EDWARDS PERIPHERAL DILATATION CATHETER

K032587 · Edwards Lifesciences, LLC · DQY · Oct 2, 2003 · Cardiovascular

Device Facts

• Record ID: K032587
• Device Name: EDWARDS PERIPHERAL DILATATION CATHETER
• Applicant: Edwards Lifesciences, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, Expedited Review

Intended Use

The Edwards Peripheral Dilatation Catheter is intended to: - dilate stenoses in 10 14mm 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 coaxial catheter; 80 cm length; distal balloon for vessel dilation. Accommodates 0.035-inch guidewire. Proximal luer adapter with dual ports for guidewire access and balloon inflation/deflation. Used by physicians in clinical settings for peripheral vascular procedures. Device provides mechanical dilation of stenoses or expansion of stent grafts. Single-use; supplied sterile.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included balloon burst strength, balloon compliance, balloon inflation, balloon fatigue, and tensile strength of delivery system joints.

Technological Characteristics

Coaxial over-the-wire catheter; 80 cm length; 0.035-inch guidewire compatibility; balloon-based dilation mechanism; luer adapter interface. Sterile, single-use.

Indications for Use

Indicated for patients requiring dilation of 10-14mm peripheral artery stenoses, 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

• Cordis MAXI LD Esophageal Dilator (K023907)
• Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)

Submission Summary (Full Text)

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K032587

ii

OCT - 2 2003

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# 510(k) Summary

## 1. Submitter's Name and Address:

Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614

#### 2. Contact:

Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC Phone: [phone] Fax: [phone] E-mail: [e-mail]

#### 3. Date Prepared:

August 21, 2003

#### 4. Device Trade Name:

Edwards Peripheral Dilatation Catheter

#### 5. Device Common Name:

Peripheral dilatation catheter

## 6. Device Classification Name:

Catheter, percutaneous (DQY), Class II

## 7. Predicate Devices:

Cordis MAXI LD Esophageal Dilator (K023907) Guidant AGILTRAC™ 035 Peripheral Dilatation Catheter (K023320)

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Image /page/1/Picture/0 description: The image shows a logo with the letter 'E' in a stylized font, set against a textured background that resembles a grid or a pattern of small squares. The letter 'E' is large and prominent, with some circular design elements incorporated into the background. Below the logo, the word 'Edwards' is printed in a serif typeface, with the first letter capitalized.

# 510(k) Summary (continued)

## 8. Device Description:

The Edwards Peripheral Dilatation 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 end of the catheter and provides the mechanism for dilating the vessel. The shaft of the delivery system is coaxial over the entire length of the catheter. The inner lumen of the coaxial catheter is designed to accommodate a maximum guidewire diameter of 0.035 inches. The outer lumen of the coaxial catheter is used for inflation and deflation of the balloon. The proximal end of the catheter contains a luer adapter with two ports; one port is used for accessing the guidewire lumen while the second port facilitates inflation and deflation of the balloon. The delivery catheter is offered in an 80 cm length. The Edwards Peripheral Dilatation Catheter products are supplied sterile and are "single-use only" devices.

## 9. Intended Use:

The Edwards Peripheral Dilatation Catheter is intended to:

- dilate stenoses in 10 14mm peripheral arteries, .
- treat obstructive lesions of native or synthetic A-V fistulae and/or .
- expand endoluminal stent graft elements in the aorta and iliac arteries .

# 10. Technological Characteristics:

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

# 11. Performance Data:

Edwards Lifesciences completed bench testing such as balloon burst strength, balloon compliance, balloon inflation, balloon fatigue, as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the Edwards Peripheral Dilatation Catheter performed in a manner substantially equivalent to the predicate devices cited in item 7 above.

## 12. Conclusion:

Since the Edwards Peripheral Dilatation Catheter has similar intended use, design, materials, performance, safety, effectiveness and labeling, it may be considered substantially equivalent to the predicate devices cited in item 7 above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2003

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

Re: K032587

Trade Name: Edwards Peripheral Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: August 21, 2003 Received: August 22, 2003

Dear Mr. Drisko:

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.

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

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Page 2 – Mr. Kevin Drisko

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 53) -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 yours,

Kalen TM

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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Page 1 of

510(k) Number (if known) _____________________________________________________________________________________________________________________________________________________

Device Name: Edwards Peripheral Dilatation Catheter

Indications for Use:

The Edwards Peripheral Dilatation Catheter is intended to:

- dilate stenoses in 10 14mm 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 .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Evaluation (CDE)

(Division Sign-Off Division of Cardio

510(k) Number K032587

Prescription Use
(per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Edwards Lifesciences 510(k) Application Edwards Peripheral Dilatation Catheter