RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER

K123544 · Ev3, Inc. · LIT · Feb 12, 2013 · Cardiovascular

Device Facts

• Record ID: K123544
• Device Name: RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
• Applicant: Ev3, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Feb 12, 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 stenosis 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

RapidCross is a rapid exchange (RX) coaxial PTA balloon dilatation catheter compatible with 0.014" guidewires. It features a distally mounted semi-compliant inflatable balloon with an atraumatic, tapered tip and a lubricious coating. The device is used by physicians in clinical settings to treat peripheral artery stenoses and arteriovenous dialysis fistulae. The physician inserts the catheter over a guidewire, positioning the balloon across the lesion using radiopaque markers. The balloon is inflated/deflated via a manifold using a contrast/saline mixture. Proper positioning is facilitated by proximal depth marks on the shaft. By dilating the vessel, the device restores blood flow, potentially improving patient outcomes in peripheral vascular disease.

Clinical Evidence

Bench testing only. Testing included crossing profile, balloon burst strength, compliance, fatigue, inflation/deflation time, bond tensile strength, kink resistance, tracking, pushability, and radiopacity. Biocompatibility testing was performed per ISO 10993-1 for short-duration blood contact (<24 hours), including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogenicity, complement activation, and thromboresistance. All tests met acceptance criteria.

Technological Characteristics

Rapid exchange (RX) coaxial catheter; 0.014" guidewire compatibility; 4F sheath compatibility. Features semi-compliant inflatable balloon, atraumatic tapered tip, and lubricious coating. Radiopaque marker bands for positioning. Available in 2-4 mm diameters and 20-210 mm lengths. Sterilization method is consistent with predicate devices.

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, K090849)
• PowerCross™ .018 OTW PTA Dilatation Catheter (K093286)
• Sterling™ Monorail™ PTA Balloon Dilatation Catheter (K053118)
• Advance® 14LP Low Profile PTA Balloon Dilatation Catheters (K090822)

Submission Summary (Full Text)

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K1235244
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Image /page/0/Picture/1 description: The image shows the logo for ev3, a medical device company. The logo consists of the letters "ev3" in a stylized font, with three black circles above the letters. To the right of the logo is the tagline "Your endovascular company."

## 510(k) Summary

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FEB 1 2 2013

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| | FEB 1 2 20<br>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 C.F.R §807.92. |
| Applicant | ev3 Inc. |
| Submitter | ev3 Inc.<br>3033 Campus Drive<br>Plymouth, MN 55441-2651 |
| Contact Person | Laura J. Lind |
| Date Prepared | February 6, 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 Codes LIT, DQY) |
| Classification Panel | Cardiovascular |
| Predicate Devices | NanoCross™ .014 OTW PTA Dilatation Catheter (K082854,<br>K090849), PowerCross™ .018 OTW PTA Dilatation Catheter<br>(K093286), Sterling™ Monorail™ PTA Balloon Dilatation<br>Catheter (K053118), and Advance® 14LP Low Profile PTA<br>Balloon Dilatation Catheters (K090822). |
| Intended use | The RapidCross™ PTA Rapid Exchange Balloon Dilatation<br>Catheter is intended to dilate stenosis 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. |
| 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 |
| | Tel: [phone]<br>Fax: [phone] |

ev3 Corporate World Headquarters / Peripheral Vascular - 3053 Campus Dive, Flynnesh, MN 55441, USA - Ph - 1763 398 7050

ev3 Neurovascular • 9775 Tolodo V/ay, Irvine, CA 92618 • Ph • 1 949 837 3700

.

ev3 Europe / International Headquarters • 108/108 ₪e La Reètie. 75008 Paris, Firaco • Ph [phone]

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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. On the 150 mm and 210 mm devices, two additional marker bands denote the middle of the balloon body. A guidewire lumen starts at a guidewire port located 35 cm from the catheter tip and extends to the distal tip. The 90 cm useable length devices have proximal depth marks printed on the proximal shaft at lengths of 55 cm and 65 cm from the distal tip while the 170 cm useable length devices have depth marks at 90 cm and 100 cm to serve as a reference during catheter insertion.

The RapidCross catheter is available in balloon sizes ranging from 2 mm to 4 mm in diameter and 20 mm to 210 mm in length; and, all sizes are compatible with 4 F sheaths.

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:

| • 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 device was tested for biocompatibility per ISO 10993-1 for <24 hours). The testing 1, intracutaneous reactivity, , pyrogen, complement tial thromboplastin time, and platelet/leukocyte count.

The RapidCross catheter met all acceptance criteria for the

| short duration contact with blood |
|--------------------------------------|
| included cytotoxicity, sensitization |
| acute systemic toxicity, hemolysis |
| activation, thromboresistance, part |
| platelet/leukocyte count |

## Performance data

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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 RapidCross catheter is determined to perform as safely and effectively as the predicates for its intended use.

The RapidCross PTA Rapid Exchange Balloon Dilatation Catheter has the following similarities to the predicate devices:

- Same intended use (all predicates) ●
- Same indications for use (NanoCross PTA Dilatation . Catheter)
- Similar fundamental scientific technology (all predicates) .
- Similar operating principle (all predicates) .
- Similar technological characteristics .
- Same sterility assurance level and sterilization method . (NanoCross)

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 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 RapidCross catheter indications for use are the same as the ev3 NanoCross PTA Dilation Catheter indications for use. The minimal differences between RapidCross and indications for use of the other predicates do not raise new safety and effectiveness questions.

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 NanoCross .014 OTW PTA Balloon Dilatation Cathetat (K082854, K090849), PowerCross PTA Dilatation Catheter (K093286) Sterling Monorail PTA Balloon Dilatation Catheter (K053118), and Advanced LP Dilatation Catheter (K090822).

## Summary of Substantial Equivalence

Conclusion

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem is a symbol of an eagle with outstretched wings, representing protection and care, which is a common symbol used by the HHS.

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

FEB 1 2 2013

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

Re: K123544

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, DQY Dated: January 23, 2013 Received: January 24, 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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours.

Matthew G. Hillebrenner

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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## Indications for Use Statement

510(k) Number (if known): K123544

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.

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)

M.A. Hillel

(Division Sign-Off) Division of Cardiovascular Devices

K123544 510(k) Number