MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)

K022026 · Medtronic Ave, Inc. · FGE · Jul 19, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K022026
• Device Name: MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
• Applicant: Medtronic Ave, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 19, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aurora is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

The Medtronic AVE Bridge Aurora Biliary Stent System is a self-expanding, nickel-titanium (nitinol) stent pre-loaded onto a sheathed delivery catheter. Used in the biliary tree for the palliation of malignant neoplasms, the device is operated by a physician under fluoroscopic guidance. The delivery system transports the stent to the stricture site; once positioned, the sheath is withdrawn to release the stent, which then expands to conform to the inner lumen of the biliary duct. Radiopaque markers on both the stent and the catheter facilitate visualization during placement. The device is provided sterile for single use. It is not intended for vascular use.

Clinical Evidence

No clinical data provided. Nonclinical performance and biocompatibility testing were conducted to confirm safety and effectiveness.

Technological Characteristics

Self-expanding tubular stent; material: nickel-titanium (nitinol); delivery system: sheathed catheter; radiopaque markers for fluoroscopic visibility; sterile; single-use.

Indications for Use

Indicated for the palliation 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.

Predicate Devices

• Bridge SE (K011080, K014205)

Submission Summary (Full Text)

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K022026 Page lofz

## JUL 1 9 2002

## 510(k) Summary for the Medtronic AVE Bridge Aurora Biliary Stent System

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Medtronic AVE, Inc. Peripheral Technologies 3576 Unocal Place Santa Rosa, California 95403 |
| Contact Person | John Riolo Vice President, Regulatory Affairs and Quality Assurance Phone: [phone] FAX: [phone] e-mail: [e-mail] |
| Date Prepared | June 20, 2002 |
| Trade Name | Medtronic AVE Bridge Aurora Biliary Stent System ("Aurora") |
| Common Name | Biliary Stent and Delivery System |
| Classification Name | Biliary Catheter and Accessories |
| Device Classification | Classification: Class II Classification Panel: 78FGE Regulation Number: 21 C.F.R. §876.5010 |
| Predicate Device | Bridge SE (K011080, K014205) |
| Performance Standards | Performance standards have not been established by the FDA under section 514 of the Federal, Food, Drug and Cosmetic Act |

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K022026 Page 2 of 2

## 510(k) Summary for the Medtronic AVE Bridge Aurora Biliary Stent System

| Device Description | The subject device is a system consisting of a single-lumen, tubular, self-<br>expanding nickel-titanium (“nitinol”) stent pre-loaded onto a sheathed<br>delivery catheter. The stent design incorporates radiopaque markers to<br>aid in stent placement during fluoroscopy. The delivery system is<br>designed to deliver the stent to the stricture site. Once positioned at the<br>stricture site, the sheath is withdrawn and the stent is released. Upon<br>release, the stent expands and conforms to the inner lumen of the biliary<br>duct. Two catheter mounted radiopaque markers aid in visibility during<br>fluoroscopy. |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Indications for Use The Aurora is indicated for use in the palliation of malignant neoplasm in the biliary tree.

The Aurora is substantially equivalent to the currently marketed Bridge Technological SE. The subject and predicate stents are technologically similar and are Characteristics intended for palliation of malignant neoplasms in the biliary tree. The subject and predicate stents are constructed of biocompatible materials. The subject and predicate stents are delivered via a sheathed delivery system. The subject device offers increased visibility under fluoroscopy. The subject and predicate stents are comparable and are intended to meet clinical needs. The difference between the subject and predicate devices are minor and are not relevant to the ability of the subject device to palliate malignant neoplasms in the biliary tree.

Preclinical testing was conducted to confirm the safe and effective Nonclinical performance of this device as well as the biocompatibility of the device. Performance

The Aurora is provided sterile. The device is not intended for reuse or Sterilization resterilization.

The Aurora is substantially equivalent to the currently cleared and Conclusion marketed device and meets the clinical needs of the physicians.

> Premarket Notification for Aurora Page 2 of 2

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 9 2002

Mr. Kevin Drisko Regulatory Affairs Manager Medtronic AVE, Inc. Medtronic Peripheral Technologies 2170-A Northpoint Parkway SANTA ROSA CA 95407

Re: K022026 Medtronic AVE Bridge Aurora Biliary Stent System Regulatory Class: II 21 CFR §876.5010 Product Code: 78 FGE Dated: June 20, 2002 Received: June 21, 2002

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

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 above is added to your labeling, as described.

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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained 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,

Bernard E. Statland, M.D., Ph. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K022026

Device Name: Medtronic AVE Bridge Aurora Biliary Stent System (Aurora)

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

The Aurora is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Prescription Use _ OR Over-The-Counter Use _
(Per 21 CFR 801.109)

David A. Leverson

(Division Si Division of and Radi 510(k) Nu