BARD ATLAS PTA BALLOON DILATATION CATHETER

K052236 · Bard Peripheral Vascular, Inc. · DQY · Aug 23, 2005 · Cardiovascular

Device Facts

• Record ID: K052236
• Device Name: BARD ATLAS PTA BALLOON DILATATION CATHETER
• Applicant: Bard Peripheral Vascular, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Aug 23, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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. This catheter is not for use in coronary arteries.

Device Story

Coaxial lumen catheter with distal balloon; two radiopaque marker bands for positioning. Used for Percutaneous Transluminal Angioplasty (PTA) of iliac arteries and treatment of obstructive lesions in dialysis fistulae. One lumen for guidewire insertion; second lumen for balloon inflation/deflation. Operated by clinicians in clinical settings. Device expands to treat vascular obstructions; benefits patient by restoring blood flow. Modification adds balloon sizes to existing predicate design.

Clinical Evidence

Bench testing only. Device met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, and test protocols.

Technological Characteristics

Coaxial lumen catheter; balloon mounted on distal tip; two radiopaque marker bands. Sterilization method consistent with predicate. 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. Contraindicated for use in coronary 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

• Atlas™ PTA Balloon Dilatation Catheter (K040243)

Submission Summary (Full Text)

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AUG 2 3 2005

## Atlas™ PTA Balloon Dilatation Catheter 510(k) Summary of Safety and Effectiveness 21 CFR 807.92.

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:

- 1. Submitter Information:
- Bard Peripheral Vascular, Inc Applicant: 1625 West 3rd Street P.O. Box 1740 Tempe, Arizona 85280 480-303-2524 Phone: [phone] Fax:

Genevieve Balutowski, Regulatory Affairs Specialist Contact:

## 2. Subject Device Name:

- Atlas™ PTA Balloon Device Trade Name: Dilatation Catheter Common or Usual Name: Percutaneous catheter Class II Classification:
- Cardiovascular Classification Panel:

## Predicate Device: 3.

Atlas™ PTA Balloon Dilatation Catheter (K040243, cleared 02/13/04)

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#### Summary of Change: 4.

The design modification to the Atlas™ PTA Balloon Dilatation Catheter as represented in this submission is additional balloon sizes. All other aspects of the subject device remain the same as the predicate device.

#### Device Description: 5.

The 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.

#### Intended Use of Device: ર.

The 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. This catheter is not for use in coronary arteries.

## Technological Comparison to Predicate Device: 7.

The technological characteristics of Atlas™ PTA Balloon Dilatation Catheter are substantially equivalent to those of the predicate device, the Atlas™ PTA Balloon Dilatation Catheter, in terms of intended use, indication for use, application, user population, basic design, performance, and sterilization method.

#### Conclusions: 8.

The Atlas™ PTA Balloon Dilatation Catheter met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. The Atlas™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate device, the Atlas™ PTA Balloon Dilatation Catheter.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 3 2005

Bard Peripheral Vascular, Inc. c/o Ms. Genevieve Balutowski 1625 West 3rd Street P.O. Box 1740 Tempe, AZ 85280-1740

Re: K052236

Bard® Atlas™ PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 16, 2005 Received: August 17, 2005

Dear Ms. Balutowski:

We have reviewed your Section 510(k) premarket notification of intent to market the device indicati we nave reviewed your becaon 310(x) premised is substantially equivalent (for the indications felerenced above and nave decembined by marketed predicate devices marketed in interstate for use stated in the encrosule) to regard chances of the Medical Device Amendments, or to commence prior to May 20, 1978, the encordance with the provisions of the Federal Food. Drug, devices that have been receasined in asset approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app allu Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The I ou may, utcrefore, market the act include requirements for annual registration, listing of general controls provisions of wactice, 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 (500 above) this Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements 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 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/industry/support/index.html.

Sincerely yours,

suma R. Vochines

er R. Vocus

Center for Devices and Radiological Health

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Enclosure

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# Indications for Use

510(k) Number (if known): Kos 223 &

Device Name: Atlas™ PTA Balloon Dilatation Catheter

Indications for Use: The 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. This catheter is not for use in coronary arteries.

Prescription Use × (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

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. DIAMS & Concertify Conce of Device Evaluation (ODE)
Concession Concerner Comment

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Number K052236

Bard Peripheral Vascular, Inc

TRADE SECRET/CONFIDENTIAL INFORMATION Notify CR Bard Before Releasing this Document.

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