PROTEGE GPS SELF-EXPANDING NITINOL STENT

K050725 · Ev3 Corporation · FGE · Apr 20, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050725
• Device Name: PROTEGE GPS SELF-EXPANDING NITINOL STENT
• Applicant: Ev3 Corporation
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Apr 20, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Device Story

Self-expanding nitinol stent with open lattice design; electropolished; provided premounted on 6Fr 0.035" delivery catheter. Device deployed in biliary tree to conform to duct inner luminal surface; provides mechanical support to maintain patency in malignant strictures. Used by physicians in clinical settings. Output is physical stent placement; aids in palliative management of biliary obstructions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Self-expanding nitinol stent; open lattice design; electropolished; 6Fr 0.035" delivery catheter; 12 mm and 14 mm diameter options.

Indications for Use

Indicated for patients requiring 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.

Submission Summary (Full Text)

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## APR 2 0 2005

## Premarket Notification (510(k)) Summary

| 510(k) Number: | K050725 |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product Name: | Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name:<br>ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442 | Official Contact:<br>Glen D. Smythe<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | March 18, 2005 |

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé® GPS™ Self-Expanding Nitinol Stent.

The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The Protégé stent is a self-expanding nitimol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.

The modified device is substantially equivalent* to the currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. Two stents in diameters of 12 and 14 mm have been added to the 6Fr 0.035" delivery system. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent meets the requirements that are considered acceptable for the intended use.

*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.

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APR 2 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Glen D. Smythe Sr. Regulatory Affairs Specialist ev3 Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920

Re: K050725

Trade/Device Name: Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: March 18, 2005 Received: March 21, 2005

Dear Mr. Smythe:

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 arior 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 wir o about for a 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 x and other of on on on tabels, 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. Glen Smythe

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) intesting major regulations affecting your device and be found may be subject to additional controls. Existing major regarder. 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 doesnot Art a gau Please be advised that TDA's Issualled of a substances with other requirements of the Act or any FDA has made a determination that your der Federal agencies. You must comply with all
Federal statutes and regulations administered by other Federal (2), CED Re- 807), Federal statures and regulations administered by one registration and listing (21 CFR Part 807); the Act s requirements, mending, van not minister requirements as set forth in the quality labeling (21 CFR Part 801), good manazatting franchically, the electronic product radiation (21) systems (QS) regulation (2) 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device The FDA finaling of substantal equivalence or your device to proceed to the market. This results in a classincation for your device and points your Section 510(k) premarket letter will allow you to begin mantents 5 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Please note that the above labeling mintations 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 as a If you desire specific information about the approached at [phone]. Also, please note (21 CFR Part 801), picase contact in Oriffecar compremarket notification" (21 CFR Part 807.97).
the regulation entitled, "Misbranding by reference to premarket notification" The regulation entitled, "Misolanding of responsibilities under the Act from the Division You may other other general mional, 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,

Nunton MD for

Jea Tillman, Ph Donna Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: K050725

Device Name: Protégé® GPS™ Self-Expanding Nitinol Stent (Biljary Indication)

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

The Protégé® GPS™ Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Prescription Use _ 4 (Per 21 CFR 801.109) OR

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Evid. Hyaon

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