ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0

K030062 · Avantec Vascular Corp. · LIT · Apr 3, 2003 · Cardiovascular

Device Facts

• Record ID: K030062
• Device Name: ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
• Applicant: Avantec Vascular Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.

Device Story

Admiral™ .035 Dilatation Catheter is an over-the-wire, coaxial, dual-lumen PTA catheter; features inflatable balloon at distal end; compatible with 0.035" guidewires. Two radiopaque markers facilitate balloon placement. Available in diameters 7.0-10.0 mm, lengths 20-40 mm, and catheter lengths 80-135 cm. Used by physicians in clinical settings for peripheral angioplasty. Device inflates to dilate stenotic vessels; improves blood flow. Benefits patients by restoring patency in peripheral arteries and dialysis fistulae.

Clinical Evidence

Bench testing only. Testing included balloon minimum burst strength, compliance, fatigue, inflation/deflation performance, bond strengths, and coating integrity. Biocompatibility testing was also performed.

Technological Characteristics

Over-the-wire, coaxial, dual-lumen catheter design. Features inflatable balloon and two radiopaque markers. Compatible with 0.035" guidewires. Available in diameters 7.0-10.0 mm, balloon lengths 20-40 mm, and catheter lengths 80-135 cm. No specific material standards or software algorithms mentioned.

Indications for Use

Indicated for percutaneous transluminal angioplasty of femoral, renal, iliac, popliteal, peroneal, and profunda arteries, and native or synthetic arteriovenous dialysis fistulae. Contraindicated for coronary or neurovasculature use.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Boston Scientific Medi-Tech® MARSHAL™ Balloon Dilatation Catheter

Submission Summary (Full Text)

{0}------------------------------------------------

# APR - 3 2003

K 030062 p 1/1

# 510(k) Summary - Admiral™.035 Dilatation Catheter

| 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] |
| Device Trade Name | Admiral™.035 Dilatation Catheter |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class II (two)<br>Product Code: 74 LIT |
| Predicate Device | Boston Scientific Medi-Tech®<br>MARSHAL™ Balloon Dilatation Catheter |
| Performance Standards | Not promulgated for PTA Catheters. |
| Intended Use | The Admiral™ .035 Dilatation Catheter is indicated for percutaneous<br>transluminal angioplasty of the femoral, renal, iliac, popliteal,<br>peroneal and profunda arteries and native or synthetic arteriovenous<br>dialysis fistulae. It is not intended for use in the coronary vasculature<br>or the neurovasculature. |
| Device Description | The Admiral™ .035 Dilatation Catheter is an Over-the-Wire, Coaxial,<br>dual lumen design with a inflatable balloon on the distal end and<br>compatible with 0.035" guidewires. Two radiopaque markers indicate<br>the dilating portion of the balloon and aid in balloon placement. The<br>device is available with balloon diameters of 7.0 - 10.0 mm, balloon<br>lengths of 20, 30 & 40 mm and catheter lengths of 80 & 135 cm. |
| Biocompatibility | The Admiral™ .035 Dilatation Catheter has passed all<br>Biocompatibility testing. |
| Performance Data | Performance testing was conducted to demonstrate Safety and<br>Effectiveness and for comparison to the predicate device.<br>Testing included: Balloon Minimum Burst Strength, Compliance,<br>Fatigue, and Inflation/Deflation performance, Bond Strengths and<br>Coating Integrity. |
| Summary | The Admiral™ .035 Dilatation Catheter 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 PTA Catheters. Bench and Biocompatibility<br>testing has demonstrated the safety and effectiveness of the device. |
| Conclusion | The Admiral™ .035 Dilatation Catheter is substantially equivalent to<br>the predicate device and other currently marketed PTA Catheters. |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with a triple helix-like design representing the interconnectedness of health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 3 2003

Avantec Vascular Corporation c/o Mr. James M. Shy 1049 Kiel Court Sunnyvale, CA 04089

Re: K030062

Trade Name: Admiral™ .035 Dilatation Catheter Regulation Number: 21 CFR §870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: II (two) Product Code: LIT Dated: January 6, 2003 Received: January 7, 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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

{2}------------------------------------------------

Page 2 -- Mr. James M. Shy

(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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 vours.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

## Indications for Use Statement

510(k) Number (if known):

Device Name: Admiral™ .035 Dilatation Catheter

Indications for Use:

The Admiral™ .035 Dilatation Catheter is indicated for percutaneous transluminal angioplasty of the femoral, renal, iliac, popliteal, peroneal and profunda arteries and native or synthetic arteriovenous dialysis fistulae. It is not intended for use in the coronary vasculature or the neurovasculature.

### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

#### Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The- Counter

(Optional Format 1-1-96)

(Division Sign-Off)
Divas... of Cardiovascula.
510(k) Number 4030062