ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM

K033393 · Guidant Corp. · FGE · Nov 10, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K033393
• Device Name: ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
• Applicant: Guidant Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Nov 10, 2003
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Self-expanding biliary stent system; pre-mounted on over-the-wire delivery catheter. Delivery system features three coaxial members (inner, retractable outer, outer-outer), guide wire lumen, distal soft tip, and proximal handle with retraction/locking mechanisms. Used in clinical settings by physicians to treat malignant biliary strictures. Stent deployment occurs via handle-activated retraction of outer member, releasing stent. Radiopaque markers facilitate placement. Device provides mechanical support to maintain biliary patency, palliating symptoms of strictures.

Clinical Evidence

Bench testing only. In vitro tests and analyses demonstrated safety and effectiveness.

Technological Characteristics

Self-expanding stent; delivery system with three coaxial members, guide wire lumen, and proximal handle. Includes radiopaque markers. Materials, biocompatibility, and sterilization methods are equivalent to predicate devices.

Indications for Use

Indicated for palliation of malignant strictures 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

• DYNALINK™ .035 Biliary Self-Expanding Stent System (K014184)
• SMART Therapeutics, Neuroform Microdelivery StentSystem (H020002)
• Cordis. SMART Control Nitinol Biliary Stent (K021898)
• AngioDynamics AngioStent Biliary Stent System (K982346)
• Cordis, SMART Nitinol Stent (K020052)
• Advantec Vascular, DuraMax Biliary Stent System (K030638)

Submission Summary (Full Text)

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Guidant Corporation

ABSOLUTE™ .035 Bi

# GUIDANT

# NOV 1 0 2003

### 510(k) SUMMARY

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

Submitter's Name: Guidant Corporation Submitter's Address: 3200 Lakeside Drive Santa Clara, CA 95052 408-845-3385 Telephone: Fax: [phone]

Kelly Pike Contact Person:

October 22, 2003 Date Prepared:

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

Device Common Name: Biliary Stent Device Classification Name: Biliary Catheter

s

Device Classification: Class II

Summary of Substantial Equivalence:

The ABSOLUTE™ .035 Biliary Self-Expanding Stent System is substantially equivalent to:

- · DYNALINK™ .035 Biliary Self-Expanding Stent System (K014184)
- · SMART Therapeutics, Neuroform Microdelivery StentSystem (H020002)
- · Cordis. SMART Control Nitinol Biliary Stent (K021898)
- · AngioDynamics AngioStent Biliary Stent System (K982346)
- · Cordis, SMART Nitinol Stent (K020052)
- · Advantec Vascular, DuraMax Biliary Stent System (K030638)

## Device Description:

The ABSOLUTE™ Biliary Self-Expanding Stent System is comprised of the ABSOLUTE™ stent pre-mounted on an over-the-wire delivery system. The delivery catheter consists of three coaxial members (an inner member, a retractable outer member, and an outer, outer member), a guide wire lumen, a distal soft tip and a proximal handle with retraction and locking features. The distal section of the outer member constrains the stent on the inner member. Deployment of the ABSOLUTE™ stent occurs when the outer member is retracted by activating the retraction features in the handle.

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KC33393

#### Guidant Corporation

ABSOLUTE™ .035 Biliary Self Expanding Stent Special 510(k)

#### Intended Use:

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

#### Technological Characteristics:

The design modifications incorporated into the ABSOLUTE™ .035 Biliary Self-Expanding Stent System include radiopaque markers at the ends of the stent, new stent lengths and a modified delivery system that has an outer jacket, a new handle design and delivery system lengths.

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.

#### Performance Data:

The results of the in vitro bench tests and analyses demonstrated the safety and effectiveness of the ABSOLUTE™ .035 Biliary Self-Expanding Stent System.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and head, suggesting a profile of a human face. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 0 2003

Mr. Kelly Pike Regulatory Affairs Guidant Corporation 3200 Lakeside Drive Santa Clara, CA 95054

Re: K033393

Trade/Device Name: Guidant ABSOLUTE™ .035 Biliary Self Expanding Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: October 22, 2003 Received: October 23, 2003

Dear Mr. Pike:

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 - Mr. Kelly Pike

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 (OS) 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 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), 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). 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.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K033393

Device Name: Guidant ABSOLUTE™ .035 Biliary Self Expanding Stent

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

The ABSOLUTE™ .035 Biliary Self Expanding Stent is intended for palliation of malignant strictures in the biliary tree.

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

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Scaglon
(Division Sigh-Off)

Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .