WELCON HUE-VU URINARY DRAINAGE BAG

K971764 · Welcon, Inc. · KNX · Jul 29, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K971764
• Device Name: WELCON HUE-VU URINARY DRAINAGE BAG
• Applicant: Welcon, Inc.
• Product Code: KNX · Gastroenterology, Urology
• Decision Date: Jul 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 2

Intended Use

The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.

Device Story

The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl receptacle for urine collection. It connects to an indwelling catheter via inlet tubing equipped with an anti-reflux valve to prevent backflow. The device features a vent for air escape and a color strip label on the front, allowing clinicians to visually compare and record the color of collected urine. It is intended for use in clinical settings where indwelling catheterization is required.

Clinical Evidence

No clinical data provided. Substantial equivalence was based solely on design and performance characteristics.

Technological Characteristics

2000 ml capacity vented vinyl collection bag; includes anti-reflux valve, sampling port, and integrated color strip label for visual urine color monitoring.

Indications for Use

Indicated for collection of urine in patients requiring an indwelling catheter.

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

• Urinary Drainage Unit (Catalog #6220) (K780837)
• Bard Center Entry Closed System Urinary Drainage Bag (Catalog #153509) (K844810/K940206)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 9 1997

Re: K971764

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Welcon, Inc. % Ms. Pamela Papineau Delphi Medical Device Consulting 50 Brewster Street Pawtucket, Rhode Island 02860

Welcon Hue-VuTM Urinary Drainage Bag ...... Dated: May 9, 1997 Received: May 13, 1997 Regulatory class: II 21 CFR §876.5250/Product code: 78 KNX

Dear Ms. Papineau:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marked predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnosic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html"

Sincerely vours.

Sincerely yours,

Lillian Yin, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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May 9, 1997 Hue-Vu™ Urinary Drainage Bag

K971764
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# 510(k) Summary

Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Welcon, Inc. is required to submit with this Premarket Notification either an "...adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Welcon chooses to submit a summary of the safety and effectiveness information. The summary is as follows:

| Trade Name: | Welcon Hue-Vu™ Urinary Drainage Bag | JUL 29 1997 |
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| Owner/Operator: | Welcon, Inc.<br>99 Hartford Avenue<br>Providence, RI 02909 | |
| Distributed by: | Welcon, Inc.<br>303 Main Street, Suite 300<br>Fort Worth, TX 76102 | |
| Manufacturing Site: | Pacific Device, Inc.<br>8572 Spectrum Lane<br>San Diego, CA 92121 | |
| Device Generic Name: | Urinary drainage bag | |
| Classification: | According to Section 513 of the Federal Food, Drug, and<br>Cosmetic Act, the device classification is Class II, Performance Standards<br>(21CFR 876.5250). | |
| Predicate Devices: | Urinary Drainage Unit (Catalog #6220)<br>Intermed, Inc.<br>Sparta, New Jersey 07871<br>K780837<br>Bard Center Entry Closed System Urinary Drainage Bag (Catalog #153509)<br>Bard Urological Division<br>Covington, GA 30209<br>K844810/K940206 | |

### Product Description:

The Welcon Hue-Vu™ Urinary Drainage Bag is a 2000 ml capacity vented vinyl urine collection receptacle intended to be used with an indwelling catheter. The bag has a hanging hook at the top, and is equipped with a sampling port near the catheter connector. The inlet tubing has an anti-reflux valve to prevent backflow. A vent allows air to escape the bag as urine enters. A Hue-Vu™ color strip label is affixed to the front of the bag, and is used to compare and record the color of the urine collected in the bag.

### Indications for Use:

The drainage bag is indicated for collection of urine when used with an indwelling catheter.

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## Safety and Performance:

Substantial equivalence for this device was based solely on design and performance characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon Hue-Vu™ device are identical to those of the predicate devices.

## Conclusion:

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Welcon Hue-Vu™ Urinary Drainage Bag has been shown to be safe and effective for its intended use.

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Welcon Hue-Vu™ Urinary-Drainage Bag_____________________________________________________________________________________________________________________________

Indications for Use:

The Welcon Hue-Vu™ Urinary drainage Bag is indicated for use for the collection of urine when used with an indwelling catheter.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K971764 |

| Prescription Use | <div> <img alt="Checkmark" src="" style="height:1em"/> </div> (Per 21 CFR 801.109) |
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| Over-the -Counter Use | |
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