ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR

K980917 · Fortune Medical Instrument Corp. · GCA · May 27, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K980917
• Device Name: ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR
• Applicant: Fortune Medical Instrument Corp.
• Product Code: GCA · Gastroenterology, Urology
• Decision Date: May 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.

Device Story

All Silicone T, Y, and T-Y drainage tubes are surgical devices used to maintain patency of the common bile duct following surgery. The tubes facilitate external bile drainage, preventing obstruction caused by post-operative edema. The T-Y configuration additionally permits flushing of the common duct. These devices are intended for use by surgeons in a clinical or hospital setting. By ensuring bile flow, the device prevents complications associated with ductal blockage and supports the healing process of the biliary system.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed of silicone; T, Y, and T-Y tube form factors; non-powered, passive drainage device.

Indications for Use

Indicated for patients requiring biliary drainage to maintain common bile duct patency and manage edema until normal drainage to the duodenum is restored. Used for T-tube, Y-tube, and T-Y tube configurations; allows for flushing of the common duct.

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

## MAY 2 7 1998

Ms. Karen U. Salinas ·Regulatory Consultant Fortune Medical Instrument Corporation c/o Holland & Associates 3722 Avenue Sausalito Irvine, California 92606

Re: K980917 All Silicone T-Drainage Tube w/wo Eyes Trade Name: All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube Regulatory Class: II GCA Product Code: Dated: March 10, 1998 March 11, 1998 Received:

Dear Ms. Salinas:

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 The general controls provisions of the Act 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 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 In addition, FDA may publish further announcements action. 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 requlations.

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## Page 2 - Ms. Salinas

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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,

C. M. Wichter, Ph. D.

a M. Witten, Ph.D., M.D. Cel Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K980917 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: All Silicone T-Drainage Tube w/wo Eyes All Silicone Y-Drainage Tube All Silicone T-Y Drainage Tube

Indications For Use:

To preserve patency of the common duct and to ensure drainage of bile out of the body until edema in the common duct has subsided enough for bile to drain into the duodenum normally. The T-Y Drainage Tube is also allowed for flush in the common duct.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | X |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

| Over-The-Counter Use | _ |
|----------------------|--------------------------|
| | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of General Restorative Devices

| 510(k) Number | K980917 |
|---------------|---------|
|---------------|---------|