MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K050073 · Invatec Innovative Technologies, S.R.L. · DQY · Feb 11, 2005 · Cardiovascular

Device Facts

• Record ID: K050073
• Device Name: MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
• Applicant: Invatec Innovative Technologies, S.R.L.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AMPHIRION™ DEEP 0.014'' OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

The AMPHIRION DEEP is a coaxial lumen PTA balloon catheter designed for percutaneous transluminal angioplasty. It features a semi-compliant balloon and a central lumen for a 0.014-inch guidewire. Two radiopaque marker bands under the balloon facilitate positioning within the vessel under fluoroscopic guidance. The distal shaft is hydrophilic coated to improve trackability. Used by physicians in clinical settings to dilate arterial stenoses or obstructive lesions in dialysis fistulae. The device is inflated via the balloon lumen to mechanically expand the vessel lumen, restoring blood flow. Benefits include minimally invasive treatment of obstructive vascular disease.

Clinical Evidence

Bench testing only.

Technological Characteristics

Coaxial lumen PTA balloon catheter; semi-compliant balloon; 0.014-inch guidewire compatibility; radiopaque marker bands; hydrophilic-coated distal shaft. No electronic components or software.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae.

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.

Submission Summary (Full Text)

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## FEB 1 ] 2005

| <b>Premarket Notification (510(k)) Summary</b> |
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| 510(k) Number: | K050013 |
|---------------------------|---------------------------------------------------------------------------------|
| Product Name: | AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter |
| Common Name: | Peripheral Transluminal Angioplasty Catheter |
| Class: | Class II, 21 CFR Sec 870.1250, Product Code DQY |
| Submitter's Name: | ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442 |
| Official Contact: | Mike Winegar<br>VP, International Regulatory Affairs<br>Telephone: [phone] |
| Summary Preparation Date: | January 10, 2005 |

This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter

The AMPHIRION™ DEEP 0.014" OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The AMPHIRION DEEP catheter is a coaxial lumen device with a semi-compliant balloon. The lumen marked "WIRE" is the central lumen of the catheter, which terminates at the distal tip. This lumen is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The lumen marked "BALLOON" is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. Two radiopaque marker bands are placed under the balloon segment of the catheter shaft to provide visual reference points for balloon positioning within the vessel. The distal catheter shaft is hydrophilic coated.

The modified device is substantially equivalent* to the currently marketed PTA balloon catheter in intended use, materials, technological characteristics and performance. Balloon diameters of 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm are being added to the product line. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRIONTM DEEP 0.014" OTW PTA Balloon Catheter meets the requirements that are considered acceptable for the intended use.

*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.

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Public Health Service

Image /page/1/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 a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

FEB 1 1 2005

ev3 Inc. c/o Mr. Mike Winegar Vice President, International Regulatory Affairs 4600 Nathan Lane North Plymouth, MN 55442

Re: K050073

Trade Name: AMPHIRION DEEP PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: January 10, 2005 Received: January 12, 2005

Dear Mr. Winegar:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bectorn of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manage of the Medical Device American son to commerce prior to May 20, 1970, the excordance with the provisions of the Federal Food, Drug, de necs marchave been reciasined in quire approval of a premarket approval application (PMA). and Cosmetic Act (710) that the device, subject to the general controls provisions of the Act. The I ou may, merciolore, manot the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is classified (see above) and . Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obecaments concerning your device in the Federal Register.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Page 2 - Mr. Mike Winegar

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dri 3 losames or our device complies with other requirements of the Act that I DA has made a seterminations administered by other Federal agencies. You must or any I catal suttated and regulaments, including, but not limited to: registration and listing (21 Comply with an the Not 8 requirements, we sees manufacturing practice requirements as set OFIC art 607), mooning (21 CFR Part 820); and if applicable, the electronic forth in the quarty systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro tegin marketing your device as described in your Section 510(k) I mis icher will anow you to ogin mailing of substantial equivalence of your device to a legally prematicate 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 If you desire specific at not 12-1 - 1 240) 276-0120. Also, please note the regulation entitled, Contact the Office of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on Jour Coll.
Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Duva R. Kirchner

Image /page/2/Picture/5 description: The image contains a signature. The signature is illegible, but it appears to be written in cursive. The signature is located on a white background. The signature is written in black ink.

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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## Indications for Use

510(k) Number (if known): Ko 50073

Device Name:

AMPHIRION DEEP™ Peripheral Transluminal Angioplasty (PTA) Balloon Catheter

Indications for Use:

The AMPHIRION™ DEEP 0.014'' OTW PTA Balloon Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

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)

Dona P. Lochner

(Division Sign-Off) Division or Cardiovascular Devices

510(k) Number_KU 5 66 7 3

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