WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM

K033909 · Abbott Laboratories · FGE · Feb 17, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K033909
• Device Name: WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM
• Applicant: Abbott Laboratories
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Feb 17, 2004
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The wavemaX™ is a balloon-expandable stent mounted on an over-the-wire (OTW) delivery system. It is used by physicians in a clinical setting to treat malignant biliary obstructions. The device is inserted into the biliary tree to provide structural support and maintain patency, thereby palliating symptoms associated with malignant neoplasms. The physician navigates the delivery system to the target site and expands the stent using the integrated balloon. The device is intended solely for biliary use; vascular use is contraindicated.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Balloon-expandable stent mounted on an over-the-wire (OTW) delivery system. Mechanical device; no software or electronic components.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree in patients requiring biliary stenting. Contraindicated for use in the vascular system.

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

• Cordis Palmaz Genesis Transhepatic Biliary Stent (K012590)
• Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic Biliary Stent System (K033537)

Submission Summary (Full Text)

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## APPENDIX A. 510(k) SUMMARY

| A. Sponsor/Submitter: | Abbott Vascular Devices<br>400 Saginaw Drive<br>Redwood City, CA 94063 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B. Contact Person: | Joanna Kuskowski<br>Regulatory Affairs Coordinator<br>Phone:[phone]<br>Fax:[phone] |
| Date of Submission: | December 16, 2003 |
| Device Trade Name: | wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System |
| Device Common Name: | Biliary Stent and Delivery System |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 876.5010 |
| Classification Name: | Biliary Catheter and Accessories |
| Product Code: | 78 FGE |
| Predicate Device: | Cordis Palmaz Genesis Transhepatic Biliary Stent (K012590)<br>Abbott Vascular Devices Xpert™ Self-Expanding Transhepatic<br>Biliary Stent System (K033537) |
| Intended Use: | The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent<br>System is intended for use in the palliation of malignant neoplasms in<br>the biliary tree. |
| Device Description: | The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent<br>System is comprised of a balloon-expandable stent mounted on an<br>over the wire (OTW) delivery system designed to deliver the stent to<br>the biliary tree. |
| Summary of Substantial Equivalence: | Abbott Vascular Devices has submitted information on indication for<br>use, design and principle of operation, biocompatibility and<br>performance characteristics to establish that wavemaX™ Balloon-<br>Expandable Transhepatic Biliary Stent System is substantially<br>equivalent to currently marketed predicate device.<br>The wavemaX™ Balloon-Expandable Transhepatic Biliary Stent<br>System has the same intended use as the predicate device. Results of<br>scientific testing have ensured that all materials are biocompatible, no<br>new adverse effects were introduced and physical properties are<br>appropriate for the intended use. Non-clinical testing was conducted.<br>In conclusion, the wavemaX™ Balloon-Expandable Transhepatic<br>Biliary Stent System has been shown to be substantially equivalent to<br>the Class II predicate upon which the device is based. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

Ms. Joanna Kuskowski Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive Redwood City, California 94063

Re: K033909

Trade/Device Name: wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 16, 2003 Received: December 17, 2003

Dear Ms. Kuskowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for use in the vascular system have not been established.

Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

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Page 2 - Ms. Joanna Kuskowski

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

Please note that the above labeling limitations arc required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, ply see note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International, and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Daniel G. Schultz, M.D.

Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K033909

## Device Name: Abbott Vascular Devices wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System

FDA's Statement of the Indications For Use for device:

The Abbott Vascular Devices wavemaX™ Balloon-Expandable Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use V (Per 21 CFR 801.109)

OR

Over-the-Counter Use -------

David le Seggern

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _