CORDIS AMIIA .014 PTA BALLOON CATHETER

K050645 · Cordis Corp. · LIT · Apr 1, 2005 · Cardiovascular

Device Facts

• Record ID: K050645
• Device Name: CORDIS AMIIA .014 PTA BALLOON CATHETER
• Applicant: Cordis Corp.
• Product Code: LIT · Cardiovascular
• Decision Date: Apr 1, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Cordis AMIIA PTA catheter is a percutaneous transluminal angioplasty device featuring a shaft with a distal inflatable balloon. Device includes radiopaque marker bands for balloon placement and proximal shaft markers to indicate catheter position relative to guiding catheter exit. Accessory flushing needle included. Used by physicians in clinical settings to dilate arterial stenoses and arteriovenous dialysis fistulae. Operation involves advancing catheter to target site, inflating balloon to dilate vessel, and monitoring position via radiopaque markers. Output is mechanical dilation of stenotic vessels, improving blood flow. Benefits include minimally invasive treatment of vascular obstructions.

Clinical Evidence

Bench testing only. Biocompatibility verified per ISO 10993-1. No clinical data presented.

Technological Characteristics

PTA balloon catheter with distal inflatable balloon. Features radiopaque marker bands and proximal shaft markers. Materials verified biocompatible per ISO 10993-1. Mechanical dilation principle. Standalone device.

Indications for Use

Indicated for patients requiring dilation of stenoses in iliac, femoral, iliofemoral, popliteal, infra-popliteal, and renal arteries, and for 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

• Cordis AVIATOR (K013581)
• Cordis M3 PTA Balloon Catheters (K003920)

Submission Summary (Full Text)

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### FDA Special 510(k) Notification

Koso645

Cordis AMIIA .014" PTA Balloon Catheter

## Attachment B:

# 510(k) Summary of Safety and Effectiveness

| Submitter & Contact person: | Cordis Europa, N.V., a Johnson & Johnson Company<br>Harm Hovinga,<br>Oosteinde 8<br>NL-9300 LJ Roden,<br>The Netherlands<br>Tel: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | March 11, 2005 |
| Trade Name | Cordis AMIIA™ Percutaneous Transluminal Angioplasty (PTA) Catheter |
| Classification Name & Device Classification | |
| Classification Name: | Percutaneous Catheter (21 CFR 870.1250) |
| Classification: | Class II |
| FDA Classification Panel: | Cardiovascular |
| Product Code: | LIT |
| Predicate Device(s) | The predicate devices in this submission are the Cordis AVIATOR (510(k) #K013581) and the Cordis M3 PTA Balloon Catheters (510(k) #K003920,<br>which have been determined substantial equivalent on November 28, 2001 and June 15, 2001 respectively. |

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#### FDA Special 510(k) Notification Cordis AMIIA .014" PTA Balloon Catheter The Cordis AMIIA PTA catheter has a shaft with a distal inflatable balloon. Device The Cordis I Info I I T I causs indicate the dilatation section of the balloon description I wo facilopaque marker bands the balloon dimensions are indicated on the and ald in banoon pracements eter configuration has two proximal shaft nub 1D band. The 112 cm cm from the distal tip to indicate the relative markers at 90 cm and 100 on fistal end of the guiding catheter. An additional position of the catheror to the dist. exit and aids in locating the exit location of the guide wire. the guide wire.
A flushing needle is packaged with the catheter as an accessory for flushing A husining necure is packaged with use as indicated in the Instructions for Use The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, Intended Use The Cordils AMILA I Pre catalogin fra popliteal and renal arteries and for the temoral, ino-remoral; popilious of native or synthetic arteriovenous dialysis fistulae. The safety and effectiveness of the subject Cordis AMIIA PTA Balloon Safety and The Safety and Criocavonstrated via data collected from non-clinical design Performance Calletel has been demonstrated 11 materials used in this modified device have Data vertification tests and analyses. 1993-Part 1 and were found biocompatible. In summary, the subject Cordis AMIIA PTA Catheter is, in our opinion, Substantial In summal y, the subject Cordis devices with respect to intended Equivalence substantial equivalent to the prechedle O, sterility and operating principles.

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#### FDA Special 510(k) Notification

### Cordis AMIIA .014" PTA Balloon Catheter

A statement of substantial equivalence to another product is required by Substantial 21 CFR 807.87 and relates only to whether the present product can be Equivalence marketed without prior reclassification or clinical approval. Statement The present submission is therefore not related to the coverage of any I he present submission serpreted as an admission or used as evidence in patcht and is not to not lawsuit. As the commissioner of the FDA stated: a patcht mirringement in equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. The lawraily markees a t intended to have any bearing whatsoever on the deter inmation is not infringement suits." 42 Federal Register 42, 50 et seq. (1977).

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2005

Cordis Europa N.V. c/o Mr. Harm Hovinga Senior Regulatory Affairs Associate Oosteinde 8, 9301 LJ Postbus 38, 9500 AA Roden The Netherlands

Re: K050645

AMIIA .014" PTA Balloon Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT Dated: March 11, 2005 Received: March 14, 2005

#### Dear Mr. Hovinga:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosals) it the enactment date of the Medical Device Amendments, or to conninered phor to May 20, 1978, are except and entitle provisions of the Federal Food, Drug, devices mat nave occh receasined in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merciole, market the act include requirements for annual registration, listing of general controls provision gractice, 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 If your device is chassified (over as a virols. Existing major regulations affecting your device can may oc subject to sach address, Title 21, Parts 800 to 898. In addition, FDA may be found in the Oous ocements concerning your device in the Federal Register.

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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 or any i 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. production 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 yours,

Bimmerman 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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APPENDIX A:

# Indications for Use

K050645 510(k) Number (if known):

Cordis AMIA PTA Catheter Device Name:

Indications For Use:

The Cordis AMIIA PTA catheter is intended to dilate stenoses in iliac, femoral, iliofemoral, popliteal, infra popliteal and renal arteries and.for the treatment of lomoral, popilisal, mostive or synthetic arteriovenous dialysis fistulae.

Prescription Use ____X__ (Part 21 CFR 801 Subpart D)

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AND/OR

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)

Blumena

Sign-Off) Division of Cardiovascular Devices 510(k) Number Kosovati

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