NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER

K141118 · Ev3, Inc. · LIT · Jul 18, 2014 · Cardiovascular

Device Facts

• Record ID: K141118
• Device Name: NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
• Applicant: Ev3, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

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 with two radiopaque markers for positioning; atraumatic tapered tip; lubricious coating. Operated by physicians in clinical settings to treat peripheral artery stenoses and arteriovenous dialysis fistulae. Inflation/deflation performed via balloon lumen using contrast/saline mixture. Device tracks over guidewire to lesion site; balloon inflation dilates vessel or stent. Benefits include restoration of blood flow in peripheral vasculature.

Clinical Evidence

Bench testing only. Testing included dimensional verification (crossing profile, balloon OD/length, tip ID), balloon performance (rated burst pressure, compliance, fatigue), mechanical integrity (pull-back force, pushability, torque strength, kink, bond strength), and biocompatibility per ISO 10993-1. Results met all acceptance criteria and were comparable to predicate devices.

Technological Characteristics

OTW coaxial catheter; 0.014" guidewire compatibility. Semi-compliant balloon; radiopaque markers. Lubricious coating. Balloon sizes: 1.5 mm to 6 mm diameter; 20 mm to 210 mm length. Biocompatibility per ISO 10993-1. Sterilization method: standard industry process.

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™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter (K132777)
• PowerCross™ 0.018" OTW PTA Dilatation Catheter (K093286)

Submission Summary (Full Text)

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K141118 p. 1 of 3

Image /page/0/Picture/1 description: The image shows the logo for "ev3", a company that specializes in endovascular products. The logo features the letters "ev3" in a stylized font, with three circles arranged in a triangular pattern above the letters. To the right of the logo, the text "Your endovascular company." is written in a smaller font.

JUL 1 8 2014

# 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] | | |
| Contact Person | Laura J. Lind | | |
| Date Prepared | June 18, 2014 | | |
| 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™ Elite 0.014" Over-the-Wire PTA Balloon<br>Dilatation Catheter (K132777), PowerCross™ 0.018" OTW PTA<br>Dilatation Catheter (K093286). | | |
| 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 | | |

ev3 Corporate World Meadquarters / Peripheral Vascular - 3033 Carryus Drive, Plynouth, MN 55411, USA - Ph + 1 763 398 7000

ev3 Neurovascular - 9775 Toledo Way, Irvine, CA 92618 - Ph [phone]

ev3 Europe / International Headquarters - 106/108 r.je La Boétie, 75008 Paris, France · Ph [phone]

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p. 2 of 3

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

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 6 mm in diameter, and from 20 mm to 210 mm in length; reference labeling for introducer sheath compatibility.

## Performance data

Bench testing was 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.

| • Dimensional Verification:<br>Crossing Profile | • Dimensional Verification:<br>Balloon OD |
|-------------------------------------------------|---------------------------------------------------------|
| • Balloon Rated Burst Pressure | • Balloon Rated Burst Pressure (In Stent) |
| • Balloon Compliance | • Radiopacity |
| • Balloon Pull-back Force | • Presence of Coating |
| • Dimensional Verification:<br>Balloon Length | • Dimensional Verification:<br>Tip/Lesion Entry Profile |
| • Inflation/Deflation Time | • Pushability |
| • Balloon Fatigue | • Dimensional Verification: Tip ID |
| • Catheter Bond Strength | • Wire Movement |
| • Kink | • Re-Insertion Force |
| • Device Tracking | • Catheter Working Length |
| • Insertion Force | • Torque Strength |
| • Particle Generation | • Coating Durability |

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:

Biocompatibility per ISO 10993-1

The NanoCross Elite catheter met all acceptance criteria for the 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.

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

| Summary of<br>Substantial<br>Equivalence | The NanoCross Elite catheter has the following similarities to<br>one or more of the predicate devices:<br>Same fundamental scientific technology Identical intended use Same operating principle Identical balloon rated burst pressures Identical balloon nominal pressure Similar balloon diameters Similar balloon lengths Identical catheter lengths A lubricious coating Packaged with the same materials and processes Same sterility assurance level and sterilization method |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The devices are compatible with 0.014" guidewires. All devices<br>have similar construction and principles of operation. All<br>devices are used by the physician in a similar manner typical of<br>PTA balloon catheters.<br>The NanoCross Elite catheter and the predicates have the same<br>intended use - all devices are intended to treat peripheral arteries.<br>All devices are intended to treat the same target population. The<br>manner in accessing and treating lesions is the same. |
| Conclusion | Based on the intended use, technological characteristics, and<br>results from safety and performance testing, the modified<br>NanoCrossTM Elite 0.014" Over-the-Wire PTA Balloon<br>Dilatation Catheter is considered substantially equivalent to the<br>legally marketed predicate devices NanoCrossTM Elite 0.014"<br>Over-the-Wire PTA Balloon Dilatation Catheter (K132777) and<br>PowerCrossTM .018" OTW PTA Dilatation Catheter (K093286). |

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Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. The image is black and white.

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 18, 2014

ev3 Inc. Ms. Brenda Johnson Regulatory Affairs Manager 3033 Campus Drive Suite N550 Plymouth, MN 55441

Re: K141118

> Trade/Device Name: NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 871.1250 Regulation Name: Catheter, Angioplasty, Peripheral, Transluminal Regulatory Class: Class II Product Code: LIT Dated: June 18, 2014 Received: June 19, 2014

Dear Ms. Johnson,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Brenda Johnson

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

**Kenneth J. Cavanaugh -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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017 See PRA Statement below.

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) ה/a

Device Name

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

#### Indications for Use (Describe)

The NanoCross™ Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the illias, femoral, ilio-femoral, 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.

| CONSULERS CONNUIL I AN AN AND LINE LINE LE LE SENSIO LEBE | Income of experience of the property of the property of the program and |
|-----------------------------------------------------------|-------------------------------------------------------------------------|
| Type of Use (Select one or both, as applicable) | |

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY J. 3"

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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