ADMIRAL XTREME PTA CATHETER

K062809 · Invatec Innovative Technologies · DQY · Oct 18, 2006 · Cardiovascular

Device Facts

• Record ID: K062809
• Device Name: ADMIRAL XTREME PTA CATHETER
• Applicant: Invatec Innovative Technologies
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ADMIRAL XTREME™ (PTA) 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

ADMIRAL XTREME™ PTA Catheter is an over-the-wire (OTW) balloon dilatation catheter; features semi-compliant inflatable balloon at distal tip; dual lumen design (guidewire and inflation lumens). Used by physicians in clinical settings for percutaneous transluminal angioplasty. Radiopaque marker bands facilitate visual positioning under fluoroscopy. Hydrophilic coating on distal shaft and balloon cones reduces friction. Device enables mechanical dilation of arterial stenoses and dialysis fistula lesions; improves vessel patency; restores blood flow.

Clinical Evidence

Bench testing only. In vitro testing demonstrated equivalent performance to predicate, including balloon compliance, burst pressure, fatigue, shaft burst pressure, bond strength, dimensions, deflation time, and guidewire/introducer compatibility.

Technological Characteristics

OTW PTA catheter; semi-compliant balloon; dual lumen; radiopaque marker bands; hydrophilic coating on distal shaft and balloon cones. Max guidewire diameter 0.035". Balloon diameters 3-12mm; lengths 20-120mm; catheter lengths 80-130cm. Non-software device.

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

• SAILOR PLUS™ Percutaneous Transluminal Angioplasty (PTA) Catheter (K042538)

Submission Summary (Full Text)

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

KOG2809 p. 4x(2

## 510(k) Summary
per of 21 C.F.R § 807.92

| Manufacturer's Name and<br>Address | Invatec Innovative Technologies<br>Via Martiri della Libertà, 7<br>25030 Roncadelle (BS) Italy<br>Tel: [phone]<br>Fax: [phone]<br>www.invatec.com<br>[e-mail]<br>OCT 1 8 2006 |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter's Name and<br>Address | ev3 Inc.<br>4600 Nathan Lane North<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | David Worrell<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | September 18, 2006 |
| Device Trade Name | ADMIRAL XTREME™ Percutaneous Transluminal Angioplasty<br>(PTA) Catheter |
| Device Common Name | Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation<br>Catheter |
| Classification Name | 21 CFR 870.1250 Percutaneous Catheter |
| Device Classification<br>Classification Panel | Regulatory Class: Class II |
| | Product Code: LIT<br>Cardiovascular |
| Predicate Device | SAILOR PLUS™ Percutaneous Transluminal Angioplasty (PTA)<br>Catheter - K042538, cleared November 8, 2004 |
| Intended use | The ADMIRAL XTREME™ (PTA) Catheter is intended to dilate<br>stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal,<br>and renal arteries, and for the treatment of obstructive lesions of<br>native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The ADMIRAL XTREME™ PTA Catheter is an OTW PTA<br>catheter with a semi-compliant inflatable balloon mounted at the<br>distal tip. It is a dual lumen catheter with a guidewire lumen and a<br>balloon inflation lumen. The catheter tapers beneath the balloon<br>segment to achieve the lowest possible deflated profile. Two<br>radiopaque marker bands are placed under the balloon segment of<br>the catheter shaft to provide visual reference points for balloon<br>positioning within the vessel. The distal catheter shaft and balloon<br>cones are hydrophilic coated (balloon excluded). The maximum<br>recommended guidewire diameter is 0.035". The device is available<br>in balloon diameters of 3-12mm, balloon lengths of 20, 40, 60, 80<br>and 120mm and catheter lengths of 80 and 130cm. |
| Biocompatibility | All materials used in the ADMIRAL XTREME™ PTA Catheter are |
| Performance data | biocompatible based on biocompatibility testing results.<br>In vitro testing was conducted to demonstrate equivalent<br>performance of the ADMIRAL XTREME™ Percutaneous<br>Transluminal Angioplasty (PTA) Catheter with the predicate device.<br>The testing included balloon compliance, balloon burst pressure,<br>balloon fatigue, shaft burst pressure, bond strength, catheter<br>dimensions, deflation time and guidewire and introducer<br>compatibility. |
| Summary of Substantial<br>Equivalence | The ADMIRAL XTREME™ Percutaneous Transluminal<br>Angioplasty (PTA) Catheter is identical to the predicate device with<br>respect to intended use, catheter design and balloon dimensions.<br>The mechanical and biocompatibility testing data met the specified<br>requirements for the ADMIRAL XTREME™ Percutaneous<br>Transluminal Angioplasty (PTA) Catheter and are comparable with<br>the predicate device. |
| Conclusion | Based on the intended use and the technological characteristics, the<br>ADMIRAL XTREME™ PTA Catheter has been shown to be<br>substantially equivalent to the SAILOR PLUS™ PTA Catheter<br>(K0402538, cleared November 8, 2004). |

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

and the comments of the comments of the comments of the comments of

:

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Invatec Innovative Technologies c/o ev3 Inc. Attn: David Worrell 9600 54th Avenue North Plymouth, MN 55442-2111

OCT 1 8 2006

Re: K062809

Trade/Device Name: ADMIRAL XTREME™ PTA Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: September 18, 2006 Received: September 19, 2006

Dear Mr. Worrell:

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, Trug, 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, EDA 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 not the Act

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

## Page 2 – Mr. David Worrell

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.

Duna R. Vachner

Image /page/3/Picture/5 description: The image shows a handwritten symbol or character. It appears to be a combination of curved and angular lines, possibly resembling a stylized letter or signature. The symbol is drawn with a thick stroke, giving it a bold appearance. The overall impression is abstract and difficult to interpret without additional context.

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): Kolo2809

Device Name: ADMIRAL XTREME™ PTA Catheter

Indications for Use:

The ADMIRAL XTREME™ PTA Balloon Dilatation 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) 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)

Donna R. Vorhies

Division Sich-Off) Division of Cardiovascular Devices

510/k) Number_K062809

Page 1 of 1