NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER

K132777 · Ev3, Inc. · LIT · Sep 26, 2013 · Cardiovascular

Device Facts

• Record ID: K132777
• Device Name: NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
• Applicant: Ev3, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Sep 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The NanoCross™ Elite 0.014" Over-the-Wire 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. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Device Story

Over-the-wire (OTW) coaxial percutaneous transluminal angioplasty (PTA) balloon catheter; compatible with 0.014" guidewires. Features distally mounted semi-compliant inflatable balloon and atraumatic tapered tip. Manifold includes inflation lumen for contrast/saline mixture and guidewire lumen. Radiopaque markers facilitate positioning relative to stenosis. Used by physicians in clinical settings for peripheral vascular interventions. Device tracks over guidewire to lesion site; balloon inflation dilates stenoses or post-dilates stents. Benefits include restoration of vessel patency and improved blood flow.

Clinical Evidence

Bench testing only. Testing included balloon dimensional verification, rated burst pressure (unconstrained and in-stent), fatigue, compliance, inflation/deflation time, catheter bond strength, kink, tracking, insertion force, pull-back force, torque strength, radiopacity, and pushability. Biocompatibility testing per ISO 10993-1 for short-duration blood contact (<24 hours) included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, PTT, and platelet/leukocyte count. All acceptance criteria met.

Technological Characteristics

OTW coaxial catheter; semi-compliant balloon; lubricious coating. Compatible with 0.014" guidewires and 4F sheaths. Balloon sizes: 1.5-4 mm diameter, 20-210 mm length. Sterilized via validated method. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries; treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae; and stent post-dilatation in peripheral vasculature.

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

• NanoCross™ .014" OTW PTA Dilatation Catheter (K082854, K090849)
• RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter (K130911)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for "ev3", which is described as "Your endovascular company." The logo consists of the letters "ev3" in a stylized font, with three circles above the letters. The text "Your endovascular company." is written in a smaller font to the right of the letters.

# 510(k) Summary

NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter

| 510(k) Summary | This 510(k) summary information is submitted in accordance<br>with the requirements of 21 CFR §807.92. | |
|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Applicant | ev3 Inc. | |
| Submitter | ev3 Inc.<br>3033 Campus Drive<br>Plymouth, MN 55441-2651<br>Tel: [phone]<br>Fax: [phone] | |
| | SEP 2 6 2013 | |
| Contact Person | Laura J. Lind | |
| Date Prepared | July 22, 2013 | |
| Device Trade Name | NanoCross™ Elite<br>0.014" Over-the-Wire<br>PTA Balloon Dilatation Catheter | |
| Device Common Name | PTA Dilatation Catheter | |
| Classification Name | Catheter, Angioplasty, Peripheral, Transluminal<br>(21 CFR §870.1250, Product Code LIT) | |
| Classification Panel | Cardiovascular | |
| Predicate Devices | NanoCross™ .014" OTW PTA Dilatation Catheter (K082854,<br>K090849), RapidCross™ PTA Rapid Exchange Balloon<br>Dilatation Catheter (K130911). | |
| Intended use | The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon<br>Dilatation Catheter is intended to dilate stenoses in the iliac,<br>femoral, ilio-femoral, popliteal, infra-popliteal, and renal<br>arteries, and for the treatment of obstructive lesions of native or<br>synthetic arteriovenous dialysis fistulae. This device is also<br>indicated for stent post-dilatation in the peripheral vasculature. | |
| Device Description | The NanoCross catheter is an over-the-wire (OTW) coaxial<br>lumen percutaneous transluminal angioplasty (PTA) balloon<br>catheter compatible with 0.014"guidewires with a distally<br>mounted semi-compliant inflatable balloon and an atraumatic<br>tapered tip. The distal portion of the catheter has a lubricious<br>coating. The manifold includes a lumen marked "THRU". This<br>is the central lumen of the catheter, which terminates at the distal | |
| • Balloon Dimensional<br>Verification | • Catheter Dimensional<br>Verification | |
| • Balloon Rated Burst Pressure<br>(Unconstrained and In Stent) | • Balloon Fatigue (Unconstrained<br>and In Stent) | |
| • Balloon Compliance | • Inflation/Deflation Time | |
| • Catheter Bond Strength | • Kink | |
| • Device Tracking | • Insertion Force | |
| • Balloon Pull-back Force | • Torque Strength | |
| • Radiopacity | • Presence of Coating | |
| • Re-Insertion Force | • Pushability | |

ev3 Corporate World Headquarters / Peripheral Vascular . 3033 Carryus Drive. Plynouth: MN 55441, USA . Ph [phone] eva Neurovascular - 9775 Tolodo Way, Irving, CA 92618 - Ph 11 949 837 3700 ev3 Europe / International Headquarters . 103/108 г.ю LB Boete, 75008 Paris: France . Ph [phone] : 10

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tip. This lumen is used to pass the catheter over a guidewire with a maximum diameter of 0.014". The lumen marked "BALLOON" 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 balloon has two radiopaque markers for positioning the balloon relative to the stenosis. The radiopaque marker bands indicate the dilating or working section of the balloon.

The NanoCross Elite catheter is available in balloon sizes ranging from 1.5 mm to 4 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.

#### Performance data

Bench testing and biocompatibility testing were performed to support a determination of substantial equivalence. Results from this testing provide assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use.

Using internal Risk Analysis procedures, the following tests were performed for one or more model sizes:

Using the same Risk Analysis procedures, the following tests were leveraged from predicate devices for one or more model sizes:

| • Balloon Dimensional<br>Verification | • Balloon Rated Burst Pressure<br>(Unconstrained and In Stent) |
|---------------------------------------------------|----------------------------------------------------------------|
| • Balloon Fatigue<br>(Unconstrained and In Stent) | • Balloon Compliance |
| • Coating Durability | • Particle Generation |

The device was tested for biocompatibility per ISO 10993-1 for short duration contact with blood (<24 hours). The testing included cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count.

The NanoCross Elite catheter met all acceptance criteria for the

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bench testing with results similar to the predicates. Based on the bench test results, comparison to legally marketed predicates, and non-clinical test results, the NanoCross Elite catheter is determined to perform as safely and effectively as the predicates for its intended use. The NanoCross Elite catheter has the following similarities to Summary of the predicate devices: Substantial Similar fundamental scientific technology Equivalence . Same intended use . . Similar operating principle Identical balloon rated burst pressures � . Similar balloon nominal pressure . Similar balloon diameters Similar balloon lengths . o Similar catheter lengths o A lubricious coating . Same cleanroom and shared manufacturing lines Same sterility assurance level and sterilization method . All devices are compatible with 0.014" wires and 4F sheaths. All devices have similar construction and principles of operation. All devices are used by the physician in a similar manner typical of PTA balloon catheters. The NanoCross Elite catheter and the predicates have the same intended use - all devices are intended to treat peripheral arteries. All devices are intended to treat the same target population. The manner in accessing and treating lesions is similar for the devices. The indications for use are identical to the RapidCross™ Catheter. Based on the intended use, technological characteristics, and Conclusion results from safety and performance testing, the NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is considered substantially equivalent to the legally marketed predicate devices NanoCross" .014" OTW PTA Balloon Dilatation Catheter (K082854, K090849) and RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter (K130911).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 26, 2013

ev3, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K132777

Trade/Device Name: NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter

Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: September 4, 2013 Received: September 5, 2013

Dear Mr. Job:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Todd D. Courtney -S

for

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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## K132777

Page 1_of_1

### Indications for Use Statement

K132777 510(k) Number (if known):

Device Name: NanoCross™ Elite 0.014` Over-the-Wire PTA Balloon Dilatation Catheter

Indications for Use:

The NanoCross™ Elite 0.014" Over-the-Wire 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. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Image /page/5/Picture/12 description: The image shows the FDA logo on the left side. On the right side of the logo, the text "Todd D. Courtney - S" is present. The text is aligned vertically, with "Todd D." on the top, "Courtney -" in the middle, and "S" on the bottom.