BARD ATLAS PTA BALLOON DILATATION CATHETER

K040243 · C.R. Bard, Inc. · DQY · Feb 13, 2004 · Cardiovascular

Device Facts

• Record ID: K040243
• Device Name: BARD ATLAS PTA BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 13, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bard® Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

Device Story

The Bard Atlas PTA Balloon Dilatation Catheter is a coaxial lumen catheter designed for percutaneous transluminal angioplasty. The device features a balloon mounted on the distal tip; two radiopaque marker bands are positioned beneath the balloon to facilitate visualization and placement within the vasculature. One lumen is dedicated to guidewire insertion, while the second serves as an inflation/deflation channel for the balloon. The device is used by clinicians in a clinical setting to dilate iliac arteries or treat obstructive lesions in arteriovenous dialysis fistulae. By inflating the balloon at the site of a lesion, the catheter restores vessel patency, thereby improving blood flow and benefiting patients with obstructive vascular conditions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Coaxial lumen catheter design; balloon-tipped; two radiopaque marker bands for positioning; inflation/deflation lumen; guidewire lumen. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty of iliac arteries or 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

• Bard® ConquestTM PTA Balloon Dilatation Catheter (K014212)
• BardTM Opti-Plast® CenturionTM 5.5F PTA Catheter (K973013)

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENESS

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:

- A. Submitter Information:

| | Applicant: | Bard Peripheral Vascular, Inc.<br>1625 West 3rd Street<br>Tempe, Arizona 85280 |
|----|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | Phone: | 480-303-2752 |
| | Fax: | 480-449-2546 |
| | Contact: | Aymee R. Berry, Associate Manager, Regulatory Affairs |
| B. | Device Name: | Bard® AtlasTM PTA Balloon Dilatation Catheter |
| | Common or<br>Usual Name: | Catheter, Percutaneous |
| | Classification: | Class II |
| C. | Predicate<br>Device Name(s): | Bard® ConquestTM PTA Balloon Dilatation Catheter<br>(K014212, cleared 01/17/02)<br><br>BardTM Opti-Plast® CenturionTM 5.5F PTA Catheter |

(K973013, cleared 06/19/98)

## D. Device Description:

The Bard® Atlas™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on its distal tip. One lumen accommodates the insertion guidewire and the second provides a channel for inflation/deflation of the balloon. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature.

- ய் Statement of Intended Use:
The Bard® Atlas™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the iliac arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

- F. Substantial Equivalence:
A variety of tests, assessments, and comparisons demonstrate that the Bard® Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the abovereferenced predicates in terms of composition, design, intended use, and performance attributes.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 2004

C.R. Bard, Inc. c/o Ms. Aymee R. Berry Associate Manager, Regulatory Affairs Bard Peripheral Vascular 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K040243

Bard Atlas PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQY Dated: February 2, 2004 Received: February 3, 2004

Dear Ms. Berry:

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 cnactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Trug, 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 max publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Aymee R. Berry

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, permitte vour 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

Sincercly vours,

Duna R. Vochner

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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## Indications for Use

| 510(k) Number (if known): | K040243 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | BardTM AtlasTM PTA Balloon Dilatation Catheter |
| Indications For Use: | The Bard® AtlasTM PTA Balloon Dilatation Catheter is<br>indicated for use in Percutaneous Transluminal<br>Angioplasty of the iliac arteries and for the treatment of<br>obstructive lesions of native or synthetic arteriovenous<br>dialysis. |

V Prescription Use (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)

DUNCAN R. VACHER

(Division Sign-Off) Division of Cardiovascular Devices

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