MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG

K972887 · Medline Industries, Inc. · KNX · Dec 11, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K972887
• Device Name: MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG
• Applicant: Medline Industries, Inc.
• Product Code: KNX · Gastroenterology, Urology
• Decision Date: Dec 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5250
• Device Class: Class 2

Intended Use

These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.

Device Story

Medline Leg Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. Device attaches to the leg of an incontinent patient to collect urine. Used with either indwelling or non-indwelling catheters. Provides mobility for catheterized patients; typically worn during the day and replaced at night with standard urinary drainage bags. Operated by the patient or caregiver.

Clinical Evidence

No clinical studies performed; bench testing only.

Technological Characteristics

Vinyl pouch construction with sterile fluid paths and adjustable comfort straps. No technological changes from predicate devices.

Indications for Use

Indicated for incontinent persons or those with medical conditions requiring urine collection via leg bag. Compatible with indwelling or non-indwelling 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

• Medline's Urine Collector Leg Bag
• Bard's Leg Bags (K780032)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Above and below the text are two parts of a compass rose. The top part of the compass rose is a triangle pointing upwards, and the bottom part is a curved shape pointing downwards.

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One Medline Place Mundelein, Illinois 60060.4486

1.847.949.3109 1.800.950.0128 Fax [phone]

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## Corporate Quality Assurance/Regulatory Affairs

SUMMARY OF SAFETY AND EFFECTIVENESS K972887 July 31, 1997 81011 COMPANY INFORMATION: 1. Dynacor Manufacturing DEC I I 1997 A Division of Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Registration #: 1417592 [phone] x1131 Phone: Fax: [phone] Contact Name: Christine M. Galea Contact Title: Corporate Regulatory Affairs 2. DEVICE NAME: Urine Collection Leg Bag for External Use Premium Leg Bag, Fabric-Bac Leg Bag, Urinary Leg Bag PROPRIETARY NAME: Leg Bag COMMON NAME: I (for devices not intended to be connected to an indwelling catheter) CLASS: II (for devices intended to be connected to an indwelling catheter)

- 3. SUBSTANTIAL EQUIVALENCE: Medline claims substantial equivalence to: Medline's Urine Collector Leg Bag Bard's Leg Bags (K780032)
These new devices are identical to what Medline is currently marketing. The only difference between the devices that are currently on the market and what we intend to market is in the labeling.

- 4. DESCRIPTION:
Medline Leo Bags are vinyl pouches with sterile fluid paths and adjustable comfort straps. This device is attached to the leg of an incontinent person and used to collect urine. This device may be used with an indwelling catheter or an external catheter. A leg bag provides the catheterized person with greater mobility and are usually worn during the day and are replaced at night with a standard urinary drainage bag.

- 5. INTENDED/INDICATIONS FOR USE: These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag on the advice of a physician and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.
- 6. TECHNOLOGICAL CHARACTERISTICS: There are no technological characteristics to the new device. The only change Medline is making is in the labeling.
- 7. CLINICAL TESTS: There are no clinical studies that have been performed on these devices, both for the predicate and the new devices.

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Image /page/1/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 its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 11 1997

Ms. Christine M. Galea Corporate Regulatory Affairs Medline Industries. Inc. One Medline Place Mundelein, Illinois 60060-4486 Re: K972887

Urine Collection Leg Bag Dated: November 12, 1997 Received: November 18, 1997 Regulatory class: II and I 21 CFR 8876.5250/Product code: 78 KNX and FAQ

Dear Ms. Galea:

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 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (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 (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 of 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 marketed 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 diagnostic 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 of the regulation of the regulation of the "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 yours.

W.Liau Yu

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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## INTENDED USE

510(k) Number (if known): (N/A)

Medline Premium Leg Bag, Fabric-Bac Leg Bag, Urinary Leg Bag Device Name:

Indications for Use:

These devices are indicated for use by incontinent persons with other medical conditions that warrant the use of a leg bag and are intended to collect urine. They may be connected to either an indwelling or non-indwelling catheter.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <div style="display:inline;">/</div> |
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| (Division Sign-Off) | |
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| Division of Reproductive, Abdominal, ENT,<br>and Radiological Devices | |
| 510(k) Number | K972887 |

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