RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM

K992319 · Guidant Corp. · FGE · Oct 8, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992319
• Device Name: RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
• Applicant: Guidant Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Oct 8, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of malignant strictures in the biliary tree.

Device Story

Device consists of balloon-expandable 316L stainless steel stent pre-mounted on either rapid exchange (RX) or over-the-wire (OTW) delivery catheter; includes XCELON (nylon blend) balloon. Used percutaneously in biliary tree to treat malignant strictures. Physician advances catheter over guide wire to stricture site; balloon inflation deploys stent. Radiopaque markers on balloon aid positioning. RX configuration uses single lumen proximal/coaxial distal design; OTW uses coaxial dual lumen. Output is mechanical support of biliary duct via expanded stent. Benefits patient by palliating malignant strictures.

Clinical Evidence

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

Technological Characteristics

Stent: 316L medical grade stainless steel. Delivery system: RX or OTW catheter with XCELON (nylon blend) balloon. Stent length: 28 mm. Balloon diameters: 6.0, 7.0, 8.0, 9.0, 10.0 mm. Catheter length: 75 cm. Deployment: Balloon-expandable. Sterilization: Not specified.

Indications for Use

Indicated for palliation of malignant strictures in the biliary tree. No specific age or gender restrictions provided.

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

• MEGALINK™ Biliary Stent (K983075)
• Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581)
• Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653)

Submission Summary (Full Text)

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8 1999

992319 H-2 1/2

## 510(k) SUMMARY

| Submitter's Name: | Guidant Corporation<br>Advanced Cardiovascular Systems, Inc. |
|-----------------------------|---------------------------------------------------------------------------------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95052 |
| Telephone: | 408-845-3000 |
| Fax: | 408-845-4278 |
| Contact Person: | Sandra Sundell |
| Date Prepared: | July 9, 1999 |
| Device Trade Name: | RX MEGALINK™ SDS Biliary Stent System<br>OTW MEGALINK™ SDS Biliary Stent System |
| Device Common Name: | Biliary stent |
| Device Classification Name: | Biliary Catheter |

Device Classification: Class II

## Summary of Substantial Equivalence:

The design, materials, method of delivery and intended use features of RX and OTW MEGALINK™ SDS Biliary Stent Systems are substantially equivalent with regard to these features in the predicate devices, the MEGALINK™ Biliary Stent (K983075), the Cordis J&J PALMAZ™ balloon-expandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653).

## Device Description:

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are comprised of a bailoon-expandable stent pre-mounted onto either a rapid exchange (RX) or an over-thewire (OTW) delivery catheter designed to be placed percutaneously into the common bile duct and intended to treat malignant strictures in the biliary tree. The stent is fabricated from a single piece of 316L medical grade stainless steel tubing. The stent is premounted onto either an RX or an OTW delivery catheter with an integrated shaft system and an XCELON™ (nylon blend) balloon bonded at the distal end. The RX shaft has a combination of a single lumen design at the proximal end and a coaxial lumen at the distal end. The proximal lumen provides for inflation of the balloon with contrast medium. The distal lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stricture to be dilated. The OTW shaft has a coaxial dual lumen extending the entire length of the catheter. The outer lumen provides for inflation of the balloon with contrast medium. The central lumen permits use of a guide wire to facilitate advancement of the catheter to and through the stricture to be dilated.

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The balloon, which is identical on both RX or OTW configurations, has 2 radiopaque markers to aid in positioning the balloon in the biliary duct, and is designed to provide an expandable segment of known diameter and length at specific pressures.

The proximal end of the RX catheter has a single arm adapter that provides access to the inflation lumen. The proximal end of the OTW catheter has a dual arm adapter, one for the guide wire lumen and the other for access to the inflation lumen. The adapter arm used to access the inflation lumen is designed with a luer-lock fitting for connection with an inflation device.

The RX and OTW MEGALINK™ SDS Biliary Stent Systems consists of an 28 mm length stent pre-mounted onto 75 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0, and 10.0 mm. The RX and OTW MEGALINK™SDS Biliary Stent Systems are intended to be delivered and deployed in the biliary tree.

### Intended Use:

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for palliation of malignant strictures in the biliary tree.

#### Technological Characteristics:

The RX and OTW MEGALINK™ SDS Biliary Stent Systems incorporate similar design, components, method of deployment, materials and intended use of the predicate devices, Cordis J&J PALMAZ™ balloon-cxpandable Stent and delivery catheter for the Biliary System (K911581) and the Cordis PERFLEX™ Balloon Expandable Stent and Delivery System for the Biliary System (K980653). The RX and OTW MEGALINK™ SDS Biliary Stent Systems consist the 28 mm length MEGALINK™ Stent (K983075) pre-mounted onto 7.5 cm length delivery catheters with balloon diameters of 6.0, 7.0, 8.0, 9.0 and 10.0 mm.

#### Performance Data:

The safety and effectiveness of the RX and OTW MEGALINK™ SDS Biliary Stent Systems have been demonstrated through data collected from in vitro bench tests and analyses.

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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 consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is written around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

8 1999 OCT

Ms. Sandra Sundell Senior Regulatory Affairs Coordinator Guidant Corporation P.O. Box 58167 Santa Clara, California 95052-8167

K992319 Re:

> RX MEGALINK™ SDS Biliary Stent System OTW MEGALINK™ SDS Biliary Stent System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 9, 1999 Received: July 12, 1999

Dear Ms. Sundell:

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)(I) 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. Sandra Sundell

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small 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.

Ame Alfert

Susan Alpert, Ph.D., M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K992319

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# Device Name: _RX MEGALINK™ SDS Biliary Stent System and OTW MEGALINK™ SDS Biliary Stent System

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

The RX and OTW MEGALINK™ SDS Biliary Stent Systems are indicated for the palliation of malignant strictures in the biliary tree.

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

David A. Segarra

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(Division Sign-Off)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devig 902319 510(k) Number.