CONQUEST PTA BALLOON DILATATION CATHETER

K083657 · C.R. Bard, Inc. · DQY · Dec 24, 2008 · Cardiovascular

Device Facts

• Record ID: K083657
• Device Name: CONQUEST PTA BALLOON DILATATION CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Dec 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Conquest™ PTA Balloon Dilatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Device Story

Coaxial lumen catheter with composite balloon mounted on distal tip; includes two radiopaque platinum iridium marker bands for visualization of balloon working length and placement. Used in clinical settings by physicians for peripheral vascular interventions. Guidewire inserted through one lumen for tracking; second lumen used for balloon inflation/deflation to dilate obstructive lesions or stent grafts. Output is mechanical dilation of vessel or graft; assists in restoring blood flow or optimizing stent graft apposition.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Coaxial lumen catheter; composite balloon; radiopaque platinum iridium marker bands. Sterilization method and packaging materials are consistent with predicate devices. No software or electronic components.

Indications for Use

Indicated for patients requiring percutaneous transluminal angioplasty of femoral, iliac, and renal arteries, treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae, and post-dilatation of peripheral stent grafts. 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)
• Dorado™ PTA Balloon Dilatation Catheter (K072283)
• Edwards Peripheral Dilatation Catheter (K052149)

Submission Summary (Full Text)

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# Conquest™ PTA Balloon Dilatation Catheter

DEC 2 4 2008

# 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part

(1)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial

equivalence determination is based is as follows:

#### Submitter Information:

| Applicant: | Bard Peripheral Vascular, Inc<br>1625 West 3rd Street<br>Tempe, Arizona 85281 |
|------------|-------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------|

Phone: [phone]

Fax: [phone]

- Genevieve Balutowski, Associate Project Manager, Regulatory Contact: Affairs
- Date November 13, 2008

### Subject Device Name:

| Device Trade Name: | Conquest™ PTA Balloon Dilatation<br>Catheter |
|-----------------------|--------------------------------------------------------------|
| Common or Usual Name: | Percutaneous Catheter (21 CFR 870.1250,<br>Product Code DQY) |
| Classification: | Class II |

Classification Panel: Cardiovascular

# Predicate Devices:

- Conquest™ PTA Balloon Dilatation Catheter (K014212; cleared January . 17, 2002)
- Dorado™ PTA Balloon Dilatation Catheter (K072283; cleared September . 19, 2007)
- Edwards Peripheral Dilatation Catheter (K052149; cleared September 2, . 2005)

Image /page/0/Picture/24 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, giving them a distinct and clear appearance. The overall design is simple and straightforward, focusing on the legibility of the word.

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#### Device Description:

The Conquest™ PTA Balloon Dilatation Catheter is composed of a coaxial lumen catheter. One lumen accommodates a guidewire for catheter tracking and the second provides a channel for balloon inflation/deflation.

A composite balloon is mounted onto the distal tip of the catheter. During use, the balloon position in the vessel is identified by two radiopaque platinum iridium marker bands that indicate the working length of the balloon and aid in placement.

#### Indications for Use of Device:

The Conquest™ PTA Balloon Difatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

# Comparison of Indications for Use to Predicate Devices:

The indication for use statement for the Conquest™ PTA Balloon Dilatation Catheter does not raise any new issues of safety and effectiveness as demonstrated through the risk analysis process based on the proposed indications for use statement as compared to the predicate devices, the Conquest™ PTA Balloon Dilatation Catheter, the Dorado™ PTA Balloon Dilatation Catheter and the Edwards Peripheral Dilatation Catheter. Therefore, the subject device, the Conquest™ PTA Balloon Dilatation Catheter, is substantially equivalent to the predicate devices.

# Technological Comparison to Predicate Devices:

The Conquest™ PTA Balloon Dilatation Catheter has the following similarities to the predicate devices:

- Similar intended use (all predicates) .
- Similar indications for use (all predicates) .
- Same target population (all predicates) .
- Same fundamental scientific technology (all predicates) .
- . Same operating principle (all predicates)

Image /page/1/Picture/19 description: The image shows the word "BARD" in a bold, outlined font. The letters are capitalized and evenly spaced. The font style appears to be a blocky, sans-serif typeface, giving the word a strong and distinct visual presence.

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- Same packaging materials and configuration (Conquest™ PTA Balloon . Dilatation Catheter)
- Same sterility assurance level and method of sterilization (Conquest™ . PTA Balloon Dilatation Catheter and Dorado™ PTA Balloon Dilatation Catheter)

# Conclusions:

The subject device, the Conquest™ 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 Conquest™ PTA Balloon Dilatation Catheter is substantially equivalent to the legally marketed predicate devices, the Conquest™ PTA Balloon Dilatation Catheter, the Dorado™ PTA Balloon Dilatation Catheter, and the Edwards Peripheral Dilatation Catheter.

Image /page/2/Picture/9 description: The image shows the word "BARD" in a bold, outlined font. The letters are all capitalized and evenly spaced. The font style is simple and geometric, with straight lines and sharp angles. The overall impression is clean and modern.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2008

Bard Peripheral Vascular, Inc. c/o Mr. Robert Mosenkis President CITECH 5200 Butler Pike Plymouth Mecting, PA 19462

Re: K083657

Conquest PTA Balloon Dilatation Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Perculaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 9, 2008 Received: December 10, 2008

Dear Mr. Mosenkis:

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 cither 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 - Mr. Robert Mosenkis

Please be advised that HDA'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 Biometrics' (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/cdrl/industry/support/index.html.

Sincerely vours.

ellmll

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):

Device Name: Conquest™ PTA Balloon Dilatation Catheter

Indications for Use: The Conquest™ PTA Balloon Dilatation Catheter is recommended 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 device is also recommended for post-dilatation of stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries.

Prescription Use X (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)

comell

n of Cardiovascular Devices K083657 510(k) Number

Image /page/5/Picture/15 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, and the interior of the letters is white. The letters are evenly spaced and aligned horizontally. The image is simple and clear, with a focus on the word itself.