VACCESS PTA BALLOON DILATATION CATHETER

K073472 · C.R. Bard, Inc. · LIT · Jan 9, 2008 · Cardiovascular

Device Facts

• Record ID: K073472
• Device Name: VACCESS PTA BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: LIT · Cardiovascular
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vaccess™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal 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

Vaccess™ PTA Balloon Dilatation Catheter is a coaxial lumen catheter with a balloon mounted on the distal tip; used for percutaneous transluminal angioplasty. Device features two lumens: one for guidewire insertion, one for balloon inflation/deflation. Two radiopaque marker bands are positioned beneath the balloon for visualization. Operated by clinicians in a clinical setting to treat obstructive lesions in peripheral arteries and dialysis fistulae. The device functions by inflating the balloon to dilate vessels, improving blood flow. Benefits include minimally invasive treatment of vascular obstructions.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence supported by design verification and validation testing against predetermined acceptance criteria.

Technological Characteristics

Coaxial lumen catheter; balloon mounted on distal tip; two radiopaque marker bands. Sterilization method and packaging configuration are equivalent to predicate. No software or electronic components.

Indications for Use

Indicated for patients requiring Percutaneous Transluminal Angioplasty of femoral, iliac, or renal 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

• Conquest™ PTA Balloon Dilatation Catheter (K014212)

Submission Summary (Full Text)

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**Page 48**

200g

# Vaccess™ PTA Balloon Dilatation Catheter

### 510(k) Summary

## 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 information upon which substantial equivalence determination is based as follows:

### 1. Submitter Information:

Applicant: Bard Peripheral Vascular, Inc.

1625 West Third Street P.O. Box 1740 Tempe, Arizona 85280 480-303-2752 Phone: Fax: [phone]

Jennifer Logvin, Regulatory Affairs Associate Contact:

# 2. Subject Device:

| Device Trade Name: | Vaccess™ PTA Balloon Dilatation Catheter |
|-----------------------|---------------------------------------------------------------------------|
| Common or Usual Name: | Catheter, Angioplasty, Peripheral, Transluminal<br>Catheter, Percutaneous |
| Classification: | Class II |
| Classification Panel: | Cardiovascular |

# 3. Predicate Device:

| Device Trade Name: | Conquest™ PTA Balloon Dilatation Catheter |
|-------------------------|-------------------------------------------|
| Cleared 510(K) Number: | K014212 |
| Date of Cleared 510(K): | 01/17/02 |

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K073472 Page 2 of 2

## 4. Summary of Change:

The modifications from the predicate device, the Conquest™ PTA Balloon Dilatation Catheter, to the subject device, the Vaccess™ PTA Balloon Dilatation Catheter, were to the balloon design, catheter design, and performance characteristics.

# 5. Device Description:

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

# 6. Indications for Use of Device:

The Vaccess™ PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This catheter is not for use in coronary arteries.

# 7. Technological Comparison to Predicate Device:

The technological characteristics of the subject device, the Vaccess™ PTA Balloon Dilatation Catheter, are substantially equivalent to those of the predicate device, the Conquest™ PTA Balloon Dilatation Catheter, in terms of intended use, indications for use, fundamental scientific technology, target population, operating principle, packaging configuration, sterility assurance level and method of sterilization.

### 8. Conclusions:

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

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol resembling three human profiles facing right, with flowing lines beneath them.

JAN -- 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bard Peripheral Vascular, Inc. c/o Ms. Jennifer Logvin Regulatory Affairs Associate 1625 West Third Street P.O. Box 1740 Tempe, Arizona 85280

Re: K073472

Trade/Device Name: Vaccess PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (Two) Product Code: LIT/DQY Dated: December 10, 2007 Received: December 11, 2007

Dear Ms. Logvin:

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.

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Page 2 – Ms. Jennifer Logvin

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.

Duna R. Vuhner

A 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): | K073472 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Vaccess ^TM PTA Balloon Dilatation Catheter |
| Indications for Use: | The Vaccess ^TM PTA Balloon Dilatation Catheter is indicated for use in Percutaneous Transluminal Angioplasty of the femoral, iliac, and renal 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwina P. Jones

(Division Sic, - Off) Division or Cardiovascular Devices

510(k) Number_Ko 73472

Bard Peripheral Vascular, Inc.

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

Image /page/4/Picture/14 description: The image shows the word "BARD" in a stylized, blocky font. The letters are outlined in black, and the interior of each letter is white. The letters are all capitalized and evenly spaced.