MEDTRONIC AVE BRIDGE STENT

K992569 · Medtronic Ave, Inc. · FGE · Aug 31, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992569
• Device Name: MEDTRONIC AVE BRIDGE STENT
• Applicant: Medtronic Ave, Inc.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Aug 31, 1999
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Medtronic AVE Bridge™ Stent System (Hi-Flex) – Biliary Indication is intended to maintain patency of a bile duct which is occluded by a malignant tumor.

Device Story

The Medtronic AVE Bridge™ Stent is a balloon-expandable, intralumenal 316L stainless steel stent premounted on an over-the-wire delivery catheter. The device is used by physicians in a clinical setting to maintain patency of bile ducts occluded by malignant tumors. During fluoroscopy, the physician uses two radiopaque platinum markers on the inner shaft to guide placement. The stent is deployed via balloon inflation; the delivery system is compatible with 0.035" guidewires and has a usable length of 75cm to 120cm. By restoring patency to the obstructed duct, the device facilitates bile flow, potentially improving patient symptoms associated with biliary obstruction. The device is provided sterile and is for single use only.

Clinical Evidence

Bench testing only. Performance testing compared the subject device to the predicate, evaluating balloon burst, deflation time, crossing profile, diameter versus inflation pressure (compliance curves), stent free area, stent length, and stent recoil. Biocompatibility testing was successfully completed.

Technological Characteristics

316L stainless steel balloon-expandable stent; PET PTA catheter; 5.3-5.8 F shaft; 6.0-10.0 mm diameter; 28 mm length; 75-120 cm length. Radiopaque platinum markers. Radiation sterilization (ANSI/AAMI/ISO 11137-1994, SAL 10^-6).

Indications for Use

Indicated for patients with bile duct obstruction caused by malignant tumor.

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

• Peripheral AVE Stent Delivery System (K983008)

Submission Summary (Full Text)

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K992569
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## 510(k) Summary for the Medtronic AVE Stent Delivery System

| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of AMDA 1990 and 21 CFR<br>807.92. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification | The assigned 510(k) number is |
| Applicant: | Medtronic AVE, Inc.<br>Peripheral Technologies<br>2330 Circadian Way<br>Santa Rosa, California 95407<br>Contact: Susan L. Walton |
| | Phone: [phone] FAX: [phone]<br>e-mail: susan.walton(@medtronic.com<br>Date submitted: July 30, 1999 |
| Tradename: | Device Name: Medtronic AVE Bridge™ Stent<br>Model Numbers: B6028, B6028L, B7028, B7028L, B8028, B8028L, B9028,<br>B9028L, B10028, B10028L<br>Classification Name: Catheter, Biliary and accessories |
| Section 513<br>Device<br>Classification | Classification: Class II<br>Classification Panel: 78FGE |
| Equivalence | Medtronic AVE claims substantial equivalence to the Peripheral AVE Stent<br>Delivery System - For Use In Biliary Indication. |
| Intended Use | The Medtronic AVE Bridge™ Stent is intended to maintain patency of a bile<br>duct which is occluded by a malignant tumor. |
| | Continuad on unaret |

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## 510(k) Summary for the Medtronic AVE Stent Delivery

System, Continued

Description of Device

The Bridge™ Stent consists of a balloon expandable intralumenal stent premounted onto the balloon of an over-the-wire delivery catheter. The device has two radiopaque platinum markers imbedded on the inner shaft (at each end of the stent) to aid in the placement of the stent during fluoroscopy. The delivery system is compatible with 0.035" guidewires and has a useable length of 75cm to 120cm. The device is provided in a sterile package.

| Size range: | Diameters: 6.0 to 10.0 mm<br>Lengths 28 mm |
|-------------|--------------------------------------------|
|-------------|--------------------------------------------|

Comparison Table

This device is intended to maintain patency of a bile duct which is occluded by a malignant tumor.

| Characteristic | Subject Device | Predicate Device |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | This device is intended to maintain patency of a bile duct which is occluded by tumor. | This device is intended to maintain patency of a biliary duct which is occluded by tumor. |
| Physical Characteristics (stent) | 316L stainless steel balloon expandable premounted stent <ul><li>Diameters 6 - 10mm</li><li>Length 28mm</li></ul> | 316L stainless steel balloon expandable premounted stent <ul><li>Diameters 5 - 10mm</li><li>Lengths 17 to 60mm</li></ul> |
| Physical Characteristics (delivery system) | Balloon delivery system <ul><li>PTA catheter (PET)</li><li>5.3 to 5.8 F shafts</li><li>75 to 120cm lengths</li><li>0.035" guidewire Ø</li></ul> | Balloon delivery system <ul><li>PTA catheter (PET)</li><li>5.3 to 5.8 F shafts</li><li>75 to 90cm lengths</li><li>0.035" guidewire Ø</li></ul> |
| Anatomical site | Bile duct | Biliary duct |
| Target population | Patients with bile duct obstruction caused by malignant tumor. | Patients with biliary duct obstruction caused by malignant tumor. |

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## 510(k) Summary for the Medtronic AVE Stent Delivery
System, Continued

System, Continued

| Performance<br>Testing | The subject device for this 510(k) is identical to the predicate device with the<br>exception of an alternate stent segment (component) and a new stent length.<br>The flexible Medtronic AVE Stent was found to be substantially equivalent in<br>K983008 approved November 25, 1998. Performance testing was conducted<br>on the subject device for the purpose of direct comparison to the predicate<br>device. The testing was chosen to highlight any differences between the<br>subject device and the predicate device. The balloon materials have not been<br>changed. The useable catheter length may be either 75 cm (cleared in<br>K983008) or a new length, 120 cm. The manufacturing process is not<br>changed. | |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test | Purpose |
| | • Balloon Burst<br>• Balloon Deflation Time<br>• Crossing Profile | To compare the stent/delivery system of the<br>subject device and the predicate device. The<br>data will support a premarket notification for<br>the Medtronic AVE Stent Delivery System -<br>For Use In Biliary Indication. |
| | • Diameter versus<br>Inflation Pressure | To create and compare the compliance curves<br>for the subject device and the predicate device.<br>The data will support a premarket notification<br>for the Medtronic AVE Stent Delivery System -<br>For Use In Biliary Indication. |
| | • Stent Free Area<br>• Stent Length<br>• Stent Recoil | To compare the stent dimensional data for the<br>subject device and the predicate device. The<br>data will support a premarket notification for<br>the Medtronic AVE Stent Delivery System -<br>For Use In Biliary Indication. |
| Conclusions | The performance testing and comparison of the Peripheral AVE Stent<br>Delivery System and the Medtronic AVE Bridge™ Stent prove the two<br>devices are substantially equivalent. | |
| Additional<br>Information | The summary includes any other information reasonably deemed necessary<br>by FDA. | |
| Biocompatibility | The materials used in the Medtronic AVE Bridge™ Stent passed all<br>biocompatibility tests. | |

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Kaa 2569
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## 510(k) Summary for the Medtronic AVE Stent Delivery

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(

| Sterilization | The Medtronic AVE Bridge™ Stent is provided sterile.<br><br>The Medtronic AVE Bridge™ Stent is not intended for sterilization or<br>reuse/resterilization by the user.<br><br>Medtronic AVE validates the sterilization method for its stent delivery<br>systems according to the ANSI/AAMI/ISO 11137 - 1994, Method I:<br>Sterilization of Healthcare Products - Requirements for Validation and<br>Routine Control - Radiation Sterilization. The Sterility Assurance Level<br>(SAL) is 10⁶.<br><br>The Medtronic AVE Bridge™ Stent is labeled pyrogen free. LAL testing is<br>performed daily in compliance with FDA guidance on Validation of Limulus<br>Amebocyte Lysate Test as an End Product Endotoxin Test for Human and<br>Animal Parenteral Drugs, Biological Products and Medical Devices - Section<br>V - 2 Inhibition and Enhancement Testing as part of Medtronic AVE's<br>product release criteria. |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized bird or human figures, with three overlapping profiles facing to the right.

Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 31 1999

Ms. Susan L. Walton Regulatory Coordinator Medtronic AVE, Peripheral Technologies 2330A Circadian Way Santa Rosa, CA 95407

Re: K992569

> Medtronic AVE Bridge™ Stent System (Hi-Flex) - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 30, 1999 Received: August 2, 1999

Dear Ms. Walton:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 -- Ms. Susan L. Walton

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 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 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html"

Sincerely vours.

Jum Cofo

Susan Alpert, Ph D., M.D Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K992569

Device Name: Medtronic AVE Bridge™ Stent System (Hi-Flex) – Biliary Indication

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

The Medtronic AVE Bridge™ Stent System (Hi-Flex) – Biliary Indication is intended to maintain patency of a bile duct which is occluded by a malignant tumor.

Tarind A. Styson

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use_