this result is further explained in Item 5b. All other testing indicates that the components are non-irritating or negligibly irritating, non-sensitizing and non-cytotoxic.

Bench testing performed on ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing included tests for connector strength of attachment, resistance to bursting, resistance to impact, and for leakage. Additionally, the anti-reflux valve was also tested. All components performed at an acceptable level and the test results appear in Item 5a.

A comparison of the indications for use, the components, functions and characteristics of ProSys™ Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient Sizing and the ProSys™ Leg Bag (Non-Sterile) indicates that these products are substantially equivalent

ProSys™
- Trademark of E.R. Squibb & Sons, Inc