LIFESTENT TURBO BILIARY STENT SYSTEM

K061235 · Edwards Lifesciences, LLC · FGE · Jun 5, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061235
• Device Name: LIFESTENT TURBO BILIARY STENT SYSTEM
• Applicant: Edwards Lifesciences, LLC
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jun 5, 2006
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Device Story

LifeStent Turbo is a balloon-expandable biliary stent system; consists of laser-cut stainless steel stent mounted on an over-the-wire delivery catheter. Used to maintain patency of major bile ducts obstructed by impinging tumors. Delivered via catheter to the site of stricture; balloon expansion deploys stent to hold duct open. Intended for use by physicians in clinical settings. Provides palliative relief for patients with malignant biliary obstructions. Subject device supplied in 11mm length with 5mm and 6mm diameters.

Clinical Evidence

Bench testing only. Testing included deployment, dimensional, compression force, balloon performance, stent deformation, and tensile strength testing. Results demonstrated performance substantially equivalent to predicate devices.

Technological Characteristics

Balloon-expandable stent; laser-cut stainless steel open lattice design; over-the-wire delivery catheter. Supplied in 11mm length, 5mm and 6mm diameters. Mechanical device; no software or electronic components.

Indications for Use

Indicated for the palliation of malignant strictures (neoplasms) 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

• LifeStent Turbo Biliary Stent System (K050627)
• Medtronic AVE Bridge Stent System - Biliary Indication (K991533)

Submission Summary (Full Text)

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CONFIDENTIAL May not be reproduced without written permission fr Edwards Lifesciences

### 510(k) Summary

JUN - 5 2006

### 1. Submitter's Name and Address:

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

### 2. Contact:

Kevin Drisko Director, Regulatory Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: [phone] FAX: [phone] E-Mail: [e-mail]

### 3. Date Prepared:

May 2, 2006

### 4. Device Trade Name:

LifeStent Turbo Biliary Stent System

### 5. Device Common Name:

Biliary Stent

### 6. Device Classification Name:

Biliary Catheter (78 FGE), Class II

### 7. Predicate Devices:

LifeStent Turbo Biliary Stent System (K050627) Medtronic AVE Bridge Stent System - Biliary Indication (K991533)

Edwards Lifesciences Special 510(k) for the LifeStent Turbo Biliary Stent System

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## 510(k) Summary (continued)

### 8. Device Description:

The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible, balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The subject device is supplied in a length of 11mm and diameters of 5mm and 6mm.

#### 9. Intended Use:

The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

#### 10. Technological Characteristics:

Comparisons of the subject and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.

#### 11. Performance Data:

Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, compression force testing, balloon performance testing, stent deformation testing as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above.

### 12. Conclusion:

Since the LifeStent Turbo has the same intended use, same materials, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in item 7 above.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 5 2006

Mr. Kevin Drisko Director, Regulatory Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614

Re: K061235

Trade/Device Name: 11mm LifeStent Turbo Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 2, 2006 Received: May 3, 2006

Dear Mr. Drisko:

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. Kevin Drisko

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.

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.

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.

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.

QeCN Tele

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

Enclosure

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# Indications for Use

510(k) Number: K061235

Device Name: LifeStent Turbo Biliary Stent System

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

The LifeStent Turbo Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Ingram
(Division Sign-Off)

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

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