RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

K130911 · Ev3, Inc. · LIT · May 24, 2013 · Cardiovascular

Device Facts

• Record ID: K130911
• Device Name: RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
• Applicant: Ev3, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: May 24, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The RapidCross™ PTA Rapid Exchange 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

RapidCross PTA Rapid Exchange (RX) Balloon Dilatation Catheter is a coaxial catheter compatible with 0.014" guidewires. It features a distally mounted semi-compliant inflatable balloon and an atraumatic, tapered tip. The device is used by physicians in clinical settings to dilate stenoses in peripheral arteries and arteriovenous dialysis fistulae, or for stent post-dilatation. The manifold includes an inflation lumen for balloon inflation/deflation. The device facilitates lesion access and treatment, potentially improving blood flow and vessel patency for the patient.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and biocompatibility testing. Bench tests included crossing profile, balloon burst strength, compliance, fatigue, bond tensile strength, kink, tracking, insertion/pull-back forces, radiopacity, coating durability, and particle generation. Biocompatibility testing performed per ISO 10993-1 for short-duration blood contact (<24 hours), including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogen, complement activation, thromboresistance, PTT, and platelet/leukocyte count.

Technological Characteristics

Rapid exchange (RX) coaxial catheter; 0.014" guidewire compatibility; semi-compliant inflatable balloon; atraumatic tapered tip; lubricious coating on distal portion; inflation/deflation manifold. Sterilization method is identical to predicates.

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 the 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

• RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter (K123544)
• PowerCross™ .018 OTW PTA Dilatation Catheter (K093286)

Submission Summary (Full Text)

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K130911 p. 1 of 3

## 510(k) Summary

## MAY 2 4 2013

## RapidCross™ PTA Rapid Exchange 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 | May 21, 2013 | |
| Device Trade Name | RapidCross™ PTA Rapid Exchange 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 | RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter<br>(K123544, cleared February 12, 2013), PowerCross™ .018<br>OTW PTA Dilatation Catheter (K093286, cleared November 13,<br>2009.) | |
| Intended use | The RapidCross™ PTA Rapid Exchange Balloon Dilatation<br>Catheter is intended to dilate stenoses in the iliac, femoral, ilio-<br>femoral, popliteal, infra-popliteal, and renal arteries, and for the<br>treatment of obstructive lesions of native or synthetic<br>arteriovenous dialysis fistulae. This device is also indicated for<br>stent post-dilatation in the peripheral vasculature. | |
| Device Description | The RapidCross PTA Rapid Exchange Balloon Dilatation<br>Catheter (RapidCross catheter) is a rapid exchange (RX) coaxial<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 an inflation lumen, which is used<br>to inflate and deflate the dilatation balloon with a mixture of | |
| Performance data | Bench testing and biocompatibility testing were performed to<br>support a determination of substantial equivalence. Results from<br>this testing provide assurance that the proposed device has been<br>designed and tested to assure conformance to the requirements<br>for its intended use.<br>Using internal Risk Analysis procedures, the following tests<br>were performed on the predicate RapidCross catheter and are<br>leveraged for the modified RapidCross catheter (K123544): | |
| | • Crossing Profile | • Radiopacity |
| | • Balloon Burst Strength | • Presence of Coating |
| | • Balloon Compliance | • Coating Durability |
| | • Balloon OD | • Particle Generation |
| | • Inflation/Deflation Time | • Pushability |
| | • Balloon Fatigue | • Support Wire Securement |
| | • Bond Tensile Strength | • Tip ID / RX Port ID |
| | • Kink | • Tip / Lesion Entry Profile |
| | • Device Tracking | • Re-Insertion Force |
| | • Insertion Force | • Catheter Working Length |
| | • Balloon Pull-back Force | • RX Port Length |
| | • Repeat Inflations (In Stent) | • RX Port OD |
| | • Torque Strength | |
| | The following tests were performed on the modified RapidCross<br>catheter: | |
| | • Balloon Burst Strength (In Stent) | |
| | hemolysis, pyrogen, complement activation, thromboresistance, partial thromboplastin time, and platelet/leukocyte count and is leveraged for the modified RapidCross catheter (K123544). | |
| | The RapidCross 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 RapidCross catheter is determined to perform as safely and effectively as the predicates for its intended use. | |
| Summary of<br>Substantial<br>Equivalence | The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter has the following similarities to the predicate devices:<br>Same intended use Similar indications for use Same fundamental scientific technology Same operating principle Same technological characteristics Identical sterility assurance level and sterilization method | |
| | The RapidCross 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 modified RapidCross catheter indications for use are identical to the ev3 PowerCross PTA Dilation Catheter indications for use. The differences between modified and predicate RapidCross catheters do not raise new safety and effectiveness questions. | |
| Conclusion | Based on the intended use, technological characteristics, and results from safety and performance testing, the RapidCross PTA Rapid Exchange Balloon Dilatation Catheter is considered substantially equivalent to the legally marketed predicate devices RapidCross PTA Rapid Exchange Balloon Dilatation Catheter (K123544) and the PowerCross PTA Dilatation Catheter (K093286). | |

ev3 Corporate World Headquarters / Peripheral Vascular - 3033 Campus Drive, Plymouth, MN 55441, USA - Ph [phone] ev3 Neurovascular • 9775 Toledo Way, Irvine, CA 92618 • Ph + 1 949 837 3700

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The predicate RapidCross catheter 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,

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a thick, black line.

#### Public Health Service

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

May 24, 2013

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

Re: K130911

Trade/Device Name: RapidCross PTA Rapid Exchange Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT Dated: April 1, 2013 Received: April 2, 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. However, we remind you 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

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Page 2 - Mr. Mark Job

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 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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours.

# Bram D. Zoggerman -S

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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### Indications for Use Statement

K130911 510(k) Number (if known):

Device Name: RapidCross™ PTA Rapid Exchange Balloon Dilatation Catheter Indications for Use:

The RapidCross™ PTA Rapid Exchange 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)

Bram I 2013 (