POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

K121442 · Cordis Corporation · LIT · Jun 14, 2012 · Cardiovascular

Device Facts

• Record ID: K121442
• Device Name: POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
• Applicant: Cordis Corporation
• Product Code: LIT · Cardiovascular
• Decision Date: Jun 14, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Powerflex™ Pro PTA catheter is intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Device Story

Powerflex™ Pro PTA catheter is a peripheral angioplasty device featuring a distal inflatable balloon and tapered tip. Designed for use with 0.035" guide wires and catheter sheath introducers. Radiopaque marker bands facilitate balloon placement. Operated by physicians in clinical settings to dilate stenoses in peripheral arteries and arteriovenous dialysis fistulae, or to perform post-dilatation of stents. Mechanical operation involves inflation of the balloon to dilate vascular lesions, improving blood flow and vessel patency. Benefits include minimally invasive treatment of obstructive vascular disease.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included marker band spacing, balloon diameter, system burst (inflation and guide wire lumens), pull strength, CSI insertion/withdrawal, kink diameter, inflation/deflation time, fatigue, torque, particle testing, hemolysis, balloon working length, and biocompatibility per ISO 10993-1:2009.

Technological Characteristics

Percutaneous balloon catheter; 0.035" guide wire compatible; radiopaque marker bands; tapered tip. Materials meet ISO 10993-1:2009. Sterilization process identical to predicate. Mechanical inflation/deflation mechanism.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, or treatment of obstructive lesions in native/synthetic arteriovenous dialysis fistulae. Also indicated for post-dilatation of balloon-expandable and self-expanding peripheral stents.

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

• Powerflex™ PRO PTA Catheters (K112797)

Submission Summary (Full Text)

{0}------------------------------------------------

K121442

JUN 1 4 2012 . . .

Special 510(k) Cordis Powerflex™ Pro PTA Catheter

**Cordis**®
a Johnson-Johnson company

## 510(k) Summary

| Submitter: | Cordis Corporation, a Johnson & Johnson company<br>430 Route 22 East<br>Bridgewater, NJ 08807 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Donna Marshall<br>Manager, Regulatory Affairs<br>Ph: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared: | May 14, 2012 |
| Device Trade Name: | Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter |
| Device Common Name: | Peripheral Transluminal Angioplasty Balloon Catheter |
| Class: | II |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Product Code: | LIT |

Predicate Devices: ·

> . :

:

. . .

| Device | Company | Product<br>Code | 510(k)<br>Number | Predicate for:<br>(if multiple predicates) |
|------------------------------|-----------------------|-----------------|------------------|--------------------------------------------------------|
| Powerflex™ PRO PTA Catheters | Cordis<br>Corporation | LIT | K112797 | Design, Materials,<br>Construction,<br>Characteristics |

{1}------------------------------------------------

## Special 510(k) Cordis Powerflex™ Pro PTA Catheter

## Device Description:

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is a catheter with a distal inflatable balloon. The Powerflex™ Pro PTA Catheter is designed for use with a 0.035″ guide wire and a catheter sheath introducer and is available in a variety of diameters and lengths. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. The catheter tip is tapered to ease entry into peripheral arteries and to facilitate the crossing of tight stenoses.

### Indications for Use:

The Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) catheter is intended to dilate stenoses in illiac, femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-difatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

#### Summary of Performance Testing:

The safety and effectiveness of the Powerflex™ Pro PTA Catheter and the substantial equivalence to the predicate devices have been demonstrated via data collected in non-clinical design verification. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are the same to the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical dévices - Part 1: Evaluation and Testing within a risk management process.

{2}------------------------------------------------

Special 510(k) Cordis Powerflex™ Pro PTA Catheter

The following in-vitro performance tests were completed for the Powerflex™ Pro PTA Catheter:

Marker Band Spacing Balloon Diameter (Nominal, RBP) System Burst (Inflation Lumen) System Burst (Guide wire Lumen) Hub to Shaft Pull Strength CSI Insertion Kink Diameter Catheter Shaft Inflation/Deflation Time Multiple Inflation (System Fatigue) Torque Testing Particle Free Hemolysis

Balloon Working Length Balloon Burst Marker Band Placement Proximal Pull Strength Tip to Balloon/inner Body Pull Strength CSI Withdrawal Force Guide Wire Compatibility Useable Catheter Length Rated Burst Pressure PreConditioning Tensile Testing Cytotoxicity Physicochemical Aqueous Extraction

## Summary of Substantial Equivalence Comparison:

The subject Powerflex Pro PTA Catheter is identical to the predicate Powerflex Pro PTA Catheter described in 510(k) #K112797, with the exception of additional length/diameter combinations within the existing ranges of length and diameter. The subject device has the same fundamental scientific technology and intended use as the current, legally marketed Powerflex™ Pro PTA Catheter. The subject and predicate devices share the same materials, design, fundamental technology (operating principle), labeling, packaging materials and configuration, shelf life and sterilization process. The additional sizes meet the same requirements as the current FDA cleared [510(k) K112797] devices.

## Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, the additional sizes of Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the Cordis Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter (K112797).

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is written in a bold, sans-serif font. The words are arranged on a single line and are centered horizontally.

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

JUN 1 4 2012

Cordis Corporation c/o Donna Marshall 430 Route 22 East Bridgewater, NJ 08807

Re: K121442

Trade/Device Name: Powerflex™ Pro Percutaneous Transluminal Angioplasty (PTA) Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: LIT, DQY Dated: May 14, 2012 Received: May 15, 2012

Dear Ms. Marshall:

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.

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

{4}------------------------------------------------

## Page 2 - Ms. Donna Marshall

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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.

M.J. Killele

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Special 510(k) Cordis Powerflex™ Pro PTA Catheter

# Indications for Use Statement

510(k) Number (if known): K12 1442

Device Name:

Powerflex™ Pro Percutaneous Transluminal Angioplasty Catheter

#### Indications for Use:

The Powerflex™ Pro PTA catheter is intended to dilote stenoses in iliac, femoral, ilio-femoral, popliteal, infra poplited and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Prescription Use א OR (Per 21 CFR 801 Subpart D)

Over-the-Counter Use (21 CFR 807 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 Wilhelm

diovascular Devices

510(k) Number K121442

Page 16 of 496