DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM

K011881 · Guidant Corp. · FGE · Jul 18, 2001 · Gastroenterology, Urology

Device Facts

• Record ID: K011881
• Device Name: DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
• Applicant: Guidant Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 18, 2001
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Device Story

The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter-based delivery system for a self-expanding nitinol stent. The system features a coaxial catheter design: an inner member compatible with a 0.035" guide wire and an outer member with a distal sheath to constrain the stent and a proximal handle for deployment. The stent is laser-cut from superelastic nitinol, heat-treated for stability, and electropolished with a titanium oxide surface finish. Used in the biliary tree, the device is operated by a physician to deploy the stent across malignant strictures to provide palliation. The system includes radiopaque markers to assist in positioning. The device is provided sterile.

Clinical Evidence

Bench testing only. Safety and effectiveness were demonstrated through in vitro bench tests and analyses.

Technological Characteristics

Materials: Superelastic nitinol (nickel titanium) stent, titanium oxide surface finish. Delivery system: Coaxial catheter, 0.035" guide wire compatible. Dimensions: Stent diameters 5-10 mm, lengths 28, 38, 56 mm. Mechanism: Self-expanding stent, pull-back handle deployment. Sterilization: Not specified.

Indications for Use

Indicated for palliation of malignant strictures in the biliary tree. Not 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

• DYNALINK™ Biliary Self-Expanding Stent System (K002143)

Submission Summary (Full Text)

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# JUL 1 8 2001

Koll 881

#### 510(k) SUMMARY

The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92

| Submitter's Name: | Guidant Corporation<br>Advanced Cardiovascular Systems, Inc. |
|-----------------------------|--------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95052 |
| Telephone:<br>Fax: | 408/845-1067<br>408/845-3743 |
| Contact Person: | Saba Modjarrad |
| Date Prepared: | June 15, 2001 |
| Device Trade Name: | DYNALINK™ .035 Biliary Self-Expanding Stent System |
| Device Common Name: | Biliary Stent |
| Device Classification Name: | Biliary Catheter |

Class II Device Classification:

## Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of DYNALINK™ .035 Biliary Self-Expanding Stent System with stents in diameters of 5-10 mm and lengths of 28, 38, and 56 mm are substantially equivalent with regard to these features in the predicate device, the DYNALINK™ Biliary Self-Expanding Stent System (K002143, October 12, 2000).

#### Device Description:

The DYNALINK™ .035 Biliary Self-Expanding Stent System is a catheter designed to deploy a self-expanding nickel titanium (Nitinol) stent into the biliary tree.

The catheter body is constructed from two coaxial members. The inner member (IM) is compatible with a 0.035" guide wire in an over-the-wire configuration. The outer member (OM) is composed of a distal sheath that constrains the unexpanded stent, an outer shaft over most of the catheter length, and a proximal handle used to retract the assembly.

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Koll881 41

The distal end of the delivery system includes the DYNALINK™ Biliary Self-Expanding The distal end of the defreery by steath restraining sheath, a soft, low profile tip, Stellt neid in hs constramod state of the stories and distal ends of the stent. At the and two fault-opaque markers to muleate and present is composed of a pull-back handle proximal end of the dell rery byseeils) it thandle to slide axially, and a luer fitting that is rigidly fixed to the shaped housing.

The DYNALINK™ Biliary Self-Expanding Stent is fabricated from superelastic nickelthe DITATIER - Dimary - Biliary Self-Expanding Stent is comprised of a thamulif (intinor). Things that are aligned along a common longitudinal axis.

The stent is laser cut from a tube of superelastic nitinol. All of the stent diameters are cut rife sicil is its its from a table e stent is expanded and heat-treated to be stable at the with simmal stents patter. The stents are electropolished to obtain a smooth finish with a thin layer of titanium oxide on the surface.

The DYNALINK™ Biliary Self-Expanding Stent is available in diameters of 5-10 mm and in lengths of 28, 38, and 56 mm.

#### Intended Use:

The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for palliation of malignant strictures in the biliary tree.

### Technological Characteristics:

Comparisons of the new and predicate devices show that technological characteristics such as materials, biocompatibility, performance properties, sterilization and packaging are substantially equivalent to the currently marketed predicate devices. The design modification of the new biliary stent system compared to that of the predicate biliary stent system is the length of the stent.

#### Performance Data:

The safety and effectiveness of the DYNALINK™ .035 Biliary Self-Expanding Stent System has been demonstrated through data collected from in vitro bench tests and analyses.

Page 2|2

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle with three heads. The eagle is facing to the right and has its wings spread.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 8 2001

Ms. Saba Modjarrad Regulatory Affairs Coordinator Guidant Corporation Vascular Intervention Group 3200 Lakeside Drive Santa Clara, California 95054

Re: K011881

DYNALINK™ .035 Biliary Self-Expanding Stent System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: June 15, 2001 Received: June 18, 2001

Dear Ms. Modjarrad:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section - rots) notifications in the indications for use above and we nave delemined the uevices marketed in interstate comments on to devices th stated in the enclosure) to legally marked precised in one of the Amendments, or to devices that prox to May 26, 1970, the chaolinen date of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions Cosmetic Act (Act). You may, defectors, marited below. The general cools provisions of the provisions of the Act and the minutures stoons of devices, good manufacturing practice,
Act include requirements for annual registration, list in Act merade requireritions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this I he Office of Device Evaluation has detectified in the proposed labeling and that such use device will be used for an michded as the racitiation 513(i)(1)(E) of the Act, the following Could Cause nami." Ear 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. Furthermore, the Indication for othary ase mast of promotional materials, in
including pouch, box, and carton labels, instructions for use, and other promotional materials, i meluding pouch, oox, and carvere, of a similar point size, and in bold print.

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Page 2 – Ms. Saba Modjarrad

If your device is classified (see above) into either class II (Special Controls) or class III
ng major reass If your device is classified (see above) into cities in controls. Existing major regulations
(Premarket Approval), it may be subject to such additions (Designal Rights Repro (Premarket Approval), it may be subject to such as a such the 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Current Good affecting your device can be found intinues compliance with the Current Good A substantially equivalent decemmants, as set forth in the Quality System Regulation (OS) for Manufacturing Practice requirences, as our 820) and that, through periodic QS
Medical Devices: General regulation (21 CFR Part 820) and that, the accumptions Medical Devices: General regulation (21 CFR Far 020) will verify auch and on mptions. Failure to inspections, the Food and Drug Auministration in addition, FDA may publish .
comply with the GMP regulation may result in regulation. Recess note: this comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concenting your arrants inn does not affect any obligation you might
response to your premarket notification submission the Flectronic Product response to your premarket nonmoution bac.Act for devices under the Electronic Product
have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Radiation Control provisions, of other Federal laws of regard to the market . This The FDA finding of substantial equivalence or your device to proceed to the market. This results in a classification for your device as described in your 510(k) premarket
letter will allow you to begin marketing your device as described letter will anow you to begin marketing your above is added to your labeling, as described.

Please note that the above labeling limitations are required by Section 513(i)(1)(2) of the Act. Please note that the above labeling innitations are required by and the 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 If you desire specific information about the upplied to the vitro diagnostic devices on the promotion and device (21 CFR Part 801 and additionally 807.10 for questions on the promotion and the Office of Compliance at [phone]. I Idalaof Compliance at [phone]. Also,
advertising of your device, please contact the Office of Compliance at (301) 594-46 advertising of your device, prease contier and on by reference to premarket notification's please note the regulation entition, "Albertainments" on the Act may be (21 CFK 9007.97). Other general 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,

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): K011881

Device Name: DYNALINK™ .035 Biliary Self-Expanding Stent System

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

The DYNALINK™ .035 Biliary Self-Expanding Stent System is indicated for the palliation of malignant strictures in the biliary tree.

Brom
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
kol1881

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use_