MANAN D BAG

K980005 · Medical Device Technologies, Inc. · EXF · Jan 30, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980005
• Device Name: MANAN D BAG
• Applicant: Medical Device Technologies, Inc.
• Product Code: EXF · Gastroenterology, Urology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2

Intended Use

The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.

Device Story

Manan™ D Bag is a 600 ml fluid drainage collection bag for biliary, nephrostomy, and abscess drainage. Device consists of a collection bag (Ethylene Methyl Acrylate Copolymer or PVC), an optional non-woven polyester backing for patient comfort, and a 30-inch silicone tube with a luer lock connector for attachment to drainage catheters. Includes an adjustable elastic Velcro strap for securing to the patient's waist, leg, or shoulder. Features a bottom twist-close valve for fluid drainage. Used in clinical or home settings to collect drainage; operated by clinicians or patients. Facilitates management of fluid drainage, improving patient mobility and comfort.

Clinical Evidence

Bench testing only.

Technological Characteristics

600 ml drainage bag; materials: Ethylene Methyl Acrylate Copolymer (SP 2255) or PVC; optional non-woven polyester backing; 30-inch silicone tubing with luer lock; adjustable elastic Velcro strap; bottom twist-close drainage valve.

Indications for Use

Indicated for patients requiring nephrostomy, abscess, or other fluid drainage collection.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• D Bag (K961986/K963849)

Submission Summary (Full Text)

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**MDTECH**
MEDICAL DEVICE TECHNOLOGIES INC

## JAN 30 1998

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

K980005

## 510(k) SUMMARY

| APPLICANT: | Medical Device Technologies, Inc.<br>4445-310 SW 35th Terrace<br>Gainesville, FL 32608 |
|----------------------|----------------------------------------------------------------------------------------|
| CONTACT: | Karl Swartz<br>Quality Assurance Manager |
| TELEPHONE: | [phone]<br>fax [phone] |
| TRADE NAMES: | Manan™ D Bag |
| COMMON NAME: | Biliary (fluid drainage) collecting bag |
| CLASSIFICATION NAME: | §876.5010-Biliary Catheters and Accessories |

## SUBSTANTIAL EQUIVALENCE:

| Company Name | Product Name | 510(k) No. |
|------------------------|--------------|-----------------|
| Manan Medical Products | D Bag | K961986/K963849 |

## DESCRIPTION OF DEVICE:

The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drainage procedures. The bag has a twist close closure at the bottom for allowing the fluid to drain out. The bag is manufactured from either SP 2255, (an Ethylene Methyl Acrylate Copolymer film) or PVC. The catalog number will be DBAG 600 when Ethylene Methyl Acrylate Copolymer film is used, and DBAG 600V when PVC is used. The bag itself has a backing made from a non-woven polyester. This backing provides comfort for the patient. This backing will be optional on the product. A tube made from silicon is attached to the bag at one end and has a luer lock at the other for attaching to the drainage catheter. The preferred length of this tube is 30 ins. Other lengths between 24 and 42 ins. could possible be used in the future. An adjustable Velcro strap with some elasticity is supplied with the bag so it can be hung about the patient's waist, leg or shoulder.

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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 30 1998

Karl Swartz Quality Assurance Manager Medical Device Technologies, Inc. 4445-310 S.W. 35th Terrace Gainesville, FL 32608

Re: K980005

Manan™ D Bag (Biliary Drainage Bag) Dated: December 29, 1997 Received: January 2, 1998 Regulatory Class: II 21 CFR 876.5010/Procode: 78 EXF

Dear Mr. Swartz:

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, listing of devices, good manufacturing and prohibitions against misbranding and additeration.

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 (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 diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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 yours,

h.Liau
William H. Liau, 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

Enclosure

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K980005

Image /page/2/Picture/1 description: The image shows the logo for MDTECH MEDICAL DEVICE TECHNOLOGIES INC. The logo is in black and white and features the company name in a bold, sans-serif font. The letters "MD" are stacked on top of "TECH", and the words "MEDICAL DEVICE TECHNOLOGIES INC" are written below the letters. The logo is enclosed in a rounded rectangle.

4445-310 S.W. 35th Terrace Gainesville, Florida 32608 TEL: [phone] FAX: [phone]

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510(k) Number (if known):

Device Name: Manan™ D Bag

Indications for Use:

The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Ratting/
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number K980005

OR

Prescription Use_L (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)