LIFESTENT TURBO BILIARY STENT SYSTEMS

K050627 · Edwards Lifesciences, LLC · FGE · Mar 22, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050627
• Device Name: LIFESTENT TURBO BILIARY STENT SYSTEMS
• Applicant: Edwards Lifesciences, LLC
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Mar 22, 2005
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

LifeStent Turbo Biliary Stent System is a balloon-expandable, stainless steel, open-lattice stent; permanently implanted to maintain patency of major bile ducts obstructed by tumors. Provided on an over-the-wire delivery system. Used by physicians in clinical settings. Stent is deployed via balloon expansion to compress impinging tissue. Benefits include restoration of bile flow in patients with malignant biliary strictures. Safety and effectiveness for vascular use not established.

Clinical Evidence

Bench testing only. Testing included deployment, dimensional, compression force, balloon performance, stent deformation, and tensile strength testing. No clinical data provided.

Technological Characteristics

Stainless steel, balloon-expandable, open-lattice stent. Delivery system is over-the-wire. Stent diameters: 5mm and 6mm; lengths: 18mm and 25mm. Sterilization method and packaging are substantially equivalent to predicate.

Indications for Use

Indicated for the palliation of malignant strictures (neoplasms) 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

• LifeStent LP SDS Biliary Stent System (K023248, K041370)

Submission Summary (Full Text)

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MAR 2 2 2005

510(k) Summary

K050627
Page 1 of 2

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

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

# 2. Contact:

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

#### 3. Date Prepared:

March 3, 2005

#### 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 LP SDS Billiary Stent System (K023248, K041370)

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510(k) Summary (continued)

K050627
Page 2 of 2

# 8. Device Description:

The LifeStent Turbo consists of a balloon expandable stent that is provided on an over-the-wire The LifeStent Turbo ochales of a bancon one manently implanted device used to cathere that aoto as a donvoly byetem structed by tissue of an impinging tumor. The flexible, maintain patchoy of a major bile decesser cutting an open lattice design into a stainless steel tube. banoon expandation of this made by labor 6 hills. 18 mm, and 25mm 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 device 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 device cited in item 7 above.

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Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. 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 emblem that resembles a stylized eagle or bird-like figure with three curved lines representing its body and wings.

MAR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614

Re: K050627

K050627
Trade/Device Name: Edwards Lifesciences LifeStent Turbo Biliary Stent System
Trade/Device Name: Edwards Frade/Don Number: 21 CFR §876.5010 Regulation Names: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: March 10, 2005 Received: March 11, 2005

Dear Mr. Drisko:

We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section >10(K) prematise includent (for the indications for the indications for referenced above and have determined in devices marketed in interstate commerce
use stated in the enclosure) to legally marketed previoes marketed in interstate shat use stated in the enclosure) to legally markets areast analyments, or to devices that
prior to May 28, 1976, the enactment date of the Medical Device Amendments prior to May 28, 1976, the enatment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Federal controls provisions o have been reclassified in accordance with the pive, subject to the general controls provisions of the
Act (Act). You may, therefore, market the seneral controls provisions o Act (Act). You may, therefore, market the devices and works.
Act and the limitations described below. The general controls provisions of the Actinelude Act and the limitations described below. The genetar confisions of them of the more
requirements for annual registration, listing of devices, good manufacturing practice, la requirements for annual beganding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that his device The Office of Device Evaluation has delemined in the proposed aboling and that such use could cause
will be used for an intended use not identify of the Act, the Act, the Act will be used for an intended use not identified in the proposed and the following limitation must
ham. Therefore, in accordance with Section 5 1 (i)(1)(E) of the Act, the fo narm. Therefore, in according 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 Furthermore, the indication for bithing use and other promotional materials, in close
pouch, box, and carton labels, instructions for use, and in hold mini pouch, box, and carton labors, mistrations of a similar point size, and in bold print.

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# Page 2 – Mr. Kevin Drisko

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
four device in the form to be Fristing major regulations affecting y If your device is classified (see above) into either class in (Special Control) of eries (
may be subject to additional controls. Existing major regulations affecting your d rr Jour be subject to additional controls. Existing major regulations from the collection
in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA m in the Code of Federal Regulations, True 21, 31.
announcements concerning your device in the Federal Register.

announce advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA's issuance of a substante coccummance of the Act or any
FDA has made a determination that your device complies with all FDA has made a determination that your device comples. You must comply with all
Federal statutes and regulations administered by other Federal openities (21 CFR Part 807); Federal statutes and regulations administered by other registration and listing (21 CFR Part 807);
the Act's requirements, including, but not limited to: registration as set the Act's requirements, including but not limited to: Teglirements as set forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as set fo labeling (21 CFR Part 801); good manufacturing practice to accordent as a comments.
systems (QS) regulation (21 CFR Part 820); and if applicable; the electronic product radia systems (QS) regulation (21 CFR Fart 020), and 1847-141-144-141-14-11-11-1000-1050.
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 proceed to the market. This The FDA finding of substantial equivalence of your device to proceed to the market. This results in a classification for your device as described in your Setion 510(k) premarket
letter will allow your obegin marketing your device as described in your labeline. letter will allow you to begin marketing your device as associated by our labeling.
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.
The Act. In and the started by Sep these limitations are modified in any way Please note that the above labeling Ilmitations are required by Bocker. Se ( ( from the device's labeling.

If you desire specific information about the application of other labeling requirements to your device If you desire specific information about the apprication of other 1900) 594-4616. Also, please note (21 CFR Part 801), please contact the United Communes at (501) for Parl 807.97).
the regulation entitled, "Misbranding by reference to premarket notification in the Division the regulation entitled, "Misbranding by responsibilities inderstine Act from the Division
You may obtain other general information on your responsibilities number You may obtain other general information on "Onsumer Assistance at its toll-free number
of Small Manufacturers, International, and Consumer Assistance at its toll-free number of Small Manufacturers, International its Internet address (600) 050 = fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

NAGTM

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

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510(k) Number: K050627

Device Name: Edwards Lifesciences LifeStent Turbo Biliary Stent System

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

I Dri s Career in
The Edwards LifeStent Turbo Biliary Stent System is indicated for use in the palliation
in the provinces and any a in the biliary tree I he Edwards Enesciences Enoblems) in the biliary tree.

Prescription Use
(Per 21 CFR 801.109)

OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy Cropton

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