MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150

K090849 · Ev3, Inc. · DQY · May 1, 2009 · Cardiovascular

Device Facts

• Record ID: K090849
• Device Name: MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
• Applicant: Ev3, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 1, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NanoCross .014" OTW PTA 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

Over-the-wire (OTW) 0.014" coaxial lumen catheter; features distally mounted semi-compliant inflatable balloon; atraumatic tapered tip; hydrophilic coating on distal shaft and balloon. Operates via inflation/deflation of balloon using contrast/saline mixture; radiopaque markers facilitate positioning relative to stenosis. Used by physicians in clinical settings for percutaneous transluminal angioplasty (PTA). Provides mechanical dilation of arterial stenoses and dialysis fistula lesions to improve blood flow.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Coaxial lumen catheter; semi-compliant balloon; hydrophilic coating; radiopaque marker bands. 0.014" guidewire compatibility. Sterilized product.

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

• NanoCross™ .014" OTW PTA Dilatation Catheter (K082854)

Submission Summary (Full Text)

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K090849

MAY - 1 2009

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## 510(k) Summary

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ev3 Corporate

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# NanoCross™ .014* OTW PTA Dilatation Catheter

| 510(k) Summary | This summary of 510(k) safety and effectiveness information is<br>being submitted in accordance with the requirements of 21 CFR<br>§ 807.92. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.<br>9600 54th Ave N<br>Plymouth, MN 55442<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person | Sara Bakker<br>Regulatory Affairs Specialist |
| Date Prepared | March 27, 2009 |
| Device Trade Name | NanoCross .014" OTW PTA Dilatation Catheter |
| Device Common Name | PTA Dilatation Catheter |
| Classification Name | Catheter, Percutaneous (21 CFR 870.1250, Product Code DQY) |
| Classification Panel | Cardiovascular |
| Predicate Device | NanoCrossTM .014" OTW PTA Dilatation Catheter (K082854) |
| Intended use | The NanoCross .014" OTW PTA Dilatation Catheter is<br>intended to dilate stenoses in the iliac, femoral, ilio-femoral,<br>popliteal, infra-popliteal, and renal arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. |
| Device Description | The NanoCross .014" OTW PTA Dilatation Catheter is an over<br>the wire (OTW) 0.014" coaxial lumen catheter with a distally<br>mounted semi-compliant inflatable balloon and an atraumatic,<br>tapered tip. The distal portion of the catheter shaft and the<br>balloon has a hydrophilic coating. The manifold includes a<br>lumen marked "THRU". This is the central lumen of the catheter<br>that terminates at the distal tip. This lumen is used to pass the<br>catheter over a guidewire with a maximum outer diameter of<br>0.014". The lumen marked "BALLOON" is used to inflate and<br>deflate the dilatation balloon with a solution of contrast medium<br>and saline. The balloon has two radiopaque markers for<br>positioning the balloon relative to the stenosis. The radiopaque<br>marker bands indicate the dilating or working section of the<br>balloon. The 210mm balloon contains two additional<br>radiopaque marker bands that denote the middle of the balloon<br>body. |
| Performance data | Bench testing was performed to support a determination of<br>substantial equivalence. Results from this testing provide<br>assurance that the proposed device has been designed and tested<br>to assure conformance to the requirements for its intended use. |

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K090849

### Summary of Substantial Equivalence

The 210mm NanoCross .014" OTW PTA Dilatation Catheter has the following similarities to the legally marketed NanoCross .014" OTW PTA Dilatation Catheter:

- Same indicated use, t
- Same operating principle, . ●
- · · Same device materials,
- . Same basic catheter design,
- Same shelf life, .
- Same packaging and sterilization processes. .

Based on the intended use, technological characteristics, safety and performance testing, the 210mm NanoCross .014" OTW PTA Dilatation Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the legally marketed NanoCross .014" OTW PTA Dilatation Catheter (K082854).

Conclusion

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a bird or eagle, with its wings spread and head turned to the side.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 1 2009

ev3 Inc. c/o Ms. Sara Bakker Regulatory Affairs Specialist 9600 54" Avenue North Plymouth, MN 55442

Re: K090849

NanoCross .014" OTW PTA Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: April 22, 2009 Received: April 23, 2009

Dear Ms. Bakker:

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.

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.

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Page 2 - Ms. Sara Bakker

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Dma R. be Ames

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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## Page 1 of 1

#### Indications for Use Statement

510(k) Number (if known): K090849

Device Name: NanoCross™ .014" OTW PTA Dilatation Catheter Indications for Use:

The NanoCross 0.014" OTW PTA 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 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Cardiovascular Devices

510(k) Number_ko90849