DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML

K030638 · Avantec Vascular Corp. · FGE · Jul 9, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K030638
• Device Name: DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML
• Applicant: Avantec Vascular Corp.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jul 9, 2003
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

Device Story

The DuraMax™ .035 Biliary Stent System is a balloon-expandable 316L stainless steel stent pre-mounted on an Over-the-Wire (OTW) delivery catheter. The system is used for the palliation of malignant neoplasms in the biliary tree. The delivery catheter features a distal balloon and two radiopaque markers to assist in accurate stent placement. The proximal end includes a Y-connector for guidewire (≤ 0.035") insertion and a standard luer connector for attachment to a balloon inflation device. The device is provided sterile for single use. Clinicians deploy the stent by inflating the balloon to expand the stent within the biliary duct to maintain patency. The device is intended for biliary use only; it is not indicated for the vascular system.

Clinical Evidence

Bench testing only. Safety and effectiveness were demonstrated through non-clinical design verification tests and analyses. Biocompatibility testing was successfully completed.

Technological Characteristics

316L stainless steel stent; balloon-expandable; Over-the-Wire (OTW) delivery catheter; radiopaque markers; Y-connector; standard luer connector; diameters 7, 8, 9, 10 mm; lengths 18, 28 mm; catheter working lengths 80 cm and 135 cm; sterile; single-use.

Indications for Use

Indicated for 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

• Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on OPTA PRO .035" Delivery System

Submission Summary (Full Text)

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## Avantec Vascular Corporation .

XIII. 510(k) Summary

K030638

## 9 2003 JUL

## 510(k) Summary - DuraMax™.035 Biliary Stent System

| Submitter | Avantec Vascular Corporation<br>1049 Kiel Court<br>Sunnyvale, CA 04089 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 6, 2003 |
| Contact Person | James M. Shy<br>Phone: [phone]<br>FAX: [phone]<br>e-mail: [e-mail] |
| Classification Name | 21 CFR 876.5010 Biliary Catheter and accessories |
| Device Common Name | Biliary Stent System |
| Device Trade Name | DuraMax™ .035 Biliary Stent System |
| Intended Use | The DuraMax™ .035 Biliary Stent System is indicated for palliation of<br>malignant neoplasms in the biliary tree |
| Device Classification | Regulatory Class: Class II (two)<br>Product Code: FGE |
| Predicate Device | Cordis® PALMAZ® GENESIS™ Transhepatic Biliary Stent on<br>OPTA PRO .035" Delivery System. |
| Performance Standards | Have not been established for this device. |
| Device Description | The DuraMax™ .035 Biliary Stent Delivery System is a balloon-<br>expandable 316L stainless steel stent pre-mounted on a delivery<br>catheter. The delivery catheter is an Over-the-Wire (OTW) design with a<br>distal balloon and two radiopaque markers to aid in the placement of the<br>stent. The proximal end of the catheter has a Y-connector that allows for<br>the use of a guidewire ≤ 0.035" and the attachment of a balloon inflation<br>device via a standard luer connector. Stents sizes include diameters of 7,<br>8, 9 & 10 mm in lengths of 18, 28 and 28 mm. The catheter is available<br>in two working lengths, 80 cm and 135 cm. Shaft markers at 93 and 103<br>cm are provided on the 135 cm catheter. The catheter system is<br>provided sterile and is intended for one use only. |
| Biocompatibility | The DuraMax™ .035 Biliary Stent System has passed all Biocompatibility<br>testing. |
| Performance Data | The safety and effectiveness of the DuraMax™ .035 Biliary Stent Delivery<br>System have been demonstrated with data collected form non-clinical<br>design verification tests and analyses. |
| Summary | The DuraMax™ .035 Biliary Stent System is constructed of similar<br>materials, is available in similar diameters and lengths, has a similar<br>design and the same indications as the Predicate Device and other<br>currently marketed Biliary Stent Systems. Bench and Biocompatibility<br>testing has demonstrated the safety and effectiveness of the device. |
| Conclusion | The DuraMax™ .035 Biliary Stent System is substantially equivalent to<br>the predicate device and other currently marketed Biliary Stent Systems. |

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a caduceus, a symbol of medicine and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

9 2003 JUL

Mr. James M. Shy V. P. Regulatory Affairs Avantec Vascular Corporation 1049 Kiel Court Sunnyvale, California 94089

Re: K030638

Trade/Device Name: DuraMax™ .035 Biliary Stent System, Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: June 19, 2003 Received: June 20, 2003

Dear Mr. Shy:

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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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 described above is added to your labeling.

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), 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.

Daniel G. Schultz. M.J.

Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K030638

Device Name: DuraMax™ .035 Biliary Stent System

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

The DuraMax™ .035 Biliary Stent System is indicated for palliation of malignant neoplasms in the biliary tree.

く Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use _

David A. Sezman

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