DRAINAGE BAG

K990428 · Remington Medical, Inc. · EXF · Aug 12, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990428
• Device Name: DRAINAGE BAG
• Applicant: Remington Medical, Inc.
• Product Code: EXF · Gastroenterology, Urology
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.

Device Story

Drainage bag for collection of bodily fluids; used in nephrostomy, biliary, and abscess drainage procedures. Device is single-use; operated by urologists or gastroenterologists in clinical healthcare settings. Collects fluid via tubing/catheter connection; provides containment for drainage. Facilitates patient management by allowing controlled fluid removal and monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use drainage collection bag. Materials and specifications not detailed in provided text. No electronic, software, or algorithmic components.

Indications for Use

Indicated for patients requiring nephrostomy, biliary, abscess, or other drainage collection. Intended for use by urologists or gastroenterologists in healthcare settings.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1:2 1999

Mr. Steve Woody Submission Correspondent Remington Medical, Inc. 6830 Meadowridge Court Alpharetta, GA 30005

Re: K990428 Drainage Bag Dated: June 25, 1999 Received: June 28, 1999 Requiatory Class: II 21 CFR §876.5010/Procode: 78 EXF

Dear Mr. Woody:

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 legally marketed predicate 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlatory 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 the Electronic Product 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), piease 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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting 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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K990428

| Remington Medical, Inc. | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Appendix B | |
| Indication for Use Statement | |
| 510(k) Number (if known): | Pending 510(k) Request |
| Device Name: | Drainage Bag |
| Indications for Use: | |
| Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess 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)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices

| 510(k) Number | K990428/5002 |
|---------------|--------------|
|---------------|--------------|

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|