BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM

K020682 · C.R. Bard, Inc. · FGE · Apr 2, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K020682
• Device Name: BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
• Applicant: C.R. Bard, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Apr 2, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

Device Story

Self-expanding nitinol metal mesh stent; pre-loaded on 6 Fr delivery system; compatible with 6 Fr introducer and .035" guidewire. Used to maintain patency of biliary ducts obstructed by malignant neoplasms. Tantalum discs at stent ends provide radiopacity. Delivery system available in 80cm and 135cm lengths. Device used by clinicians in interventional procedures. Stent expands upon deployment to support ductal walls, facilitating bile flow and potentially relieving symptoms associated with malignant biliary obstruction.

Clinical Evidence

Bench testing only.

Technological Characteristics

Nitinol metal mesh stent; tantalum discs for radiopacity; self-expanding; 6 Fr delivery system; compatible with .035" guidewire; disposable.

Indications for Use

Indicated for patients with biliary strictures resulting from malignant neoplasms. 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

• Bard® LUMINEXX™ Biliary Stent and Delivery System

Submission Summary (Full Text)

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1020682

Bard Peripheral Technologies C.R. Bard, Inc. 13183 Harland Dr., N.E. Covington, GA 30014

APR 02 2002

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENES INFORMATION

- Submitter Information: A.
C.R. Bard, Inc., Peripheral Technologies Division Submitter's Name: Submitter's Address: 13183 Harland Drive, Covington, GA 30014 Carol Vierling Contact Person: Contact Person's Telephone Number: [phone] Contact Person's FAX Number: [phone] Date of Preparation: February 28, 2002

- B. Device Name:
Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System

- C. Predicate Devices:
Bard® LUMINEXX™ Biliary Stent and Delivery System

- D. Device Description:
The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Bard® LUMINEXX™ Biliary Stent pre-loaded on a unique delivery system. This 6 Fr delivery system is compatible with a 6 Fr introducer and accepts a .035" guidewire. The stent is available in various diameters and lengths. The delivery system is available in lengths of 80cm and 135cm.

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#### E. Intended Use:

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

### Technological Characteristics Summary: F.

The Bard® LUMINEXX™ 6 Fr Biliary Stent is a metal mesh stent constructed of nitinol. Tantalum discs on each end of the stent provide enhanced radiopacity. The stent is self-expanding and is packaged pre-mounted on a disposable delivery system.

### G. Performance Data:

Bench data indicate that the Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is comparable to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Carol Vierling Director. Regulatory Affairs C.R. Bard, Inc. 13183 Harland Drive, N.E. Covington, Georgia 30014

APR 0 2 2002

Re: K020682

Trade/Device Name: Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System Regulation Number: 21 CFR 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 28, 2002 Received: March 4, 2002

Dear Ms. Vierling:

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 (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. Carol Vierling

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 above is added to your labeling, as described.

Please note that the above labeling limitations are 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 and additionally Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Bernard E. Statland, M.D., Ph.D.

Bernard E. Statland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known): K020682

Device Name: Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System

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

The Bard® LUMINEXX™ 6 Fr Biliary Stent and Delivery System is indicated for use in The Burde Lonni ary strictures resulting from malignant neoplasms.

Prescription Use V OR (Per 21 CFR 801.109)

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| | Nancy C. Brogdon |
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| Division Sign-On | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020682 |