PRIMUS GPS BILIARY STENT SYSTEM

K061566 · Ev3, Inc. · FGE · Aug 31, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K061566
• Device Name: PRIMUS GPS BILIARY STENT SYSTEM
• Applicant: Ev3, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 31, 2006
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PRIMUS™ GPS™ Biliary Stent System™ is intended as a palliative treatment for malignant neoplasms in the biliary tree.

Device Story

The PRIMUS™ GPS™ Biliary Stent System is a balloon-expandable stainless steel stent with an open lattice design, provided premounted on a balloon delivery catheter. The device is used by clinicians in a clinical setting to treat malignant neoplasms in the biliary tree. Upon balloon inflation, the crimped stent expands to conform to the duct inner luminal surface and retains its expanded state upon balloon deflation. The device provides mechanical support to maintain biliary patency. The stent features an electropolished surface and modified cell length compared to previous versions. The delivery system incorporates design features from predicate devices. The device is intended for prescription use only.

Clinical Evidence

Bench testing only.

Technological Characteristics

Balloon-expandable stainless steel stent; open lattice design; electropolished surface; premounted on balloon delivery catheter. No software or electronic components.

Indications for Use

Indicated for palliative treatment of malignant 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)

{0}------------------------------------------------

## Premarket Notification (510(k)) Summary

| 510(k) Number: | K061566 |
|---------------------------|---------------------------------------------------------------------------------------------------------|
| Product Name: | PRIMUSTM GPSTM Biliary Stent System (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc.<br>9600 54 ^th Avenue North<br>Plymouth, MN 55442 |
| Official Contact: | Melissa Sommerfeld<br>Sr. Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | June 5, 2006 |

AUG 3 1 2006This summary is provided in compliance with section 513(1)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the PRIMUS™ Stent and Delivery System.

The PRIMUS™ GPS™ Biliary Stent System is intended as a palliative treatment of malignant neoplasms in the biliary tree.

The PRIMUS™ GPS™ Stent is a balloon expandable stainless steel stent with an open lattice design. The stent is electropolished. The device is provided premounted on a balloon delivery catheter. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.

The modified device is substantially equivalent* to the previously cleared stent and delivery system in intended use, materials, technological characteristics and performance. The stent was modified to increase cell length. The stent delivery balloon catheter was modified combining design features from the predicates. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the PRIMUS™ GPSTM Biliary Stent System 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 36 of the US Code.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, with three lines representing the snakes and a base representing the staff. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA".

AUG 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tamima Itani, Ph.D., R.A.C. Vice President, Clinical & Regulatory Affairs ev3. Inc. 9600 54th Avenue North PLYMOUTH MN 55442-2111

Re: K061566

Trade/Device Name: PRIMUSTM GPSTM Biliary Stent System TM Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: July 24, 2006 Received: July 25, 2006

Dear Dr. Itani:

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.

{2}------------------------------------------------

## Page 2 - Ms. Melissa Sommerfeld

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 yours,

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

Enclosure

{3}------------------------------------------------

Page 1 of 1

510(k) Number: K061566

Device Name: PRIMUSTM GPSTM Biliary Stent System TM

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

The PRIMUS™ GPS™ Biliary Stent System™ is intended as a palliative treatment for malignant 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 R. Hodgson

(Divisi Divis. roductive. F and Radiolouical Devices ﻟﻠﻌﺐ ﺍﻟﻤﺴﺎﺑﻘﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Page 1 of 1