SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX

K042537 · Invatec Innovative Technologies · DQY · Nov 8, 2004 · Cardiovascular

Device Facts

• Record ID: K042537
• Device Name: SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX
• Applicant: Invatec Innovative Technologies
• Product Code: DQY · Cardiovascular
• Decision Date: Nov 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SUBMARINE PLUS Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

SUBMARINE PLUS is a coaxial PTA catheter with a semi-compliant inflatable balloon at the distal tip; designed for percutaneous transluminal angioplasty. The device is tracked over a 0.018-inch guidewire to the target vessel site. The balloon is inflated using a contrast medium/saline mixture to dilate stenoses or obstructive lesions in peripheral arteries and dialysis fistulae. Two radiopaque marker bands under the balloon facilitate fluoroscopic positioning. The distal shaft features a hydrophilic coating to improve trackability. Used by physicians in clinical settings (e.g., interventional radiology or vascular surgery suites). The device provides mechanical dilation of vascular obstructions, potentially restoring blood flow and improving patient outcomes in peripheral arterial disease or dialysis access maintenance.

Clinical Evidence

Bench testing only. Testing included balloon compliance, burst pressure, fatigue, shaft burst pressure, bond strength, catheter dimensions, and guidewire/introducer compatibility. No clinical data presented.

Technological Characteristics

Coaxial lumen catheter with semi-compliant balloon; hydrophilic coating on distal shaft; radiopaque marker bands; compatible with 0.018" guidewires; available in diameters 2.0-7.0mm and lengths 20-120mm; usable lengths 90cm or 130cm. 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

• Cordis SAVVY™ Balloon Dilatation Catheter

Submission Summary (Full Text)

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

K042537
page 1 of 2

## 510(k) Summary

## SUBMARINE PLUS Percutaneous Transluminal Angioplasty (PTA) 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<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 17th, 2004 |
| Device Trade Name | SUBMARINE PLUS Percutaneous Transluminal Angioplasty<br>(PTA) 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 Device | Cordis SAVVY™ Balloon Dilatation Catheter |
| Intended use | The SUBMARINE PLUS Balloon Dilatation Catheter is intended to<br>dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra<br>popliteal, renal arteries and for the treatment of obstructive lesions<br>of native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The SUBMARINE PLUS Balloon Dilatation Catheter is a catheter<br>with a semi-compliant inflatable balloon mounted at the distal tip.<br>It has a coaxial lumen. The central lumen of the catheter, which<br>terminates at the distal tip, is used to pass the catheter over a<br>guidewire with a maximum outer diameter of 0.018 inch (0.45 mm).<br>The other lumen is the balloon inflation lumen, which is used to<br>inflate and deflate the dilatation balloon with a mixture of contrast<br>medium and saline solution. 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 |
| page dot d | |
| | positioning within the vessel. The distal catheter shaft is hydrophilic<br>coated (balloon excluded). The SUBMARINE PLUS Balloon<br>Dilatation Catheter is available in different balloon sizes (balloon<br>diameters of 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 and 7.0mm and<br>balloon lengths of 20, 40, 60, 80 and 120mm). Nominal balloon<br>diameter and length are printed on the hub. The maximum<br>recommended guidewire diameter is 0.018" and the usable catheter<br>length is 130 or 90 cm. |
| Biocompatibility | All material used in SUBMARINE PLUS Percutaneous<br>Transluminal Angioplasty (PTA) Catheter are biocompatible based<br>on the biocompatibility testing. |
| Performance data | In vitro testing was conducted to demonstrate the safety and<br>effectiveness of SUBMARINE PLUS Percutaneous Transluminal<br>Angioplasty (PTA) Catheter. The testing included balloon<br>compliance, balloon burst pressure, balloon fatigue, shaft burst<br>pressure, bond strength, catheter dimensions and guidewire and<br>introducer compatibility. |
| Summary of Substantial<br>Equivalence | The SUBMARINEPLUS Balloon Dilatation Catheter is similar to<br>the predicate with respect to the intended use, and with respect to<br>their physical characteristics, such the catheter and balloon<br>dimensions and catheter design and material. SAILOR PLUS<br>Balloon Dilatation Catheter is therefore substantially equivalent to<br>the Predicate device. Further, the mechanical and biocompatibility<br>testing data is indicative of the safety and effectiveness of<br>SUBMARINE PLUS Balloon Dilatation Catheter. Therefore based<br>on its own performance characteristics and the technological<br>similarities, SUBMARINE PLUS Balloon Dilatation Catheter is<br>expected to perform similar to the predicate device and other<br>comparable, currently marketed PTA catheters. |
| Conclusion | SUBMARINE PLUS Balloon Dilatation Catheter is substantially<br>equivalent to the Predicate device and other currently marketed PTA<br>catheters. |

Submarine Plus OTW PTA Balloon Catheter
Traditional 510(k) 510(k) Summary

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

.

·

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

Image /page/2/Picture/2 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2004

Invatec Innovative Technologies c/o Mr. Mike Winegar Vice President, International RA ev3 Inc. 4600 Nathan Lane North Plymouth, MN 55442

Re: K042537

KU42337
SUBMARNE PLUSTM Percutaneous Transluminal Angioplasty (PTA) Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: September 17, 2004 Received: September 20, 2004

Dear Mr. Winegar:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 310(x) premained in the tabstantially equivalent (for the indications
referenced above and have determined the device is substantial in intersta referenced above and nave declinined the arrased predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Amendments, or to
commerce prior to May 28, 1976, the enactment at the Federal Food. Dou commerce prior to May 28, 1970, the chactinent and of the Federal Food. Drug, devices that have been recults in accordance with as proval application (PMA).
and Cosmetic Act (Act) that do not require approval assesses approvisions of the Act. The and Cosmetic Act (Act) that do not require approval or a provisions of the Act. The
You may, therefore, market the device, subject to the general controls provisions of the You may, therefore, market the device, subject to the gentlation annual registration, listing of
general controls provisions of the Act include requirements misbranding and general controls provisions of the Act morate requirements.
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 If your device is classified (see above) mo exisi crows in trepulations affecting your device can
may be subject to such additional controls. Tim may be subject to such additions. Laisung major regal to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Pederal Regaraters, concerning your device in the Federal Register.

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

Page 2 - Mr. Mike Winegar

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be deviloed alla i termination that your device complies with other requirements of the Act that I Dri has made a active and regulations administered by other Federal agencies. You must or uny I cather 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 CFK in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also quarty 25 cool provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including in begin marketing your device as described in your Section 510(k) This icter will anow you to begin inding of substantial equivalence of your device to a legally promaticated 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 If you docure 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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Bhimmer for

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

Enclosure

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

## Indications for Use

510(k) Number: K04 2537

Device Name: SUBMARINE™ PLUS PTA Balloon Dilatation Catheter

Indications For Use:

The SUBMARINE™ PLUS 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 (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)

Blommor

Sivision Sign-Off) Division of Cardiovascular Devices 510(k) Number_

Page I of

Submarine Plus PTA Balloon Catheter Traditional 510(k) 510(k) Body