MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K052791 · Invatec Innovative Technologies, S.R.L. · DQY · Nov 4, 2005 · Cardiovascular

Device Facts

• Record ID: K052791
• 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: Nov 4, 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 0.014" guidewires. Two radiopaque marker bands facilitate precise positioning within the vessel under fluoroscopy. The distal shaft includes a hydrophilic coating to improve trackability. Operated by physicians in clinical settings, the device is inflated via the balloon lumen to dilate arterial stenoses or obstructive lesions in dialysis fistulae. The mechanical expansion of the balloon restores vessel patency, improving blood flow and potentially alleviating symptoms associated with vascular obstructions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Coaxial lumen design; semi-compliant balloon; hydrophilic coated distal shaft; two radiopaque marker bands for positioning; compatible with 0.014" guidewires.

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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## NOV - 4 2005

## Premarket Notification (510(k)) Summary

| 510(k) Number: | K052791 |
|---------------------------|-------------------------------------------------------------------------------------------|
| 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: | Stephanie K. Isgrigg Robinson<br>Regulatory Affairs Specialist<br>Telephone: [phone] |
| Summary Preparation Date: | September 30, 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". 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. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the AMPHIRION™ 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ev3 Inc. c/o Ms. Stephanie K. Isgrigg Robinson Regulatory Affairs Specialist 4600 Nathan Lane North Plymouth, MN 55442

Re: K052791

Trade Name: AMPHIRION DEEP PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 30, 2005 Received: October 03, 2005

Dear Ms. Isgrigg Robinson:

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.

NOV - 4 2005

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 - Ms. Stephanie K. Isgrigg Robinson

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] vr [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

iener R. bochner

Image /page/2/Picture/5 description: The image contains a signature on the left and the letters 'E' and 'I' on the right. The signature appears to be a stylized combination of curved and angular lines. The letters 'E' and 'I' are in a simple, sans-serif font and are positioned next to 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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## Indications for Use

510(k) Number (if known):

Device Name: Kos279 )

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 (Part 21 CFR 801 Subpart D)

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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)

DRung R. Vachner

AND/OR

J

Division Sign-Off) Division ... Cardiovascular Devices

510(K) Number_K6527 41

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