MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM

K050501 · Abbott Vascular Devices · FGE · Mar 14, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050501
• Device Name: MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
• Applicant: Abbott Vascular Devices
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 14, 2005
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System consists of a self-expanding nitinol stent and an over-the-wire (OTW) delivery system. It is used by physicians to treat malignant neoplasms in the biliary tree. The device is delivered to the target site via the delivery system, where the stent expands to provide palliation. The device is intended for clinical use in a hospital or procedural setting. It is not indicated for use in the vascular system.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitinol self-expanding stent; over-the-wire (OTW) delivery system. Class II device. Regulation 21 CFR 876.5010. Product code 78 FGE.

Indications for Use

Indicated for the palliation of malignant neoplasms in the biliary tree. Prescription use only.

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

• Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System (K050103)

Submission Summary (Full Text)

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# APPENDIX A. 510(k) SUMMARY

| Sponsor/Submitter: | Abbott Laboratories<br>Abbott Vascular Devices<br>400 Saginaw Drive<br>Redwood City, CA 94063 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ann E. Leonard<br>Regulatory Affairs Coordinator<br>Phone:[phone]<br>Fax:[phone] |
| Date of Submission: | February 25, 2005<br>MAR 1 4 2005 |
| Device Trade Name: | Xceed Nitinol Self-Expanding 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: | Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System<br>(K050103) |
| Intended Use: | The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent<br>System is intended for use in the palliation of malignant neoplasms<br>in the biliary tree. |
| Device Description: | The Abbott Vascular Devices Xceed Nitinol Self-Expanding<br>Transhepatic Biliary Stent System is comprised of a delivery system<br>and a self-expanding stent. The delivery system is an over the wire<br>(OTW) system designed to deliver the self-expanding stent to the<br>biliary tree. |
| Summary of Substantial<br>Equivalence: | The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent<br>System is substantially equivalent to the predicate device.<br>Substantial equivalence was confirmed through non-clinical testing. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Ann E. Leonard, Ph.D. Regulatory Affairs Coordinator Abbott Vascular Devices 400 Saginaw Drive REDWOOD CITY CA 94063

Re: K050501

KU50301
Trade/Device Name: Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 25, 2005 Reccived: February 28, 2005

Dear Dr. Leonard:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave revewed your section 510(x) premained is substantially equivalent (for the indications for referenced above and nave actemined and as a so a set a sevices marketed in interstate commerce use stated in the encrosure/ to regally manythe Medical Device Amendments, or to devices that prior to May 26, 1770, the ondemont adts the provisions of the Federal Food, Drug, and Cosmetic nave been reclassified in accordants that e device, subject to the general controls provisions of the Act (Act). Tou may, mercerors, markew. The general controls provisions of the Act include Act and the infridations desorroed betwn - 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 I fie Office of De vice Evaranton has deterfied in the proposed labeling and that such use could cause will be used for an intended ass not resmaion 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 runnermore, the marculen for of estructions 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 - Dr. Ann Leonard

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be found may be subject to additions. Exismigations Existing major organism FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination doest not mean that Please be advised that IDA's Issualled of a sace annolies with other requirements of the Act of any FDA has made a determination that your der Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (21 GED B. 4807) Federal statutes and regulations dammisted to: registration and listing (21 CFR Part 807); the Act s requirements, mending, but not mined to: 10 reguirements as set forth in the quality labeling (21 CFR Part 801), good manataling problicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product Systems (QD) regulation (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 The FDA Inding Of substantar equivalence or your device to proceed to the market. This results in a classification for your device and permise your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling immations 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 If you desire specific information association as appliance at [phone]. Also, please note (21 CFR Fart 6017), prease contact ins Officence to premarket notification'' (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division I ou may obtain other general ational, 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,

jQeGTn

Jonna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number: K050501

## Device Name: Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System

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

The Abbott Vascular Devices™ Xceed™ Nitinol Self-Expanding Transhepatic Biliary Stent System I he Abbott vascular Doviees
is intended for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use (Pcr 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

) Nancy Hogdon
(Division Sign-Off)

Oivision of Reproductive, Abdom ind Radiological Devices 10(k) Number_ 05091