SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX

K042538 · Invatec Innovative Technologies · DQY · Nov 8, 2004 · Cardiovascular

Device Facts

• Record ID: K042538
• Device Name: SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX
• 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 SAILOR PLUS 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.

Device Story

SAILOR PLUS is an Over-The-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) catheter featuring a semi-compliant inflatable balloon at the distal tip. Used by physicians in clinical settings to treat arterial stenoses and arteriovenous dialysis fistulae. Device includes dual lumen design (guidewire and inflation lumens) and two radiopaque markers for positioning. Tapered tip facilitates entry into peripheral arteries and crossing of tight stenoses. Physician advances catheter over a 0.035" guidewire to the lesion site; balloon is inflated to dilate the vessel. Output is mechanical dilation of the vessel, improving blood flow. Benefits include restoration of patency in peripheral vasculature and dialysis access sites.

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 provided.

Technological Characteristics

OTW PTA catheter; semi-compliant balloon; dual lumen; radiopaque markers; tapered tip. Compatible with 0.035" guidewires. Available in 3-12mm balloon diameters, 20-120mm balloon lengths, and 40-130cm catheter lengths. 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 OPTA™ PRO Balloon Dilatation Catheter

Submission Summary (Full Text)

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

K042538
page 1 of 2

510(k) Summary SAILOR 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 | SAILOR PLUS Percutaneous Transluminal Angioplasty (PTA)<br>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 OPTA™ PRO Balloon Dilatation Catheter |
| Intended use | The SAILOR PLUS PTA Balloon Dilatation Catheter is intended to<br>dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-<br>popliteal, and renal arteries, and for the treatment of obstructive<br>lesions of native or synthetic arteriovenous dialysis fistulae. |
| Device Description | The SAILOR PLUS Balloon Dilatation Catheter is OTW PTА<br>catheter with a semi-compliant inflatable balloon mounted at the<br>distal tip. It has a dual lumen catheter with a guidewire lumen and<br>a balloon inflation lumen. Two radiopaque markers indicate the<br>dilating portion of the balloon and help in correctly positioning the<br>balloon within the vessel. The catheter tip is tapered to ease entry<br>into peripheral arteries and to facilitate the crossing of tight<br>stenoses. The maximum recommended guidewire diameter is<br>0.035". The device is available in balloon diameters of 3-12mm,<br>balloon lengths of 20, 40, 60, 80 and 120mm and catheter lengths<br>of 130. 80 and 40cm |
| Biocompatibility | All material used in SAILOR PLUS Percutaneous Transluminal<br>Angioplasty (PTA) Catheter are biocompatible based on the<br>biocompatibility testing. |
| Performance data | In vitro testing was conducted to demonstrate the safety and<br>effectiveness of SAILOR 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 SAILOR PLUS Balloon Dilatation Catheter is similar to the<br>predicate with respect to intended use and to physical<br>characteristics, such as catheter and balloon dimensions and catheter<br>design and materials. Further, the mechanical and biocompatibility<br>testing data is indicative of the safety and effectiveness of SAILOR<br>PLUS Balloon Dilatation Catheter. |
| Conclusion | SAILOR PLUS Balloon Dilatation Catheter is substantially<br>equivalent to the Predicate device |

| Sailor Plus PTA Balloon Dilatation Catheter Traditional 510(k)
510(k) Summary

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

.

·

04533

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the 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: K042538

K042336
SAILOR PLUS™ 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 indication We have reviewed your Section J I (t), I premaint is substantially equivalent (for the indications
referenced above and have determined the device is substantially equivaled referenced above and nave detenmitted the devices marketed in interstate for use stated in the enclosure) to tegally inanced to the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment of the Federal Food. Drug. commerce prior to May 28, 1976, the enactinent and or or the Federal Food. Drug, devices that have been reclassified in accordance who areas approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the gents for annual registration, listing of
general controls provisions of the Act include required whileities anainet mis general controls provisions of the Act morade requirement.
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 aove) mits chass in expendsions affecting your device can
may be subject to such additional controls. Existing major regulations allection, may be subject to such adultional controlis: Extrems, "And to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 Register be found in the Code of Federal Regarations, 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 Ticase oc advised that I Dr Pressunt to syour device complies with other requirements of the Act that I Dri has made a sond regulations administered by other Federal agencies. You must or any I cacal statutes and regainents and limited to: registration and listing (21 Comply with an the Act 8 requirements) (1); good manufacturing practice requirements as set CFR Part 6077, adoning (21 OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product including on to begin marketing your device as described in your Section 510(k) rms letter will and w you've obgen finding of substantial equivalence of your device to a legally promative noticate 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 spocific ac ripliance 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 sales and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

(2017-15-05) fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blummenfor

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:

Device Name: SAILOR™ PLUS PTA Balloon Dilatation Catheter

Indications For Use:

The SAILOR™ PLUS 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 V (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)

Bhummmmar
(Division Sign Off)

(Division Sign-Off) Division of Cardlovascular Devices 510fk) Number KO *

Page 1 of