EDWARDS PERIPHERAL DILATION CATHETER

K052149 · Edwards Lifesciences, LLC · DQY · Sep 2, 2005 · Cardiovascular

Device Facts

• Record ID: K052149
• Device Name: EDWARDS PERIPHERAL DILATION CATHETER
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Edwards Peripheral Dilation Catheter is intended to: - dilate stenoses in peripheral arteries, . - treat obstructive lesions of native or synthetic A-V fistulae and/or . - re-expand endoluminal stent graft elements in the aorta and iliac arteries .

Device Story

Over-the-wire peripheral dilation catheter; flexible distal shaft with mounted balloon for vessel dilation. Features two lumens: one for 0.035-inch guidewire, one for balloon inflation/deflation. Proximal end includes luer adapter with dual ports and strain relief. Available in 80cm and 120cm lengths. Used by clinicians in clinical settings to treat peripheral arterial stenoses, A-V fistula obstructions, and to re-expand aortic/iliac stent grafts. Operates via manual inflation/deflation of the balloon to exert radial force on target lesions or stent structures. Benefits include restoration of vessel patency and proper stent graft apposition.

Clinical Evidence

Bench testing only. Testing included dimensional analysis, balloon minimum burst strength, balloon compliance, inflation/deflation cycles, balloon fatigue, and tensile strength. No clinical data presented.

Technological Characteristics

Over-the-wire catheter; dual-lumen design; balloon-tipped; 0.035-inch guidewire compatibility; 80cm/120cm working lengths; luer adapter interface. Materials, biocompatibility, and sterilization methods are consistent with predicate devices.

Indications for Use

Indicated for patients requiring dilation of stenoses in peripheral arteries, treatment of obstructive lesions in native or synthetic A-V fistulae, or re-expansion of endoluminal stent graft elements in the aorta and iliac 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.

Predicate Devices

• Edwards Peripheral Dilation Catheter (K032587)
• LifeStent Turbo Biliary Stent System (K050627)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of the company name, "Edwards Lifesciences," in a serif font. To the left of the name is a small, abstract graphic, possibly representing a stylized heart or circulatory system.

CONFIDENTIA May not be reproduced without written permission fre Edwards Lifesciences

# 510(k) Summary

SEP 0 2 2005

# 1. Submitter's Name and Address:

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

### 2. Contact:

Kevin Drisko Sr. Regulatory Manager Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: [phone] FAX: [phone] E-Mail: [e-mail]

### 3. Date Prepared:

August 5, 2005

### 4. Device Trade Name:

Edwards Peripheral Dilation Catheter

### 5. Device Common Name:

Peripheral Dilation Catheter

### 6. Device Classification Name:

Catheter, percutaneous (DQY), Class II

# 7. Predicate Devices:

Edwards Peripheral Dilation Catheter (K032587) and LifeStent Turbo Biliary Stent System (K050627)

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p. 20

FIDENTIAL

Image /page/1/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized graphic on the left, followed by the company name "Edwards Lifesciences" in a clear, sans-serif font. The text is horizontally aligned and the overall design is clean and professional.

May not be reprodu

# 510(k) Summary (continued)

## 8. Device Description:

The Edwards Peripheral Dilation Catheter is an over-the-wire catheter with a flexible distal portion for maneuvering through regions of the peripheral vasculature. A balloon is mounted on the distal for mather and provides the mechanism for dilating the vessel. Two (2) lumens extended end of the cather and prohless the The first lumen is designed to accommodate a maximum this only of 0.035 inches. The second lumen is used for inflation and deflation of the galloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used bulloon. The guidewire lumen while the second port facilitates inflation and deflation of the beloon. A strain relief between the proximal shaft and the luer adapter provides rigidity and transition between the two parts. The delivery catheter is offered in both 80cm and 120cm working lengths.

## 9. Intended Use:

The Edwards Peripheral Dilation Catheter is intended to:

- dilate stenoses in peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- re-expand endoluminal stent graft elements in the aorta and iliac arteries �

## 10. Technological Characteristics:

Comparisons of the subject and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.

### 11. Performance Data:

Edwards Lifesciences completed bench testing, such as dimensional testing, balloon minimum burst strength, balloon compliance, balloon inflation/deflation, balloon fatigue and tensile strength testing on the Edwards Peripheral Dilation Catheter. The results indicate that the Edwards Perinheral Dilation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.

### 12. Conclusion:

Since the Edwards Peripheral Dilation Catheter has the same intended use, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in item 7 above.

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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 2 2005

Edwards Lifesciences LLC c/o Mr. Kevin Drisko Senior Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614

Re: K052149

Edwards Peripheral Dilation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 5, 2005 Received: August 11, 2005

Dear Mr. Drisko:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 310(K) premailsche equivalent (for the indications for the indications for referenced above and have determiled the devices marked in interstate commerce
use stated in the enclosure) to legally markets marketed in intervices that use stated in the enclosure) to legally materials Device Amendments, or to devices that prior to May 28, 1976, the enacment une visuale of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Peneral Proom of Cosme have been reclassified in accordance will the provisions of wal application (PMA). You may,
Act (Act) that do not require approval of a premarket approval application of th Act (Act) that do not require approval of a premated arcols provisions of the Act. The general
therefore, market the device, subject to the general controls provisions of th therefore, market the device, subject to the generation, listing of devices, good
controls provisions of the Act include requirements for annual registration, controls provisions of the Act include requirements for alsome of adulteration.
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 If your device is classified (see above) into Eline Class II (president affecting your device can be
may be subject to such additional controls. Existing mayor regulations may be subject to such additional controls. Existing major regaracter and organization, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to Regu found in the Code of Federal Regalations, and in the Federal Register.

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# Page 2 – Mr. Kevin Drisko

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that ITDA s Issualled of a sabetained of the requirements of the Act or that FDA nas made a decentination mar your centry Federal agencies. You must comply with CDP Part 907V any Pederal Statutes and regulations administered of to: registration and listing (21 CFR Part 807); all the Act s requirements, mending, but noving were morements as set forth in the quality labeling (21 CFR Part 801), good manataling production of the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic produc Systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 551-512 or the 107), device as described in your Section 510(k) I his letter will anow you to begin manusing of substantial equivalence of your device to a legally premarket notification. The I DA midning of basistant 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 If you desire specific advice for your active of our accesse note the regulation entitled, Contact the Office of Compliance at (210) 21 0 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 10 - 11 MISolanding by reference to promaibilities under the Act from the Division of Small general intornation on your responsibilities and its toll-free number [phone] or Manufacturers, International and Consultation://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Donna P. Vichner

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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Image /page/4/Picture/0 description: The image shows the logo for Edwards Lifesciences. The logo consists of a stylized letter "E" on the left, followed by the text "Edwards Lifesciences" in a serif font. A horizontal line is present under the text.

510(k) Number (if known): _ Kos 2149_

Device Name: Edwards Peripheral Dilation Catheter

Indications for Use:

The Edwards Peripheral Dilation Catheter is intended to:

- dilate stenoses in peripheral arteries, .
- diffate stenoses in perfordial ations of native or synthetic A-V fistulae and/or
treat obstructive lesions of native or synthetic A-V fistulae and/or .
- treat obstructive lesions of hative of officient in the aorta and iliac arteries .

Prescription Use: X (Part 21 CFR 801 Subpart D) 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)

Buna R. Vahner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K 652149

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Edwards Lifesciences LLC Edwards Lifesciences EEO
Special 510(k) for the Edwards Peripheral Dilation Catheter