MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM

K063481 · Abbott Vascular, Inc. · FGE · Sep 14, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K063481
• Device Name: MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM
• Applicant: Abbott Vascular, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Sep 14, 2007
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RX Herculink® Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Device Story

The RX Herculink Elite Biliary Stent System is a balloon-expandable, L605 cobalt-chromium alloy stent pre-mounted on a rapid exchange (RX) delivery catheter. It is used by physicians in a clinical setting to treat malignant biliary strictures. The delivery system features radiopaque markers for fluoroscopic visualization of stent position and working length, as well as proximal shaft markers for catheter positioning. A third marker aids in guide wire exit lumen location and catheter exchange. The device is deployed via balloon inflation; the delivery system can also be used to optimize stent wall apposition post-deployment. The system is designed to provide palliative relief by maintaining patency in obstructed biliary ducts.

Clinical Evidence

Bench testing only. Testing included foreshortening, uniformity of expansion, balloon rated burst pressure, inflation/deflation times, tensile strength, and deployment accuracy. All tests met acceptance criteria.

Technological Characteristics

L605 cobalt-chromium alloy stent; balloon-expandable; rapid exchange (RX) delivery catheter; radiopaque markers; balloon sizes 4.0-7.0mm; quad-fold balloon configuration; balloon heat set and press processes; USON Sprint Dry Leak Tester used for in-process inspection.

Indications for Use

Indicated for palliation of malignant strictures in the biliary tree.

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

• RX Herculink Elite Biliary Stent System (K053454)
• RX Herculink Plus Biliary Stent System (K010684)

Submission Summary (Full Text)

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p66/nt-2

2007

RX Herculink ® Elite™ Biliary Stent System K063481 510(k) Amendment

# Appendix C - 510(k) SUMMARY

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

| Submitter's Name: | Abbott Vascular<br>(351931722) | SEP 14 |
|------------------------|----------------------------------------------|--------|
| Submitter's Address: | 3200 Lakeside Drive<br>Santa Clara, CA 95054 | |
| Telephone: | 951-914-2292 | |
| Fax: | 951-914-1069 | |
| Contact Person: | Nadine Smith, Regulatory Affairs Associate | |
| Date Prepared: | 11/09/2006 | |
| Device Trade Name: | RX Herculink® Elite™ Biliary Stent System | |
| Device Common Name: | Biliary Stent | |
| Device Classification: | Class II | |

### Summary of Substantial Equivalence:

The modified RX Herculink Elite™ Biliary Stent System is substantially equivalent to the original RX Herculink Elite Biliary Stent System (K053454, cleared 3/6/2006) and RX Herculink Plus Biliary Stent System (K010684, cleared 4/12/2001). Changes made to the original RX Herculink Elite Biliary Stent System focused primarily on the delivery system.

#### Device Description:

The modified RX Herculink Elite Biliary Stent System includes:

- . A balloon expandable L605 cobalt chromium alloy stent pre-mounted on the balloon of a rapid exchange (RX) stent delivery system;
- Two radiopaque markers located underneath the balloon which identify the stent . position and fluoroscopically mark the working length of the balloon;
- . Proximal shaft markers to aid with delivery catheter position, relative to a biliary guiding catheter tip;
- � A third marker located approximately 30 cm from the center of the balloon that aids in locating the guide wire exit lumen and facilitating catheter removal and exchange.

The delivery system can be utilized to optimize the stent wall apposition post stent deployment.

#### Summary of Changes to Previously Cleared Device

- The balloon fold configuration for 5.5 and 6.0 mm balloons was changed from . Tri-fold (3) to Quad-fold (4)
- The RX Herculink Plus balloon folding process was applied to 4.0 6.0mm . balloon diameters as appropriate.
- Added Balloon Press to 5.0 7.0mm balloon diameters .

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K.No.2451 page No.2.

RX Herculink ® Elite™ Biliary Stent System K063481 510(k) Amendment

- . Added Balloon Heat Set to all balloon sizes from 4.0-7.0mm balloon diameters
- Added a 100% in process inspection using a USON Sprint Dry Leak Tester. I .

### Intended Use:

The intended use for the modified device has not changed as a result of the modifications.

> The RX Herculink Elite Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

## Performance Data:

The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety and effectiveness of the modified RX Herculink Elite Biliary Stent System.

# Verification and Validation (V & V) Tests:

Verification and Validation testing was performed as relevant to the modifications to the RX Herculink Elite Biliary Stent System as follows:

| Test | Results |
|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Foreshortening, Uniformity of Expansion | Pass<br>Foreshortening and Uniformity of<br>Expansion met the acceptance criteria. |
| Balloon Rated Burst Pressure (RBP) | Pass<br>The balloon rupture met the acceptance<br>criteria. Labeling 25% above RBP, 17<br>ATM met the acceptance criteria. |
| Inflation/ Deflation | Pass<br>Acceptance criteria for the inflation and<br>deflation times were met. |
| Tensile Strength | Pass<br>The acceptance criterion for the catheter<br>soft tip was met. |
| Deployment<br>Accuracy of stent placement Low pullback resistance of a deflated balloon Capable of safely removing the delivery system | Pass<br>The acceptance criteria for deployments<br>were met.<br>Comparison Rating - Equal |
| Overall test device performance rating.<br>Was the function of the test article clinically<br>acceptable for its intended use? | Pass |

Table 11 - V&V Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 4 2007

Ms. Nadine Smith Regulatory Affairs Associate Abbott Vascular Vascular Solutions 3200 Lakeside Drive SANTA CLARA CA 95054-2807

Re: K063481

Trade/Device Name: RX Herculink® Elite™ Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 4, 2007 Received: April 5, 2007

Dear Ms. Smith:

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 - Ms. Nadine Smith

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 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 vours.

for

Donna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K063481

Device Name: RX Herculink® Elite™ Biliary Stent System

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

:

The RX Herculink® Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Prescription Use **__**
(Per 21 CFR 801.109)

OR

Over-the-Counter Use **__**

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number