CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER

K071189 · Cordis Europa, N.V. · LIT · May 16, 2007 · Cardiovascular

Device Facts

• Record ID: K071189
• Device Name: CORDIS AVIATOR PLUS PTA BALLOON DILATATION CATHETER
• Applicant: Cordis Europa, N.V.
• Product Code: LIT · Cardiovascular
• Decision Date: May 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is intended for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Story

Rapid exchange PTA balloon dilatation catheter; utilizes 0.014" guide wire. Features tapered distal tip for lesion crossing; proximal hub for balloon inflation; two radiopaque marker bands for balloon placement. Used by physicians in clinical settings for peripheral artery angioplasty and stent post-dilatation. Device expands to treat obstructive lesions; improves blood flow; benefits patients by restoring vessel patency.

Clinical Evidence

Bench testing only. Safety and effectiveness demonstrated via non-clinical design verification and design validation tests and analyses.

Technological Characteristics

Rapid exchange PTA balloon catheter; 0.014" guide wire compatibility; tapered tip; radiopaque marker bands. Materials and sterilization methods are consistent with predicate device standards.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty in peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, carotid arteries) and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. Also indicated for post-dilatation of balloon-expandable and self-expanding stents in peripheral vasculature.

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

• Cordis AMIIA PTA Balloon Dilatation Catheter (K063563)
• Cordis AMIIA PTA Balloon Dilatation Catheter (K050645)

Submission Summary (Full Text)

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# K071189 p. I of 2

## Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter

| Attachment 5: | 510(k) Summary | MAY 16 2007 |
|---------------|----------------|-------------|
|---------------|----------------|-------------|

| Submitter & Contact person: | Harm Hovinga<br>Senior Regulatory Affairs Associate<br>Cordis Europa, N.V.<br>Oosteinde 8<br>9301 LJ Roden<br>Netherlands |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 26, 2007 |
| Trade Name | Cordis AVIATOR PLUS Percutaneous Transluminal Angioplasty Balloon<br>Dilatation Catheter |

Classification Name and Device Classification

| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
|---------------------------|-----------------------------------------|
| Classification: | Class II |
| FDA Classification Panel: | Cardiovascular |
| Product Code: | LIT |

| Predicate Device(s) | The predicate device in this submission is the Cordis AMIIA PTA Balloon<br>Dilatation Catheter (510(k) #K063563 & #K050645), which was determined<br>substantial equivalent on March 7, 2007 and April 1, 2005 respectively. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is a catheter<br>with a distal balloon and utilizes a rapid exchange design and accepts a<br>0.014" guide wire. The catheter tip is tapered to facilitate crossing of tight<br>lesions. The proximal hub is used as a balloon inflation port. Two radiopaque<br>marker bands within the balloon indicate the dilating section of the balloon<br>and aid in balloon placement. |

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### Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter

| Intended Use | The Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter is intended<br>for Percutaneous Transluminal Angioplasty in the peripheral vasculature,<br>including iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal, and<br>carotid arteries and for the treatment of obstructive lesions of native or<br>synthetic arteriovenous dialysis fistulae. This device is also indicated for post-<br>dilatation of balloon-expandable and self-expanding stents in the peripheral<br>vasculature. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and<br>Performance<br>Data | The safety and effectiveness of the subject Cordis AVIATOR PLUS PTA<br>Balloon Catheter has been demonstrated via data collected from non-clinical<br>design verification and design validation tests and analyses. |
| Substantial<br>Equivalence<br>Conclusion | In summary, the subject Cordis AVIATOR PLUS PTA Catheter is<br>substantial equivalent to the predecessor / predicate Cordis AMIIA PTA<br>Balloon Dilatation Catheter. |

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human profiles facing right, connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 16 2007

Cordis Europa, N.V. c/o Mr. Harn Hovinga Senior Regulatory Affairs Associate Oosteinde 8 9301 LJ Roden, Netherlands

Re: K071189

Trade/Device Name: Aviator Plus PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: April 26, 2007 Received: April 30, 2007

Dear Mr. Hovinga:

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.

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Page 2 – Mr. Harn Hovinga

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. 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/industry/support/index.html.

Sincerely yours,

Dmna R. Lochner

Image /page/3/Picture/5 description: The image shows a stylized signature. The signature appears to be a combination of curved lines and a straight line. The curved lines form a shape that resembles the letters 'S' and 'V' stacked on top of each other. A straight line is drawn below the curved lines, possibly underlining the signature.

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

Enclosure

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### Special 510(k): Device Modification Cordis AVIATOR PLUS PTA Balloon Dilatation Catheter

#### Attachment 3

### Intended Use Statement

Page 1 of 1

510(k) Number (if known): K071189

Device Name:

Cordis AVIATOR PLUS Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter

#### Indications for Use Statement

The Cordis AVIATOR PLUS PTA Balloon Dilatation catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac. femoral, ilio-femoral, popliteal, infra popliteal, renal, and carotid arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R. Vochner

(Division Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number k071189