AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER

K042624 · Invatec Innovative Technologies, S.R.L. · DQY · Jan 10, 2005 · Cardiovascular

Device Facts

• Record ID: K042624
• Device Name: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER
• Applicant: Invatec Innovative Technologies, S.R.L.
• Product Code: DQY · Cardiovascular
• Decision Date: Jan 10, 2005
• Decision: SESE
• Submission Type: Traditional
• 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

Amphirion Deep is a 0.014" over-the-wire (OTW) peripheral transluminal angioplasty (PTA) balloon catheter. Device features a semi-compliant inflatable balloon at the distal tip and a coaxial lumen design. One lumen facilitates guidewire passage; the other enables balloon inflation/deflation using a contrast medium and saline mixture. Radiopaque marker bands under the balloon segment assist in visual positioning. The distal shaft and balloon are hydrophilic coated. Used in clinical settings by physicians to dilate arterial stenoses and treat obstructive lesions in dialysis fistulae. By inflating the balloon at the target site, the device restores vessel patency, improving blood flow and potentially alleviating symptoms associated with vascular obstructions.

Clinical Evidence

Bench testing only. In-vitro testing included balloon compliance, burst pressure, fatigue, shaft burst pressure, bond strength, catheter dimensions, and guidewire/introducer compatibility. Biocompatibility testing confirmed material safety.

Technological Characteristics

Coaxial lumen PTA catheter; semi-compliant balloon; hydrophilic coating on distal shaft and balloon; 0.014" guidewire compatibility; 1.5-2.0 mm balloon diameters; 20-120 mm balloon lengths; 120 cm usable length; radiopaque marker bands; biocompatible materials.

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.

Predicate Devices

• Boston Scientific SYMMETRY Small Vessel Balloon Dilatation Catheter
• Cordis AVIATOR Peripheral Dilatation Catheter

Submission Summary (Full Text)

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K04262 y

## 510(k) Summary AMPHIRION™ DEEP 0.014" OTW PTA BALLOON CATHETER

| 510(k) Summary | This summary of 510(k) Safety and Effectiveness information is<br>being submitted in accordance with the requirements of 21 C.F.R §<br>807.92. |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant<br>(Manufacturer) | Invatec Innovative Technologies, s.r.l.<br>Via Martiri della Libertà, 7<br>25030 Roncadelle (BS) Italy<br>Tel: [phone]<br>Fax: [phone]<br>www.invatec.com<br>[e-mail] |
| Submitter | ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Mike Winegar<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| Date Prepared | September 24th, 2004 |
| Device Trade Name | AMPHIRIONTM DEEP 0.014" OTW PTA BALLOON CATHETER |
| Device Common Name | Peripheral Transluminal Angioplasty (PTA) Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification | Regulatory Class: Class II<br>Product Code: LIT |
| Classification Panel | Cardiovascular |
| Predicate Devices | Boston Scientific SYMMETRYTM Small Vessel Balloon Dilatation<br>Catheter<br>Cordis AVIATORTM Peripheral Dilatation Catheter |
| Intended Use | The AMPHIRIONTM DEEP 0.014" OTW PTA BALLOON<br>CATHETER is intended to dilate stenoses in the iliac, femoral, ilio-<br>femoral, popliteal, infra-popliteal, and renal arteries, and for the<br>treatment of obstructive lesions of native or synthetic arteriovenous<br>dialysis fistulae. |
| Device Description | The AMPHIRION DEEP catheter has a semi-compliant inflatable balloon mounted at the distal tip. It has a coaxial lumen. The central lumen of the catheter, which terminates at the distal tip, is used to pass the catheter over a guidewire with a maximum outer diameter of 0.014 inch. The other lumen is the balloon inflation lumen, which is used to inflate and deflate the dilatation balloon with a mixture of contrast medium and saline solution. The catheter tapers beneath the balloon segment to achieve the lowest possible deflated profile. 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 (balloon included). The AMPHIRION DEEP catheter is available in different balloon sizes (balloon diameters of 1.5 and 2.0 mm and balloon lengths of 20, 40, 80 and 120 mm). Nominal balloon diameter and length are printed on the hub. The maximum recommended guidewire diameter is 0.014" and the usable catheter length is 120cm. |
| Biocompatibility | All material used in the AMPHIRION DEEP catheter are biocompatible, based on test results. |
| Performance Data | In-vitro testing was conducted to demonstrate the safety and effectiveness of the AMPHIRION DEEP catheter. This testing included balloon compliance, balloon burst pressure, balloon fatigue, shaft burst pressure, bond strength, catheter dimensions and guidewire and introducer compatibility. |
| Summary of Substantial<br>Equivalence | The AMPHIRION DEEP catheter is similar to the predicates with respect to intended use and with respect to physical characteristics, such as catheter and balloon dimensions and catheter design and materials. The AMPHIRION DEEP catheter is therefore substantially equivalent to the predicate devices. Mechanical and biocompatibility testing data is indicative of the safety and effectiveness of the AMPHIRION DEEP catheter. Therefore, based on its own performance characteristics and the technological similarities, the AMPHIRION DEEP catheter is expected to perform similar to the predicate devices and other comparable, currently marketed PTA catheters. |
| Conclusion | The AMPHIRION DEEP catheter is substantially equivalent to the predicate devices and other currently marketed PTA catheters. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping chevrons or swooshes, creating a sense of movement or flow.

JAN 1 0 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042624 Trade Name: AMPHIRION DEEP PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II (two) Product Code: DQY Dated: September 24, 2004 Received: September 27, 2004

Dear Mr. Winegar:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 9 rotty premeined 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 manatis and the Medical Device American so to commerce prior to May 28, 1976, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the dis devices that have been icclassified in accercance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval one You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, merciole, market the device, experients for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), in If your device is crassified (see above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller a Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous of concerning your device in the Federal Register.

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Page 2 – Mr. Mike Winegar

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession requirements of the Act
that FDA has made a determination that your device complies with other matt that FDA has made a determination that your active federal agencies. You must of any Federal statutes and regulations annualines but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 820); good if applicable, the electronic Iorni in the quality systems (QD) regalates (Sections 531-542 of the Act); 21 CFR 1000-1050. product fadiation control provisions (Decleons De Levice as described in your Section 5 10(k) I his letter will anow you to begin manceing your and equivalence of your device to a legally premarket nothication. The PDA maing of backers on the said 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 arvice for your as 1100 % 276-0120. Also, please note the regulation entitled, p Colliact the Office of Complians as (21 trip Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, International and Oolisanter : 16www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Danna R. Victines

Bram D. Zuckerman, M.D. ﮐﮯ 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: KC)42624

Device Name: AMPHIRION™ DEEP 0.014" OTW 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
(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)

Muna R. Vochner
(Division Sign-Off)

ovision of Cardiovascular Devices

510(k) Number_KO

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