MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION

K991533 · Peripheral Ave · FGE · Jul 29, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991533
• Device Name: MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION
• Applicant: Peripheral Ave
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 29, 1999
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic AVE Stent Delivery System - For Use In Biliary Indication device is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.

Device Story

The Medtronic AVE Stent Delivery System consists of a 316L stainless steel balloon-expandable stent premounted on an over-the-wire delivery catheter. The system includes radiopaque platinum markers on the stent to aid in fluoroscopic placement. The delivery catheter is compatible with 0.035-inch guidewires and has a usable length of 75cm to 120cm. The device is used by physicians in a clinical setting to maintain patency of biliary ducts occluded by malignant tumors. The physician navigates the delivery system to the site of the obstruction and inflates the balloon to deploy the stent. 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 device, including balloon rated burst pressure, balloon deflation time, diameter versus inflation pressure (compliance curves), balloon bond strength, and crossing profile. Biocompatibility testing was performed and passed. Sterilization was validated per ANSI/AAMI/ISO 11137-1994.

Technological Characteristics

Stent: 316L stainless steel, balloon-expandable, 5.0-10.0 mm diameter, 10.0-34.0 mm length. Delivery system: PTA catheter, 5.3 F shaft, 75-120 cm length, 0.035-inch guidewire compatible. Radiopaque platinum markers. Sterilization: Radiation (ANSI/AAMI/ISO 11137-1994), SAL 10^-6. Pyrogen-free.

Indications for Use

Indicated for patients with biliary 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 - For Use In Biliary Indication

Submission Summary (Full Text)

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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>2330A Circadian Way<br>Santa Rosa, California 95407<br>Contact: Susan L. Walton<br>Phone: [phone] FAX: [phone]<br>e-mail: [e-mail]<br>Date submitted: April 30, 1999 | |
| Tradename: | Device Name: Medtronic AVE Stent Delivery System - For Use In Biliary<br>Indication<br>Model Numbers: TBD<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 Stent Delivery System - For Use In Biliary Indication<br>device is intended to maintain patency of a biliary duct which is occluded by<br>a malignant tumor. | |
| | Continued on next page | |
| Size range: | Diameters: | 5.0 to 10.0 mm |
| | Lengths: | 10.0 to 34.0 mm |

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

System, Continued

The device consists of a balloon expandable intralumenal stent premounted
and the consisted and secure delivery catheter. The device has two The device consists of a balloon expandable mire delivery cather.
onto the balloon of an over-the-wire delivery catheter. The device has two
re the balloon of an and on the Description of onto the balloon of an over-the-wire denvely canced." I also end of the Device radiopaque platinum markers mounted on the stent during fluorossopy. The deliver
stent) to aid in the placement of the stent during and has a useable length a stent) to aid in the placement of the stent uning nacross and has a useable length of
system is compatible with 0.035inch guidewires and has a useable length of
the states of system is compatible with 0.055men gulder wees
75cm to 120cm. The device is provided in a sterile package.

This device is intended to maintain patency of a biliary duct which is a
re and the success the sames Comparison occluded by a malignant turnor. Table

| Characteristic | Subject Device | Predicate Device |
|--------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Intended Use | This device is intended to maintain patency of a biliary duct which is occluded by tumor. | This device is intended to maintain patency of a biliary duct which is occluded by tumor. |
| Physical<br>Characteristics<br>(stent) | 316L stainless steel balloon expandable premounted stent Diameters 5 - 10mm Lengths 10 to 34mm | 316L stainless steel balloon expandable premounted stent Diameters 5 - 10mm Lengths 16 to 60mm |
| Physical<br>Characteristics<br>(delivery system) | Balloon delivery system PTA catheter (AVEd) 5.3 F shafts 75 to 120cm lengths 0.035 in guidewire Ø | Balloon delivery system PTA catheter (PET) 5.3 to 5.8 F shafts 75 to 90cm lengths 0.035 in guidewire Ø |
| Anatomical site | Biliary duct | Biliary duct |
| Target population | Patients with biliary duct obstruction caused by malignant tumor. | Patients with biliary duct obstruction caused by malignant tumor. |

Continued on next page

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

System, Continued

| Performance<br>Testing | The subject device for this 510(k) is identical to the predicate device with the<br>exception of a new delivery system. Performance testing was conducted on<br>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. | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Test | Purpose |
| | • Balloon Rated Burst<br>• Balloon Deflation Time | To compare the minimum burst pressure and<br>deflation times of the subject device and the<br>predicate device. The data will support a<br>premarket notification for the Medtronic AVE<br>Stent Delivery System - For Use In Biliary<br>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. |
| | • Balloon Bond Strength | To create and compare the balloon bond<br>strength for the subject device and the predicate<br>device. The data will support a premarket<br>notification for the Medtronic AVE Stent<br>Delivery System - For Use In Biliary<br>Indication. |
| | • Crossing Profile | To create and compare the crossing profile for<br>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. |
| Conclusions<br>Additional<br>Information | The performance testing and comparison of the Peripheral AVE Stent<br>Delivery System - For Use In Biliary Indication and the Medtronic AVE Stent<br>Delivery System - For Use In Biliary Indication prove the two devices are<br>substantially equivalent.<br>The summary includes any other information reasonably deemed necessary<br>by FDA. | |

Continued on next page

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

System, Continued

#### The material used in the Medtronic AVE Stent Delivery System - For Use In Biocompatibility Biliary Indication passed all biocompatibility tests. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is Sterilization provided sterile. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is not intended for sterilization or reuse/resterilization by the user. Medtronic AVE validates the sterilization method for its stent delivery systems according to the ANSI/AAMI/ISO 11137 - 1994, Method I: Sterilization of Healthcare Products - Requirements for Validation and Routine Control - Radiation Sterilization. The Sterility Assurance Level (SAL) is 10°. The Medtronic AVE Stent Delivery System - For Use In Biliary Indication is labeled pyrogen free. LAL testing is performed daily in compliance with FDA guidance on Validation of Limulus Amebocyte Lysate Test as an End Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products and Medical Devices - Section V - 2 Inhibition and Enhancement Testing as part of Medtronic AVE's product release criteria.

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Public Health Service

Image /page/4/Picture/2 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines forming its wings and body, giving it a modern and abstract appearance.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### UL 29 1999

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

K991533 Re:

K991333
Medtronic AVE Bridge™ Stent System - Biliary Indication Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: April 30, 1999 Received: May 3, 1999

Dear Ms. Walton:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section 310(K) notincentially equivalent (for the indications for use above and we have determined the cevee is subscated in interstate commence
stated in the enclosure) to legally marketed prodicate devices marketed in interstate comments, or stated in the enclosure) to legally marketed preview device Amendments, or to devices that prior to May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the rederal controls provisions have been reclassified in accordance with the provisions of the general controls provisions of
Act (Act). You may, therefore, market the device, subject to the Act include Act (Act). You may, therefore, market the devices stored spovisions of the Act include the Act and the limitations described below. The general setting practice, labeling, and prohibitions against misbranding and adulteration.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this The Office of Device Evailation nas detecting.com the proposed labeling and that such use device will be used for an mentee and not identify and the Section 513 (i) (i) (E) of the Act, the following
could cause harm. Therefore, in accordance with and the daily of could cause harm. "Therefore, in accordently 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 Furthermore, the indication for billary use most or promotional materials, in close
pouch, box, and carton labels, instructions for use, and other promotional materials, in c pouch, box, and carton labels, hasimilar 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) on class III
ng insideration in the control and controls. Incolditional controls. Existing ma If your device is classified (see above) into entrely class in topedial only regulations.
(Premarket Approval), it may be subject to such additions Title 21, Parts 800 to 89 (Premarket Approval), it may be subject to such additions Title 21, Parts 800 to 895.
affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 8 affecting your device can be found in the ssumes compliance with the Current Grood A substantially equivalent determination assemes continues web the Manufacturing Practice requirements, as servior in the John in any of the J
Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS Medical Devices: General regulation (ZTCFK Part 620) and rifty, unco assumptions. Failure to
inspections, the Food and Drug Administration (FDA) will verify and assumptions inspections, the Food and Drug Administration (1777) will vienny butlains and publish
comply with the GMP regulation may resident in the Firster Register Please note: this comply with the GMP regulation may result in the Federal Register. Please note: this further announcements concerning your device in the regence any obligation you might have
response to your premarket notification submission does not allectronic Product Radi response to your premarket nothication submission access under the Electronic Product Radiation
under sections 531 through 542 of the Act for devices under the Electronic Pro under sections 551 through - Federal laws or regulations.

The FDA finding of substantial equivalence of your device to a legally marketed proceed to the market. This The FDA finding of substantial equivalence of your device to proceed to the market. This
results in a classification for your device and permits your device to proceed to th results in a classification for your device and perints your 510(K) premarket
letter will allow you to begin marketing your device as described letter will allow you to begin marketing your 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.
The Act. In the first to the first for any livitations are modified in any wa Please note that the above labeling innitations are required of required in any way or removed from the device's labeling.

If you desire specific information about the application of other labeling requirements to your If you desire specific information about the applied on be severing devices), please contact device (21 CFR Part 801 and additionally 807 : 0 : 0 : 2011 : 11 : 0 : gustions on the promotion and the Office of Compliance at (01) >>4-4010. Administraliance at [phone]. Also,
advertising of your device, please contact the Office of Compliance at [phone]. please note the regulation entitled, "Misbranding by reference to premarket notification"
please note the regulation entitled, "Misbranding by references tijlities under the please note the regulation entitled, "Misoration on your responsibilities under the Act may be
(21 CFR 807.97). Other general information on your responsibilities unmber (21 CFR 807.97) Other general miormation on your espance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html" .

Sincerely yours,

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

Enclosure

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Page _ I of 1

510(k) Number (if known): K991533

Device Name: Medtronic AVE Bridge™ Stent System - Biliary Indication

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

The Medtronic AVE Bridge™ Stent System – Biliary Indication is intended to maintain patency of a biliary duct which is occluded by a malignant tumor.

David H. Bowman

(Division Sign-Off) (Division Sign-OG)
Division of Repreductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use V OR (Per 21 CFR 801.109)

Over-The-Counter Use_