CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA

K032737 · Cordis Europa, N.V. · DQY · Oct 2, 2003 · Cardiovascular

Device Facts

• Record ID: K032737
• Device Name: CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA
• Applicant: Cordis Europa, N.V.
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries. The POWERFLEX P3 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 OPTA PRO PTA catheter is intended to dilate stenoses in ilio-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) PTA balloon catheters; dual-lumen design with distal inflatable balloon; two radiopaque marker bands for positioning; inflation lumen for balloon expansion; guide wire lumen for tracking or contrast/saline injection. Used by physicians in clinical settings for percutaneous transluminal angioplasty. Modified design features include polyamide hub (replacing polycarbonate) and injection-molded hub (replacing UV-glued).

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-Part 1. No clinical data provided.

Technological Characteristics

Dual-lumen PTA balloon catheter; polyamide hub; injection-molded construction; radiopaque marker bands for visualization. Biocompatible materials per ISO 10993-Part 1.

Indications for Use

Indicated for patients requiring treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae or dilation of stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries.

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.

Submission Summary (Full Text)

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K032737

510(k) Premarket Notification

| Attachment 1 | | OCT - 2 2003 | |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Summary of Safety and Effectiveness | | | |
| Submitter & Contact person: | Cordis Europa, N.V., a Johnson & Johnson Company Oosteinde 8 NL-9300 LJ Roden, The Netherlands | | |
| | Harm Hovinga Senior Regulatory Affairs Associate Tel (+31) (5050) 22479 Fax: (+31) (5050)-22456 e-mail: [e-mail] | | |
| Date Prepared | October 1, 2003 | | |
| Trade Name | Cordis PowerFlex ^TM Extreme PTA Balloon Catheter Cordis PowerFlex ^TM P3 PTA Balloon Catheter Cordis OPTA ^TM PRO PTA Balloon Catheter | | |
| Classification Name & Device Classification | Common Name: Peripheral Transluminal Angioplasty Balloon Catheter. Classification Name: 21 CFR 870.1250: Percutaneous Catheter. Class II; Product Code: #74LIT. | | |

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1

| Device<br>description | The modified PTA catheters described in this submission are virtually identical to its original cleared devices, which received 510(k) concurrence. |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Cordis over-the-wire (OTW) PTA balloon catheters have a dual lumen design with a distal inflatable balloon. Two radiopaque marker bands indicate the dilatation section of the balloon and aid in balloon placement. The radiopaque marker bands indicate the nominal length of the balloon. The balloon inflation lumen is used to inflate and deflate the balloon. The guide wire lumen is used to track the catheter over a pre-positioned guide wire or to inject contrast medium and/or saline. |
| | Compared to the previously cleared predicate devices, the devices in this submission are identical, except for the following feature:<br>Polyamide hub instead of polycarbonate hub Injection molded hub instead of UV-glued hub Slight design configuration change for user preference. |
| Name of<br>affected<br>devices | Cordis PowerFlex™ Extreme PTA Balloon Catheter<br>Cordis PowerFlex™ P3 PTA Balloon Catheter<br>Cordis OPTA™ PRO PTA Balloon Catheter |
| Performance<br>standards | The FDA under section 514 of the Food, Drug and Cosmetic Act has not established performance standards for these devices. |
| Conclusion | The Cordis PowerFlex Extreme, PowerFlex P3 and Opta Pro PTA balloon catheters are substantially equivalent to the predicate devices. |

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The POWERFLEX EXTREME PTA catheter is intended for the treatment Intended Use of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries. The POWERFLEX P3 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 OPTA 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. Safety and The safety and effectiveness of the affected PTA Balloon Catheters have been Performance demonstrated via data collected from non-clinical design verification tests and Data analyses. All materials used in these modified devices have been tested according to ISO 10993-Part 1 and were found biocompatible.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

Cordis Corporation c/o Ms. Karen Wilk Manager, Regulatory Affairs 7 Powder Horn Drive Warren, NJ 07059

Re: K032737

Trade/Device Name: Cordis PowerFlex Extreme, PowerFlex P3, and OPTA PRO Percutaneous Transluminal Balloon Catheters Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DOY Dated: September 3, 2003 Received: September 4, 2003

Dear Ms. Wilk:

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 such 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. Karen Wilk

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely vours.

Dna Heuseler for
Brad D. Zuckerman, MD

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510 (k) Number:

## The Cordis POWERFLEX™ EXTREME Percutaneous Transluminal Angioplasty Device Names: (PTA) Catheter, the POWERFLEX™ P3 PTA Catheter and the OPTA™ PRO PTA Catheter

Indications For Use:

The POWERFLEX EXTREME PTA catheter is intended for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae and to dilate stenoses in iliac, femoral, popliteal, infra popliteal and renal arteries.

The POWERFLEX P3 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 OPTA PRO PTA catheter is intended to dilate stenoses in ilio-femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | | OR | Over-The-Counter Use |
|------------------------------------------|--|----|--------------------------|
| | | | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of Cardiovascular, Respiratory and Neurological Devices

| 510(k) Number | K032737 |
|---------------|---------|
|---------------|---------|

Special 510 (k) Number: