MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)

K014205 · Medtronic Ave, Inc. · FGE · Jan 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K014205
• Device Name: MODIFICATION TO BRIDGE SELF-EXPANDING BILIARY STENT DELIVERY SYSTEM (BRIDGE SE)
• Applicant: Medtronic Ave, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 14, 2002
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System is indicated for use in the palliation of malignant neoplasms in the biliary tree.

Device Story

System consists of self-expanding nitinol stent pre-loaded on sheathed delivery catheter; used for biliary strictures via transhepatic access. Physician positions device under fluoroscopic guidance using radiopaque markers; sheath is withdrawn to release stent, which expands to conform to biliary duct lumen. Provides palliative relief for malignant biliary obstructions. Device is single-use, sterile, and non-reusable.

Clinical Evidence

Bench testing only; no clinical data provided. Preclinical testing confirmed device performance and biocompatibility.

Technological Characteristics

Self-expanding nitinol (nickel-titanium) stent; sheathed delivery catheter; radiopaque markers for fluoroscopic visualization. Provided sterile; single-use. No software or electronic components.

Indications for Use

Indicated for palliation of malignant neoplasms in the biliary tree in patients requiring biliary stenting.

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 Biliary Self-Expanding Stent Delivery System (K011080)

Submission Summary (Full Text)

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## 510(k) Summary for the Bridge SE Biliary Self-Expanding Stent Delivery System

| JAN 1 4 2002 | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
| Submitter | Medtronic AVE, Inc., Peripheral Technologies<br>2170-A Northpoint Parkway<br>Santa Rosa, California 95407 |
| Contact Person | John Riolo<br>Vice President, Regulatory Affairs and Quality Assurance<br>Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| Date Prepared | December 20, 2001 |
| Trade Name | Bridge SE Biliary Self-Expanding Stent Delivery System ("Bridge SE") |
| Common<br>Name | Biliary Stent and Delivery System |
| Classification<br>Name | Biliary Catheter and Accessories |
| Device<br>Classification | Classification: Class II<br>Classification Panel: 78FGE<br>Regulation Number: 21 C.F.R. §876.5010 |
| Predicate<br>Device | Bridge SE Biliary Self-Expanding Stent Delivery System<br>K011080; cleared 10/11/2001 |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act |
| 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 delivery system is designed to deliver the stent to<br>the stricture site via transhepatic access. Once positioned at the stricture<br>site, the sheath is withdrawn and the stent is released. Upon release, the<br>stent expands and conforms to the inner lumen of the biliary duct. The<br>device has two radiopaque markers to aid in stent placement during<br>fluoroscopy. |
| Indications for Use | The Bridge SE Biliary Self-Expanding Stent Delivery System is<br>indicated for use in the palliation of malignant neoplasm in the biliary<br>tree. |
| Technological<br>Characteristics | The Bridge SE Biliary Self-Expanding Stent Delivery System ("Bridge<br>SE") is substantially equivalent to the currently marketed Bridge SE<br>Biliary Self-Expanding Stent Delivery System. The subject and predicate<br>stents are technologically similar and are intended for palliation of<br>malignant neoplasms in the biliary tree. The subject and predicate stents<br>are constructed of biocompatible materials. The subject and predicate<br>stents are delivered percutaneously via sheathed delivery systems. The<br>subject device offers additional stent sizes and a longer catheter length.<br>The subject and predicate stents are comparable and are intended to meet<br>clinical needs. The difference between the subject and predicate devices<br>are minor and are not relevant to the ability of the subject device to<br>palliate malignant neoplasms in the biliary tree. |
| Nonclinical<br>Performance | Preclinical testing was conducted to confirm the safe and effective<br>performance of the Bridge SE Biliary Self-Expanding Stent Delivery<br>System as well as the biocompatibility of the device. |
| Sterilization | The Bridge SE Biliary Self-Expanding Stent Delivery System is provided<br>sterile. The device is not intended for reuse or resterilization. |
| Conclusion | The Bridge SE Biliary Self-Expanding Stent Delivery System is<br>substantially equivalent to the currently cleared and marketed device and<br>meets the clinical needs of the physicians. |

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### 510(k) Summary for the Bridge SE Biliary Self-Expanding Stent Delivery System

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 1 4 2002

Mr. Kevin Drisko Regulatory Affairs Manager Medtronic AVE, Inc. Medtronic Peripheral Technologies 2170-A Northpoint Parkway Santa Rosa, California 95407

Re: K014205

Trade/Device Name: Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 20, 2001 Received: December 21, 2001

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.D.

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

Enclosure

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Page 1 of 1

510(k) Number (if known): K014205

Device Name: Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System

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

The Medtronic AVE Bridge SE Biliary Self-Expanding Stent Delivery System 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)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number: K014205

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